Department of Veterans Affairs 

Office of Inspector General 

Healthcare Inspection 

Comparison of VA and University 

Affiliated IRB Compliance with VHA 

Handbook 1200.5 

Report No. 06-00980-217 September 28, 2007

VA Office of Inspector General 

Washington, DC 20420 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Contents 

Page 

Executive Summary ..............................................................................................i

Introduction ..........................................................................................................1

Purpose............................................................................................................................. 2

Background...................................................................................................................... 2

Scope and Methodology .................................................................................................. 4

Results ..................................................................................................................7

I. IRB Chairpersons, Members and Coordinators .......................................................... 7

II. IRB Compliance with Documentation Requirements of VHA Handbook 1200.5.. 10

III. Principal Investigator Profiles and Documentation Requirements......................... 14 

IV. Reporting of Adverse Events and Protocol Modifications in Multi-Center Trials 16 

Conclusions.................................................................................................................... 18

Recommendations.......................................................................................................... 19 

Appendixes

A. Requirements for IRB Standard Operating Procedures........................................... 20

B. IRB Meeting Minutes Requirements ....................................................................... 22

C. Under Secretary for Health Comments.................................................................... 24

D. OIG Contact and Staff Acknowledgments .............................................................. 29

E. Report Distribution................................................................................................... 30

VA Office of Inspector General 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Executive Summary 

The Veterans Health Administration (VHA) supports and participates in a large research 

program that has made major contributions, including the development of cardiac 

pacemakers, liver transplants, and prosthetic devices. Resources available for VHA’s 

Research and Development Program in fiscal year 2007 totaled $1.6 billion. 

VA adheres to the Common Rule, a set of Federal regulations requiring that all research 

involving human subjects be approved by an Institutional Review Board (IRB). VHA 

Handbook 1200.5, Requirements for the Protection of Human Subjects in Research, 

July 15, 2003, describes the means by which IRB review occurs in the VA, including 

documentation standards and required standard operating procedures. The Office of 

Research Oversight (ORO) within VHA provides oversight of these human subjects 

protections. Consistent with this function, VHA Handbook 1058.1, Reporting Adverse 

Events in Research to the Office of Research Oversight, November 19, 2004, requires 

reporting of certain adverse events to ORO. 

The Office of Inspector General conducted a national review of VHA research to assess 

compliance with certain requirements of Handbook 1200.5 and Handbook 1058.1, 

focusing on compliance with IRB standard operating procedures (SOPs), IRB minutes, 

progress reports, and reporting of adverse events and protocol modifications in 23 phase 

IV clinical trials. We conducted a total of 41 site visits, reviewed documents for 58 

separate reviews from 47 unique IRBs, and interviewed IRB coordinators, chairpersons, 

and members at each site. 

While our review disclosed overall good compliance with IRB documentation 

requirements found in VHA Handbook 1200.5, we found that fewer university IRB 

representatives stated that they disclosed reportable adverse events to medical center 

officials than did VA IRB representatives. Both VA and University IRB SOPs did not 

consistently address the requirement to report privacy or information security violations 

to appropriate personnel. Finally, while not a policy requirement, we note a lack of 

communication between IRBs in multicenter trials concerning adverse events and 

protocol modifications. 

We recommended that VHA ensure that all IRBs reviewing VA protocols comply with 

the requirements of VHA Handbook 1058.1 and VHA Handbook 1200.5 in the reporting 

of adverse events. We further recommended VHA examine current SOPs of IRBs 

reviewing VA protocols to ensure that they include mechanisms for the reporting of 

privacy or information security violations in accordance with the requirements of VHA 

Handbook 1200.5. The Under Secretary for Health agreed with the findings and 

recommendations and provided acceptable improvement plans. We will follow up on the 

planned actions until they are completed. 

VA Office of Inspector General i 
DEPARTMENT OF VETERANS AFFAIRS

Office of Inspector General 

Washington, DC 20420 

TO: Under Secretary for Health (10) 

SUBJECT: Healthcare Inspection – Comparison of VA and University Affiliated 

IRB Compliance with VHA Handbook 1200.5 

Introduction 

The Department of Veterans Affairs specifies that research is part of its core mission. 

Historically, Veterans Health Administration (VHA) supported research contributed to 

such landmark developments as the cardiac pacemaker, the first successful liver 

transplant, and multiple advances in prosthetic limbs. VHA’s Medical and Prosthetic 

Research Program (more commonly referred to as VHA’s Research and Development 

(R&D) Program) currently maintains four organizational units for the selection of 

funding applications and administration of awards: Biomedical Laboratory Research and 

Development Service, Clinical Science Research and Development Service, Health 

Services Research and Development Service, and Rehabilitation Research and 

Development Service. In 2004, these services conducted more than 15,000 research 

projects at more than 115 facilities nationwide. Resources available for VA’s Research 

and Development Program in fiscal year 2007 total $1.6 billion. 

VA and 17 other Federal agencies adhere to the Common Rule, a set of Federal 

regulations governing research involving human beings. All VHA institutions that 

perform Federally funded or supported research must file a Federalwide Assurance 

(FWA) stating that the institution will comply with the Common Rule. The Office of 

Research Oversight (ORO), located within VHA and charged with oversight of VHA 

research, manages the FWA program and is responsible for oversight and compliance 

with the Common Rule and VA policies. VHA has codified the Common Rule at 38 CFR 

Part 16. It is estimated that there were 120 facilities holding FWAs on April 30, 2007. 

Compliance with the Common Rule requires a significant investment of resources. “Top 

professional staff must perform necessary, labor-intensive activities associated with 

research involving human subjects, including education and training of clinician 

investigators and research staff, ensuring compliance with applicable regulations, 

VA Office of Inspector General 1 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

credentialing of research staff, and operation of Institutional Review Board (IRB) 

committees.”1

 IRBs are committees constituted at the level of the medical center or 

institution conducting the research that provide the “primary mechanism for ensuring the 

adequacy of informed consent and other aspects of human subjects protections....” The 

Common Rule requires that an IRB review all research involving human beings, that the 

research subjects give informed consent, and that institutions give assurances that they 

will comply with the regulations. 

VHA Handbook 1200.5, Requirements for the Protection of Human Subjects in Research,

adopted July 15, 2003, outlines agency policy for compliance with the Common Rule’s 

requirements for the ethical conduct of research involving human subjects. The 

Handbook requires all such research to be approved by an IRB, but permits a VA medical 

center to use an affiliate university’s IRB if it executes a written Memorandum of 

Understanding (MOU) with the affiliate and reflects the arrangement in the VAMC 

Federalwide Assurance. However, VHA Handbook 1200.5 states: “An IRB established 

by an affiliated medical or dental school that is serving as an IRB of record for a VA 

facility must agree to comply with...the provisions of this Handbook when reviewing VA 

research.” 

