Institutional Review Boards and post-approval monitoring (PAM) of human research: content analysis of select university (academic health center) web pages across the USA

Shereen Coxa Centre for Medical Ethics, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, NorwayCorrespondence[email protected] [email protected]

https://orcid.org/0000-0002-9674-8544 View further author information

Jan Helge Solbakka Centre for Medical Ethics, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, NorwayView further author information

Frederick Luthardt Jrc OHSR Compliance Monitoring Program, Johns Hopkins University School of Medicine, Baltimore, MD, USAView further author information

Rosemarie DLC Bernabea Centre for Medical Ethics, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway;b The Faculty of Health and Social Sciences, University of Southeastern Norway, Kongsberg, NorwayView further author information

Pages 341-350 | Received 28 Oct 2022, Accepted 31 Jan 2023, Published online: 14 Feb 2023

Cite this article
https://doi.org/10.1080/03007995.2023.2175999
CrossMark

Full Article
Figures & data
References
Citations
Metrics
Licensing
Reprints & Permissions
View PDF PDF View EPUB EPUB

References

Kim WO. Institutional Review Board (IRB) and ethical issues in clinical research historical views on human subject research. Korean J Anesthesiol. 2012;62(1):3–12.
PubMedGoogle Scholar
Savulescu J, Chalmers I, Blunt J. Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability. BMJ. 1996;313(7069):1390–1393.
PubMedGoogle Scholar
Weijer C, Shapiro S, Fuks A, et al. Monitoring clinical research: an obligation unfulfilled. CMAJ. 1995;152(12):1973–1980.
PubMed Web of Science ®Google Scholar
Shafiq N, Kumari S, Kumar V, et al. On-site monitoring of clinical trials by an ethics committee in India: a road less travelled. Res Ethics. 2021;17(1):45–54.
Google Scholar
Rice TW. The historical, ethical, and legal background of human-subjects research. Respir Care. 2008;53(10):1325–1329.
PubMed Web of Science ®Google Scholar
Cox S, Solbakk JH, Bernabe RDLC. The role of research ethics committees after the approval of clinical trial protocols in the EU and the USA: a descriptive content analysis of international and regional normative documents. Curr Med Res Opin. 2021;37(6):1061–1069.
PubMed Web of Science ®Google Scholar
Cox S, Solbakk JH, Bernabe RDLC. Research ethics committees and post-approval activities: a qualitative study on the perspectives of european research ethics committee representatives. Curr Med Res Opin. 2022;38(11):1897–1907.
PubMed Web of Science ®Google Scholar
Brown B, Kinsler J, Folayan MO, et al. Post-approval monitoring and oversight of U.S.-initiated human subjects research in resource-constrained countries. J Bioeth Inq. 2014;11(2):119–123.
PubMed Web of Science ®Google Scholar
Young M. In new common rule era, there is role for post-approval monitoring. Relias Media. 2019. [cited 2021 Sep 11]. https://www.reliasmedia.com/articles/145106-in-new-common-rule-era-there-is-role-for-post-approval-monitoring.
Google Scholar
Young M. Sample models of post-approval monitoring programs. Relias Media. 2019. [cited 2021 Sep 11]. https://www.reliasmedia.com/articles/145107-sample-models-of-post-approval-monitoring-programs.
Google Scholar
AAHCI. Academic health centers. Association of Academic Health Centers. 2022. [cited 2022 Sep 15]. https://www.aahcdc.org/About/Academic-Health-Centers.
Google Scholar
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101.
Google Scholar
Braun V, Clarke V. One size fits all? What counts as quality practice in (reflexive) thematic analysis? Qual Res Psychol. 2020;18(3):328–352.
Web of Science ®Google Scholar
Boateng O, Ndebele P, Mwesiga-Kayongo D. Research ethics in Africa: a resource for research ethics committees. Stellenbosch: SUN MeDIA; 2014.
Google Scholar
