Responsible Conduct of Research Training

Working with Animals Responsibly in Biomedical Research Presented by Amy Cassano, DVM, DACLAM, cVMA. Attending Veterinarian of DLAR on January 4^th, 2024. This workshop discusses considerations and practical approaches to the responsible conduct of animal-based biomedical research. Strategies to foster productive, collaborative working relationships and facilitate successful animal research at the University of Pittsburgh will be presented. (Subject matter: animal subjects) 

Authorship Conflict Presented by Tetsuro Sakai, MD, PhD, MHA, Professor of Anesthesiology and CTSI, Vice-Chair for Professional Development, Director, Resident Research Rotation, Department of Anesthesiology and Perioperative Medicine on January 8^th, 2024. Upon the completion of this workshop based on actual examples of authorship conflict observed in an academic center, the attendees will be able to describe authorship eligibility in scientific manuscripts, indicate potential types and causes of authorship conflict, and discuss possible methods to solve, address, and avoid authorship conflict. (subject matter: responsible authorship) 

NIH Data Management & Sharing Plan: Where to Share Data Presented by Helenmary Sheridan, MLIS, Data Services Librarian, Health Sciences Library System, University of Pittsburgh on January 9^th, 2024. This is the second in a series of three sessions on NIH's Policy for Data Management and Sharing (DMS Policy), which went into effect on January 25, 2023.  This Policy requires NIH-funded researchers to prospectively submit a plan outlining how scientific data from their research will be managed and shared. The Policy includes an expectation that researchers will maximize their data sharing within ethical, legal, or technical constraints, and explicitly encourages researchers to incorporate data sharing via deposit into a public repository into their standard research process. (subject matter: secure and ethical data use). This session will cover the "where" of data sharing through the following topics:  What is a repository? Repositories vs. data storage vs. data backup, Choosing the right repository for your discipline, data format, and legal/ethical considerations, Understanding potential costs for data sharing (and how to include them in a grant application), and Evaluating the robustness of a repository

Strategies for Effective Teaching and Mentoring of Students Presented by Bill Yates, Ph.D., Vice-Chancellor, Research Protections, Professor of Otolaryngology & Neuroscience & Clinical and Translational Science Vice-Chair, School of Medicine Curriculum Committee on January 16^th,2024 Providing education to diverse populations (e.g., residents, medical students, graduate students, undergraduate students, lay members of the public) is an important component of a scientist's responsibilities. However, unlike K-12 teachers, scientists receive little or no formal education about teaching strategies.  This workshop is intended to provide general education strategies that are effective for any audience. (subject matter: mentor/mentee) 

iThenticate for Grant Proposals Presented by Melissa Ratajeski, MLIS, AHIP, RLAT, Assistant Director for Data and Publishing Services, IACUC Liaison on January 23rd, 2024. iThenticate is a plagiarism detection software supported by the University of Pittsburgh.  It allows researchers to easily upload and scan manuscripts and other professional works for instances of plagiarism. Use of iThenticate is highly encouraged by the Office of Sponsored Programs prior to submission of all grant proposals. In addition to class registration, participants must complete the iThenticate account request form. (subject matter: research misconduct) This hands-on class will cover: How the software works and what material it uses for comparison, Uploading files and configuration options for the interface, Viewing and understanding the “similarity report” and Sharing across user profiles to support collaborative editorial review

Communication Ethics for Preventing Misconduct Presented by Emily Herrington, University of Pittsburgh Science, Ethics, and Society Initiative Program Coordinator. New title: Visiting Lecturer, Department of Communication on January 26th, 2024. Much of bioethics “on the ground” can be considered communication ethics. This workshop offers tools for developing ethically principled dialogue with research participants and community stakeholders on the view that investigators who practice communication ethics reduce possibilities for misunderstanding and misconduct (subject matter: research misconduct). 

Laboratory Safety:  Beyond Bloodborne Pathogens and Chemical Hygiene Presented by Molly S. Stitt-Fischer, PhD, CPH, CBSP, SM(NRCM), Director and Alternate Responsible Official for Select Agents, Department of Environmental Health and Safety, University of Pittsburgh on January 29th, 2024. Do you know when you should use a chemical fume hood vs a biosafety cabinet?  Are you confident that your chemicals are appropriately separated and stored?  Do you feel confident listing the biological, chemical, physical, and other hazards present in your research laboratory and identifying the measures used to mitigate risks associated with these hazards?  This session will use case studies to point out key differences between risk assessment for hazards in research laboratories and non-laboratory environments.  We will discuss EH&S resources available to assist you in assessing risk and developing safe research plans.  We will also review answers to common questions and observations made during EH&S laboratory safety surveys and training sessions. (subject matter: safe laboratory practices) 

NIH Data Management & Sharing Plan: Documentation, Metadata, and the "How" of Deposit Presented by Helenmary Sheridan, MLIS, Data Services Librarian, Health Sciences Library System, University of Pittsburgh on February 1st, 2024. This is the third in a series of three sessions on NIH's Policy for Data Management and Sharing (DMS Policy), which went into effect on January 25, 2023. This Policy requires NIH-funded researchers to prospectively submit a plan outlining how scientific data from their research will be managed and shared. The Policy includes an expectation that researchers will maximize their data sharing within ethical, legal, or technical constraints, and explicitly encourages researchers to incorporate data sharing via deposit into a public repository into their standard research process. (subject matter: secure and ethical data use) This session will cover the data deposit process and explore these topics: How to write a good README, user manual, or data dictionary, Assigning metadata to your data files to make it discoverable on the web, Creating documentation templates to streamline the deposit process and Understanding licenses and use restrictions in repositories

The Publication Process: An Editor’s View Presented by Bill Yates, PhD, Vice Chancellor for Research Protections and Professor of Otolaryngology on February 6th, 2024. In today’s competitive funding environment, productivity is extremely important. However, the peer review process has been compromised by time constraints of researchers. This session discusses the problems that may occur during peer review of manuscripts (including ethical concerns) and the steps that authors can take to address these problems. The session is intended to provide insights into how an author can best guide their paper successfully through the peer review process. (subject matter: responsible authorship)

Managing Up, Down, and All Around Presented by Thomas R. Radomski, MD, MS (he/him), Assistant Professor of Medicine and Clinical & Translational Science; Assistant Director & Director of Graduate Programs in Clinical and Translational Science, Institute for Clinical Research Education; Core Faculty, Center for Pharmaceutical Policy and Prescribing; Core Faculty, VA Center for Health Equity Research and Promotion (CHERP), Division of General Internal Medicine, University of Pittsburgh and UPMC on February 8^th, 2024. Leadership involves successfully managing relationships with people above, below, and lateral to you in the academic hierarchy. This session highlights the importance of these relationships and provides tips on managing your mentor (up), being a good mentor and staff supervisor (down), and providing peer mentorship to colleagues (all around) (subject matter: mentor/mentee) 

Conflicts of Interest (COI) Disclosures Presented by Allison T. Reinersmann, JD, COI Program Manager, COI Division, Office of Research Protections, University of Pittsburgh on February 13^th, 2024. This RCR is the 3rd session in the Conflict of Interest Series offered by the Conflict of Interest Division. In this session, we will discuss the importance of disclosing potential conflicts of interest, including disclosure to the University in MyDisclosures, as well as disclosing to funding agencies, in publications and presentations and to research subjects. (subject matter: conflict of interest)

Bias in Scientific Literature Presented by Keith Vogt, MD PhD, Associate Professor, Departments of Anesthesiology & Perioperative Medicine and Bioengineering on February 15^th, 2024. In this workshop, we will discuss sources of bias in scientific literature, including falsified and incorrectly analyzed data, possible bias from publishers and media, the impact of proliferation of low-impact and predatory journals, and current research culture favoring positive results and little replication. (subject matter: peer review)

Pitt + Me Presented by Jennifer Rush, Pitt+Me Facilitator, CTSI & Kate Underwood, Regulatory Facilitator, CTSI on February 20^th, 2024. The Pitt+Me registry is a database of research volunteers of all ages, who have consented to be contacted, to learn about research studies in which they may wish to participate.  The registry is a pre-screening tool for research study teams with a University of Pittsburgh affiliation, to connect with potential participants to support their recruitment efforts. The registry facilitates a connection between research and the community. Join us to find out how your study team can use this free service to recruit participants you need to meet your research goals. (subject matter: human participant research)

Pitching your Science Presented by Aneesh Ramaswamy, PhD, Assistant Director for Program Management, CTSI Innovation Dana Farrell, Senior Project Manager for Health Research, CTSI Innovation on February 23rd, 2024. This workshop is designed to help you convert scholarly descriptions of your work to clear, vivid writing and presentations that accurately convey the purpose and promise of your science to a variety of audiences. We will talk through inspiring curiosity within your specific audience, give an overview of the “Hourglass Method” for science communication, and address any concerns you have with science communication techniques for your presentation style. (subject matter: scientist in society) 

Relationship Therapy: Investigators and Statisticians Presented by Maria Mori Brooks, Ph.D., Professor of Epidemiology, Biostatistics and Clinical and Translational Science, University of Pittsburgh School of Public Health, BERD CTSI, and Li Wang, MS, CTSI BERD on February 26^th, 2024. The objective of this workshop is to go beyond the usual generic advice given to researchers seeking to consult with biostatisticians. Specific suggestions will be provided for common problem areas in the investigator/statistician collaboration. Through a series of case vignettes and discussion, best methods for working productively with a biostatistician on your research we be illustrated. (subject matter: collaborative research)

Data Collection-- Monitoring and Reporting Presented by Deborah Martin and Theresa Sax, CTSI BERD on March 5^th, 2024. Research data must be constantly monitored and reported as it accrues.  We will discuss issues in quality control for completeness, correctness, and logical consistency; specimen tracking; reporting on data accrual; alerting appropriate parties about problems or exceptions; and modifying forms and underlying data mid-study as necessary (subject matter: data acquisition). Note: This workshop is the third in a series of five workshops co-sponsored by CTSI Biostatistics, Epidemiology, and Research Design Core and the RCR Center. 

NIH Resources & Personnel that Can Help You Get Funded Presented by Michelle Kienholz, CTSI on March 7th, 2024. Understanding Your First NIH Audience: Institutes & Centers. Using NIH tools and expertise can improve the odds of a successful application. Confirming that your research is a priority and of interest to your sponsor – in this case, NIH Institutes and Centers – is a critical first step. Finding and developing a working relationship with one or more Program Officers (POs) is also important to a successful career in academic biomedical research. In this workshop, we will discuss strategies to make the most of NIH staff and resources to plan and prepare a competitive application, with a focus on NIH RePORT, NIH RePORTER, NIH Guide to Grants and Contracts, and POs. The peer review process is covered separately in Planning Your NIH Grant Application for the Best Review Possible (including the New Review Framework) on March 21. Strategies for drafting and refining the research narrative and what happens after submission are discussed in Developing your NIH Aims & Research Strategy on April 4. Bring any questions you might have about the NIH itself and its grant application process. (subject matter: peer review)

Linguistic Justice in Research: Promoting Best Practices for Equitable Inclusion of Linguistically Diverse Communities Presented by Maya Ragavan, MD, MPH, MS, Assistant Professor of Pediatrics, Children's Hospital of Pittsburgh, and Patricia I. Documet, MD, DrPH, Associate Professor, Behavioral and Community Health Sciences Director, Doctoral Program, Latinx Research and Outreach Director, Center for Health Equity, University of Pittsburgh on March 11th, 2024. This session will provide an introduction to equitably including communities whose primary language is not English into research. Inclusion of non-English speaking communities is essential to promoting health equity and ensuring that our work centers the perspectives of the growing immigrant and non-English speaking communities in Pittsburgh. Objectives of this RCR include: 1) understanding the inclusion of non-English speaking communities into clinical and translational research, from a health equity and anti-racist perspective; 2) reviewing best practices for translations; and 3) building bilingual and bicultural research teams. (subject matter: human participants)

(Don’t) Lie with Statistics Presented by Maria Mori Brooks, Ph.D., Professor of Epidemiology, Biostatistics and Clinical and Translational Science, University of Pittsburgh School of Public Health, BERD CTSI, and Li Wang, MS, CTSI BERD on March 12th, 2024. How do you know your statistics are done right? In this workshop, accounts of misleading or inaccurate use of statistics in research and provide approaches on how to avoid these common pitfalls will be discussed. (subject matter: research misconduct)