In addition to the IRB’s responsibilities to approve research and ensure the execution of a 

proper informed consent, IRBs must conduct continuing reviews not less than once per 

year on previously approved protocols to ensure ongoing compliance with Handbook 

1200.5 (38 CFR 16.109(e)). They must also have Standard Operating Procedures (SOPs) 

describing how they meet this obligation (see Appendix A). So that IRBs may be 

updated on the status of ongoing research projects, investigators are required to submit 

progress reports at least annually as part of the continuing review process. VHA 

Handbook 1200.5 describes what information must be contained within those progress 

reports. In addition, IRBs must record minutes of meetings that contain certain elements 

as described in VHA Handbook 1200.5 (see Appendix B) and reflect decisions relative to 

the review process. 

Purpose 

The Office of Inspector General, Office of Healthcare Inspections (OHI), conducted this 

national project to assess compliance with certain requirements of VHA Handbook 

1200.5 in the IRB review of 23 Phase IV protocols within VHA. 

Background

VHA Handbook 1200.5 describes IRB composition and functions in detail. IRBs within 

the VA, or those IRBs that the VA uses to review its protocols, must conform to certain 

standards. These standards include having at least five members with sufficient 

 

1

 VHA Directive 2003-031, June 13, 2003. 

VA Office of Inspector General 2 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

qualifications to review the research. Members must include at least one scientific and 

one non-scientific member. IRBs then review protocols for their compliance with the 

requirements of the Common Rule; they have the authority to approve, disapprove or 

require modifications to such protocols. IRBs ensure that risks to human subjects are 

minimized by using sound research techniques, that the risks to human subjects are 

reasonable in relation to any anticipated benefits, and that the protocol contains adequate 

provisions for monitoring the safety of participants. Other areas reviewed by IRBs 

include educational requirements of principal investigators (PIs) and all other 

investigators in the protection of human subjects, as well as protocol provisions to ensure 

the privacy and confidentiality of research subjects. 

As part of its obligation to oversee the safety of research subjects, IRBs “are responsible 

for reviewing and managing adverse events (AEs) in research,”2

 as described in VHA 

Handbook 1058.1, Reporting Adverse Events in Research to the Office of Research 

Oversight, November 19, 2004. Handbook 1058.1 includes a requirement that IRBs 

develop SOPs that provide detailed instructions on how to report and manage AEs. VA 

facilities must report certain types of AEs to ORO. The AEs that must be reported to 

ORO include AEs that result in either an IRB taking substantive action or an unexpected 

death of a research subject, regardless of IRB action. Substantive action is defined as 

“[a]n action taken by an IRB that materially alters the substance and meaning of a 

protocol, informed consent form or process, or investigator status, including, but not 

limited to, restriction, suspension or termination of a study or investigator participation, 

and actions taken to prevent future occurrence(s) of the AE in research.”3

In 2003, prior to the enactment of VHA Handbook 1200.5, VA’s Office of Research and 

Development (ORD) identified the need for ongoing quality assurance programs at 

facilities conducting research involving human subjects. ORD specified four broad 

compliance-related activities that need to be carried out at every research site: 

• Training and education of lead investigators and research staff. 

• Credentialing of research staff. 

• Ensuring compliance with applicable human research protection standards. 

• Accrediting of the facility Human Subjects Protection Program by the National 

Committee for Quality Assurance (NCQA). 

ORD contracted with the National Committee for Quality Assurance (NCQA), to assess 

standards through site surveys conducted by researchers. Beginning December 1, 2005, 

ORD awarded a new contract for accreditation of VHA research facilities to the 

Association for Accreditation of Human Research Protection Programs, Incorporated 

 

2

 VHA Handbook 1058.1, p. 1. 

3

 VHA Handbook 1058.1, p. 1. 

VA Office of Inspector General 3 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

(AAHRPP). As of April 30, 2007, 9 facilities were accredited by AAHRPP, 52 by 

NCQA, and 25 facilities had AAHRPP accreditation pending. 

Additional initiatives undertaken by ORD to ensure human subjects protections in 

research include the Program for Research Integrity Development & Education (PRIDE). 

“PRIDE is responsible for all policy development and guidance, and all training and 

education in human research protection throughout the VA.”4

 VHA Directive 2003-036, 

Credentials and Training of Employees Involved in Human Subjects Research, issued 

July 7, 2003, required facility directors with human research programs to ensure 

appropriate training for those individuals engaged in research activities. This Directive 

specifically indicates that all investigators and all members and staff of a VA IRB must 

complete an educational or web-based course on the protection of human research 

subjects and Good Clinical Practice (GCP) as required by Food and Drug Administration 

(FDA) regulations. 

The FDA divides clinical trials into different phases, depending upon the stage of 

development of the regulated drug. Phase 45

 clinical trials are those research protocols 

that involve a drug already approved for general use by the FDA that is subjected to 

further testing or tested on a different population for the purpose of expanding its FDAapproved indications. Information on FDA trials may now be found on several websites, 

including ClinicalTrials.gov. ORD registers VA-sponsored research on 

ClinicalTrials.gov and assists VA investigators in completing this registration process. 

The U.S. National Institutes of Health (NIH) developed this website in collaboration with 

the FDA as a result of the FDA Modernization Act of 1997. “The website 

ClinicalTrials.gov currently contains more than 41,000 clinical studies sponsored by the 

National Institutes of Health, other Federal agencies, and private industry. Studies listed 

in the database are conducted in all 50 States and in over 120 countries. 

ClinicalTrials.gov receives over 20 million page views per month and hosts 

approximately 31,000 visitors daily.”6

 

Scope and Methodology 

This review examines specific requirements of VHA Handbook 1200.5 as applied to the 

continuing review of 23 Phase IV protocols within VHA. It is not a comprehensive 

compliance review of all applicable human subjects protections regulations nor of all 

provisions of VHA Handbook 1200.5. This review focuses on four areas of compliance: 

documentation of IRB standard operating procedures (SOPs), IRB minutes, investigator 

progress reports, and the reporting of adverse events and protocol modifications. 

Comparisons are made between VA and university affiliated IRBs. The relative training 

 

4

 Overview, Program for Research Integrity Development and Education, www.research.va.gov/programs/PRIDE

10/2/2006 

5

 FDA regulations use the convention of Arabic numbers for designating phases, rather than the Roman numerals 

used elsewhere. 

6

 About Clinical Trials.gov: http://www.clinicaltrials.gov/ct/info/about; June 15, 2007. 

VA Office of Inspector General 4 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

and experience of IRB chairpersons, coordinators, IRB members, and PIs are reported 

only for general profiling and background purposes. 

