RCR Workshops Descriptions

A Sample of One: Biohacking

Karen Schmidt, PhD, Regulatory Knowledge and Support, CTSI.

A popular biohacker said, “You can hack your own biology” to discover innovative approaches to improving human health. In this workshop we explore the ethical implications of individuals experimenting on themselves and the potential impact of biohackers on traditional research and development of medical products.

Work/Work Balance: Conflict of Commitment

Karen Schmidt, PhD, Regulatory Knowledge and Support, CTSI.

Academic researchers face non-financial conflicts of interest daily when deciding among competing demands on their time. Research design, data collection, mentoring, teaching, and other duties compete for attention. In this workshop, we discuss the multiple competing demands on investigators and potential strategies for evening out the work/work balance in an ethical and responsible manner.

Managing Conflicts of Interest

Shawna Porter, MSW, Research Conduct and Compliance Office.

This workshop introduces the importance of conducting safe, ethical, and successful research. We use cases to illustrate specific RCR issues, such as conflict of interest and research misconduct. Attendees will be equipped to identify RCR issues and policies that guide their research management.

Qualitative Research Ethics

Megan Hamm, PhD, Department of Medicine.

Qualitative research (interviews, focus groups, and observation) is human-subjects research and involves ethical decisions and considerations like any other research. However, the specific risks and benefits of participating in qualitative research are somewhat different than in other areas of research. This workshop walks participants through those issues and discusses how to conduct qualitative research in an ethical and rigorous manner.

Make it Real: Taking the Leap from Proposal to Study Protocol

Patrick Fawcett, Research Conduct and Compliance Office

Karen Schmidt, PhD, Regulatory Knowledge and Support, CTSI.

In clinical research, operationalizing a study via a written protocol is distinct from the grant proposal and IRB application. It is important to specify and describe certain key aspects in writing, including endpoints and outcomes to be measured, before beginning the study. As registering and disseminating summary results of clinical trials in the public domain is evolving beyond legal and policy requirements to be more of an ethical expectation, having a solid study protocol in place is more important now than ever before. Join us for a workshop exploring some available tools to facilitate and simplify the protocol writing process.

Ethics of Rare Disease Research

Karen Schmidt, PhD, Regulatory Knowledge and Support, CTSI.

Research ethics dilemmas faced by rare-disease researchers are discussed as a special case in the wider context of research integrity. A combination of factors converges to create unique challenges for the application of traditional research ethics concepts and standards in rare disease research. Primary among these concerns are the expectations for advocacy and resulting potential conflicts of interest in researchers working with the rare-disease patient population.

Informed Consent 101

Michael Green, MD, MPH, Professor of Pediatrics and Surgery

Karen Schmidt, PhD, Regulatory Knowledge and Support, CTSI.

Discussion points include ethical implications, protecting participant rights, and ways to help participants understand biomedical research and form more honest, trusting, and respectful relationships with clinical investigators.

High Stakes Consenting

Michael Green, MD, MPH, Professor of Pediatrics and Surgery

Karen Schmidt, PhD, Regulatory Knowledge and Support, CTSI.

Vulnerable populations present a unique set of demands for clinical research. Using cases, we will discuss how to identify potentially vulnerable participants and develop strategies and techniques for designing a consent experience that supports a responsible and ethical research consent process.

Show me the Money:  Paying Research Participants

Karen Schmidt, PhD, Regulatory Knowledge and Support, CTSI

George Cerminara, Office of Finance. 

During this presentation we will discuss a variety of compensation issues.  Why do people participate in research? Should subjects be “incentivized” or otherwise compensated? What types of incentives are appropriate? How should the value be established? And do “special populations” require special treatment?

Responsible Use of Animals in Biomedical Research

David Schabdach, MS, DVM, Senior Executive Director, DLAR.

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 are presented.

Using Animals Responsibly in Biomedical Research

Amy Cassano, Senior Executive Director of DLAR. 

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.

Building A Lab Culture

Paula Davis, MA, Assistant Vice Chancellor for Health Sciences Diversity.

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 includes discussion of how lab culture is established and how it can made to be more inclusive.

Strategies for Effective Teaching and Mentoring of Students

Bill Yates, PhD, Co-Director, Research Conduct and Compliance Office.

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.

Establishing Positive Culture in Clinical Research

Sanjay Patel, MD, PhD, Professor of Medicine, Director, Sleep and Cardiovascular Outcomes Center.

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.

Establishing and Managing Multidisciplinary Research Teams

Mindi Styn, PhD., Thomas Starzl Transplantation Institute.

The research team, including staff and students, can make or break a research study. In this workshop, we discuss strategies for developing the most appropriate research team for your study, creative approaches to building a team, and managing teams with diverse experience and expectations.

Responsibly Reusing Data

Melissa Ratajeski, MLIS, AHIP, Health Science Librarian.

Need to find a dataset to act as a control for your study? Or do you want to reuse open access data? This workshop offers tips for locating and citing data, and includes hands-on exercises to explore directories of data repositories and data journals.