Close Encounters of the Authorship Kind – Why You Need an Authorship Agreement Presented by Colleen Mayowski, EdD, MLIS, University of Pittsburgh Institute for Clinical Research Education on March 19th, 2024. What is an Authorship Agreement? Do you really need one? In this session, we’ll look at several examples of authorship misconduct highlighted in the scientific literature, share evidence of the need for an authorship agreement at the University of Pittsburgh, and introduce a newly developed, easy-to-use online Authorship Agreement that you can customize for your own use. (subject matter: responsible authorship)

Planning Your NIH Application for the Best Review Possible (Including the New Review Framework) Presented by Michelle Kienholz, CTSI on March 21st, 2024. Understanding Your Second NIH Audience: Peer Reviewers. When planning and preparing an NIH grant application of any type, your focus must be on the intended readers: your peers on the Scientific Review Group (study section). This workshop will review NIH tools to use in identifying the best review group(s) for your science – a critical task in planning and preparing any NIH grant application. We will then go through the current and future review framework and criteria, so you are prepared for the transition in 2025. The goal is to help applicants prepare competitive applications that give the right reviewers the right information to complete an informed review. Finding the right Institute, funding opportunity and program officer was covered separately in NIH Resources & Personnel that Can Help You Get Funded on March 7. Strategies for drafting and refining the research narrative and what happens after submission are discussed in Developing your NIH Aims & Research Strategy on April 4. Bring questions you might have about the peer review process. (subject matter: peer review)  

An Author’s Responsibilities: Publication and Authorship Presented by Robert Weyant, DMD, DrPH, Professor and Associate Dean, School of Dental Medicine on March 25th, 2024. The author’s role in writing, submitting, and ultimately publishing scientific research results ethically will be discussed. Perspectives of the first author, coauthors, journal editors, and other contributors to scientific publication will be addressed. (subject matter: responsible authorship)

Integrating Underrepresented Populations in Research Presented by Leah Mckown, Community Engagement Coordinator on March 26th, 2024. Integrating populations historically excluded from biomedical research is essential if we seek generalizable study findings. But the long and tragic history of research abuses inflicted on some of these populations leads to marked resistance to participation. Building trust in the community is the most critical part of engaging those harder-to-reach participants. This session will review some of the historic crimes inflicted upon "othered" populations and discuss ways to authentically and intentionally build trust moving forward. (subject matter: safe research environments) 

Responsible Conduct of Research Principles and Application Presented by Teri Reiche, CIP, CTSI on September 6th, 2023. Principles of Responsible Conduct of Research (RCR) that promote safe, ethical, and successful research will be examined. Case studies illustrating specifics such as conflict of interest and research misconduct will be discussed, along with information on federal and university research resources that are available for investigators and students. (subject matter: scientist in society)

Using Critical Appraisal to Assess the Rigor of the Prior Research Presented by Rebekah Miller, MLIS, Health Sciences Library System on September 12th, 2023. This session is part of a series on Rigor & Reproducibility. When applying for grants, have you ever wondered how best to meet the NIH requirement to assess the rigor of the prior research in your field? Critical appraisal can help readers determine whether a study's results are valid, what the results are, and whether they are relevant to you. This class will cover the basics of critically appraising studies, including study design, methods, bias, and confounding.  Join us for the follow-up session entitled, “Critical Appraisal Journal Club, individual session” on September 27. You must register for each session separately. (subject matter: data acquisition and analysis)

Community Partner Research Ethics Training (CPRET) Presented by Elizabeth Miller, MD, Ph.D., Director, Division of Adolescent and Young Adult Medicine, Academic Co-Director, CTSI Community PARTners (Community Engagement Core) and RaNaja Kennedy, Senior Community Engagement Facilitator, CTSI Community PARTners on September 19th, 2023. Join us to learn about Pitt-IRB-approved research ethics training for community partners. CPRET was designed to help principal investigators and research coordinators tailor research ethics training for a specific study and to encourage dialogue with community members who will participate on the research team. This training is particularly relevant for investigators engaged in clinical and translational research involving community stakeholders. Investigators have the opportunity to create and discuss scenarios that may arise in the course of their specific study while ensuring that Core research ethics principles – i.e., autonomy, beneficence, and justice – are defined and reviewed. Particular attention will be paid to reflecting on history and the vital importance of building trustworthiness in research through this CPRET process. (subject matter: collaborative research)

Study Design Presented by Anthony Fabio, Ph.D., MPH, Associate Professor of Epidemiology Data Center, University of Pittsburgh Director, Consortium for Injury Research and Community Action (CIRCA) on September 21st, 2023. For a research study to successfully answer the clinical question being addressed, the appropriate study design must be implemented.  The purpose of this workshop will be to provide a basic overview of common study designs, as well as the advantages and limitations of each approach. (subject matter: data acquisition and analysis) Note: This workshop is co-sponsored by CTSI Biostatistics, Epidemiology, and Research Design Core and the RCR Center.

Critical Appraisal Journal Club, *individual session* Presented by Rebekah Miller, MLIS, Health Sciences Library System & Maria Mori Brooks, Ph.D., Professor of Epidemiology and Biostatistics, CTSI BERD on September 27th, 2023. As a follow-up to the RCR session, “Using Critical Appraisal to Assess the Rigor of the Prior Research” on September 12 this session is part of a series on Rigor & Reproducibility. This session will be a discussion-based journal club, critically appraising a journal article in order to determine its validity, relevance, and rigor. The article will be provided before this session. Those who attended “Using Critical Appraisal to Assess the Rigor of the Prior Research” are encouraged to attend this session. (subject matter: data acquisition and analysis)

Ensure Study Proposal Rigor with Risk of Bias Tools Presented by Helena VonVille, MLS, MPH, School of Public Health Liaison and Research and Instruction Librarian on October 12th, 2023. Risk of Bias (RoB) is defined as “a systematic error, or deviation from truth, in results” (Cochrane Handbook, Chapter 7) and can occur as a result of “flaws in design, conduct, analysis, and/or reporting” (Cochrane Handbook, Chapter V). RoB tools have been developed to assess for potential bias in studies selected for inclusion in a systematic review. They can also be utilized to self-assess your grant proposal to ensure you have not introduced excessive bias into your study. (subject matter: data acquisition and analysis) By the end of this session, participants will be able to: Define the risk of bias and explain how RoB is typically used; Compare and contrast RoB and critical appraisal; List and describe RoB domains; Find and utilize RoB assessment tools.

Individual Conflicts of Interest (COIs) Presented by Allison T. Reinersmann, JD, COI Program Manager, COI Division, Office of Research Protections, University of Pittsburgh on October 16th, 2023. This RCR is the 1st of 3 sessions of the Conflict of Interest Series offered by the Conflict of Interest Division. In this session, we will discuss individual conflicts of interest as defined by University policy RI 01, including what they are, how they are reviewed and managed, and the importance of managing individual conflicts in research. (subject matter: conflict of interest)

Communicating Science Presented by Judy Cameron, Ph.D., Department of Psychiatry on October 19th, 2023. All audiences want to learn interesting new scientific information and have it delivered as a good story in an understandable format. This workshop will assist you in learning how to convey the importance of your message while being interesting, maintaining the attention of the audience, and making the learning process enjoyable. An overview of scientific communication skills, including knowing your audience and why they are interested in the information you are speaking about, how to translate scientific jargon into understandable concepts for the public, and how to keep the audience engaged will be presented. (subject matter: scientist in society) Note: Please have available for this workshop an article or presentation abstract on which you are working.

“3R” Literature Searching for Animal Research Protocols Presented by Melissa Ratajeski, MLIS, AHIP, Health Sciences Library System on October 24th, 2023. Literature searches for the "3R’s" -- Refinement, Reduction, and Replacement -- are required for Institutional Animal Care and Use Committee (IACUC) protocols that include animals covered by the Animal Welfare Act (AWA) and that are classified in the USDA Pain Classifications D or E. This session will cover the regulations and provide tips for searching the literature. (subject matter: animal subjects) 

Incorporating Equity Into Medical Research: Essential Frameworks and Potential Data Sources Presented by Leslie R. M. Hausmann, Ph.D., Associate Professor and Assistant Dean for Medical Student Research, University of Pittsburgh School of Medicine, Investigator and Co-Director, Equity Capacity Building Core, VA Pittsburgh Healthcare System Center for Health Equity Research and Promotion on October 30th, 2023. This session will provide an introduction to research on disparities in health and health care. Following a brief review of key terms and historical context, the session will orient participants to several conceptual models that have been developed to guide disparities research. The session will end with a discussion of publicly available data sources that participants can use to begin incorporating equity into their own research agendas. Objectives include defining important terms in disparities research and making important distinctions, such as social justice, differences vs. disparities, health vs. health care disparities, and marginalized populations, describing different conceptual models of health care disparities, and explaining where to find publicly available data sources that can be used to detect disparities in health and healthcare. Attendees should plan to join this interactive discussion on their computers and not by phone. (subject matter: safe research environments)

Preprints, How, Why, and Should I? Presented by Stephen Gabrielson, MSLIS, Scholarly Communication Librarian, HSLS on November 6th, 2023. This session will introduce participants to how preprints can fit into their publication workflow. We’ll define what preprints are, discuss the benefits of preprinting, and walk through the process of how to post a preprint to help increase the awareness and impact of your research (subject matter: responsible authorship)

Describing and Defining Your Data Presented by Deborah Martin and Theresa Sax, CTSI BERD on November 9th, 2023. Beginning with the assumption that a study has been designed, its aims and hypotheses clearly defined, and the data to be collected have been broadly identified, this workshop will address Part 1 - How to critically review your proposed data collection instruments, including issues of form design, validated vs standardized instruments, and foreign language translations. Part 2 – How to convert the Table of Measures from your grant proposal into a tool to document data collection sources and track form development, file transfer protocols, and versioning. Part 3 - How to create a data dictionary that can be used to build a data collection system.  Topics include variable naming conventions, types, codes, dependency, and validations (subject matter: data acquisition and analysis). This workshop is part of a series of 5 workshops co-sponsored by CTSI Biostatistics, Epidemiology and Research Design, and the RCR Center.

Enhancing Reproducibility through Transparency in Reporting Experimental Details Presented by Melissa Ratajeski, MLIS, AHIP, RLAT, Assistant Director for Data and Publishing Services, IACUC Liaison on November 14^th, 2023.This session is part of a series on Rigor & Reproducibility. NIH expects full transparency in reporting experimental details so that others may reproduce and extend the findings.  This session will discuss ways to report experimental details including open dissemination of methodology protocols, pre-registration of study protocols, and publication of registered reports (subject matter: secure & ethical data use)

Informed Consent: Because it is the Right Thing to Do, Not Because its Required Presented by Cindy S. McCarthy, DHCE, MA, NREMT (she/her), Visiting Associate Professor, Department of Human Genetics, Director, Bioethics Certificate University of Pittsburgh, School of Public Health on November 16^th, 2023. A brief historical overview will be presented with the primary portion of the presentation focusing on the elements of informed consent. There will be a particular focus on why informed consent is important ethically and how to best advocate for patients when having an informed consent discussion. (Subject matter: human subjects)

NIH Policy for Data Management and Sharing Presented by Melissa Ratajeski, MLIS, AHIP, RLAT, Assistant Director for Data and Publishing Services, IACUC Liaison & Laura Kingsley, Director, Office of Sponsored Programs on November 27^th, 2023. This Policy, which went into effect on January 25, 2023, requires NIH-funded researchers to prospectively submit a plan outlining how scientific data from their research will be managed and shared. This session will cover the plan’s elements and allowable costs as well as tools to help with your own plan creation. (subject matter: secure and ethical data use)

Smooth Sailing with the IRB Presented by Jean Barone, HRPO Director, and Melissa Miklos, HRPO Associate Director on November 28^th, 2023. There is more to know about your submission to the IRB than compliance with the regulations.  This session will recommend ways to strengthen your IRB submission and explore areas that may require special care and consideration (including but not limited to community research, single IRB, recruitment, and incentive challenges). (Subject matter: human participant research)

Creating a Data Collection System Presented by Deborah Martin and Theresa Sax, CTSI BERD on December 8^th, 2023. In this workshop, you will learn how to build a REDCap longitudinal data collection system that includes eConsenting, automated surveys, quality control features, simple reporting, and exporting your data for analyses. (subject matter: data acquisition and analysis) Note: This workshop is the second in a series of five workshops co-sponsored by CTSI Biostatistics, Epidemiology, and Research Design Core and the RCR Center.