Sample Selection

We utilized ClinicalTrials.gov to identify a sample for this review. On 

December 1, 2005, a search of this database revealed a total of 24 Phase IV clinical trials 

(subject protocols) conducted at VA medical centers (VAMCs) during the past 3 years. 

One protocol was not ongoing and had enrolled no subjects. The remaining 23 protocols 

were included in this review. The 23 protocols involved a total of 41 VAMCs and 

47 different IRBs. The subject protocols included eight industry-sponsored trials, nine 

trials sponsored solely by the Department of Veterans Affairs, and six sponsored by other 

agencies and nonprofits. They ranged in size from single site protocols to one protocol 

that involved 17 different VAMCs. Because multicenter trials were involved, this 

resulted in a total of 58 unique IRB reviews. 

Document Review

OHI conducted a total of 41 site visits from February 2006 to June 2006 to determine 

compliance with specific aspects of VHA Handbook 1200.5. We first determined which 

IRB(s) at the facility reviewed the subject protocol or protocols, and grouped these IRBs 

by VA or affiliate status. Inspectors obtained the following while at the facility: SOPs for 

the IRB(s) reviewing subject protocols, the most recent IRB minutes, investigator 

progress reports pertaining to the subject protocol(s), IRB rosters, consent forms, and 

copies of all adverse events and protocol modifications. Inspectors obtained information 

both from IRB files and from the files of the PIs. When the subject protocol was 

conducted at more than one facility, inspectors also obtained all correspondence 

pertaining to adverse events and protocol modifications between facility IRBs, 

investigators, and data safety monitoring boards (DSMB). 

Interviews

Following the identification of the specific IRBs evaluating the subject protocols, we 

prepared for interviews. Each interviewer received 8 hours of training in use of the 

instruments. We began with interviews of each IRB chairperson, each IRB coordinator, 

and one scientific IRB member. The scientific IRB member was chosen at random, 

utilizing a sequential numbering system of IRB members from rosters obtained prior to 

site visits by OIG inspectors. In addition, we interviewed the PI of each subject protocol 

at each facility. Administering a standard set of questions to all, we asked each 

individual about his/her educational requirements and attainments pertaining to human 

subjects protections, as well as his/her relevant professional experience and knowledge of 

reporting requirements for adverse events. 

VA Office of Inspector General 5 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Statistical Analysis

Pearson Chi-square statistics were used to examine associations between IRB type (VA 

or university affiliated) and compliance with certain requirements of VHA Handbook 

1200.5. When at least one of the table cell sizes was fewer than 5, Fisher’s exact test was 

used, instead of the Chi-square test. All p-values were two-sided. The association was 

considered statistically significant if its corresponding p-value was less than 0.05. All 

analyses were performed using SAS (Cary, North Carolina) Version 9.1. 

VA Office of Inspector General 6 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Results 

Forty-seven IRBs at 41 separate sites reviewed the clinical trials in our sample. Of these 

47 IRBs, 23 were VA IRBs, and 24 were university affiliated IRBs, reviewing VA 

protocols pursuant to Memoranda of Understanding. All 47 IRBs had at least five 

members as required by VHA Handbook 1200.5. 

I. IRB Chairpersons, Members and Coordinators 

A. IRB Chairpersons, Coordinators, and Members of VA and University IRBs 

We categorized our interviews with IRB chairpersons, members, and coordinators by 

whether their respective IRBs were VA or university affiliated IRBs. In general, 

university affiliated IRBs tended to review more protocols than VA IRBs (p = 0.01). 

Further, 11 of 24 (46 percent) university IRBs employed certified IRB professionals as 

coordinators compared to only 2 of 23 (8 percent) VA IRBs that utilized a certified IRB 

professional in this capacity (p = 0.01). While this represented a significant difference in 

the utilization of certified IRB professionals between VA and university IRBs, the 

experience of IRB coordinators as defined by the number of years of service at the 

facility did not vary significantly by IRB type (p = 0.29). 

IRB chairpersons were in all cases either Medical Doctors (M.D.s) or held scientific 

doctorate degrees (Ph.D.s). VA or university affiliation of the IRB made no difference in 

the likelihood of holding one degree or the other (p = 0.45). IRB chairpersons selfreported the total number of publications listing themselves as a first author. Most 

chairpersons reported between 6 and 50 publications listing themselves as first author 

(VA = 12 (52 percent); university = 16 (66 percent)) with no significant difference 

between chairpersons of VA and university affiliated IRBs (p = 0.32). Forty-six of 

47 chairpersons reported receiving some training in human subjects protections during 

2004 or 2005. 

More of the 47 IRB scientific members interviewed were M.D.s (VA = 55 percent, 

university = 58 percent) rather than Ph.D.s (VA = 29 percent, university = 39 percent). 

While all but one of the university IRB scientific members interviewed were M.D.s or 

Ph.D.s, 16 percent of VA IRB scientific members held degrees at the Master’s level or 

less. However, this difference in educational attainment between VA and university IRB 

scientific members was not statistically significant (p = 0.26). The difference in the 

number of publications listing the scientific members interviewed as the first author 

between VA and university IRB members was statistically significant (p = 0.015) with 

university IRB members having more publications than VA IRB members 

Forty-six of the 47 IRB scientific members reported that their IRBs required that they 

take some human subjects protection training annually. 

VA Office of Inspector General 7 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

B. Institutional Adverse Event Reporting Practices as Described by IRB 

Chairpersons and IRB Coordinators 

We also asked all IRB chairpersons and coordinators whether or not their institutions 

disclosed reportable adverse events to certain entities. Based on the chairpersons’ 

responses, the VA IRB chairpersons indicated that their facility disclosed reportable 

adverse events to the medical center director (VA = 26 percent, university = 11 percent; p 

= 0.03), the Associate Chief of Staff for Research (VA = 38 percent, university = 21 

percent; p = 0.01), and other IRBs in the event that the clinical trial involved multiple 

sites (VA = 19 percent; university = 2 percent; p = < 0.01) more frequently than their 

university counterparts. Twenty-one of 23 (91 percent) VA and 18 of 24 (75 percent) 

university IRB Coordinators indicated that their facility did not report adverse events to 

other IRBs in the event that a clinical trial was ongoing at multiple sites. The responses 

of VA IRB Chairpersons indicated a higher reporting rate. 

VA IRB chairpersons also indicated that their facilities commonly reported adverse 

events to ORO (VA = 43 percent). In contrast, only 3 of 24 (13 percent) university IRB 

chairpersons stated that their facilities reported adverse events to ORO (p < 0.0001). IRB 

coordinators generally reported similar practices. We were told by ORO that university 

IRBs were not required to report adverse events to ORO, but were instead required only 

to report them to the facility through the medical center director as specified in VHA 

Handbook 1200.5 section 7d(5). The expectation was that the medical center would then 

report the events to ORO. However, as previously discussed, university IRBs did not 

consistently report adverse events to medical center directors either. In addition, IRB 

coordinator responses indicated that VA coordinators reported adverse events to the 

medical center director (VA = 30 percent, university = 13 percent; p = 0.01) and the 

Associate Chief of Staff for Research (VA = 38 percent, university = 23 percent; p = 

0.02) more frequently than university IRB coordinators. Twenty of 23 (87 percent) VA 

IRB coordinators stated that their institutions reported adverse events to ORO, compared 

to 5 of 24 (21 percent) university IRB coordinators (p < 0.0001), as seen in Figure 1: 

VA Office of Inspector General 8 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Figure 1: Percentages of Reporting Adverse Events to the 

Office of Research Oversight Based on Self-reports from 

Chairperson and Coordinator, by IRB Type

0

10

20

30

40

50

60

70

80

90

100

University VA 

Type of IRB

Percent of Affirmative Responses 

Chairperson

Coordinator

When IRB chairpersons were interviewed regarding their understanding of the definition 

of adverse events reportable to ORO, 18 of 23 (78 percent) VA IRB chairpersons 

correctly identified the definition compared to 6 of 24 (25 percent) university IRB 

chairpersons (p = 0.01). Seven of 23 (32 percent) university IRB coordinators compared 

with 16 of 23 (70 percent) VA IRB coordinators correctly identified the definition of an 

adverse event reportable to ORO (p = 0.02). IRB chairperson responses are compared to 

IRB coordinator responses in Figure 2: 

VA Office of Inspector General 9 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Figure 2: Correct Identification of Adverse Events Reportable to 

ORO by IRB Type

0

10

20

30

40

50

60

70

80

University VA

Type of IRB

Percent of Correct Responses

 Chairperson

 Coordinator

II. IRB Compliance with Documentation Requirements of VHA 

Handbook 1200.5 

A. IRB Standard Operating Procedures 

To better assess adverse event reporting practices at VHA facilities as well as to 

determine compliance with the requirements of VHA Handbook 1200.5, we reviewed 

IRB SOPs from all 47 IRBs. However, institutions with more than one IRB utilized the 

same SOPs, giving a total of 41 unique sets, 22 for VA IRBs and 19 for university IRBs. 

VHA Handbook 1200.5 requires facilities to develop SOPs in a number of different 

areas. We reviewed facility compliance in nine areas listed in Table 1: 

VA Office of Inspector General 10 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Table 1: Frequency and Percent Compliance with VHA Handbook 1200.5 

Requirements for Standard Operating Procedures 

Standard Operating 

Procedure* 

VA IRB 

Frequency 

(Percent Compliance)

University IRB 

Frequency

(Percent Compliance)

P

Value 

Initial and continuing 

review. 

21 (95.5) 19 (100) 0.35 

More frequent 

review. 

22 (100) 19 (100) 0.46 

Verification of no 

protocol changes. 

21 (95.5) 17 (89.5) 0.47 

Reporting of protocol 

am or endments 

consent form 

changes. 

22 (100) 18 (94.7) 0.28 

Reporting to IRB 

noncompliance by 

study personnel. 

20 (90.9) 18 (94.7) 0.64 

Informed consent 

observation. 

20 (90.9) 14 (73.7) 0.15 

Audits of protocols. 18 (81.8) 17 (89.5) 0.49 

Reporting to privacy 

officer. 

4 (18.1) 5 (26.3) 0.53 

Reporting of VA 

information security

violations. 

3 (13.6) 6 (31.6) 0.17 

* See ppendix A for a full listing of IRB Standard Operating Procedures required by VHA Handbook 1200.5. 

There was no statistically significant diff rence in compliance in these nine areas 

With regard to reporting adverse events, VHA Handbook 1200.5 requires the IRB to 

maintain a written procedure for notifying medical center officials and VA central office 

A

e

between VA and university IRBs (Table 1). Of 41 unique sets of IRB Standard 

Operating Procedures, we found that the majority of facilities complied in seven of the 

nine areas reviewed. The two areas in which the majority of facilities failed to maintain 

standard operating procedures involved “reporting to the privacy officer any unauthorized 

use, loss or disclosure of individually identifiable patient information” and “reporting 

violations of VA information security requirements to the appropriate VHA Information 

Security Officer.” Only 4 of 22 (18 percent) VA IRBs and 5 of 19 (28 percent) university 

IRBs maintained a standard operating procedure for reporting events to the privacy 

officer while only 3 (14 percent) VA IRBs and 6 (32 percent) university IRBs maintained 

procedures for reporting information security violations to a VHA Information Security 

Officer. 

VA Office of Inspector General 11 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

of adverse events occurring that cause harm or risk of harm to human subjects. It further 

requires a written procedure stating that facilities will report adverse events “as required 

by VA and Federal policy and regulations.” While most facilities maintain SOPs for 

reporting as required by VA and Federal policy and regulations (VA = 100 percent, 

university = 90 percent), fewer facilities maintained a procedure for notifying medical 

center officials or VA central office (VA = 55 percent, university = 37 percent). 

Differences in adverse event SOPs between VA and university IRBs were not statistically 

significant. 

To better clarify the type of adverse event reporting procedure maintained by each 

facility, we asked whether the procedure contained the following three elements: 

nt differences in reporting requirements 

between VA and university IRBs for most areas, we did find that university IRBs were 

that 

VA IRBs reported adverse events to ORO and/or the medical center director with greater 

 IRBs is beyond the 

scope of this review. However, during the course of our inspection, one facility’s SOP 

t and Memorandum of Understanding 

(MOU) between the [university IRB] and the [VAMC], the [university IRB] 

(1) Definition of events that should be reported to a given agency, (2) Time frame for 

reporting an event to a regulatory agency, and (3) Specific agencies to which those events 

should be reported. We found that most facility SOPs contained at least those three 

elements for reporting of adverse events. [For (1), VA = 86 percent, 

university = 94 percent; (2) VA = 91 percent, university = 79 percent; 

(3) VA = 95 percent, university = 95 percent]. However, there was wide variability in 

whether the SOP required notification of medical center directors (VA = 50 percent, 

university = 53 percent), Associate Chiefs of Staff for Research (VA = 55 percent, 

university = 47 percent), other IRBs (VA = 9 percent, university = 10 percent), and ORO 

(VA = 95 percent, university = 55 percent). 

While there were no statistically significa

less likely to have an SOP requiring reporting of adverse events to ORO (p = 0.009). 

This was consistent with IRB chairperson and IRB coordinator responses indicating 

frequency than university IRBs. We also note that only two (9 percent) VA IRBs and 

two (10 percent) university IRBs maintained an SOP that referenced reporting of adverse 

events to other IRBs. This was more consistent with responses obtained from IRB 

coordinators indicating that most IRBs do not report adverse events to other IRBs. VA 

IRB Chairpersons described a higher rate of reporting between IRBs. 