Respectfully Engaging and Retaining Diverse Research Communities in Research Practices

Bee Schindler, Community Engagement Coordinator, CTSI

Maddie Rigatti, CTSI

Erricka Hager, The Urban League of Greater Pittsburgh. 

This session discusses how to engage communities through transparency and inclusion while fostering understanding of research practices in diverse communities. Learn tips and best practices for staff involved with research in communities. Develop skills that help to diversify recruitment efforts while remaining compassionate, kind, and respectful of all persons with a focus on inclusion and retention. Special attention and training is provided regarding community collaboration with ethnic minorities and older adult populations.

Investigators and Statisticians: Relationship Therapy

Nalyn Siripong, PhD, and Li Wang, MS,

Biostatistics, Epidemiology, and Research Design Core, CTSI.

This workshop goes beyond the usual generic advice given to researchers seeking to consult with biostatisticians and provides specific suggestions for common problem areas in the investigator/statistician collaboration. Through a series of case vignettes and discussions, we illustrate the best methods for working productively with a biostatistician on your research. 

It’s only a Model: Understanding what can and can’t be learned from computation

Timothy Lezon, PhD, Department of Computational and Systems Biology.

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 addresses the strengths and limitations of computational models and explores strategies for effectively communicating across disciplines.

Risks and Rewards of Collaborating through Shared Data Repositories

James Ibinson, MD, PhD, Department of Anesthesiology.

Funding agencies have compelled researchers to include plans for sharing data from their research projects through data repositories. Although sharing is widely encouraged, the relative risks and rewards of using these data to fuel scientific collaborations remain relatively unknown for many investigators. This workshop promotes discussion of potential benefits for sharing research data through existing and emerging data repositories.

How to Partner with and Recruit in Schools

Elizabeth Miller, MD, PhD, FSAHM, Director, Division of Adolescent and Young Adult Medicine Medical Director, Children's Hospital of Pittsburgh; Academic Co-Director, Community PARTners, CTSI.

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. In this session, we share experiences about partnering with schools to facilitate research and lead a discussion about how to work with schools. 

Writing manuscript reviews

Daniel Buysse, MD, Professor of Psychiatry. Director, HUB Capacity, CTSI.

Peer review of manuscripts is a cornerstone of the scientific process —but all reviews are not equal. Writing a GOOD manuscript review is a skill and an art that can benefit the reviewer as much as the reviewee. This session will delve into the why, how, and what of writing fair and incisive manuscript reviews.

Crafting a Data Management Plan

Carrie Iwema, PhD, MLS, AHIP, Health Sciences Library System.

This session presents the overwhelming advantages of devising and implementing a data management plan for research studies. Investigators are provided with specific steps and tools that can be used to develop and maintain a successful data management plan.

Best Practices for Reproducible Data

Janette Lamb, PhD, and Deborah Hollingshead, MS, Genomics Research Core, Health Sciences Core Research Facilities.

It has been estimated that at least 50 percent of basic and pre-clinical research cannot be reproduced. How can project design contribute to robust, reproducible data?  We discuss how replication can lead to greater data confidence, what controls are appropriate, and how N affects high content technologies.

Study Design

Stephen Wisniewski, PhD, Professor of Epidemiology, Co-Director, Epidemiology Data Center, Vice Provost for Data and Information.

This workshop is part of a series of workshops 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 is to provide a basic overview of common study designs, as well as the advantages and limitations of each approach.

Describing and Defining Your Data

Heather Eng, CTSI Biostatistics, Epidemiology, and Research Design

This workshop is part of a series of workshops co-sponsored by CTSI Biostatistics, Epidemiology and Research Design Core 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 addresses:

• Part 1:  How to critically review your proposed data collection instruments, including issues of form design, validated versus 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.

Data Collection:  Monitoring and Reporting

Heather Eng, CTSI Biostatistics, Epidemiology, and Research Design

This workshop is part of a series of workshops co-sponsored by CTSI Biostatistics, Epidemiology and Research Design Core and the RCR Center.

Accruing data must be constantly monitored and reported. We 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.

Preparing Data for Analysis

Heather Eng, CTSI Biostatistics, Epidemiology, and Research Design.

This workshop is part of a series of 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 include creation of analysis variables and summary datasets, periodic database freezes, and cataloging of analysis data, programs, and results.

Study Closeout

Heather Eng, CTSI Biostatistics, Epidemiology, and Research Design

This workshop is part of a series of 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, it must be archived and, as requested, publicly shared. Techniques in sharing, de-identification, and archiving are discussed.

Setting Up a Data Collection System

Heather Eng, CTSI Biostatistics, Epidemiology, and Research Design

This workshop is part of a series co-sponsored by CTSI Biostatistics, Epidemiology and Research Design Core and the RCR Center.

In this workshop, you will build a sample REDCap project and learn about point of entry quality control, longitudinal design, double entry verification, and exporting to Excel or SAS.