Institutional Conflicts of Interest (COIs) Presented by Allison T. Reinersmann, JD, COI Program Manager, COI Division, Office of Research Protections, University of Pittsburgh on December 12th, 2023. This RCR is the 2nd session in the Conflict of Interest Series offered by the Conflict of Interest Division. – In this session, we will discuss institutional conflicts of interest as defined by University policy RI 11, including what they are, how they are reviewed and managed, and the importance of managing institutional conflicts of interest. (subject matter: conflict of interest)

Strategies for Effective Teaching and Mentoring of Students Presented by Bill Yates, Ph.D., Vice Chancellor for Research Protections and Professor of Otolaryngology on January 5th, 2023. Providing education to diverse populations (e.g., residents, medical students, graduate students, undergraduate students, lay members of the public) is an important component of a scientist's responsibilities.   However, unlike K-12 teachers, scientists receive little or no formal education about teaching strategies.  This workshop is intended to provide general education strategies that are effective for any audience. (subject matter: mentor/mentee)

Authorship Conflict Presented by Tetsuro Sakai, MD, Ph.D., MHA, Professor of Anesthesiology and CTSI, Vice-Chair for Professional Development, Director, Resident Research Rotation, Department of Anesthesiology and Perioperative Medicine on January 9th, 2023. Upon the completion of this workshop based on actual examples of authorship conflict observed in an academic center, the attendees will be able to describe authorship eligibility in scientific manuscripts, indicate potential types and causes of authorship conflict, and discuss possible methods to solve, address, and avoid authorship conflict. (subject matter: responsible authorship)

Using Animals Responsibly in Biomedical Research Presented by Amy Cassano, DVM, DACLAM, cVMA. Attending Veterinarian of DLAR on January 10th, 2023. This workshop discusses considerations and practical approaches to the responsible conduct of animal-based biomedical research. Strategies to foster productive, collaborative working relationships and facilitate successful animal research at the University of Pittsburgh will be presented. (Subject matter: animal subjects)

(Don’t) Lie with Statistics Presented by Maria Mori Brooks, Ph.D., Professor of Epidemiology, Biostatistics and Clinical and Translational Science, University of Pittsburgh School of Public Health, BERD CTSI, and Li Wang, MS, CTSI BERD on January 17th, 2023. How do you know your statistics are done right? In this workshop, accounts of misleading or inaccurate use of statistics in research and provide approaches on how to avoid these common pitfalls will be discussed. (subject matter: research misconduct)  

Organizational Conflicts of Interest Presented by Allison T. Reinersmann, JD, COI Program Manager, COI Division, Office of Research Protections, University of Pittsburgh on January 19th, 2023. This RCR is the 3^rd session in the Conflict of Interest Series offered by the Conflict of Interest Division. In this session, we will discuss organizational conflicts of interest, which can arise when the University bids on contracts offered by federal government agencies.  We will discuss federal regulatory requirements and University policy RI 04. (subject matter: conflict of interest) 

iThenticate for Grant Proposals Presented by Melissa Ratajeski, MLIS, AHIP, RLAT, Assistant Director for Data and Publishing Services, IACUC Liaison on January 23rd, 2023. iThenticate is a plagiarism detection software supported by the University of Pittsburgh.  It allows researchers to easily upload and scan manuscripts and other professional works for instances of plagiarism.  Use of iThenticate is highly encouraged by the Office of Sponsored Programs prior to the submission of all grant proposals. In addition to class registration, participants must complete the iThenticate account request form. (subject matter: research misconduct). This hands-on class will cover: How the software works and what material it uses for comparison, Uploading files, and configuration options for the interface, Viewing and understanding the “similarity report” and Sharing across user profiles to support collaborative editorial review

How the NIH Can Help You Get Funded Presented by Michelle Kienholz, CTSI January 31st, 2023. Using NIH tools and expertise can improve the odds of a successful application. In this workshop, we will discuss strategies to make the most of NIH staff and resources to plan and prepare a competitive application. We will also discuss what to anticipate and how to manage the post-submission period prior to the award. The peer review process is covered separately in the fall workshop, Planning Your NIH Grant Application for the Best Review Possible. Bring questions you might have about the NIH itself and its grant application process. (subject matter: peer review)

 Managing Up, Down, and All-Around Presented by Thomas R. Radomski, MD, MS (he/him), Assistant Professor of Medicine and Clinical & Translational Science, Assistant Director & Director of Academic Programs, Institute for Clinical Research Education, Core Faculty, Center for Pharmaceutical Policy and Prescribing, Research Health Scientist, VA Center for Health Equity Research and Promotion (CHERP), Division of General Internal Medicine, University of Pittsburgh and UPMC on February 2, 2023. Leadership involves successfully managing relationships with people above, below, and lateral to you in the academic hierarchy. This session highlights the importance of these relationships and provides tips on managing your mentor (up), being a good mentor and staff supervisor (down), and providing peer mentorship to colleagues (all around). (subject matter: mentor/mentee)

The Publication Process: An Editor’s View Presented by Bill Yates, Ph.D., Vice Chancellor for Research Protections and Professor of Otolaryngology on February 9, 2023. In today’s competitive funding environment, productivity is extremely important. However, the peer review process has been compromised by time constraints of researchers. This session discusses the problems that may occur during peer review of manuscripts (including ethical concerns), and the steps that authors can take to address these problems. The session is intended to provide insights into how an author can best guide their paper successfully through the peer review process. (subject matter: responsible authorship)

Laboratory Safety:  Beyond Bloodborne Pathogens and Chemical Hygiene Presented by Molly S. Stitt-Fischer, Ph.D., CPH, CBSP, SM(NRCM), Director and Alternate Responsible Official for Select Agents, Department of Environmental Health and Safety, University of Pittsburgh on February 14, 2023. Do you know when you should use a chemical fume hood vs a biosafety cabinet?  Are you confident that your chemicals are appropriately separated and stored?  Do you feel confident listing the biological, chemical, physical, and other hazards present in your research laboratory and identifying the measures used to mitigate risks associated with these hazards?  This session will use case studies to point out key differences between risk assessment for hazards in research laboratories and non-laboratory environments.  We will discuss EH&S resources available to assist you in assessing risk and developing safe research plans.  We will also review answers to common questions and observations made during EH&S laboratory safety surveys and training sessions. (subject matter: safe laboratory practices)

Pitt + Me Presented by Jennifer Rush, Pitt+Me Facilitator, CTSI & Kate Underwood, Regulatory Facilitator, CTSI on February 16, 2023. The Pitt+Me registry is a database of research volunteers of all ages, who have consented to be contacted, to learn about research studies in which they may wish to participate. The registry is a pre-screening tool for research study teams with a University of Pittsburgh affiliation, to connect with potential participants to support their recruitment efforts. The registry facilitates a connection between research and the community. Join us to find out how your study team can use this free service to recruit the participants you need to meet your research goals. (subject matter: human participant research)

Bias in Scientific Literature Presented by Keith Vogt, MD Ph.D., Assistant Professor, Departments of Anesthesiology & Perioperative Medicine and Bioengineering on February 21, 2023. In this workshop, we will discuss sources of bias in scientific literature, including falsified and incorrectly analyzed data, possible bias from publishers and media, the impact of the proliferation of low-impact and predatory journals, and current research culture favoring positive results and little replication. (subject matter: peer review)

How to Partner with and Recruit in Schools Presented by Dr. Elizabeth Miller, MD, Ph.D., FSAHM, Director, Division of Adolescent and Young Adult Medicine Medical Director, Children's Hospital of Pittsburgh; Academic Co-Director, CTSI Community PARTners (Community Engagement Core), University of Pittsburgh. Jessica C. Levenson, Ph.D., Licensed Clinical Psychologist, Assistant Professor of Psychiatry and Pediatrics at the University of Pittsburgh School of Medicine on February 23, 2023. There are special considerations and processes for how to partner with schools to conduct research in schools as well as to recruit for research studies through schools. We will share experiences partnering with schools to promote reciprocity and to facilitate research and will lead a discussion about how to work with schools. (subject matter: collaborative research)

Communication Ethics for Preventing Misconduct Presented by Emily Herrington, University of Pittsburgh Science, Ethics, and Society Initiative Program Coordinator on February 28, 2023. Much of bioethics “on the ground” can be considered communication ethics. This workshop offers tools for developing ethically principled dialogue with research participants and community stakeholders on the view that investigators who practice communication ethics reduce possibilities for misunderstanding and misconduct (subject matter: research misconduct). 

Inclusion of English Learners in Clinical and Translational Research Presented by Maya Ragavan, MD, MPH, MS, Assistant Professor of Pediatrics, Children's Hospital of Pittsburgh and Patricia I. Documet, MD, DrPH, Associate Professor, Behavioral and Community Health Sciences Director, Doctoral Program, Latinx Research and Outreach Director, Center for Health Equity, University of Pittsburgh on March 2, 2023. This session will provide an introduction to equitably including communities whose primary language is not English into research. Inclusion of non-English speaking communities is essential to promoting health equity and ensuring that our work centers the perspectives of the growing immigrant and non-English speaking communities in Pittsburgh. Objectives of this RCR include 1) understanding the inclusion of non-English speaking communities into clinical and translational research, from a health equity and anti-racist perspective; 2) reviewing best practices for translations; and 3) building bilingual and bicultural research teams. (subject matter: human participants)

Data Collection-- Monitoring and Reporting Presented by Deborah Martin and Theresa Sax, CTSI BERD on March 7, 2023. Research data must be constantly monitored and reported as it accrues.  We will discuss issues in quality control for completeness, correctness, and logical consistency; specimen tracking; reporting on data accrual; alerting appropriate parties about problems or exceptions; and modifying forms and underlying data mid-study as necessary (subject matter: data acquisition). Note: This workshop is the third in a series of five workshops co-sponsored by CTSI Biostatistics, Epidemiology and Research Design Core and the RCR Center

Pitching your Science Presented by Aneesh Ramaswamy, Ph.D., Assistant Director for Program Management, CTSI Innovation Dana Farrell, Project Manager for Health Research, CTSI Innovation on March 16, 2023. This workshop is designed to help you convert scholarly descriptions of your work to clear, vivid writing and presentations that accurately convey the purpose and promise of your science to a variety of audiences. We will talk through inspiring curiosity within your specific audience, give an overview of the “Hourglass Method” for science communication, and address any concerns you have with science communication techniques for your presentation style. (subject matter: scientist in society)

Close Encounters of the Authorship Kind – Why You Need an Authorship Agreement Presented by Colleen Mayowski, EdD, MLIS, the University of Pittsburgh Institute for Clinical Research Education on March 21, 2023. What is an Authorship Agreement? Do you really need one? In this session, we’ll look at several examples of authorship misconduct highlighted in the scientific literature, share evidence of the need for an authorship agreement at the University of Pittsburgh, and introduce a newly developed, easy-to-use online Authorship Agreement that you can customize for your own use. (subject matter: responsible authorship)

An Author’s Responsibilities: Publication and Authorship Presented by Robert Weyant, DMD, DrPH, Professor and Associate Dean, School of Dental Medicine March 23, 2023. The author’s role in writing, submitting, and ultimately publishing scientific research results ethically will be discussed. Perspectives of the first author, coauthors, journal editors, and other contributors to scientific publication will be addressed. (subject matter: responsible authorship) 

New NIH Policy for Data Management and Sharing Presented by Melissa Ratajeski, MLIS, AHIP, RLAT, Assistant Director for Data and Publishing Services, IACUC Liaison & Laura Kingsley, Director, Office of Sponsored Programs on March 27, 2023. This NIH Policy for Data Management and Sharing, which went into effect on January 25, 2023, requires NIH-funded researchers to prospectively submit a plan outlining how scientific data from their research will be managed and shared. This session will cover the plan’s elements and allowable costs as well as tools to help with your own plan creation. (subject matter: secure and ethical data use)

Relationship Therapy: Investigators and Statisticians Presented by Maria Mori Brooks, Ph.D., Professor of Epidemiology, Biostatistics and Clinical and Translational Science, University of Pittsburgh School of Public Health, BERD CTSI and Li Wang, MS, CTSI BERD on March 28, 2023. The objective of this workshop is to go beyond the usual generic advice given to researchers seeking to consult with biostatisticians. Specific suggestions will be provided for common problem areas in the investigator/statistician collaboration. Through a series of case vignettes and discussion, best methods for working productively with a biostatistician on your research will be illustrated.  (subject matter: collaborative research)

Integrating Underrepresented Populations in Research Presented by RaNaja Kennedy, Senior Community Engagement Coordinator, Leah Mckown, and Zylphia Ford, Community Engagement Coordinators on March 30, 2023. Integrating populations historically excluded from biomedical research is essential if we seek generalizable study findings. But the long and tragic history of research abuses inflicted on some of these populations leads to marked resistance to participation. Building trust in the community is the most critical part of engaging those harder-to-reach participants. This session will review some of the historic crimes inflicted upon "othered" populations and discuss ways to authentically and intentionally build trust moving forward. (subject matter: safe research environments)

Intellectual Property Concepts Presented by Michael Madison, JD, University of Pittsburgh School of Law on April 5, 2023. The presentation will review basic concepts defining patent law and other IP systems, and how they relate to university-based research, scholarship, and teaching. (Subject matter: scientist in society)

Scientific Corroboration, Near and Far and with the Dark Side Presented by Michael R. Pinsky, MD CM, Dr hc, FCCP, MCCM, FAPS, Professor of Critical Care Medicine, Bioengineering, Cardiovascular Disease and Anesthesiology, Department of Critical Care Medicine on April 6, 2023. The workshop will discuss issues like Scope of Work, transparency, right to publish, and advantages, disadvantages, and pitfalls of collaboration research with local and international collaborators, as well as with industry. (Subject matter: collaborative research)

The New NIH Data Management & Sharing Plan: Where to Share Data Presented by Helenmary Sheridan, MLIS, Data Services Librarian, Health Sciences Library System, University of Pittsburgh on April 11, 2023. This is an encore presentation on NIH's new Policy for Data Management and Sharing (DMS Policy) that went into effect on January 25, 2023.  This Policy requires NIH-funded researchers to prospectively submit a plan outlining how scientific data from their research will be managed and shared. The Policy includes an expectation that researchers will maximize their data sharing within ethical, legal, or technical constraints, and explicitly encourages researchers to incorporate data sharing via a deposit into a public repository into their standard research process. (Subject matter: secure and ethical data use). This session will cover the "where" of data sharing through the following topics: What is a repository? Repositories vs. data storage vs. data backup. Choosing the right repository for your discipline, data format, and legal/ethical considerations. Understanding potential costs for data sharing (and how to include them in a grant application). Evaluating the robustness of a repository.

