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

Figures & data

Figure 1. PRISMA flowchart of the selection process.

Table 1. States (30) and names of selected institutions (54).

	States	Institutions
1	Alabama	University of Alabama, University of Southern Alabama
2	California	Chapman University, University of California, University of Southern California
3	Carolina	Charlotte University, Duke University, East Carolina, University of North Carolina, Wake Forest
4	Colorado	University of Denver
5	Connecticut	University of Connecticut, Yale
6	Delaware	University of Delaware
7	Florida	Florida State University, Nova Southeastern University, University of South Florida
8	Georgia	University of Georgia
9	Hawaii	University of Hawaii
10	Illinois	Northwestern University, University of Illinois
11	Indiana	Indiana University, Purdue University
12	Louisiana	Tulane University
13	Maryland	John Hopkins University, University of Maryland
14	Massachusetts	Boston University, University of Massachusetts
15	Michigan	Michigan State University, University of Michigan, Wayne State University
16	Missouri	St Louis University, University of Missouri
17	Nebraska	Creighton University
18	New Jersey	Princeton
19	New Mexico	University of New Mexico
20	New York	Albany University, Binghamton University, University of Rochester
21	Nevada	University of Nevada
22	Ohio	Case Western University, Ohio State University
23	Pennsylvania	Penn State University, Thomas Jefferson University
24	Virginia	Virginia Tech University
25	Rhode Island	Brown University , University of Virginia
26	Washington	Washington State University
27	Wisconsin	University of Wisconsin
28	Tennessee	University of Tennessee at Chattanooga
29	Texas	Texas A&M University, Texas Tech, University of Houston, University of Texas
30	Utah	University of Utah

Figure 2. Final thematic map showing main themes and explanations.

Table 2. Thematic examples of reasons for PAM.

Themes	Examples
Ensuring compliance and preserving research integrity	The PAM Program functions to maximize the safety of research participants and ensure data integrity by confirming that research is implemented in a manner consistent with the IRB approved protocol and in compliance with applicable regulations and institutional policies (University of Wisconsin)
Protection of research participants	The compliance unit performs various post-approval monitoring and directed review activities primarily to ensure the rights and welfare of research participants are protected (Northwestern University)
Advisory/Educational support	The program aims to ensure research staff have the educational resources and guidance necessary to successfully conduct research and provide the research community the study support tools and other resources needed to perform compliant research (Northwestern University).
Suggest corrective actions for identified issues	The final visit report will list actionable findings, as well as areas in which deficiencies were identified. In cases where problems are noted, the investigator has the opportunity to respond to recommendations of the monitor or to provide clarifications or to develop a plan of corrective action to eliminate the potential for future problems(John Hopkins University)
Institutional risk management	The PAM program also aims to provide researchers with education and tools to fulfill their role as principal investigators (PI) and reduce institutional risk (University of Wisconsin.)

Figure 3. Descriptors identified as reasons for study selection. The diagram is intended to provide insight into some of the listed reasons for study selection. It should not be interpreted to mean that some AHCs do not include these reasons in their programs. The data analyzed is from webpages and as such is limited. AHCs may have internal practice, policies and procedures that are not reflected on the webpages. This is a limitation of this type of study.

Table 3. Documents reviewed by PAM monitors and commonly identified non-compliance issues.

Documents reviewed by IRB PAM monitor

Non-compliance identified

Regulatory documents Approved protocols Consents and authorizations Recruitment materials Survey instruments IRB correspondence related to the study Data security methods Adverse event and unexpected occurrence records Pharmacy Dispensing logs Lab records Training and licensing documents Advertisements for study

Issues regarding consent process or forms Unapproved modifications to the informed consent document (i.e. a change made to the consent document by the investigator) without the approval of the IRB Lost or missing consent forms Consent forms signed after the implementation of research procedures No informed consent obtained prior to study procedures The informed consent document on file is not complete (i.e. only the page containing the signature is on file). The IRB-approved version of the informed consent or assent document was not used. Dates on informed consent document for participant and researcher are not the same. Collaborative IRB Training Initiative (CITI) training for study personnel is expired or is not on file. Study personnel do not have a current conflict of interest disclosure on file Study documents not stored as indicated in the approved protocol OR stored with linking list. Modifications to the protocol (i.e. a change in study procedure) without the approval of the IRB Failure to report events or deviations Deficient documentation of eligibility assessment Adverse events and unexpected occurrence

Table 4. Legislative and policy support for HRPP in the USA.

USA Legislation	Policies
45 CFR 46.103(b)(5) 45CFR46.109(e) FDA 21CFR56.108(b) 21CFR56.109 (f)	Association for the Accreditation of Human Research Protection Programmes I.5.A, I.5.B OHRP Federalwide Assurance (FWA) for the Protection of Human Subjects (4) (5)