Q4RE: RCR Breakout Session D

RCR Breakout Session: Breaking Down the Silos in RCR Training
Tuesday, August 8, 2017
11:00AM - 12:30PM

Breakout Description
Presentations followed by Q&A.
Talks by Sharon Shriver, Ph.D. (PRIM&R), Aurali Dade, Ph.D. (George Mason University); Patricia Alt, Ph.D. (Towson University) and Mary Louise Healey (Johns Hopkins University); Session moderated by Debra Schaller-Demers, MSOM (Memorial Sloan Kettering Cancer Center).

Various institutional officials including RIOs, institutional counsel, and research administrators, may have different perspectives on what RCR training should focus on. This session tackles the need for RCR coordinators to incorporate these different perspectives, including trainees’ perspective, into the RCR program curriculum

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Thinking outside the box: RCR education for diverse audiences
Sharon Shriver, Ph.D.

Encouraging the responsible conduct of research is a multifaceted endeavor for any institution, and providing effective RCR education and training is a key component. There is no “one-size-fits-all” RCR curriculum or delivery method; programs need to be tailored to be a good fit for the institution and its goals, for the instructors and resources available, for the setting, and for the audience. This talk will discuss considerations when creating RCR educational programs for various audiences, including factors such as career stage, learner goals, background, and field or discipline. How can a training program be thorough and consistent, utilize best practices in RCR education, and still be specific and relevant to diverse audiences? Practical issues in program creation and management, such as limited resources, will be discussed.

About Sharon Shriver, PhD
Sharon Shriver is Director of Programs for Public Responsibility in Medicine and Research (PRIM&R), where she helps lead the organization in its efforts to educate and engage the public and the research community on research ethics and public policy issues. Before joining PRIM&R, Dr. Shriver was Assistant Director of Penn State’s Office for Research Protections, where she led the university’s research integrity educational initiatives. The Scholarship and Research Integrity at PSU (SARI@PSU) program, which she helped create, has reached over 10,000 students and researchers with discipline-specific, interactive programs on the responsible conduct of research. Dr. Shriver has been a member of the Developer’s Group of the Collaborative Institutional Training Initiative at the University of Miami, serving with the Responsible Conduct of Research working group. She has extensive background in science and ethics, having taught undergraduate and graduate courses in genetics, molecular medicine, and bioethics at Penn State and the University of Pittsburgh. Following her doctoral work in molecular genetics, Dr. Shriver held clinical investigator positions at the MD Anderson Cancer Center and the University of Pittsburgh Medical Center, where she identified smoking-induced mutations that contribute to increased risk of lung cancer in women.

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The role of the research administration climate and research administrators on promoting RCR
Aurali Dade, Ph.D.

Individuals who assist scientist with grant seeking and preparation, contracting, post-award accounting, and compliance, commonly called research administrators, are intimately connected to the research projects. They are tasked with making many decisions that impact the conduct of funded research. Often research administrators also are witness to questionable research practices, poor stewardship of research funds, and sometimes, actual instances of research misconduct. Their unique position in the Institution gives them good placement to be agents of intervention and problem-solving, however they may not believe they have the knowledge or ability to intervene when they suspect research misconduct. Properly trained, research managers and administrators can teach, lead and build a foundation of support on which researchers can depend during moments of stress and pressure that may otherwise end in compliance and integrity violations. They also can serve as active participants in raising concerns about misconduct with the knowledge that they understand what constitutes misconduct and when to report these concerns.
This talk will present findings from a survey of research administrators and an ORI funded conference (Grant #ORIIR160026), the Research Integrity Management Intensive (RIMI), in which research administrators spent two intensive days learning about and discussing ways in which research administrators and research culture can support the responsible conduct of research. This talk will also highlight resources that are being developed as a result of RIMI that will enable training research administrators in RCR in a manner that allows them to understand, recognize, and respond to integrity issues that they might witness.

