TY - JOUR
T1 - Exception From Informed Consent
T2 - How IRB Reviewers Assess Community Consultation and Public Disclosure
AU - Chisolm-Straker, Makini
AU - Nassisi, Denise
AU - Daya, Mohamud R.
AU - Cook, Jennifer N.B.
AU - Wilets, Ilene F.
AU - Clesca, Cindy
AU - Richardson, Lynne D.
N1 - Funding Information:
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). 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.
Publisher Copyright:
© 2020 Taylor & Francis Group, LLC.
PY - 2020
Y1 - 2020
N2 - 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.
AB - 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.
KW - Human subjects research
KW - community consultations
KW - exception from informed consent
KW - informed consent
KW - institutional review board (IRB)
KW - public disclosure
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U2 - 10.1080/23294515.2020.1818878
DO - 10.1080/23294515.2020.1818878
M3 - Article
C2 - 32990501
AN - SCOPUS:85091725465
SN - 2329-4515
VL - 12
SP - 24
EP - 32
JO - AJOB Empirical Bioethics
JF - AJOB Empirical Bioethics
IS - 1
ER -