2016 Webinar: Familiar Faces

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Overview

Seeing a familiar face at a study site is not uncommon in either biomedical or social and behavioral research. Oftentimes researchers and institutional review board (IRB) staff discover that a subject in one of their trials was enrolled, is planning to enroll, or is currently enrolled in multiple studies. This creates a potentially unsafe situation for the subject and risks compromising study data. It also puts investigators and IRBs at risk of violating the subject’s confidentiality and autonomy should they confront or expose the individual. Learning to weigh these risks enables IRBs and researchers to make informed decisions to prevent and manage problems related to simultaneous and sequential study enrollment. 

Federal regulations are silent on this issue, and so it falls on institutions to address multiple study enrollments on a local level. How can researchers modify their recruitment strategies to prevent co-enrollment? And how can IRBs best support and guide researchers? 

During this webinar, an IRB professional and an experienced researcher:

  • Defined and estimated the prevalence of simultaneous and sequential study enrollment across the research enterprise 
  • Discussed best practices for IRBs and investigators to address this complex situation
  • Presented multidisciplinary case studies from a range of research activities to aid attendees in recognizing and preventing co-enrollment at their own institutions
  • Provided clear considerations for policy development

What will I learn?

By the end of this intermediate-level webinar, attendees were able to:

  • Appreciate and navigate the tension between subject autonomy, risk, confidentiality, and data integrity when it comes to simultaneous and sequential study enrollment
  • Provide informed support to their local research community for how to effectively manage this scenario
  • Draft a Standard Operating Procedure (SOP) related to policy on co-enrollment 

Who should attend?

IRB chairs, members, administrators, and staff; researchers and research staff; as well as other compliance personnel benefited from this webinar.

Faculty

Stephanie Collins ReedStephanie Collins Reed, PhD, CIP, is an assistant professor of Clinical Neurobiology and an IRB protocol analyst in the Psychiatry Department of Columbia University at the New York State Psychiatric Institute. She has a PhD in Experimental Psychology from Boston University and over 20 years of research experience.  She has spent the past 12 years conducting behavioral and biomedical human subjects’ research and her research focus has been on sex differences and women’s issues in drug use disorders.  She has been an investigator on seven federally-funded grants, has over 30 publications, and has been involved in approximately 60 poster and oral presentations at a variety of research conferences.  In addition to her ongoing research, Dr. Reed has spent the past three years as an IRB protocol analyst, which has given her a newfound appreciation for, and understanding of, the ethical conduct of human subjects’ research.  Most recently, she presented a workshop on Managing Subject Complaints with her co-presenter, Dr. Wilets, at the 2014 and 2015 PRIM&R Advancing Ethical Research conferences. She enjoys having the opportunity to use her investigator and IRB roles to better align the missions of those conducting research and those providing ethical oversight of research.

Ilene WiletsIlene Wilets, PhD, CIP, is an assistant professor of medical psychology in the Department of Psychiatry at Columbia University Medical Center. She has a PhD in Psychology, with a specialization in Measurement, Evaluation, and Applied Statistics from the Columbia Graduate School of Arts and Sciences, and received a Certificate in Bioethics and Medical Humanities from the Montefiore-Einstein Center for Bioethics. 

Dr. Wilets serves as executive director of the New York State Psychiatric Institute IRB and the Institute's Program for Human Subjects Research. In addition, she is on faculty with the Columbia University Program in Bioethics, and co-teaches a core course in Research Ethics. Before coming to Columbia, Dr. Wilets was on faculty in the Department of Emergency Medicine at the Icahn School of Medicine at Mount Sinai. At Mount Sinai, she served as an IRB chair, assistant director of the Program for the Protection of Human Subjects, and research subject advocate for the General Clinical Research Center.

Her interests involve decision-making for research participation, the communication of study risk and benefit, voluntariness, mental health research, and global health research. She is a long-standing and grateful member of PRIM&R, and is active as an educator, mentor and volunteer.

Thank You to Our Webinar Supporter!

DupCheckDupCheck
www.dupcheck.org
DupCheck is a web-based tool used globally to screen for duplicate patients and volunteers in clinical trials across studies, sponsors and therapeutic areas. Duplicate enrollment harms both study participants and studies.

Mention of commercial products, processes, or services on our website or in our email publications should not be construed as an endorsement or recommendation.  

Certificates of Attendance

Certificates of attendance will be made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

If you would like to receive a certificate of attendance for a previous PRIM&R educational program, please email info@primr.org or call 617.423.4112, ext. 0.

CE Credit for Certified IRB Professional (CIP®) Recertification
Webinar participants holding the CIP® credential who wish to apply credits from this webinar toward CIP® recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 60-minute webinar counts as 1 CE credit hours.

For recertification by CE, CIPs must complete 30 documented hours of continuing education. At least 15 of the 30 hours must either carry credits issued by a recognized accrediting body or have received advanced recognition from the Council for Certification of IRB Professionals (CCIP). Credits from PRIM&R webinars have received such advance recognition, and may be counted towards these 15 hours.

Additional information about CIP® recertification can be found here.

Contact Information

If you have additional questions about webinar archives, please contact us by phone (617.423.4112, ext. 1876) or via email.