Preparing Data for Analysis Presented by Deborah Martin and Theresa Sax, CTSI BERD on April 13, 2023. Publication of results is the point of a trial and collected data may need to be groomed and summarized for proper analysis.  Topics will include the creation of analysis variables and summary datasets, periodic database freezes, and cataloging of analysis data, programs, and results (subject matter: data acquisition). Note: This workshop is the fourth in a series of five workshops co-sponsored by CTSI Biostatistics, Epidemiology and Research Design Core and the RCR Center

Building a Lab Culture Presented by Bee Schindler, LMSW, Diversity, and Inclusion Training Manager, Health Sciences Diversity, Equity, and Inclusion, University of Pittsburgh on April 17, 2023. Laboratories have cultures unto themselves, separate and apart from the larger organizational culture.  How do leaders and supervisors influence lab culture?  How can leaders and supervisors change lab culture? This workshop will include a discussion of how lab culture is established and how it can be made to be more inclusive and sustainable. (Subject matter: mentor/mentee)

Rigor & Reproducibility (R&R) in Reporting: From Project Proposal to Publication Presented by Helena VonVille, MLS, MPH, School of Public Health Liaison and Research and Instruction Librarian on April 24, 2023. This session is part of a series on Rigor & Reproducibility. Receiving approval for funding from granting agencies is more competitive than ever. Granting agencies expect both rigor and reproducibility without providing much guidance. This session will focus on health research reporting guidelines to enhance rigor and reproducibility while writing project proposals/protocols, IRB submissions, conference presentations, and publications of findings. (Subject matter: secure & ethical data use)

Performing and Interpreting a Meta-Analysis Presented by Maria Mori Brooks, Ph.D., Professor of Epidemiology, Biostatistics, and Clinical and Translational Science, University of Pittsburgh School of Public Health, BERD CTSI on April 25, 2023. This session will review the principles for conducting a meta-analysis.  We will describe key steps for planning a systematic review, performing a meta-analysis, and interpreting the results.  STATA will be used to demonstrate how to derive overall estimates and assess the risk of biases. (Subject matter: data acquisition and analysis) 

Confronting Research Misconduct – What You Need to Know Presented by Susan R. Sesack, Ph.D., Professor of Neuroscience and Psychiatry, Deputy Research Integrity Officer on April 27, 2023. Attendees will learn how federal regulation and University policy define research misconduct, and what to do if they observe possible misconduct.  Case studies will be presented, and the University's response to allegations of research misconduct will be described, including the process of investigation and sanctions. Attendees will also learn steps to take that can help reduce the possibility of research misconduct in their laboratories. (Subject matter: research misconduct) 

The New NIH Data Management & Sharing Plan: Documentation, Metadata, and the "How" of Deposit Presented by Helenmary Sheridan, MLIS, Data Services Librarian, Health Sciences Library System, University of Pittsburgh on May 1^st, 2023. This is an encore presentation on NIH's new Policy for Data Management and Sharing (DMS Policy) that went into effect on January 25, 2023. This Policy requires NIH-funded researchers to prospectively submit a plan outlining how scientific data from their research will be managed and shared. The Policy includes an expectation that researchers will maximize their data sharing within ethical, legal, or technical constraints, and explicitly encourages researchers to incorporate data sharing via a deposit into a public repository into their standard research process. (Subject matter: secure and ethical data use). This session will cover the data deposit process and explore these topics: How to write a good README, user manual, or data dictionary, assigning metadata to your data files to make them discoverable on the web, creating documentation templates to streamline the deposit process, Understanding licenses and use restrictions in repositories.

Intersectionality and Community Cultural Wealth Presented by Lilcelia A. Williams, Ph.D., Post-Doctoral Associate, Department of Occupational Therapy on May 4, 2023. In this workshop, we will discuss the importance of incorporating the principles of intersectionality and the tenets of community cultural wealth to improve patient engagement, patient outcomes and to mitigate health disparities. The information presented will provide invaluable resources to help clinicians and researchers acknowledge and incorporate the lived experiences of patients/participants into the treatment plan, as well as the rich descriptive evidence that will emerge during the data-gathering and analysis process. (Subject matter: safe research environments)

Study Closeout and Archiving Presented by Deborah Martin and Theresa Sax, CTSI BERD on May 16, 2023. The study database is rarely the final resting place for data.  Data may be shared throughout the project, and at study, closeout must be archived and as requested, publicly shared.  Techniques in sharing, de-identification, and archiving will be discussed. (Subject matter: secure & ethical data use). This workshop is the final in a series of five workshops co-sponsored by CTSI Biostatistics, Epidemiology and Research Design Core, and the RCR Center.

Informed Consent 101 Presented by Michael Green, MD, MPH, Professor of Pediatrics, Surgery & Clinical and Translational Science, Clinical Translational Science Institute the University of Pittsburgh School of Medicine on May 22, 2023. This session will include a discussion of ethical & regulatory implications of informed consent, protecting participant rights, and ways to help participants understand biomedical research in the hopes to form a more honest, trusting, and respectful relationship with clinical investigators. Case studies will be discussed. (Subject matter: human participants) 

Animal Research Protections and the Institutional Animal Care and Use Committee (IACUC) Presented by Deborah L. Chapman, Ph.D., Associate Professor, Department of Biological Sciences, Chair, Institutional Animal Care and Use Committee on May 23, 2023. This workshop is for researchers using vertebrate animals in research and education. It will cover 1) the role of the Institutional Animal Care and Use Committee (IACUC), 2) laws and agencies that govern how the IACUC functions, 3) the IACUC protocol submission and review process, including who can submit a protocol, turnaround time, tips for writing a protocol, 4) training and who to reach out to for additional help with animal research, and 5) how to maintain compliance. (Subject matter: animal subjects)

Responsible Conduct of Research Principles and Application, Presented by Teri Reiche, CIP, CTSI on September 8, 2022. This workshop discusses Principles of Responsible Conduct of Research (RCR) that promote safe, ethical, and successful research will be examined. Case studies illustrating specifics such as conflict of interest and research misconduct will be discussed, along with information on federal and university research resources that are available for investigators and students. (subject matter: scientist in society)

Using Critical Appraisal to Assess the Rigor of the Prior Research Presented by Rebekah Miller, MLIS, Health Sciences Library System on September 13, 2022. This session is part of series on Rigor & Reproducibility. When applying for grants, have you ever wondered how best to meet the NIH requirement to assess the rigor of the prior research in your field? Critical appraisal can help readers determine whether a study's results are valid, what the results are, and whether they are relevant to you. This class will cover the basics of critically appraising studies, including study design, methods, bias, and confounding.  Join us for the follow up session entitled, “Critical Appraisal Journal Club, individual session” on October 4. You must register for each session separately. (subject matter: data acquisition)

Study Design, Presented by Anthony Fabio, PhD, MPH, Associate Professor of Epidemiology Data Center, University of Pittsburgh, Director, Consortium for Injury Research and Community Action (CIRCA) on September 20, 2022. Note: This workshop is co-sponsored by CTSI Biostatistics, Epidemiology and Research Design Core and the RCR Center. For a research study to successfully answer the clinical question being addressed, the appropriate study design must be implemented.  The purpose of this workshop will be to provide a basic overview of common study designs, as well as the advantages and limitations of each approach. (subject matter: data acquisition)

Smooth Sailing with the IRB, Presented by Jean Barone, HRPO Director and Melissa Miklos, HRPO Associate Director. On September 22, 2022. There is more to know about your submission to the IRB than compliance with the regulations.  This session will recommend ways to strengthen your IRB submission and explore areas that may require special care and consideration (including but not limited to community research, single IRB, recruitment and incentive challenges). (subject matter: human participant research)

Ethical Study Design and Informed Consent in Biomedical Research with Special Populations, Presented by Aimee B. Biller, M.D., Ethics facilitator, CTSI, Associate Professor of Pediatrics, UPSOM on September 27, 2022. To achieve the goals of precision medicine it is imperative that human subjects research be inclusive and conducted in a way that inspires trust in all populations.  Bioethical principles require vigilance both in the design of, and consent for, clinical trials in many special populations.  Attendees will learn the moral reasoning behind current safeguards for certain populations as well as consider emerging bioethical issues in human subjects research. (subject matter: human participant research)

Community Partner Research Ethics Training (CPRET), Presented by Elizabeth Miller, MD, PhD, Director, Division of Adolescent and Young Adult Medicine, Academic Co-Director, CTSI Community PARTners (Community Engagement Core) and RaNaja Kennedy, Senior Community Engagement Facilitator, CTSI Community PARTners on September 29, 2022. Join us to learn about a Pitt-IRB approved research ethics training for community partners. CPRET was designed to help principal investigators and research coordinators tailor research ethics training for a specific study and to encourage dialogue with community members who will participate on the research team. This training is particularly relevant for investigators engaged in clinical and translational research involving community stakeholders. Investigators have the opportunity to create and discuss scenarios that may arise in the course of their specific study while ensuring that Core research ethics principles – i.e., autonomy, beneficence, and justice – are defined and reviewed. Particular attention will be paid to reflecting on history and the vital importance of building trustworthiness in research through this CPRET process. (subject matter: collaborative research)

Preparing for the New NIH Data Management & Sharing Plan: Where to Share Data, Presented by Helenmary Sheridan, MLIS, Data Services Librarian, Health Sciences Library System, University of Pittsburgh on October 3, 2022. This is the first in a series of three sessions on NIH's new Policy for Data Management and Sharing (DMS Policy), which goes into effect January 25, 2023. This Policy will require NIH-funded researchers to prospectively submit a plan outlining how scientific data from their research will be managed and shared. The Policy includes an expectation that researchers will maximize their data sharing within ethical, legal, or technical constraints, and explicitly encourages researchers to incorporate data sharing via deposit into a public repository into their standard research process. (subject matter: secure and ethical data use). This session will cover the "where" of data sharing through the following topics: What is a repository? Repositories vs. data storage vs. data backup, Choosing the right repository for your discipline, data format, and legal/ethical considerations, Understanding potential costs for data sharing (and how to include them in a grant application) and Evaluating the robustness of a repository

Critical Appraisal Journal Club (individual session), Presented by Rebekah Miller, MLIS, Health Sciences Library System & Maria Mori Brooks, PhD, Professor of Epidemiology and Biostatistics, CTSI BERD on October 4, 2022. As a follow up to the RCR session, “Using Critical Appraisal to Assess the Rigor of the Prior Research” on September 13 this session is part of series on Rigor & Reproducibility.  This session will be a discussion-based journal club, critically appraising a journal article in order to determine its validity, relevance, and rigor. The article will be provided before this session. Those who attended “Using Critical Appraisal to Assess the Rigor of the Prior Research” are encouraged to attend this session. (subject matter: data acquisition)

“3R” Literature Searching for Animal Research Protocols, Presented by Melissa Ratajeski, MLIS, AHIP, Health Sciences Library System on October 10, 2022. Researchers using warm-blooded species (other than birds, mice of the genus Mus, and rats of the genus Rattus) classified in the USDA Pain Classification D or E are required to conduct a literature review addressing the 3Rs: Refinement, Reduction, and Replacement.  This session will provide tips for searching the literature and meeting the IACUCs requirements. (subject matter: animal subjects)

Ensure Study Proposal Rigor with Risk of Bias Tools, Presented by Helena VonVille, MLS, MPH, School of Public Health Liaison and Research and Instruction Librarian on October 13, 2022. Risk of Bias (RoB) is defined as “a systematic error, or deviation from truth, in results” (Cochrane Handbook, Chapter 7) and can occur as a result of “flaws in design, conduct, analysis, and/or reporting” (Cochrane Handbook, Chapter V). RoB tools have been developed to assess for potential bias in studies selected for inclusion in a systematic review. They can also be utilized to self assess your grant proposal to ensure you have not introduced excessive bias into your study. (subject matter: data acquisition and analysis). By the end of this session, participants will be able to: Define risk of bias and explain how RoB is typically used; Compare and contrast RoB and critical appraisal; List and describe RoB domains; and Find and utilize RoB assessment tools.

