The Complaint Department: How IRBs Handle Complaints, Questions and Concerns from Study Participants

Transcription

1 Webinar Series The Complaint Department: How IRBs Handle Complaints, Questions and Concerns from Study Participants July 29, 2015 Presented by: James MacFarlane, HRPP Director, University of New Mexico

2 About the Webinar Access webinar audio via computer speakers or telephone dial-in Troubleshooting: Webinar Series Log out and log back in Try switching from computer audio to phone dial-in Recording and archive Q&A: via in-webinar tools and Webinar survey Certificate of attendance

3 About Schulman Associates IRB Established in 1983 Superior audit history with FDA five consecutive audits with no Webinar findings Series 21 CFR Part 11 compliant electronic systems Compliant with FDA, OHRP and Health Canada requirements Full board meetings five days a week Dedicated daily expedited review of qualifying minimal risk protocols

4 About Schulman Associates IRB Review outcome provided within one business day of new study review One business Webinar Series day turnaround for complete new site submissions Phase I Board with streamlined processes tailored to Phase I timelines Oncology Review Board for all phases of oncology research Customized services for institutions Experienced primary points of contact for sponsors, CROs, institutions and sites

5 About Schulman Associates IRB Clinical Quality Assurance (CQA) and Human Research Protection (HRP) consulting services provided by Provision Research Compliance Services Webinar Series Provision is a joint venture between Schulman Associates IRB and Falcon Consulting Group

6 Webinar Series

7 About Today s Presenter James MacFarlane, BS, CIP HRPP Director, University of New Mexico BS in History of Science and Medicine from Northern Kentucky University With UNM since 2014 Previously served as Schulman IRB s Director of Board Services Member of PRIM&R and Mensa

8 Objectives Define the regulations and guidances regarding the IRB s responsibility for managing study participant complaints and inquiries Discuss common study participant inquiries Identify approaches an IRB may take to address participant inquiries

9 Participant Complaints The Regulations OHRP Tips on Informed Consent The regulations provide for the identification of contact persons who would be knowledgeable to answer questions of subjects about the research, rights as a research subject, and research-related injuries. These three areas must be explicitly stated and addressed in the consent process and documentation. Furthermore, a single person is not likely to be appropriate to answer questions in all areas. This is because of potential conflicts of interest or the appearance of such. Questions about the research are frequently best answered by the investigator(s). However, questions about the rights of research subjects or research-related injuries (where applicable) may best be referred to those not on the research team. These questions could be addressed to the IRB, an ombudsman, an ethics committee, or other informed administrative body. Therefore, each consent document can be expected to have at least two names with local telephone numbers for contacts to answer questions in these specified areas.

10 Participant Complaints The Regulations FDA Institutional Review Boards Frequently Asked Questions #49 21 CFR 50.25(a)(7) requires contacts for questions about the research, the research subject's rights and in case of a research-related injury. It does not specify whom to contact. The same person may be listed for all three. However, FDA and most IRBs believe it is better to name a knowledgeable person other than the clinical investigator as the contact for study subject rights. Having the clinical investigator as the only contact may inhibit subjects from reporting concerns and/or possible abuses.

11 Participant Complaints Other Guidance AAHRPP Accreditation Standards and Elements Element I.1.C. The Organization has and follows written policies and procedures that allow the Institutional Review Board or Ethics Committee to function independently of other organizational entities in protecting research participants. Standard I-4: The Organization responds to the concerns of research participants. Element I.4.A. The Organization has and follows written policies and procedures that establish a safe, confidential, and reliable channel for current, prospective, or past research participants or their designated representatives that permits them to discuss problems, concerns, and questions; obtain information; or offer input with an informed individual who is unaffiliated with the specific research protocol or plan. Element III.1.G. Researchers and Research Staff have a process to address participants concerns, complaints, or requests for information.

12 Participant Complaints The Challenge At times the most challenging and most important function of HRPP Open communication with the participant population is critical for all research professionals Depending on the perceived issue, participants can be challenging to communicate with Remember: these communications have a different tone and must be handled in a different manner compared to most communications and interactions entered into by research professionals day in and day out Remember the mission: protect rights and welfare of study participants

13 Participant Complaints Initial Processing Have a system for carefully documenting and tracking the participant's concern Offer a concrete time and date for your initial response to the participant Participant complaints may be an indicator of a reportable event, including UPs, serious and/or continuing noncompliance

14 Participant Complaints Initial Processing When evaluating the complaint, consider: Have there been other complaints involving the same project? Does the event potentially infer an immediate risk to participants? Once you have all of the information you can gather, contact other entities as appropriate Communicate your findings and proposed resolution back to the participant on the agreed upon date and time

15 Participant Complaints Other Considerations Be professional, be pleasant, but be factual Be creative Confirm that the issue is resolved from the participant's perspective Ask the participant if they d be interested in a follow-up discussion at a later date

16 Case Studies

17 Case Study The Union Participant calls to report perceived misconduct by the site Participant identifies himself as the spokesman for a group of 8 participants participating in a sleep study Participant reports that house rules are too strict, inhumane Participant threatens to walk out with his constituency

18 Case Study Threats An agitated participant calls to report perceived underpayment from the site After careful analysis, it is determined that the participant was paid appropriately The participant becomes angry and threatens the staff member and their property

19 Case Study Please, Allow Me to Take the Drug The spouse of a participant participating in a terminated Alzheimer s study calls to make an emotional plea for access to the drug The study was terminated due to safety concerns The caller tells you that since the termination of the study, she has noticed a significant decline in her husband s condition

20 Case Study The Doors Are Locked A confused study participant calls, noting that the doors to the research site are chained shut The site is nonresponsive to attempts at communication The IRB learns that the site has closed, and that the PI has disappeared without following up or compensating the participants

21 Case Study The Conspiracy A participant calls to report perceived injustice in the study s inclusion criteria After analysis, the IRB and sponsor agree that the site acted appropriately The participant refuses to accept this answer, and calls the IRB every hour, verbally abusing any staff that attempt to communicate with him The participant is convinced that the IRB, sponsor, and site are conspiring to keep him out of the study

22 Conclusion Be professional AND compassionate Be creative Document everything Have a process Confirm that the subject's concerns have been addressed

23 Webinar Series The Complaint Department: How IRBs Handle Complaints, Questions and Concerns from Study Participants July 29, 2015 Presented by: James MacFarlane, HRPP Director, University of New Mexico