Webinar SeriesWebinar Series

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

ParticipantsJuly 29, 2015

James MacFarlane, HRPP Director, University of New Mexico

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Established in 1983

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James MacFarlane, BS, CIPHRPP 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

About Today’s Presenter

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

Objectives

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.

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.

Participant Complaints – The Regulations

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.

Participant Complaints – Other Guidance

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

Participant Complaints – The Challenge

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

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

Participant Complaints – Initial Processing

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

Participant Complaints – Other Considerations

Case Studies

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

Case Study – The Union

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

Case Study – Threats

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

Case Study – Please, Allow Me to Take the Drug

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

Case Study – The Doors Are Locked

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

Case Study – The Conspiracy

Be professional AND compassionate

Be creative

Document everything

Have a process

Confirm that the subject's concerns have been

addressed

Conclusion

Webinar SeriesWebinar Series

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

ParticipantsJuly 29, 2015

James MacFarlane, HRPP Director, University of New Mexico

Presented by: