A platform for research: civil engineering, architecture and urbanism
A platform for research: civil engineering, architecture and urbanism
Exception From Informed Consent: How IRB Reviewers Assess Community Consultation and Public Disclosure
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.
Exception From Informed Consent: How IRB Reviewers Assess Community Consultation and Public Disclosure
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.
Exception From Informed Consent: How IRB Reviewers Assess Community Consultation and Public Disclosure
Chisolm-Straker, Makini (author) / Nassisi, Denise (author) / Daya, Mohamud R. (author) / Cook, Jennifer N.B. (author) / Wilets, Ilene F. (author) / Clesca, Cindy (author) / Richardson, Lynne D. (author)
AJOB Empirical Bioethics ; 12 ; 24-32
2021-01-02
9 pages
Article (Journal)
Electronic Resource
Unknown
Informed consent: Beyond legalities
| Elsevier | 1979
Trust and informed consent: insights from community members on the Kenyan coast
| British Library Conference Proceedings | 2005
Informed Consent Readability: Subject Understanding of 15 Common Consent Form Phrases
| British Library Online Contents | 1995
DNA Banking and Informed Consent - Part 1
| British Library Online Contents | 1995
DNA Banking and Informed Consent - Part 2
| British Library Online Contents | 1995