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

Abstract

Objective

To conduct a content analysis of IRB webpages of select universities (academic health centers) in the USA that describe post IRB- approval monitoring activities.

Method

This was a qualitative study. Thematic analysis was the method to review the webpage content of selected academic health centers (AHC) within the USA.

Results

Some US academic health “centers” IRB administrative or research compliance offices conduct post- approval monitoring (PAM) of human subjects’ research including clinical trials. The goals of this PAM programmes are to (a) ensure compliance to approved protocols, (b) preserve research integrity, (c) manage institutional risks, d) provide advisory/educational support to researchers, (e) recommend corrective actions for identified issues, and most importantly, (f) to protect the safety, rights, and well-being of research participants. Although not a requirement by law, the PAM program has legislative support in the US Code of Federal Regulations as part of the US Office for Human Research Protection’s (OHRP) Federal Wide Assurance (FWA). This is especially for institutions that conduct studies funded by the Federal government. PAM on-site checks reveal various incidents of protocol deviations and violations. This includes issues with recruitment processes, informed consent discrepancies, and incidents of non-compliance. When a study protocol is identified as non-compliant, the principal investigator works with the PAM monitor to develop a corrective action plan that would allow the study to become compliant and avoid sanctions from the IRB or the regulatory authority.

Conclusions

REC/IRB post-approval monitoring of clinical trials is a valuable mechanism of protection for research participants while giving educational and quality assurance support to researchers. The program enables early detection and resolution of non-compliance to approved protocols. The impact of the program in the USA requires further exploration.

Keywords:

• Clinical trials
• compliance
• Institutional Review Boards
• research ethics committees
• post-approval monitoring
• protection
• role

Correction Statement

This article has been corrected with minor changes. These changes do not impact the academic content of the article.

Transparency

Declaration of financial/other relationships

The authors are employees of the University of Oslo, Norway. The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

All the authors were involved in the writing of this manuscript. First author, a PhD research fellow, is the main author and did most of the core research. There were regular meetings with 2nd and 4th authors throughout the research process who were involved in conceptualization, design, interviews, analysis, and interpretation. Third author’s expertise in US Law and experience in research governance at a US AHC was important for the correct interpretation of regulatory terms and policy procedures. The manuscript was drafted by 1st author, while other authors were involved in the revision and final version to be published.

Acknowledgements

None.

Notes

i The PAM monitor throughout this paper is not referring to the compliance monitoring by pharmaceutical sponsor agencies which is described within the ICH: Good Clinical Practice guidelines.

ii Throughout this paper, reference to REC/IRB is regarding REC/IRB or research compliance offices and administrative staff employed to the office and not the actual committee members. IRBs/RECs are usually supported by staff who carry out various functions on the Committee’s behalf. PAM monitors/administrators may report their findings directly to the IRB chair or to other relevant institutional managerial staff such as research integrity office based on the organizational structure of that institution. A Human Research Protection program (HRPP) is an institutional compliance program that encompasses a wide range of quality assurance and institutional risk management systems which may include auditing the IRB itself. This paper does not intend to go into the range of activities within this program. The focus is on activities of the PAM monitor/administrator regarding IRB approved protocols only. However, a majority of the reviewed webpages note these activities are part of their institutional HRPP.

iii Association of Academic Health Centers defines an academic health center as: “An academic health center encompasses all the health-related components of universities, including their health professions schools, patient care operations, and research enterprise” (29).

Additional information

Funding

This manuscript was developed as part of a project at the Centre for Medical Ethics, University of Oslo. There was no external funding.