About Aurali Dade, Ph.D.
Aurali Dade is the Associate Vice President for Research Development, Integrity and Assurance (RDIA) at George Mason University. RDIA’s mission is to nurture and promote state-of-the-art research, scholarship and creative work, providing resources that: promote the ethical and responsible conduct of research; and, assist the Mason faculty-postdoc-student community with the identification of external funding opportunities and the development of high quality proposals, sponsored projects and translational activities. Dade leads RDIA, enabling high quality faculty proposals, serving as the Research Integrity Officer (RIO) and the Institutional Official (IO) for the human subjects protection program, animal care and use program, and export compliance program. In addition to these programs, Dade has developed and served as the course director for two Responsible Conduct of Research Training Programs, Chairs the Conflict of Interest (COI) committee, and serves as the vice-chair for the Enterprise Risk Management (ERM) Committee.

Dade has a PhD in Environmental Science, an MS in Biology, and a BS in Environmental Biology. She teaches classes at the university focused on data ethics, policy, and risk. Dade is the Principal Investigator for the ORI funded conference grant Supporting Responsible Research Organizations: A Framework for Engaged Research Managers and Administrators and conducts research and scholarship related to research compliance and ethics. She served as the editor and author of two chapters for: Implementing a Comprehensive Research Compliance Program: A Handbook for Research Officers, a book published by Information Age Press in 2015.

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Context is Key: Models for RCR Education
Patricia Alt, Ph.D. and Mary Louise Healy

This presentation discusses the variety of modes of teaching RCR to professionals and students, including using organized classes in person or online, seminars, or on an individual level. It examines the need for diversity in perspectives, along with the value of balance between legal and ethical concerns in regulating research. The role of "real life" cases and participatory learning in RCR training will also be emphasized.

About Patricia Alt, Ph.D.
Patricia Alt has been a Professor in Towson University's College of Health Professions, focusing on health policy, ethics, and legal/ethical issues in administration and clinical practice. She has chaired/served on two IRBs for over 30 years (Maryland Department of Health & Mental Hygiene IRB and the Towson University IRB). She has also developed and taught graduate courses on RCR (as a Professor at Towson University) as well as group training sessions for staff and faculty, and served for several years on a statewide university group providing annual conferences on the topic. She previously served as a Health Policy Analyst at the Maryland Department of Health & Mental Hygiene, staffing the IRB at its inception. Her PhD is in Political Science.

About Mary Louise Healy
Mary Louise Healy is a Certified Research Administrator and has been in the field of research administration for more than 25 years. She is currently the Director of Research for the Krieger School of Arts and Sciences, Johns Hopkins University and previously served as Assistant Vice President for Research at Towson University, where she administered the IRB. Her IRB responsibilities included planning and delivering both required and optional training and tracking compliance. In her current position, she is an IRB member and serves as an IRB staff member at heavy application times.

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Moderator: Debra Schaller-Demers, MSOM
Debra Schaller-Demers has been in research management for 15 years. As Research Outreach and Compliance Director at MSK, she has oversight for 1) A quality assurance program to ensure compliance with all regulations pertaining to grants/contracts management; 2) Programs to educate and train the research community in the responsible conduct of research (RCR) and about related policies, procedures, and initiatives; 3) Mechanisms to communicate effectively with the MSK research community to provide timely information in support of its research activities; 4) Policies and procedures that deal with issues of research integrity (including assistance with investigation of research misconduct allegations), compliance and administration; and 5) External outreach initiatives to foster an awareness of MSK’s research and technology transfer competencies and successes.

In addition she serves as administrative contact for Embryonic Stem Cell Research Oversight, and administrative director for the Institutional Animal Care and Use Committee, Institutional Biosafety Committee, and the Export Controls program.

Schaller-Demers is a founding member and serves on the Board of Directors of the Association of Research Integrity Officers (ARIO) and is a long-standing member of the Society of Research Administrators International (SRAI). She has held several SRAI positions and is a frequent facilitator in the areas of research Integrity and professional development. She is a Co-Investigator for the ORI funded conference grant, Supporting Responsible Research Organizations: A Framework for Engaged Research Managers and Administrators and is the author of a chapter on RCR programs for: Implementing a Comprehensive Research Compliance Program: A Handbook for Research Officers, a book published by Information Age Press in 2015.

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