Preparing for the New NIH Data Management & Sharing Plan: Documentation, Metadata, and the "How" of Deposit, Presented by Helenmary Sheridan, MLIS, Data Services Librarian, Health Sciences Library System, University of Pittsburgh on October 17, 2022. This is the second in a series of three sessions on NIH's new Policy for Data Management and Sharing (DMS Policy), which goes into effect January 25, 2023. This Policy will require NIH-funded researchers to prospectively submit a plan outlining how scientific data from their research will be managed and shared. The Policy includes an expectation that researchers will maximize their data sharing within ethical, legal, or technical constraints, and explicitly encourages researchers to incorporate data sharing via deposit into a public repository into their standard research process. (subject matter: secure and ethical data use). This session will cover the data deposit process and explore these topics: How to write a good README, user manual, or data dictionary, Assigning metadata to your data files to make it discoverable on the web, Creating documentation templates to streamline the deposit process and Understanding licenses and use restrictions in repositories.

Communicating Science, Presented by Judy Cameron, PhD, Department of Psychiatry on October 27, 2022. All audiences want to learn interesting new scientific information and have it delivered as a good story in an understandable format. This workshop will assist you in learning how to convey the importance of your message while being interesting, maintaining the attention of the audience and making the learning process enjoyable. An overview of scientific communication skills, including knowing your audience and why they are interested in the information you are speaking about, how to translate scientific jargon into understandable concepts for the public, and how to keep the audience engaged will be presented. (subject matter: scientist in society)

Enhancing Reproducibility through Transparency in Reporting Experimental Details, Presented by Melissa Ratajeski, MLIS, AHIP on November 1, 2022. This session is part of series on Rigor & Reproducibility. NIH expects full transparency in reporting experimental details so that others may reproduce and extend the findings.  This session will discuss ways to report experimental details including: open dissemination of methodology protocols, pre-registration of study protocols, and publication of registered reports. (subject matter: data acquisition)

Describing and Defining Your Data, Presented by Deborah Martin and Theresa Sax, CTSI BERD on November 4, 2022. This workshop is part of a series of 5 workshops co-sponsored by CTSI Biostatistics, Epidemiology and Research Design and the RCR Center. Beginning with the assumption that a study has been designed, its aims and hypotheses clearly defined, and the data to be collected have been broadly identified, this workshop will address: Part 1 - How to critically review your proposed data collection instruments, including issues of form design, validated vs standardized instruments, and foreign language translations. Part 2 – How to convert the Table of Measures from your grant proposal into a tool to document data collection sources and track form development, file transfer protocols, and versioning. Part 3 - How to create a data dictionary that can be used to build a data collection system. Topics include variable naming conventions, types, codes, dependency, and validations (subject matter: data acquisition).

Preprints, How, Why, and Should I?, Presented by Stephen Gabrielson, MSLIS, Scholarly Communication Librarian, HSLS on November 8, 2022. In this workshop, we will discuss the facts and myths of preprint publication, addressing the questions: “What are preprints?” “Can I still publish in a peer reviewed journal?” (subject matter: responsible authorship)

Introduction to Conflict of Interest and Conflict Management, Presented by Allison T. Reinersmann, JD, COI Program Manager, COI Division, Office of Research Protections, University of Pittsburgh on November 10, 2022. This RCR is the 1st of 3 sessions of the Conflict of Interest Series offered by the Conflict of Interest Division. In this session, we will discuss conflicts of interest – what they are and why COI management is important for research. We will discuss potential conflicts, including conflicts of commitment, and how Pitt identifies and manages potential conflicts of interest. (subject matter: conflict of interest)

Planning Your NIH Application for the Best Review Possible. Presented by Michelle Kienholz, CTSI. This session is part of series on Rigor & Reproducibility on November 17, 2022. When planning and preparing an NIH grant application of any type, your focus must be on the intended audience: your peers on the Scientific Review Group (study section). This workshop will first review NIH tools to use in identifying the best review group(s) for your science – a critical task in planning and preparing any NIH grant application. We will then focus on crafting the application narratives to address the stated review criteria as well as the rigor, reproducibility, and scientific merit of the research more broadly throughout. We will also go through available training in methods to enhance reproducibility, which is important in T, F, and K applications. The goal is to help applicants prepare competitive applications that give the right reviewers the right information to complete an informed review – and to make this task as easy and pleasant as possible. (subject matter: peer review)

Incorporating Equity Into Medical Research: Essential Frameworks and Potential Data Sources. Presented by Leslie R. M. Hausmann, Ph.D., Associate Professor and Assistant Dean for Medical Student Research, University of Pittsburgh School of Medicine, Investigator and Co-Director, Equity Capacity Building Core, VA Pittsburgh Healthcare System Center for Health Equity Research and Promotion on November 21, 2022. This session will provide an introduction to research on disparities in health and health care. Following a brief review of key terms and historical context, the session will orient participants to several conceptual models that have been developed to guide disparities research. The session will end with a discussion of publicly available data sources that participants can use to begin incorporating equity into their own research agendas. Objectives include defining important terms in disparities research, and make important distinctions, such as social justice, differences vs. disparities, health vs. health care disparities, and marginalized populations, describing different conceptual models of health care disparities, and explaining where to find publicly available data sources that can be used to detect disparities in health and healthcare. Attendees should plan to join this interactive discussion on their computers and not by phone. (subject matter: safe research environments)

Institutional Conflicts of Interest. Presented by Allison T. Reinersmann, JD, COI Program Manager, COI Division, Office of Research Protections, the University of Pittsburgh on December 1st, 2022. This RCR is the 2^nd session in the Conflict of Interest Series offered by the Conflict of Interest Division. In this session, we will discuss institutional conflicts of interest and the requirements of the University’s new Institutional Conflict of Interest policy (Policy RI 11). (Subject matter: conflict of interest)

Preparing for the New NIH Data Management & Sharing Plan: Elements, Costs, and Tools. Presented Melissa Ratajeski, MLIS, AHIP, RLAT, Assistant Director for Data and Publishing Services, IACUC Liaison on December 6^th, 2022.This is the last in a series of three sessions on NIH's new Policy for Data Management and Sharing (DMS Policy), which goes into effect on January 25, 2023. This Policy will require NIH-funded researchers to prospectively submit a plan outlining how scientific data from their research will be managed and shared. NIH has a new policy going into effect on January 25, 2023, that will require NIH-funded researchers to prospectively submit a plan outlining how scientific data from their research will be managed and shared. This session will cover the plan’s elements and allowable costs as well as tools to help with your own plan creation. (subject matter: secure and ethical data use)

Creating a Data Collection System Presented by Deborah Martin and Theresa Sax, CTSI BERD. on December 8^th, 2022. Note: This workshop is the second in a series of five workshops co-sponsored by CTSI Biostatistics, Epidemiology, and Research Design Core and the RCR Center. In this workshop, you will learn how to build a REDCap longitudinal data collection system that includes eConsenting, automated surveys, quality control features, simple reporting, and exporting your data for analyses. (Subject matter: data acquisition)

Using Animals Responsibly in Biomedical Research, presented by Amy Cassano, DVM, DACLAM, cVMA, Attending Veterinarian of DLAR, on January 5, 2022. This workshop discusses considerations and practical approaches to the responsible conduct of animal based biomedical research. Strategies to foster productive, collaborative working relationships and facilitate successful animal research at the University of Pittsburgh will be presented. (Subject matter: animal subjects)

Strategies for Effective Teaching and Mentoring of Students, presented by Bill Yates, PhD, Vice Chancellor for Research Protections and Professor of Otolaryngology, on January 6, 2022. Providing education to diverse populations (e.g., residents, medical students, graduate students, undergraduate students, lay members of the public) is an important component of a scientist's responsibilities. However, unlike K-12 teachers, scientists receive little or no formal education about teaching strategies. This workshop is intended to provide general education strategies that are effective for any audience. (subject matter: mentor/mentee)

(Don’t) Lie with Statistics, presented by Li Wang, MS and PJ Grosse, CTSI Biostatistics, Epidemiology and Research Design on January 11, 2022. How do you know your statistics are done right? In this workshop, we will present accounts of misleading or inaccurate use of statistics in research and provide approaches on how to avoid these common pitfalls. (subject matter: research misconduct)

Authorship Conflict, presented by Tetsuro Sakai, MD, PhD, MHA, Professor of Anesthesiology and CTSI, Vice-Chair for Professional Development, Director, Resident Research Rotation, Department of Anesthesiology and Perioperative Medicine, on January 13, 2022. Upon the completion of this workshop based on actual examples of authorship conflict observed in an academic center, the attendees will be able to describe authorship eligibility in scientific manuscripts, indicate potential types and causes of authorship conflict, and discuss possible methods to solve, address, and avoid authorship conflict. (subject matter: responsible authorship)

“3R” Literature Searching for Animal Research Protocols, presented by Melissa Ratajeski, MLIS, AHIP, Health Sciences Library System, on January 25, 2022. Researchers using warm-blooded species (other than birds, mice of the genus Mus, and rats of the genus Rattus) classified in the USDA Pain Classification D or E are required to conduct a literature review addressing the 3Rs: Refinement, Reduction, and Replacement. This session will provide tips for searching the literature and meeting the IACUCs requirements. (subject matter: animal subjects)

Laboratory Safety: Beyond Bloodborne Pathogens and Chemical Hygiene, presented by Molly S. Stitt-Fischer, PhD, CPH, CBSP, SM(NRCM), University Biosafety Officer and Alternate Responsible Official for Select Agents, Department of Environmental Health and Safety, University of Pittsburgh, on February 2, 2022. Do you know when you should use a chemical fume hood vs a biosafety cabinet?  Are you confident that your chemicals are appropriately separated and stored?  Do you feel confident listing the biological, chemical, physical and other hazards present in your research laboratory and identifying the measures used to mitigate risks associated with these hazards?  This session will use case studies to point out key differences between risk assessment for hazards in research laboratories and non-laboratory environments.  We will discuss EH&S resources available to assist you in assessing risk and developing safe research plans.  We will also review answers to common questions and observations made during EH&S laboratory safety surveys and training sessions. (subject matter: safe laboratory practices)

Managing Conflict of Interest: Protecting the Integrity of Research, presented by Jane Volk, Office of Research Protections, Conflict of Interest Division on February 8, 2022. This workshop introduces the importance of conducting safe, ethical, and successful research. Topics include conflicts of interest and research misconduct. Attendees will be equipped to identify RCR issues and policies that guide their research management. (subject matter: conflict of interest)

The Publication Process: An Editor’s View, presented by Bill Yates, PhD, Vice Chancellor for Research Protections and Professor of Otolaryngology, on February 10, 2022. In today’s competitive funding environment, productivity is extremely important. However, the peer review process has been compromised by time constraints of researchers. This session discusses the problems that may occur during peer review of manuscripts (including ethical concerns), and the steps that authors can take to address these problems. The session is intended to provide insights into how an author can best guide their paper successfully through the peer review process. (subject matter: responsible authorship)

Managing Up, Down, and All Around, presented by Doris Rubio, Assistant Vice Chancellor for Clinical Research Education and Training, Health Sciences, Director, Institute for Clinical Research Education, Professor of Medicine, Biostatistics, Biomedical Informatics, Nursing, and Clinical Translational Science, on February 15, 2022. Leadership involves successfully managing relationships with people above, below, and lateral to you in the academic hierarchy. This session highlights the importance of these relationships and provides tips on managing your mentor (up), being a good mentor and staff supervisor (down), and providing peer mentorship to colleagues (all around). (subject matter: mentor/mentee)

Bias in Scientific Literature, presented by Keith Vogt, MD PhD, Assistant Professor, Departments of Anesthesiology & Perioperative Medicine and Bioengineering on February 22, 2022. In this workshop, we will discuss sources of bias in scientific literature, including: falsified and incorrectly analyzed data, possible bias from publishers and media, the impact of proliferation of low-impact and predatory journals, and current research culture favoring positive results and little replication. (subject matter: peer review)

How to Partner with and Recruit in Schools, presented by Ethan Copperman, MPPc, Senior Research Coordinator, and Dr. Elizabeth Miller, MD, PhD, FSAHM, Director, Division of Adolescent and Young Adult Medicine Medical Director, Children's Hospital of Pittsburgh; Academic Co-Director, CTSI Community PARTners (Community Engagement Core), University of Pittsburgh, on February 24, 2022. There are special considerations and processes for how to partner with schools to conduct research in schools as well as to recruit for research studies through schools. We will share experiences partnering with schools to promote reciprocity and to facilitate research, and will lead a discussion about how to work with schools. (subject matter: collaborative)

Relationship Therapy: Investigators and Statisticians, presented by Li Wang and PJ Grosse, CTSI Biostatistics, Epidemiology, and Research Design Core, on March 2, 2022. Our objective in this workshop is to go beyond the usual generic advice given to researchers seeking to consult with biostatisticians. We will provide specific suggestions for common problem areas in the investigator/statistician collaboration. Through a series of case vignettes and discussion, we will illustrate the best methods for working productively with a biostatistician on your research. (subject matter: collaborative research)

Pitching your Science, presented by Aneesh Ramaswamy, PhD, CTSI Project Manager, and Dana Farrell, Program Manger, on March 3, 2022. This workshop is designed to help you convert scholarly descriptions of your work to succinct, vivid pitches that accurately convey the purpose and promise of your science. Our objective is to enable you to effectively communicate your science to stakeholders at different presentation lengths (30 seconds, 2-5 minutes, 10 minutes) while generating excitement and interest in the work. (subject matter: Science in society)

Communication Ethics for Preventing Misconduct, presented by Emily Herrington, University of Pittsburgh Science, Ethics, and Society Initiative Program Coordinator, on March 8, 2022. Much of bioethics “on the ground” can be considered communication ethics. This workshop offers tools for developing ethically principled dialogue with research participants and community stakeholders on the view that investigators who practice communication ethics reduce possibilities for misunderstanding and misconduct (subject matter: research misconduct). 

Data Collection - Monitoring and Reporting, presented by Deborah Martin and Theresa Sax, CTSI BERD, on March 15, 2022. Research data must be constantly monitored and reported as it accrues.  We will discuss issues in quality control for completeness, correctness, and logical consistency; specimen tracking; reporting on data accrual; alerting appropriate parties about problems or exceptions; and modifying forms and underlying data mid-study as necessary. (subject matter: data acquisition) Note: This workshop is the third in a series of five workshops co-sponsored by CTSI Biostatistics, Epidemiology and Research Design Core and the RCR Center.

An Author’s Responsibilities: Publication and Authorship, presented by Robert Weyant, DMD, DrPH, professor and Associate Dean, School of Dental Medicine, on March 17, 2022. The author’s role in writing, submitting, and ultimately publishing scientific research results ethically will be discussed. Perspectives of the first author, coauthors, journal editors, and other contributors to scientific publication will be addressed. (subject matter: responsible authorship) 

It’s Only a Model: What Can and Can’t Be Learned from Computation, presented by Timothy Lezon, PhD, Department of Computational & Systems Biology, on March 23, 2022. Like any research tool, computational modeling is most effective if the user has a good feel for its inner workings. Communication failure between quantitative and wet bench scientists can doom transdisciplinary projects. This session will address the strengths and limitations of computational models, and will explore strategies for effectively communicating across disciplines. (subject matter: collaborative research)

Intellectual Property Concepts, presented by Michael Madison, JD, University of Pittsburgh School of Law, on March 29, 2022. The presentation will review basic concepts defining patent law and other IP systems, and how they relate to university-based research, scholarship, and teaching. (subject matter: scientist in society)

How the NIH Can Help You Get Funded, presented by Michelle Kienholz, CTSI, on March 31, 2022. Using NIH tools and expertise can improve odds of a successful application. In this workshop, we will discuss strategies to make the most of NIH staff and resources to plan and prepare a competitive application. We will also discuss what to anticipate and how to manage the post-submission period prior to award. The peer review process is covered separately in the fall workshop, Planning Your NIH Grant Application for the Best Review Possible. Bring questions you might have about the NIH itself and its grant application process. (subject matter: peer review)

Using Electronic Lab Notebooks, presented by Carrie Iwema, PhD MLIS AHIP, on April 5, 2022. This workshop will focus on the Electronic Lab Notebook (ELN) selected by the University of Pittsburgh, LabArchives. We will cover how to get started using it, including access, lab notebook creation and organization, adding and editing entries, linking, and sharing data. (subject matter: data acquisition)

Inclusion of English Learners in Clinical and Translational Research, presented by Maya Ragavan, MD, MPH, MS, Assistant Professor of Pediatrics, Children's Hospital of Pittsburgh and Patricia I. Documet, MD, DrPH, Associate Professor, Behavioral and Community Health Sciences Director, Doctoral Program, Latinx Research and Outreach Director, Center for Health Equity, University of Pittsburgh on April 13, 2022. This session will provide an introduction to equitably including communities whose primary language is not English into research. Inclusion of non-English speaking communities is essential to promoting health equity and ensuring that our work centers the perspectives of the growing immigrant and non-English speaking communities in Pittsburgh. Objectives of this RCR include: 1) understanding the inclusion of non-English speaking communities into clinical and translational research, from a health equity and anti-racist perspective; 2) reviewing best practices for translations; and 3) building bilingual and bicultural research teams. (subject matter: human participants)

Preparing Data for Analysis, presented by Deborah Martin and Theresa Sax, CTSI BERD, on April 19, 2022. Note: This workshop is fourth in a series of five workshops co-sponsored by CTSI Biostatistics, Epidemiology and Research Design Core and the RCR Center. Publication of results is the point of a trial, and collected data may need to be groomed and summarized for proper analysis.  Topics will include creation of analysis variables and summary datasets, periodic database freezes, and cataloging of analysis data, programs, and results. (subject matter: data acquisition)

Informed Consent 101, presented by Michael Green, MD, MPH, Professor of Pediatrics, Surgery & Clinical and Translational Science, Clinical Translational Science Institute University of Pittsburgh School of Medicine, on April 20, 2022. This session will include a discussion of ethical & regulatory implications of informed consent, protecting participant rights, and ways to help participants understand biomedical research in the hopes to form a more honest, trusting, and respectful relationship with clinical investigators. Case-studies will be discussed. (subject matter: human participants)

Confronting Research Misconduct – What you need to know, presented by Craig Wilcox, PhD, Research Integrity Officer, on April 26, 2022. Attendees will learn how federal regulation and University policy define research misconduct, and what to do if they observe possible misconduct.  Case studies will be presented, and the University response to allegations of research misconduct will be described, including the process of investigation and sanctions. Attendees will also learn steps to take that can help reduce the possibility of research misconduct in their laboratories. (subject matter: research misconduct) 

Rigor & Reproducibility (R&R) in Reporting: From Project Proposal to Publication, presented by Helena Vonville, Graduate School of Public Health Liaison AND Research and Instruction Librarian, on May 3, 2022. This session is part of series on Rigor & Reproducibility. Receiving approval for funding from granting agencies is more competitive than ever. Granting agencies expect both rigor and reproducibility without providing much guidance. This session will focus on health research reporting guidelines to enhance rigor and reproducibility while writing project proposals/protocols, IRB submissions, conference presentations, and publications of findings.  (subject matter: data acquisition)

Study Closeout and Archiving, presented by Deborah Martin and Theresa Sax, CTSI BERD, on May 18, 2022. The study database is rarely the final resting place for data. Data may be shared throughout the project, and at study, closeout must be archived and, as requested, publicly shared. Techniques in sharing, de-identification, and archiving will be discussed. (subject matter: data acquisition) This workshop is the final in a series of five workshops co-sponsored by CTSI Biostatistics, Epidemiology, and Research Design Core and the RCR Center.

Animal Research Protections and the Institutional Animal Care and Use Committee (IACUC), presented by Deborah L. Chapman, Ph.D., Associate Professor, Department of Biological Sciences, Chair, Institutional Animal Care and Use Committee on May 19, 2022. This workshop is for researchers using vertebrate animals in research and education. It will cover 1) the role of the Institutional Animal Care and Use Committee (IACUC), 2) laws and agencies that govern how the IACUC functions, 3) the IACUC protocol submission and review process, including who can submit a protocol, turnaround time, tips for writing a protocol, 4) training and who to reach out to for additional help with animal research, and 5) how to maintain compliance. (subject matter: animal subjects)

Building a Lab Culture, presented by Bee Schindler, LMSW, Diversity and Inclusion Training Manager, Health Sciences Diversity, Equity, and Inclusion, University of Pittsburgh, on June 7, 2022. Laboratories have cultures unto themselves, separate and apart from the larger organizational culture.  How do leaders and supervisors influence lab culture?  How can leaders and supervisors change lab culture? This workshop will include discussion of how lab culture is established and how it can made to be more inclusive and sustainable. (subject matter: mentor/mentee)

Responsible Conduct of Research Principles and Application, presented by Teri Reiche, CIP, CTSI, on September 8, 2021. Principles of Responsible Conduct of Research (RCR) that promote safe, ethical, and successful research will be examined. Case studies illustrating specifics such as conflict of interest and research misconduct will be discussed, along with information on federal and university research resources that are available for investigators and students. (subject matter: scientist in society)

Using Critical Appraisal to Assess the Rigor of the Prior Research, presented by Rebekah Miller, MLIS, Health Sciences Library System on September 15, 2021. This session is part of series on Rigor & Reproducibility. When applying for grants, have you ever wondered how best to meet the NIH requirement to assess the rigor of the prior research in your field? Critical appraisal can help readers determine whether a study's results are valid, what the results are, and whether they are relevant to you. This class will cover the basics of critically appraising studies, including study design, methods, bias, and confounding. Join us for the follow up session entitled, “Critical Appraisal Journal Club, individual session” on September 28. Note: You must register for each session separately. (subject matter: data acquisition)

Smooth Sailing with the IRB, presented by Jean Barone, HRPO Director and Melissa Miklos, HRPO Associate Director on September 23, 2021. There is more to know about your submission to the IRB than compliance with the regulations. This session will recommend ways to strengthen your IRB submission and explore areas that may require special care and consideration (including but not limited to community research, single IRB, recruitment and incentive challenges). (subject matter: human participant research)

Critical Appraisal Journal Club (individual session), presented by Rebekah Miller, MLIS, Health Sciences Library System & Maria Mori Brooks, PhD, Professor of Epidemiology and Biostatistics, CTSI BERD, on September 28, 2021. As a follow up to the RCR session, “Using Critical Appraisal to Assess the Rigor of the Prior Research” on September 15, this session is part of series on Rigor & Reproducibility. This session will be a discussion-based journal club, critically appraising a journal article in order to determine its validity, relevance, and rigor. The article will be provided before this session. Those who attended “Using Critical Appraisal to Assess the Rigor of the Prior Research” are encouraged to attend this session. (subject matter: data acquisition)

Ethical Study Design and Informed Consent in Biomedical Research in Special Populations, presented by Aimee B. Biller, M.D., Ethics facilitator, CTSI, Associate Professor of Pediatrics, UPSOM on October 5, 2021. To achieve the goals of precision medicine it is imperative that human subjects research be inclusive and conducted in a way that inspires trust in all populations. Bioethical principles require vigilance both in the design of, and consent for, clinical trials in many special populations. Attendees will learn the moral reasoning behind current safeguards for certain populations as well as consider emerging bioethical issues in human subjects research. (subject matter: human participant research)

Study Design, presented by Anthony Fabio, PhD, MPH, Associate Professor of Epidemiology Data Center, University of Pittsburgh, Director, Consortium for Injury Research and Community Action (CIRCA), and G.K. Balasubramani, MSc., PhD., Associate Professor, Department of Epidemiology, University of Pittsburgh on October 12, 2021. Note: This workshop is co-sponsored by CTSI Biostatistics, Epidemiology and Research Design Core and the RCR Center. For a research study to successfully answer the clinical question being addressed, the appropriate study design must be implemented. The purpose of this workshop will be to provide a basic overview of common study designs, as well as the advantages and limitations of each approach. (subject matter: data acquisition)