Addressing the reasons for the differences between VA and university

was noted to contain the following statements: 

Under an IRB Authorization Agreemen

provides IRB review for human subjects research conducted at the VAMC. 

The agreement specifies that IRB-01 operates under the condition of the 

VA Office of Inspector General 12 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

[university’s] FWA only and does not obligate the IRB-01 to operate under any 

additional VAMC-specific regulations or policies.7

This is contrary to VHA policy that VAMCs with university affiliated IRBs reviewing 

VHA research comply with the same standards for human subjects protections required 

of VA IRBs. 

B. IRB Documentation Standards: Review of IRB Minutes by Protocol 

We also examined whether IRB minutes contained eight necessary elements described in 

VHA Handbook 1200.5. We reviewed 58 sets of minutes referencing our 23 subject 

protocols. Thirty (52 percent) of these reviews were conducted by VA IRBs, while 

28 (48 percent) reviews were conducted by university IRBs. Among the required 

elements, IRB rosters must list member names, earned degrees, affiliated or nonaffiliated 

status, and voting status of all IRB members. Because IRB members change, however, 

we looked at IRB minutes to determine whether there was sufficient information to 

determine member names, earned degrees, affiliated or nonaffiliated status and voting 

status of IRB members. All 30 sets of VA IRB minutes contained member names and 

degrees while 26 (87 percent) recorded affiliation, and 28 (93 percent) recorded voting 

status. This compared to 28 sets of university IRB minutes in which 27 of 28 (96 

percent) contained names, but only 23 (82 percent) contained degrees, 17 (61 percent) 

described affiliations, and 19 (68 percent) listed voting status. VA IRBs were more likely 

to record degree (p = 0.02), affiliation (p = 0.03), and voting status (p = 0.01) than were 

their university counterparts. Information about degrees and voting status (other than 

recusals) is not specifically required to be in the minutes. The remaining required 

elements discussed in this review are presented in Table 2: 

Table 2: Frequency and Percent Compliance with Handbook 1200.5 

Required Elements for the 58 IRB Minutes 

VA IRB Minutes 

Frequency 

(Percent Compliance) 

University IRB Minutes 

Frequency 

(Percent Compliance) 

P

Values 

The minutes include 

sufficient information to 

determine that a quorum is 

present. 

28 (93.3) 15 (53.27) 0.002 

A non-scientific member 

of the IRB is recorded as 

present. 

30 (100) 21 (75) 0.003 

 

7

 ORO stated they were aware of the language in the MOU and were working with the VA facility at the time of the 

OIG visit to ensure correction of the MOU. 

VA Office of Inspector General 13 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

 The minutes record votes 

on actions including the 

number of members 

voting for, against, or 

abstaining. 

29 (96.7) 27 (96.4) 0.96 

The minutes describe the 

basis for required changes 

in the research. 

29 (96.7) 12 (42.9) <0.0001 

At least one of the two VA 

employees on the IRB is

listed as present and as a 

voting member. 

30 (100) 14 (50) <0.0001 

As presented in Table 2, VA IRB minutes contained information that a 

nonscientific member and VA employee were present and voting members more 

often than did university IRB minutes (p = < 0.0001). In addition, VA IRB 

minutes were more likely to indicate the presence of a quorum than were 

university IRB minutes. Both VA and university IRB minutes indicated high rates 

of compliance in recording the number of members voting for or against issues or 

abstaining from voting. 

III. Principal Investigator Profiles and Documentation Requirements 

A total of 57 different PIs were involved in the 23 subject protocols. We interviewed all 

of them regarding their publication history, human subjects protection training status, and 

IRB documentation, including progress reports, adverse event reporting, and protocol 

modifications. These PIs varied widely in terms of their publication history. Six of 

the 57 (10 percent) PIs indicated they were not the first author on any publication; 

18 (32 percent) were first authors on 1–5 publications; 17 (30 percent) had 6–20 such 

publications; and 16 (28 percent) PIs had more than 20 publications listing themselves as 

first author. All 57 indicated that they were required by their local IRB to participate in 

some form of human subjects protection training. 

We reviewed 58 continuing review applications, one submitted for each IRB that 

reviewed any one of the 23 subject protocols. We assessed whether the reports contained 

11 elements required under the terms of VHA Handbook 1200.5. Results are described 

in Table 3: 

VA Office of Inspector General 14 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Table 3: Frequency and Percent Compliance with Handbook 1200.5 

IRB Progress Report Requirements 

VA IRB Submissions 

Total = 30 

Frequency 

(Percent Compliance)

University IRB 

Submissions 

Total = 28 

Frequency 

(Percent Compliance)

P 

Values 

Summary of research 

methodology and 

procedures. 

23 (76.7) 21 (75.0) 0.88 

Number of subjects 

entered and 

withdrawn.

30 (100) 26 (92.9) 0.14 

Gender and minority 

status of those entered 

into protocol. 

25 (83.3) 18 (64.3) 0.10 

Number of subjects 

that are members of 

specific vulnerable 

populations. 

15 (50) 11 (39.2) 0.41 

Copy of the current 

consent document. 

30 (100) 26 (92.9) 0.14 

Copy of the current 

HIPAA Authorization. 

28 (93.3) 25 (89.3) 0.58 

Adverse events, 

unanticipated 

problems and 

complaints. 

29 (96.7) 28 (100) 0.33 

Research findings to 

date. 

17 (*) 16 (57.1) 0.62 

Summary of Data 

Safety Monitoring 

Board or Committee 

Meetings. 

16 (*) 14 (*) 0.16 

An assurance that all 

SAEs and UAEs have 

been reported. 

23 (76.7) 20 (71.4) 0.65 

New scientific findings 

in the literature. 

16 (53.3) 16 (57.1) 0.62 

*No percentage compliances were calculated for these specific elements because the requirement did not apply 

to all protocols. For example, a total of 13 continuing review applications (4 for VA IRBs, 9 for university 

IRBs) were reviewed for protocols that did not use a data safety monitoring board. Therefore, the requirement 

for a summary of meetings of the data safety monitoring board would not be applicable. 

VA Office of Inspector General 15 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

While in some areas, compliance rates exceeded 90 percent, we find that certain 

measures revealed reduced compliance. For example, compliance rates for 

documentation of new scientific findings in the literature were 53.3 percent and 

57.1 percent respectively, and documentation of the involvement of vulnerable 

populations occurred in only 50 percent and 39.2 percent of VA and university IRBs. 

Differences in compliance rates between VA and university IRBs were not statistically 

significant in these areas. 

