Exception From Informed Consent: How IRB Reviewers Assess Community Consultation and Public Disclosure

Abstract

Exception from Informed Consent (EFIC) regulations detail specific circumstances in which Institutional Review Boards (IRB) can approve studies where obtaining informed consent is not possible prior to subject enrollment.

To better understand how IRB members evaluate community consultation (CC) and public disclosure (PD) processes and results, semi-structured interviews of EFIC-experienced IRB members were conducted and analyzed using thematic analysis.

Interviews with 11 IRB members revealed similar approaches to reviewing EFIC studies. Most use summaries of CC activities to determine community members’ attitudes; none reported using specific criteria nor recalled any CC reviews that resulted in modifications to or denials of EFIC studies. Most interviewees thought metrics based on Community VOICES’s domains (feasibility, participant selection, quality of communication, community perceptions, investigator/IRB perceptions) would be helpful.

IRB members had similar experiences and concerns about reviewing EFIC studies. Development of metrics to assess CC processes may be useful to IRBs reviewing EFIC studies.

Keywords:

• Human subjects research
• institutional review board (IRB)
• informed consent
• public disclosure
• community consultations
• exception from informed consent

Acknowledgments

The authors would like to acknowledge their fellow Community VOICES 3 Investigators: Jill Baren, Michelle Biros, Neal Dickert, Ahamed Idris, Steven Levine, Vernay Mitchell, LaTanya Phelps, Deborah Fish Ragin, Rosamond Rhodes, Peggy Shepard, Margaret Smirnoff, Craig Warden, Gary Winkel, and David Wright.

Author’s contributions

MCS is responsible for the data analysis and drafting of the manuscript.

DN is responsible for study design, data collection and analysis, and manuscript revision.

MRD, JNBC, IW are responsible for data analysis and manuscript revision.

CC is responsible for data collection and analysis, and manuscript revision.

The Community VOICES investigators are responsible for study concept and design, and manuscript revision.

LDR is responsible for study conception and design, data analysis, and manuscript drafting and revision.

Conflicts of interest

No potential conflict of interest was reported by the author(s). (Forms completed).

Ethical approval

This study was approved by the institutional review board at the Icahn School of Medicine at Mount Sinai.

Additional information

Funding

The Community VOICES 3 Study (Views on Informed Consent in Emergency Situations) was supported by the NIH/National Heart, Lung & Blood Institute (3R01HL07338; PI: Richardson). Dr. Makini Chisolm-Straker was supported by a Faculty Research Supplement to Increase Diversity the NIH/National Heart, Lung & Blood Institute (3R01HL073387-11S1; PI: Richardson).