Fishing without a license: How data dredging can lead to misguided conclusions

Lauren Terhorst, Associate Professor, Department of Occupational Therapy.

Running several statistical analyses using the same data set without an a priori hypothesis can inflate the probability of a false significant finding. In this workshop, several examples of how data dredging has led to misguided conclusions in health research are discussed.

Using Electronic Lab Notebooks

Carrie Iwema, PhD, MLS, AHIP, Health Sciences Library System.

This workshop focuses on the Electronic Lab Notebook (ELN) used by the University of Pittsburgh, LabArchives. We cover how to get started using it, including access, lab notebook creation and organization, adding and editing entries, linking, and sharing data.

P-Hacking: Lessons from the Brian Wansink Scandal

Andrew D. Althouse, PhD, Assistant Professor of Medicine.

Dr. Brian Wansink was a professor at Cornell University, well-funded, highly visible, author of bestselling books—until his own blog post revealed a series of papers published using questionable research practices, setting his downfall in motion.  After years of grousing by statisticians, suddenly everyone is talking about “p-hacking” – always lurking under the surface, now thrust into the academic spotlight.  Learn what “p-hacking” is, why it’s problematic, and how to avoid it in your research.

Myths about Misconduct

Karen Schmidt, PhD, Regulatory Knowledge and Support, CTSI.

Researchers seeking to prevent research misconduct in their labs and in their research communities should be prepared to recognize the threats to scientific integrity that may arise. In this workshop, we will discuss myths about misconduct that may hamper early identification of questionable research practices or misconduct. Our objective is to communicate the current understanding of the facts surrounding sources of misconduct and the vulnerability of scientists to unethical behavior.

Digitally detecting plagiarism: approaches for protecting your science

Karen Schmidt, PhD, Regulatory Knowledge and Support, CTSI.

This workshop will provide current standards for evaluating scientific manuscripts for evidence of plagiarism, as well as a demonstration of state-of-the-art methods for digital detection of misappropriated work. A brief review of scientific plagiarism will be followed with discussion of best practices for presenting original work and protecting the integrity of your scientific publications.

An Author’s Responsibilities: Publication and Authorship  

Robert Weyant, DMD, DrPH, Professor and Associate Dean, School of Dental Medicine.

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.

The Publication Process: An Editor’s View

Bill Yates, PhD, Co-Director, Research Conduct and Compliance Office.

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.

Authorship Conflict

Tetsuro Sakai, MD, PhD, Professor, Director, Resident Research Rotation, Department of Anesthesiology.

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.

Is Social Science Reproducible?

Karen Schmidt, PhD, CTSI.

Recent investigations of scientific misconduct in the social sciences have raised questions about how social science data and qualitative research data in general are collected and shared. Replicating social science analyses and determining if results are reproducible can be difficult given the lack of information made available by investigators. We will discuss current thinking and methodological advances in social and behavioral data collection with the goal of optimizing scientific reproducibility through greater transparency. Improving reproducibility has the potential to advance research and at the same time may have the side effect of reducing misconduct.

Social Media in Research

Sarah Hurley, CTSI.

Social media can be a useful tool for your recruitment efforts, but advertising on social media is very different than just posting on Facebook. Learn how to determine if social media recruitment is right for you, how to go about setting it up and what the best practices are for success. Find answers to these questions as well as when you should start thinking about marketing your study.

Identifying Issues in the Responsible Conduct of Research

Karen Schmidt, PhD, Regulatory Knowledge and Support, CTSI.

Concepts of Responsible Conduct of Research (RCR) that promote safe, ethical, and successful research will be discussed. Case studies illustrating specifics such as conflict of interest and research misconduct will be shared, along with information on federal and University research resources that are available for investigators and students.

Ethical Marketing of your Research Study

Bill Young, Director of Marketing and Communications, CTSI.

Where do you turn to find study participants and what resources do CTSI and the University offer that can help you? Find out the answers to these questions as well when you should start thinking about marketing your study.

Communicating Science

Judy Cameron, PhD, Department of Psychiatry.

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.

Navigating the Path to Commercialization

John Maier, MD, PhD, Director, Innovation, CTSI, Assistant Professor of Family Medicine,

Don Taylor, PhD MBA, sciVelo Executive Director, Assistant Vice Chancellor for Commercial Translation in the Health Sciences.

In this workshop, we bring together experts in medical innovation to discuss multiple facets of the decision to commercialize health science innovations. Whether you are wondering about patenting your invention, what kind of funding might be appropriate for your next steps, or what commercialization might mean for your career, you are welcome to come and begin the discussion with us.

Plain Language for Research

Karen Schmidt, PhD, Regulatory Knowledge and Support, CTSI.

Communicating complex information about research studies to the public can be a challenge, and the best way to do this is to develop plain language descriptions of our work. In this workshop we will demonstrate best practices for presenting scientific research in accessible, simple, and accurate ways.