IV. Reporting of Adverse Events and Protocol Modifications in 

Multi-Center Trials 

A total of 40 of the 58 unique protocol reviews examined in this report involved 

multi-center trials. We examined IRB files for evidence of communication regarding 

adverse events. Table 4 below describes the number of protocol reviews in which 

evidence was found of communication regarding adverse events between the IRB and the 

sponsor, PI, IRBs at other sites, and PIs at other sites. 

Table 4: Frequency and Percent of IRBs Communicating With Other Entities 

Regarding Adverse Events 

VA IRB 

Total = 26 

Frequency 

Percent Communicating AEs) 

University IRB 

Total = 17 

Frequency 

(Percent Communicating 

AEs) 

P

Value 

(

Sponsors. 8 (31) 1 (6) 0.05 

PI. 19 (73) 12 (71) 0.86 

Other IRBs. 0 (0) 1 (6) 0.21 

Other PIs. 2 (8) 3 (18) 0.32 

rse events. This is generally the role of the 

sponsor, data coordinating center, or DSMB. 

While most files contained correspondence regarding adverse events between the PIs and 

IRBs at the individual sites, we note that very few contained evidence of correspondence 

between IRBs or between an IRB and a PI at another site. This was consistent with IRB 

chairperson and coordinator interviews, as well as evaluation of facility SOPs that 

determined it was not common practice for one IRB to notify another IRB of adverse 

events occurring at a given facility. VHA policy does not currently require IRBs to 

notify other IRBs in multicenter trials of adve

VA Office of Inspector General 16 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

For example, one protocol (Protocol #9) enrolled two subjects at a single site. One 

subject subsequently decided not to participate in the study. The second subject 

experienced six adverse events before the decision was made to terminate the study at 

that site. There was no evidence in either the PI’s files or the IRB files that IRBs at other 

sites were notified of these adverse events or of the decision to discontinue the study at 

that site. It is also not documented as to whether the adverse events experienced by the 

fications. Table 5 below describes 

correspondence between the site IRBs and sponsors, PIs, PIs at other sites, and IRBs at 

oth

Table 5: Frequency and Percent of IRBs Communicating With Other Entities 

R ocol Mod

sole participant in the study at that site resulted in the decision to close the protocol. 

In addition to IRB reporting practices relating to adverse events, we also reviewed the 

subject protocols for numbers of modifications. Of 30 unique protocol reviews by VA 

IRBs, 29 contained evidence that at least one protocol modification or amendment was 

reported to the IRB compared with only 12 of 28 unique protocol reviews by university 

IRBs (p =< 0.0001). In multi-center trials, 33 of 40 sites’ IRB files contained 

correspondence describing protocol modi

er sites regarding protocol modifications. 

egarding Prot ifications 

VA IRB 

Total = 26 

Frequency 

(Percent Compliance) 

Un B iversity IR

Total = 17 

P 

Value 

Frequency 

(Percent Compliance) 

Sponsors. 10 (39) 2 (12) 0.06 

PI. 2 2 (85) 1 4 (82) 0.85 

Other IRBs. 2 (8) 0 (0) 0.25 

Other PIs. 3 (12) 1 (6) 0.53 

The IRB files maintained by VA IRBs were more likely to contain correspondence 

between the IRB and the sponsor regarding protocol modifications than were university 

IRB files. There were no other significant differences in documentation of 

communication regarding protocol modifications between VA and university IRBs. The 

vast majority of IRB files reviewed contained no documentation of correspondence 

regarding protocol modifications between IRBs or between one IRB and the PI at another 

site. 

VA Office of Inspector General 17 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Conclusion 

Overall, we found good compliance with the documentation requirements of VHA 

Handbook 1200.5 for IRBs and PIs. In the area of standard operating procedures for 

IRBs, we noted the lowest compliance rates with the requirements of standard operating 

procedures ensuring reporting of privacy or information security violations to the 

appropriate officials. However, data collection occurred prior to a number of significant 

information security developments and initiatives within VHA. IRB minutes maintained 

by VA IRBs demonstrated excellent compliance, with all rates above 90 percent. 

However, we note significantly lower compliance rates in at least three areas in the 

maintenance of minutes by university IRBs. Both VA and university compliance with 

the required elements of PI progress reports should target improvement in the description 

of vulnerable populations and documentation of new scientific findings in the literature 

that might affect the research. 

Because of the lack of communication between IRBs in multi-center trials as well as the 

lack of consistent procedures for reporting adverse events to medical center officials 

among university affiliates, we identify the reporting of adverse events and protocol 

modifications as an area for potential improvement within VHA. In the sample of 

protocols discussed in this report, there was not a consistent mechanism by which those 

multi-center trials that did not maintain data safety monitoring boards communicated 

with other sites. Neither IRB files nor PI files consistently contained evidence that IRBs 

or individual PIs communicated with any other site. We note that this is not currently 

required under VHA policy. While PI files contained some evidence of correspondence 

with the sponsor regarding these events, we found that affiliate IRBs were less likely to 

have documentation from the sponsor in their files describing protocol modifications or 

adverse events occurring at other sites. 

In addition, the individuals interviewed as well as IRB standard operating procedures and 

documentation in PI and IRB files did not demonstrate that university IRBs consistently 

notified the medical center director of reportable adverse events. If adverse events are 

not properly reported to ORO by the medical center director, this would circumvent 

another means by which VHA could centrally monitor at least certain types of adverse 

events in multi-center trials. 

While identification of potential causes for non-compliance or differences in compliance 

is beyond the scope of this review, we do note that there were no significant differences 

in the background and experience of IRB Chairpersons between VA and university IRBs. 

In addition, while university IRBs as a whole reviewed more protocols and employed 

more certified IRB professionals, we found that, where significant differences existed in 

compliance between VA and university IRBs, these differences reflected less compliance 

by university IRBs rather than VA IRBs. 

VA Office of Inspector General 18 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Recommendations 

1. We recommend that the Under Secretary for Health ensure that all IRBs 

reviewing VA protocols disclose reportable adverse events to the VA 

facility, which must then report adverse events to ORO in compliance with 

the requirements of VHA Handbook 1058.1. 

2. We recommend that the Under Secretary for Health ensure that VHA 

compliance offices review current standard operating procedures of IRBs 

reviewing VA protocols to ensure that they include mechanisms for the 

reporting of privacy or information security violations in accordance with 

the requirements of VHA Handbook 1200.5. 

3. We recommend that the Under Secretary for Health ensure that VHA 

facilities require university affiliated IRBs to follow VHA Handbook 

1200.5 and to verify that corrections are made to address deficiencies 

identified in this report. 

Comments 

The Under Secretary for Health agreed with the findings and recommendations and 

provided acceptable improvement plans. (See Appendix C, pages 24–28, for the full text 

of comments.) We will follow up on the planned actions until they are completed. 