Enhancing Reproducibility through Transparency in Reporting Experimental Details, presented by Melissa Ratajeski, MLIS, AHIP, on October 13, 2021. This session is part of a series on Rigor & Reproducibility. NIH expects full transparency in reporting experimental details so that others may reproduce and extend the findings. This session will discuss ways to report experimental details including: open dissemination of methodology protocols, pre-registration of study protocols, and publication of registered reports. (subject matter: data acquisition)

Communicating Science, presented by Judy Cameron, PhD, Department of Psychiatry, on November 2, 2021. All audiences want to learn interesting new scientific information and have it delivered as a good story in an understandable format. This workshop will assist you in learning how to convey the importance of your message while being interesting, maintaining the attention of the audience and making the learning process enjoyable. An overview of scientific communication skills, including knowing your audience and why they are interested in the information you are speaking about, how to translate scientific jargon into understandable concepts for the public, and how to keep the audience engaged will be presented. (subject matter: scientist in society)

Incorporating Equity Into Medical Research: Essential Frameworks and Potential Data Sources, presented by Leslie R. M. Hausmann, PhD, Associate Professor of Medicine, Division of General Internal Medicine, on November 3, 2021. This session will provide an introduction to research on disparities in health and health care. Following a brief review of key terms and historical context, the session will orient participants to several conceptual models that have been developed to guide disparities research. The session will end with a discussion of publicly available data sources that participants can use to begin incorporating equity into their own research agendas. Objectives include defining important terms in disparities research, and make important distinctions, such as social justice, differences vs. disparities, health vs. health care disparities, and marginalized populations, describing different conceptual models of health care disparities, and explaining where to find publicly available data sources that can be used to detect disparities in health and healthcare. (subject matter: scientist in society)

Preprints, How, Why, and Should I? presented by Melissa Ratajeski, MLIS, AHIP and Carrie Iwema, PhD, HSLS, on November 16, 2021. In this workshop, we will discuss the facts and myths of preprint publication, addressing the questions: “What are preprints?” “Can I still publish in a peer reviewed journal?” (subject matter: responsible authorship)

Describing and Defining Your Data, presented by Deborah Martin and Theresa Sax, CTSI BERD on November 17, 2021. Note: This workshop is part of a series of 5 workshops co-sponsored by CTSI Biostatistics, Epidemiology and Research Design and the RCR Center. Beginning with the assumption that a study has been designed, its aims and hypotheses clearly defined, and the data to be collected have been broadly identified, this workshop will address: Part 1 - How to critically review your proposed data collection instruments, including issues of form design, validated vs standardized instruments, and foreign language translations; Part 2 – How to convert the Table of Measures from your grant proposal into a tool to document data collection sources and track form development, file transfer protocols, and versioning; Part 3 - How to create a data dictionary that can be used to build a data collection system.  Topics include variable naming conventions, types, codes, dependency, and validations (subject matter: data acquisition).

Community Partner Research Ethics Training (CPRET), presented by Elizabeth Miller, MD, PhD, Director, Division of Adolescent and Young Adult Medicine, Academic Co-Director, CTSI Community PARTners (Community Engagement Core) and RaNaja Kennedy, Community Engagement Facilitator, CTSI Community PARTners on November 23, 2021. Join us to learn about a Pitt-IRB approved research ethics training for community partners. CPRET was designed to help principal investigators and research coordinators tailor research ethics training for a specific study and to encourage dialogue with community members who will participate on the research team. This training is particularly relevant for investigators engaged in clinical and translational research involving community stakeholders. Investigators have the opportunity to create and discuss scenarios that may arise in the course of their specific study while ensuring that Core research ethics principles – i.e., autonomy, beneficence, and justice – are defined and reviewed. Particular attention will be paid to reflecting on history and the vital importance of building trustworthiness in research through this CPRET process. (subject matter: collaborative research)

Planning Your NIH Application for the Best Review Possible, presented by Michelle Kienholz, CTSI, on November 30, 2021. This session is part of series on Rigor & Reproducibility. When planning and preparing an NIH grant application of any type, your focus must be on the intended audience: your peers on the Scientific Review Group (study section). This workshop will first review NIH tools to use in identifying the best review group(s) for your science – a critical task in planning and preparing any NIH grant application. We will then focus on crafting the application narratives to address the stated review criteria as well as the rigor, reproducibility, and scientific merit of the research more broadly throughout. We will also go through available training in methods to enhance reproducibility, which is important in T, F, and K applications. The goal is to help applicants prepare competitive applications that give the right reviewers the right information to complete an informed review – and to make this task as easy and pleasant as possible. (subject matter: peer review)

Pitt + Me + Kids, presented by Kerri Jackson, CTSI, on December 8, 2021. Pitt+Me links participants of all ages with research studies at the University of Pittsburgh and UPMC. Join us to find out how your study team can use this free service to recruit the pediatric participants you need to meet your research goals. (subject matter: human participant research)

Creating a Data Collection System (RCR workshop), presented by Deborah Martin and Theresa Sax, CTSI BERD, on December 14, 2021. Note: This workshop is the second in a series of five workshops co-sponsored by CTSI Biostatistics, Epidemiology and Research Design Core and the RCR Center. In this workshop, you will learn how to build a REDCap longitudinal data collection system that includes eConsenting, automated surveys, quality control features, simple reporting, and exporting your data for analyses. (subject matter: data acquisition)

Building Reproducibility Into Research Practice: Authentication Requirements and Research Design, presented by Janette Lamb, PhD, Genomics Research Core, Health Sciences Core Research Facilities, on December 15, 2021. This session is part of a series on Rigor & Reproducibility. It has been estimated that at least 50% of basic and preclinical research cannot be reproduced. How can project design contribute to robust, reproducible data? We will discuss how replication can lead to greater data confidence, what controls are appropriate and how N affects high content technologies. (subject matter: data acquisition)

Communicating Science, presented by Judy Cameron, Ph.D., Department of Psychiatry on January 12, 2021. All audiences want to learn interesting new scientific information and have it delivered as a good story in an understandable format. This workshop will assist you in learning how to convey the importance of your message while being interesting, maintaining the attention of the audience, and making the learning process enjoyable. An overview of scientific communication skills, including knowing your audience and why they are interested in the information you are speaking about, how to translate scientific jargon into understandable concepts for the public, and how to keep the audience engaged will be presented. (subject matter: scientist in society)

Authorship Conflict, presented by Tetsuro Sakai, MD, PhD, MHA, Professor of Anesthesiology and CTSI, Vice-Chair for Professional Development, Director, Resident Research Rotation, Department of Anesthesiology and Perioperative Medicine, on January 14, 2021. Upon the completion of this workshop based on actual examples of authorship conflict observed in an academic center, the attendees will be able to describe authorship eligibility in scientific manuscripts, indicate potential types and causes of authorship conflict, and discuss possible methods to solve, address, and avoid authorship conflict. (subject matter: responsible authorship)

“3R” Literature Searching for Animal Research Protocols, presented by Melissa Ratajeski, MLIS, AHIP, Health Sciences Library System, on January 21, 2021. Researchers using warm-blooded species (other than birds, mice of the genus Mus, and rats of the genus Rattus) classified in the USDA Pain Classification D or E are required to conduct a literature review addressing the 3Rs: Refinement, Reduction, and Replacement.  This session will provide tips for searching the literature and meeting the IACUCs requirements. (subject matter: animal subjects)

Mentoring and Teaching Students, presented by Bill Yates, PhD, Vice Chancellor for Research Protections and Professor of Otolaryngology, on January 26, 2021. Providing education to diverse populations (e.g., residents, medical students, graduate students, undergraduate students, lay members of the public) is an important component of a scientist's responsibilities. However, unlike K-12 teachers, scientists receive little or no formal education about teaching strategies. This workshop is intended to provide general education strategies that are effective for any audience. (subject matter: mentor/mentee)

Using Animals Responsibly in Biomedical Research, presented by Amy Cassano, DVM, DACLAM, cVMA. Attending Veterinarian of DLAR, on January 28, 2021. This workshop discusses considerations and practical approaches to the responsible conduct of animal based biomedical research. Strategies to foster productive, collaborative working relationships and facilitate successful animal research at the University of Pittsburgh will be presented. (subject matter: animal subjects)

Managing Conflict of Interest: Protecting the Integrity of Research, presented by Jane Volk, Office of Research Protections, Conflict of Interest Division, on February 2, 2021. This workshop introduces the importance of conducting safe, ethical, and successful research. Topics include conflicts of interest and research misconduct. Attendees will be equipped to identify RCR issues and policies that guide their research management. (subject matter: conflict of interest)

Managing Up, Down, and All Around, presented by Doris Rubio, Assistant Vice Chancellor for Clinical Research Education and Training, Health Sciences, Director, Institute for Clinical Research Education, Professor of Medicine, Biostatistics, Biomedical Informatics, Nursing, and Clinical Translational Science, on February 4, 2021. Leadership involves successfully managing relationships with people above, below, and lateral to you in the academic hierarchy. This session highlights the importance of these relationships and provides tips on managing your mentor (up), being a good mentor and staff supervisor (down), and providing peer mentorship to colleagues (all around). (subject matter: mentor/mentee)

Study Design (RCR/BERD workshop), presented by Stephen Wisniewski, PhD, Professor of Epidemiology, Co-Director, Epidemiology Data Center, Vice Provost for Budget and Analytics, on February 9, 2021. For a research study to successfully answer the clinical question being addressed, the appropriate study design must be implemented.  The purpose of this workshop will be to provide a basic overview of common study designs, as well as the advantages and limitations of each approach. Note: This workshop is co-sponsored by CTSI Biostatistics, Epidemiology and Research Design Core and the RCR Center. (subject matter: data acquisition) 

(Don’t) Lie with Statistics, presented by Li Wang, MS, and PJ Grosse, CTSI Biostatistics, Epidemiology and Research Design, February 10, 2021. How do you know your statistics are done right? In this workshop, we will present accounts of misleading or inaccurate use of statistics in research and provide approaches on how to avoid these common pitfalls. (subject matter: research misconduct)

Creating a Data Collection System (RCR workshop), presented by Heather Eng, CTSI BERD, on February 11, 2021. In this workshop, you will learn how to build a REDCap longitudinal data collection system that includes eConsenting, automated surveys, quality control features, simple reporting, and exporting your data for analyses. Note: This workshop is the second in a series of five workshops co-sponsored by CTSI Biostatistics, Epidemiology and Research Design Core and the RCR Center. (subject matter: data acquisition)

The Publication Process: An Editor’s View, presented by Bill Yates, PhD, Vice Chancellor for Research Protections and Professor of Otolaryngology, on February 17, 2021. In today’s competitive funding environment, productivity is extremely important. However, the peer review process has been compromised by time constraints of researchers. This session discusses the problems that may occur during peer review of manuscripts (including ethical concerns), and the steps that authors can take to address these problems. The session is intended to provide insights into how an author can best guide their paper successfully through the peer review process. (subject matter: responsible authorship)

How to Partner with and Recruit in Schools, presented by Lisa Ripper, MPH, CPH, CTSI Community Health Research Manager, and Dr. Elizabeth Miller, MD, PhD, FSAHM, Director, Division of Adolescent and Young Adult Medicine Medical Director, Children's Hospital of Pittsburgh; Academic Co-Director, CTSI Community PARTners (Community Engagement Core), University of Pittsburgh, on February 18, 2021. There are special considerations and processes for how to partner with schools to conduct research in schools as well as to recruit for research studies through schools. We will share experiences partnering with schools to facilitate research and will lead a discussion about how to work with schools. (subject matter: collaborative research)

Bias in Scientific Literature, presented by Keith Vogt, MD, PhD, Assistant Professor, Departments of Anesthesiology & Perioperative Medicine and Bioengineering, on February 25, 2021. In this workshop, we will discuss sources of bias in scientific literature, including: falsified and incorrectly analyzed data, possible bias from publishers and media, the impact of proliferation of low-impact and predatory journals, and current research culture favoring positive results and little replication. (subject matter: peer review)

Data Collection: Monitoring and Reporting, presented by Heather Eng, CTSI, on March 4, 2021. Research data must be constantly monitored and reported as it accrues.  We will discuss issues in quality control for completeness, correctness, and logical consistency; specimen tracking; reporting on data accrual; alerting appropriate parties about problems or exceptions; and modifying forms and underlying data mid-study as necessary. Note: This workshop is the third in a series of five workshops co-sponsored by CTSI Biostatistics, Epidemiology and Research Design Core and the RCR Center. (subject matter: data acquisition)