Berry J, Piwncess T, Hospital R, et al. Local research ethics committees can audit ethical standards in research. J Med Ethics. 1997;23(6):379–381.
PubMed Web of Science ®Google Scholar
McNeill PM, Berglund CA, Webster IW. Do Australian researchers accept committee review and conduct ethical research. Soc Sci Med. 1992;35(3):317–322.
PubMed Web of Science ®Google Scholar
Pickworth E. Should local research ethics committees monitor research they have approved. J Med Ethics. 2000;26(5):330–333. ?
PubMed Web of Science ®Google Scholar
OHRP. Federalwide assurance instructions. HHS.gov. 2017. [cited 2021 Feb 09]. https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/forms/fwa-instructions/index.html.
Google Scholar
Steinbrook R. Improving protection for research subjects. N Engl J Med. 2002;346(18):1425–1430.
PubMed Web of Science ®Google Scholar
Rinde M. The death of Jesse Gelsinger, 20 years later [Online]. Science History Institute. Distillations. 2019. [cited 2022 Mar 18]. https://www.sciencehistory.org/distillations/the-death-of-jesse-gelsinger-20-years-later.
Google Scholar
Stephenson J. Gene therapy trials oversight. JAMA. 2000;283(15):1950–1950.
PubMed Web of Science ®Google Scholar
Savulescu J, Spriggs M. The hexamethonium asthma study and the death of a normal volunteer in research. J Med Ethics. 2002;28(1):3–4.
PubMed Web of Science ®Google Scholar
Babb S. Regulating human research: IRBs from peer review to compliance bureaucracy. Stanford: Stanford University Press; 2020.
Google Scholar
FDA. IRB continuing review after clinical investigation. Rockville (MD): US Food and Drug Administration; 2012. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/irb-continuing-review-after-clinical-investigation-approval.
Google Scholar
FDA. 21 CFR 56. 2019. https://www.ecfr.gov/cgi-bin/text-idx?SID=7681dfad0d169cfef7a609461bcf00b4&mc=true&node=pt21.1.56&rgn=div5.
Google Scholar
Bernabe R, van Thiel G, Breekveldt N, et al. Drug regulators and ethics: which GCP issues are also ethical issues. Drug Discov Today. 2016;21(2): 217–224.
PubMed Web of Science ®Google Scholar
Bernabe R, van Thiel G, Breekveldt N, et al. Ethics in clinical trial regulation: ethically relevant issues from EMA inspection reports. Curr Med Res Opin. 2019;35(4):637–645.
PubMed Web of Science ®Google Scholar
Seife C. Research misconduct identified by the US food and drug administration: out of sight, out of mind, out of the peer-reviewed literature. JAMA Intern Med. 2015;175(4):567–577.
PubMed Web of Science ®Google Scholar
Klitzman R. The ethics police?: ‘IRBs’ views concerning their power. PLoS One. 2011;6(12):e28773.
PubMed Web of Science ®Google Scholar

Share icon
Back to Top

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.

People also read
Recommended articles
Cited by

To cite this article:

Reference style: APA Chicago Harvard

Citation copied to clipboard

Reference styles above use APA (6th edition), Chicago (16th edition) & Harvard (10th edition)

Download citation

Download a citation file in RIS format that can be imported by citation management software including EndNote, ProCite, RefWorks and Reference Manager.

Choose format: RIS BibTex RefWorks Direct Export

Choose options: Citation Citation & abstract Citation & references

Institutional Review Boards and post-approval monitoring (PAM) of human research: content analysis of select university (academic health center) web pages across the USA

References

Information for

Open access

Opportunities

Help and information

Your download is now in progress and you may close this window

Login or register to access this feature

Institutional Review Boards and post-approval monitoring (PAM) of human research: content analysis of select university (academic health center) web pages across the USA

References

Related research

To cite this article:

Download citation

Information for

Open access

Opportunities

Help and information

Keep up to date