 (original signed by) 

 JOHN D. DAIGH, JR., MD 

 Assistant Inspector General for

 Healthcare Inspections 

 

VA Office of Inspector General 19 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Appendix A 

Requirements for IRB Standard Operating Procedures 

(From VHA Handbook 1200.5) 

The IRB must establish written procedures for, but not limited to:8

1. Conducting its initial and continuing review of research and for reporting its 

findings and actions to the investigator and the R&D Committee. 

2. Determining which projects require review more often than annually and which 

projects need verification from sources, other than the investigator, that no material 

changes have occurred since previous IRB review. 

3. Ensuring that investigators promptly report proposed changes in a research activity 

including amendments to the protocol, or the consent form, to the IRB, and ensuring 

that such changes in approved research are not initiated without the IRB’s review 

and approval, except when necessary to eliminate apparent immediate hazard to the 

subject. 

4. Reporting promptly to the IRB regarding non-compliance by study personnel. 

5. Notifying medical center officials and VA Central Office of any AEs that cause 

harm or risk of harm to human subjects or groups as required by this Handbook, 

other VA policies, or Federal regulations, any instance of serious or continuing 

noncompliance with this Handbook or the requirements or determinations of the 

IRB; and suspension or termination of IRB approval. 

6. Reporting any AE as required by VA and Federal policy and regulations. 

7. Termination and/or suspension of IRB approval. 

8. Observing the informed consent process when the IRB determines it to be 

appropriate. 

9. Conducting audits of protocols and other IRB activities. 

10.Ensuring that initial and continuing education requirements for the IRB Chair, IRB 

members, and IRB alternate members are met. 

11.Notifying members of expedited reviews and decisions about exemptions. 

12.Reporting to the Privacy Officer any unauthorized use, loss, or disclosure of 

individually-identifiable patient information. 

 

8

 VHA Handbook 1200.5, Requirements for the Protection of Human Subject in Research, July 15, 2003, pages 13, 

and 14. 

VA Office of Inspector General 20 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Appendix A 

13. Reporting violations of VA information security requirements to the appropriate 

VHA Information Security Officer. 

VA Office of Inspector General 21 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Appendix B 

IRB Meeting Minutes Requirements 

(From VHA Handbook 1200.5) 

1. Proceedings must be written and available for review within 3 weeks of the 

meeting date. Once approved by the members at a subsequent IRB meeting, the 

minutes must not be altered by anyone including a higher authority. Minutes of 

IRB meetings must contain sufficient detail to show:9

a. The presence of a quorum throughout the meeting including the presence of 

one member whose primary concern is in a non-scientific area. 

b. Attendance at the meetings including those members or alternate members 

who are participating through videoconference or teleconference and 

documentation that those attending through videoconferencing or 

teleconferencing received all pertinent material prior to the meeting and 

were able to actively and equally participate in all discussions. 

c. Alternate members attending the meeting and for whom they are 

substituting. 

d. Actions taken by the IRB including those involving full review. The IRB 

may choose to use the minutes to notify IRB members of actions taken 

through expedited review and those studies that have been determined to be 

exempt from IRB review. 

NOTE: These required notifications may be carried out through other 

mechanisms. 

e. Documentation of the four required findings (36CFR 16.116(d)) when 

approving a consent procedure that does not include or that alters some or 

all of the required elements of informed consent, or when waiving the 

requirement to obtain an informed consent. 

f. The vote on actions including the number of members voting for, against, 

and abstaining. 

g. A note indicating that when an IRB member has a real or potential conflict 

of interest relative to the proposal under consideration, that the IRB 

member was not present during the deliberations or voting on the proposal 

(and that the quorum was maintained). 

 

9

 VHA Handbook 1200.5, Requirements for the Protection of Human Subject in Research, July 15, 2003, pages 16 

and 17. 

VA Office of Inspector General 22 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Appendix B 

h. The basis for requiring changes in or disapproving research and 

documentation of resolution of these issues when resolution occurs. 

VA Office of Inspector General 23 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Appendix C 

Under Secretary for Health Comments 

Department of 

Veterans Affairs Memorandum

Date: September 25, 2007 

From: Under Secretary for Health (10) 

Subject: OIG Draft Report: Healthcare Inspection: Comparison of 

VA and University Affiliated IRB Compliance with VHA 

Handbook 1200.5 (Project No. 2006-00980-HI-0257/ 

WebCIMS 385907)

To: Assistant Inspector General for Healthcare Inspections (54) 

1. I have reviewed this draft report and am pleased that your findings 

reflect overall good compliance by VA and university-affiliate Institutional 

Review Boards (IRB) in meeting the documentation requirements included 

in VHA Handbook 1200.5. As you are aware, VHA has a long-standing 

commitment to ensuring that protection of human subjects in research 

remains a top priority, and we will continue to strive for ongoing 

improvements in this broad and complex area. I concur with your findings 

and recommendations and include, as an attachment, our planned corrective 

actions in response to each recommendation. 

2. I agree that there is considerable confusion in the field about how to 

implement established IRB adverse event reporting protocols, and the 

Offices of Research Oversight (ORO) and Research and Development 

(ORD) are taking immediate steps to address this situation. For example, 

ORO will revise and clarify VHA Handbook 1058.1, outlining definitive 

processes involved with the reporting of adverse events by the IRBs to 

medical facility management, who then submit the report directly to ORO. 

As part of their efforts to better define the reporting process, ORO will also 

identify oversight monitoring tools that can be implemented at various 

organizational levels to assess IRB and facility compliance with Handbook 

guidance for disclosing reportable adverse events. As detailed in our action 

plan, these compliance requirements will also be points of discussion at a 

variety of educational seminars that will be attended by VA research 

professionals, including a series of ORD-sponsored regional meetings on 

research accountability at the local level, as well as the five regional 

VA Office of Inspector General 24 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Appendix C 

Network Cluster Meetings for VISN and medical center directors. ORO 

and ORD will also jointly sponsor training sessions about adverse event 

reporting during the upcoming annual meeting of the Society of Research 

Administrators International, which will be attended by a large number of 

both VA and university-affiliate research managers. These educational 

forums will also address issues that you raise about the reporting of privacy 

or information security violations in accordance with the requirements of 

VHA Handbook 1200.5, dealing with the protection of human subjects in 

research. 

3. Another planned VHA research initiative also responds directly to your 

recommendations. I recently requested that ORO fully explore VA’s use of 

university-affiliated IRBs. This comprehensive endeavor will include 

targeted on-site reviews of the effectiveness of university IRBs for VA 

research programs. ORO has additionally been directed to strengthen 

newly required annual facility research program assessments and facility 

director certification of research oversight to include use of university 

IRBs. ORD will also be actively involved in these expanded functions, 

particularly in relation to reviewing accreditation standards and findings for 

VA use of university IRBs, in reviewing the effectiveness of oversight by 

VA Research and Development Committees, and in developing and 

implementing education programs addressing VA use of university IRBs. 