An Author’s Responsibilities: Publication and Authorship, presented by Robert Weyant, DMD, DrPH, professor and Associate Dean, School of Dental Medicine, on March 10, 2021. The author’s role in writing, submitting, and ultimately publishing scientific research results ethically will be discussed. Perspectives of the first author, coauthors, journal editors, and other contributors to scientific publication will be addressed. (subject matter: responsible authorship) 

Relationship Therapy: Investigators and Statisticians, presented by Li Wang and PJ Grosse, CTSI Biostatistics, Epidemiology, and Research Design Core, on March 12, 2021. Our objective in this workshop is to go beyond the usual generic advice given to researchers seeking to consult with biostatisticians. We will provide specific suggestions for common problem areas in the investigator/statistician collaboration. Through a series of case vignettes and discussion, we will illustrate the best methods for working productively with a biostatistician on your research. (subject matter: collaborative research)

Pitching Your Science, presented by Aneesh Ramaswamy, PhD, CTSI Project Manager, and Dana Farrell, BS, Project Manager, on March 16, 2021. Pitching your Science is a workshop designed to help you convert scholarly descriptions of your work to succinct, vivid pitches that accurately convey the purpose and promise of your science. Our objective is to enable you to effectively communicate your science to stakeholders at different presentation lengths (30 seconds, 2-5 minutes, 10 minutes) while generating excitement and interest in the work. (subject matter: science in society)

Close Encounters of the Authorship Kind – Why You Need an Authorship Agreement, presented by Colleen Mayowski, EdD, MLIS, University of Pittsburgh Institute for Clinical Research Education, on March 17, 2021. What is an Authorship Agreement? Do you really need one? In this session, we’ll look at several examples of authorship misconduct highlighted in the scientific literature, share evidence of the need for an authorship agreement at the University of Pittsburgh, and provide an Authorship Agreement template that you can customize for your own use. (subject matter: responsible authorship)

Incorporating Equity into Medical Research: Essential Frameworks and Potential Data Sources, presented by Leslie R. M. Hausmann, PhD, Associate Professor of Medicine, Division of General Internal Medicine, March 23, 2021. This session will provide an introduction to research on disparities in health and health care. Following a brief review of key terms and historical context, the session will orient participants to several conceptual models that have been developed to guide disparities research. The session will end with a discussion of publicly available data sources that participants can use to begin incorporating equity into their own research agendas. Objectives include defining important terms in disparities research, and make important distinctions, such as social justice, differences vs. disparities, health vs. health care disparities, and marginalized populations, describing different conceptual models of health care disparities, and explaining where to find publicly available data sources that can be used to detect disparities in health and healthcare. Attendees should plan to join this interactive discussion on their computers and not by phone. (subject matter: scientist in society)

How the NIH Can Help You Get Funded, presented by Michelle Kienholz, CTSI, March 25, 2021. Using NIH tools and expertise can improve odds of a successful application. In this workshop, we will discuss strategies to make the most of NIH staff and resources to plan and prepare a competitive application and manage the post-submission outcome. Bring questions you might have about the NIH and its grant application and review process. (subject matter: peer review)

It’s Only a Model: What Can and Can’t Be Learned from Computation, presented by Timothy Lezon, PhD, Department of Computational & Systems Biology, on March 30, 2021. Like any research tool, computational modeling is most effective if the user has a good feel for its inner workings. Communication failure between quantitative and wet bench scientists can doom transdisciplinary projects. This session will address the strengths and limitations of computational models, and will explore strategies for effectively communicating across disciplines. (subject matter: collaborative research) 

Intellectual Property Concepts, presented by Michael Madison, JD, University of Pittsburgh School of Law, on April 2, 2021. The presentation will review basic concepts defining patent law and other IP systems, and how they relate to university-based research, scholarship, and teaching. (subject matter: scientist in society)

Preparing Data for Analysis, presented by Heather Eng, CTSI BERD, on April 6, 2021. Publication of results is the point of a trial, and collected data may need to be groomed and summarized for proper analysis. Topics will include creation of analysis variables and summary datasets, periodic database freezes, and cataloging of analysis data, programs, and results. (subject matter: data acquisition) Note: This workshop is the fourth in a series of five workshops co-sponsored by CTSI Biostatistics, Epidemiology and Research Design Core and the RCR Center.

Establishing Positive Culture in Clinical Research, presented by Sanjay Patel, MD, MS, Professor of Medicine, Director, Sleep and Cardiovascular Outcomes Center, on April 14, 2021. Having a positive culture in the workplace is vital for optimizing productivity and this is particularly true in clinical research labs where teams must work together to be effective. Challenges to establishing and maintaining the work environment in clinical research will be reviewed as well as strategies to foster a high performance culture. (subject matter: collaborative research)

Using Electronic Lab Notebooks, presented by Carrie Iwema, PhD, MLIS, AHIP, on April 20, 2021. This workshop will focus on the Electronic Lab Notebook (ELN) selected by the University of Pittsburgh, LabArchives. We will cover how to get started using it, including access, lab notebook creation and organization, adding and editing entries, linking, and sharing data. (subject matter: data acquisition)

Confronting Research Misconduct – What You Need to Know, presented by Craig Wilcox, PhD, Research Integrity Officer, on April 21, 2021. Attendees will learn how federal regulation and University policy define research misconduct, and what to do if they observe possible misconduct. Case studies will be presented, and the University response to allegations of research misconduct will be described, including the process of investigation and sanctions. Attendees will also learn steps to take that can help reduce the possibility of research misconduct in their laboratories.(subject matter: research misconduct) 

Establishing Positive Culture in Clinical Research, presented by Sanjay Patel, MD, MS, Professor of Medicine, Director, Sleep and Cardiovascular Outcomes Center on April 14, 2021. Having a positive culture in the workplace is vital for optimizing productivity and this is particularly true in clinical research labs where teams must work together to be effective. Challenges to establishing and maintaining the work environment in clinical research will be reviewed as well as strategies to foster a high performance culture. (subject matter: collaborative research)

Using Electronic Lab Notebooks, presented by Carrie Iwema, PhD, MLIS, AHIP, on April 20, 2021. This workshop will focus on the Electronic Lab Notebook (ELN) selected by the University of Pittsburgh, LabArchives. We will cover how to get started using it, including access, lab notebook creation and organization, adding and editing entries, linking, and sharing data. (subject matter: data acquisition)

Confronting Research Misconduct – What You Need to Know, presented by Craig Wilcox, PhD, Research Integrity Officer, on April 21, 2021. Attendees will learn how federal regulation and University policy define research misconduct, and what to do if they observe possible misconduct. Case studies will be presented, and the University response to allegations of research misconduct will be described, including the process of investigation and sanctions. Attendees will also learn steps to take that can help reduce the possibility of research misconduct in their laboratories.(subject matter: research misconduct) 

Inclusion of English Learners in Clinical and Translational Research, presented by Maya Ragavan, MD, MPH, MS, Assistant Professor of Pediatrics, Children's Hospital of Pittsburgh and and Patricia I. Documet, MD, DrPH, Associate Professor, Behavioral and Community Health Sciences Director, Doctoral Program, Latinx Research and Outreach Director, Center for Health Equity, University of Pittsburgh, on April 29, 2021. This session will provide an introduction to equitably including communities whose primary language is not English into research. Inclusion of non-English speaking communities is essential to promoting health equity and ensuring that our work centers the perspectives of the growing immigrant and non-English speaking communities in Pittsburgh. Objectives of this RCR include: 1) understanding the inclusion of non-English speaking communities into clinical and translational research, from a health equity and anti-racist perspective; 2) reviewing best practices for translations; and 3) building bilingual and bicultural research teams. (subject matter: human participants)

Animal Research Protections and the Institutional Animal Care and Use Committee (IACUC), presented by Deborah L. Chapman, Ph.D., Associate Professor, Department of Biological Sciences, Chair, Institutional Animal Care and Use Committee, on April 30, 2021. This workshop is for researchers using vertebrate animals in research and education. It will cover 1) the role of the Institutional Animal Care and Use Committee (IACUC), 2) laws and agencies that govern how the IACUC functions, 3) the IACUC protocol submission and review process, including who can submit a protocol, turnaround time, tips for writing a protocol,  4) training and who to reach out to for additional help with animal research, and 5) how to maintain compliance. (subject matter: animal subjects)

Study Closeout and Archiving, presented by Heather Eng, CTSI BERD, on May 4, 2021. Note: This workshop is the final in a series of five workshops co-sponsored by CTSI Biostatistics, Epidemiology and Research Design Core, and the RCR Center. The study database is rarely the final resting place for data. Data may be shared throughout the project, and at study, closeout must be archived and, as requested, publicly shared. Techniques in sharing, de-identification, and archiving will be discussed. (subject matter: data acquisition)

Informed Consent 101, presented by Michael Green, MD, MPH, Professor of Pediatrics, Surgery & Clinical and Translational Science, Clinical Translational Science Institute University of Pittsburgh School of Medicine, on May 19, 2021. This session will include a discussion of ethical & regulatory implications of informed consent, protecting participant rights, and ways to help participants understand biomedical research in the hopes to form a more honest, trusting, and respectful relationship with clinical investigators. Case-studies will be discussed. (subject matter: human participants)

Laboratory Safety:  Beyond Bloodborne Pathogens and Chemical Hygiene, presented by Molly S. Stitt-Fischer, PhD, CPH, CBSP, SM(NRCM), University Biosafety Officer and Alternate Responsible Official for Select Agents, Department of Environmental Health and Safety, University of Pittsburgh, on May 20, 2021. Do you know when you should use a chemical fume hood vs a biosafety cabinet?  Are you confident that your chemicals are appropriately separated and stored?  Do you feel confident listing the biological, chemical, physical and other hazards present in your research laboratory and identifying the measures used to mitigate risks associated with these hazards?  This session will use case studies to point out key differences between risk assessment for hazards in research laboratories and non-laboratory environments.  We will discuss EH&S resources available to assist you in assessing risk and developing safe research plans.  We will also review answers to common questions and observations made during EH&S laboratory safety surveys and training sessions. (subject matter: safe laboratory practices)

Responsible Conduct of Research Principles and Application, presented by Teri Reiche, CTSI, on November 18, 2020. Principles of Responsible Conduct of Research (RCR) that promote safe, ethical, and successful research will be examined. Case studies illustrating specifics such as conflict of interest and research misconduct will be discussed, along with information on federal and university research resources that are available for investigators and students. (subject matter: scientist in society)

Community Partner Research Ethics Training (CPRET): A Strategy for Improving Recruitment and Retention, presented by Bee Schindler, LMSW, and Erricka Hager, MPH, Community Engagement Coordinators, CTSI Community PARTners, on November 19, 2020. Join us to learn about a Pitt-IRB approved research ethics training for community partners. CPRET was designed to help principal investigators and research coordinators tailor research ethics training for a specific study and to encourage dialogue with community members who will participate on the research team. This training is particularly relevant for investigators engaged in clinical and translational research involving community stakeholders. Investigators have the opportunity to create and discuss scenarios that may arise in the course of their specific study while ensuring that Core research ethics principles – i.e., autonomy, beneficence, and justice – are defined and reviewed (subject matter: collaborative research)

Conducting Ethical Human Participant Research, presented by Teri Reiche, CTSI, on November 24, 2020. This workshop discusses ethical issues and policies, using recent cases to highlight ethical principles governing human participant research. Attendees will learn to recognize lapses in ethical research practice and the importance of human participant safety in conducting successful clinical research. (subject matter: human participant research)

Preprints, How, Why, and Should I? presented by Melissa Ratajeski, MLIS, AHIP and Carrie Iwema, PhD, HSLS, on December 4, 2020. In this workshop, we will discuss the facts and myths of preprint publication, addressing the questions: “What are preprints?” “Can I still publish in a peer reviewed journal?” (subject matter: responsible authorship)

Pitt + Me + Kids, presented by Kerri Jackson & Heather Rockwell, CTSI, on December 8, 2020. The Pitt + Me Research Recruitment Program is CTSI’s strategic platform for study recruitment, engagement, and retention. Come to this workshop to find out how your study team can recruit the pediatric participants you need to meet your research aims, using Pitt + Me. (subject matter: human participant research)

Best Practices for Reproducible Science, presented by Janette Lamb, PhD, Genomics Research Core, Health Sciences Core Research Facilities, on December 14, 2020. It has been estimated that at least 50% of basic and preclinical research cannot be reproduced. How can project design contribute to robust, reproducible data? We will discuss how replication can lead to greater data confidence, what controls are appropriate and how N affects high content technologies. (subject matter: data acquisition)