4. In summary, your focused findings have assisted in helping us to 

prioritize some specific improvement actions. VHA’s planned actions are 

responsive to the issues that you identify, and I look forward to sharing 

ongoing progress with you. If additional information is requested, please 

contact Margaret M. Seleski, Director, Management Review Service 

(10B5), at 565-7638. 

(original signed by) 

Michael J. Kussman, MD, MS, MACP 

Attachment 

VA Office of Inspector General 25 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Appendix C 

VETERANS HEALTH ADMINISTRATION

Action Plan Response

OIG Draft Report: Healthcare Inspection: Comparison of VA and University 

Affiliated IRB Compliance with VHA Handbook 1200.5 

(Project No. 2006-00980-HI-0257)

Recommendations/ Status Completion 

Actions Date 

Recommendation 1. We recommend that the Under Secretary for Health 

ensure that all IRBs reviewing VA protocols disclose reportable adverse 

events to the VA facility, which must then report adverse events to ORO in 

compliance with the requirements of VHA Handbook 1058.1.

Concur 

VHA acknowledges the need to refine and clarify existing guidance on the 

required steps that the IRBs and field facilities must take in reporting 

adverse events to Office of Research Oversight (ORO) and to assure that all 

involved parties understand and comply with that guidance. Specific 

actions are already planned by both ORO and the Office of Research and 

Development (ORD) to address issues identified in this report. As a first 

step, ORO will revise and update VHA Handbook 1058.1, Reporting 

Adverse Events in Research to the Office of Research Oversight, with 

emphasis on defining step-by-step processes involved with the reporting of 

adverse events by the IRBs to medical facility management, who will then 

submit the reports directly to ORO. 

Compliance requirements for research-related adverse event reporting will 

be reinforced at a variety of educational forums that will be attended by VA 

research professionals. For example, beginning in October 2007, ORD will 

conduct five regional meetings on “Local Accountability for Research in 

VA Facilities.” ORO program managers will also participate in these 

meetings, as will up to five representatives from each VA facility 

performing research. Included on the planned agenda of these meetings is 

training on adverse event reporting as defined in VHA Handbooks 1058.1 

and 1200.5 (Requirements for the Protection of Human Subjects in 

Research). 

At the October 2007 annual meeting of the Society of Research 

Administrators International, which is widely attended by both VA and 

university affiliated research professionals, ORO and ORD will jointly 

VA Office of Inspector General 26 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Appendix C 

sponsor training sessions that will also provide thorough instruction in 

adverse event reporting. 

In addition, ORO’s Chief Officer will participate in five regional Network 

Cluster Meetings that are planned by the Deputy Under Secretary for 

Health for Operations and Management (DUSHOM). These meetings will 

be attended by both network directors and medical facility directors. The 

responsibilities of facility managers in adverse event reporting, as well as in 

the reporting of privacy and security violations and other issues addressed 

in this report, will again be highlighted. 

The Under Secretary for Health recently expanded ORO’s functional 

responsibilities to include a comprehensive assessment of all aspects of 

VA’s use of affiliate IRBs. As part of this mission expansion, ORO will 

conduct targeted on-site reviews of the effectiveness of university IRBs for 

VA research programs, develop more precise annual facility research 

program assessments, and research oversight certification tools to include 

use of university IRBs. Issues identified in this report, including adverse 

event reporting by the IRBs, will be incorporated into the ORO assessment 

process and subsequent educational program development. 

 Planned October 2007 and Ongoing 

Recommendation 2. We recommend that the Under Secretary for Health 

ensure that VHA compliance offices review current standard operating 

procedures of IRBs reviewing VA protocols to ensure that they include 

mechanisms for the reporting of privacy or information security violations 

in accordance with the requirements of VHA Handbook 1200.5. 

Concur 

As noted above, both ORD and ORO are actively involved in the planning 

and execution of a series of research educational forums, all of which will 

include intensive training on privacy and information security reporting 

requirements for VA research. Because research privacy and information 

security reporting extend well beyond the IRB to the medical facility as a 

whole, these issues will also be addressed during the planned Network 

Cluster Meetings. At the same time, ORO will address privacy and 

information security concerns during their reviews of affiliate IRB standard 

operating procedures and recommend supplemental training and follow-up 

action as required. 

 Planned October 2007 and Ongoing 

VA Office of Inspector General 27 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Appendix C 

Recommendation 3. We recommend that the Under Secretary for Health 

ensure that VHA facilities require university affiliated IRBs to follow VHA 

Handbook 1200.5 and to verify that corrections are made to address 

deficiencies identified in this report. 

Concur 

This will be a core goal in ORO’s expanded mission to ensure the efficacy 

and effectiveness of affiliated IRBs that review VA research protocols. 

ORO will be directly involved with strengthening newly required annual 

facility research program assessments and facility director certification of 

research oversight to include use of university IRBs. ORD will also be an 

active participant with ORO in reviewing the effectiveness of oversight of 

the IRBs by VA Research and Development Committees and in developing 

and implementing educational programs to address identified issues. 

 Planned February 2008 and Ongoing 

VA Office of Inspector General 28 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Appendix D 

OIG Contact and Staff Acknowledgments 

OIG Contact Andrea Buck, M.D., J.D., Senior Physician 

Office of Healthcare Inspections 

(202) 565-8305 

Acknowledgments Annette Acosta 

Gail Bozzelli 

Limin Clegg, Ph.D. 

Marnette Dhooghe 

Dorothy Duncan 

Donna Giroux 

Jeanne Martin, Pharm.D. 

Nelson Miranda 

Roxanna Osegueda 

Katherine Owens 

Michelle Porter 

Reba Ransom 

Annette Robinson 

Sunil Sen-Gupta, Ph.D. 

Randall Snow, J.D. 

Carol Torczon 

John Tryboski 

VA Office of Inspector General 29 
Comparison of VA and University Affiliated IRB Compliance with VHA Handbook 1200.5 

Appendix E 

Report Distribution 

VA Distribution

Office of the Secretary 

Veterans Health Administration 

Assistant Secretaries 

General Counsel 

Non-VA Distribution

House Committee on Veterans’ Affairs 

House Appropriations Subcommittee on Military Construction, Veterans Affairs, and 

Related Agencies 

House Committee on Oversight and Government Reform 

Senate Committee on Veterans’ Affairs 

Senate Appropriations Subcommittee on Military Construction, Veterans Affairs, and 

Related Agencies 

Senate Committee on Homeland Security and Governmental Affairs 

National Veterans Service Organizations 

Government Accountability Office 

Office of Management and Budget 

This report is available at http://www.va.gov/oig/publications/reports-list.asp. 

VA Office of Inspector General 30