Department of Veterans Affairs 

Office of Inspector General 

Healthcare Inspection 

Review of Informed Consent in the 

Department of Veterans Affairs 

Human Subjects Research 

Report No. 08-02725-127 May 15, 2009

VA Office of Inspector General 

Washington, DC 20420 
 

 

 

To Report Suspected Wrongdoing in VA Programs and Operations 

Telephone: 1-800-488-8244 between 8:30AM and 4PM Eastern Time,

 Monday through Friday, excluding Federal holidays

 E-Mail: vaoighotline@va.gov 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

Contents 

Page 

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

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

Purpose............................................................................................................................. 1

Background...................................................................................................................... 1

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

Results and Conclusions ....................................................................................9 

Findings......................................................................................................................... 12 

Part I. Protocols Exempt from Informed Consent...................................................... 12 

Issue 1: Insufficient Institutional Review Board Waiver Documentation ............. 12 

Part II. Protocols That Required Informed Consent .................................................. 13

Issue 2: Absence of Informed Consent Forms ....................................................... 14 

Issue 3: Noncompliance of Consent Forms............................................................ 16 

Conclusions................................................................................................................... 21 

Recommendations........................................................................................................ 21 

Appendixes

A. Thirty Sampled VA Research Facilities Visited by Inspectors ............................... 23

B. Under Secretary for Health Comments.................................................................... 24

C. OIG Contact and Staff Acknowledgments............................................................... 31

D. Report Distribution .................................................................................................. 32

VA Office of Inspector General 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

Executive Summary 

Introduction 

Representative Steve Buyer, Ranking Member of the House Committee on Veterans’ 

Affairs, requested VA Office of Inspector General, conduct a review to determine 

whether VA research involving human subjects had on file either the informed consent 

forms or a waiver for this requirement from the institutional review board (IRB), and to 

determine for consent forms on file whether they comply with the Federal and VA 

regulations and Veterans Health Administration (VHA) policies. 

The study population consisted of all enrollees of human subjects research projects 

conducted under VA auspices that were active and required informed consent, and had at 

least one enrollee as of August 20, 2008. The study used a complex, three-stage sample 

design that included stratification, clustering, and unequal probabilities of selection. 

From the 102 facilities that had at least one applicable protocol, we statistically randomly 

selected 30 (29.4 percent) facilities where we conducted onsite inspections. There were 

5,993 sampled participants. 

Results 

The Common Rule and VA regulations authorize IRBs to waive the required informed 

consent if they find and document specific criteria when approving the waiver. We found 

insufficient IRB documentation for the waiver for 2 of the 33 sampled research protocols 

that were waived from the required informed consent process. 

We estimated that 1.7 percent of the 367,103 VA research subject consent forms could 

not be located, and we are 95 percent confident that the true percent value is somewhere 

from 0.6 percent to 4.5 percent. It appears that some investigators utilized consent 

procedure as “deferred consent” or “ratification” since research subjects were added to 

the enrollee list before completing the informed consent. The requirement to obtain the 

legally effective informed consent of individuals before involving them in research is one 

of the central protections provided for under the Common Rule. Any informed consent 

procedures, other than the required prospectively obtained consent, fail to constitute 

informed consent under the regulations for the protection of human research subjects. 

Subjects should not be added to the enrollee list or counted as enrollees in the annual 

progress report to the IRB for continuing review until their informed consents are 

prospectively executed. 

Thirty-one percent (110,231) of the 361,042 VA research subject consent forms on file 

were estimated to be noncompliant; most (97 percent) lacked witness signature. We 

found that (annual) IRB-approved consent forms for particular protocols did not 

consistently include witness blocks over the course of the research, which likely 

VA Office of Inspector General i 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

VA Office of Inspector General ii 

contributed to the high percent of missing witnesses. In addition, investigators may have 

mistakenly taken the required witness as an option. 

We estimated that nearly 1 percent (1,023) of the 110,231 VA noncompliant forms 

lacked subject or subject’s authorized representative signature. As mandated by the 

Common Rule and VA regulations, consent forms without subject signature are not

“legally effective.” 

Recommendations 

Recommendation 1: We recommended that the Under Secretary for Health require that 

facility Directors ensure sufficient IRB written documentation of waiver from informed 

consent. 

Recommendation 2: We recommended that the Under Secretary for Health establish 

procedures requiring facility Directors to ensure signed informed consent forms are on 

file. 

Recommendation 3: We recommended that the Under Secretary for Health establish 

procedures requiring facility Directors to ensure that informed consents are prospectively 

obtained, which includes adding subjects to enrollee lists and/or to annual research 

progress reports only after obtaining the informed consent. 

Recommendation 4: We recommended that the Under Secretary for Health require 

facility Directors to ensure that witnesses are obtained for all VA consent forms as 

required. 

Recommendation 5: We recommended that the Under Secretary for Health establish 

procedures requiring facility Directors to ensure that IRB-approved informed consent 

forms consistently contain witness blocks or ensure sufficient IRB written documentation 

of waiver from the witness requirement. 

Comments 

The Under Secretary agreed with the findings and recommendations and provided an 

appropriate improvement plan. See Appendix B (pages 24–30) for the full text of his 

comments. We will follow up on all recommendations until they are completed. 

 (original signed by:)

JOHN D. DAIGH, JR., M.D. 

Assistant Inspector General for 

Healthcare Inspections 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

VA Office of Inspector General 1 

Introduction 

Purpose 

In a letter dated July 3, 2008, Representative Steve Buyer, Ranking Member of the House 

Committee on Veterans’ Affairs, requested that the Department of Veterans Affairs, 

Office of Inspector General, Office of Healthcare Inspections, conduct a review of human 

subject protection in VA research, particularly in the area of informed consent. The 

objectives for the review were (1) to determine whether VA research involving human 

subjects had on file either the informed consent forms or a waiver for this requirement 

from the institutional review board (IRB), and (2) for consent forms on file, determine 

whether they comply with the Federal and VA regulations and VHA policies.

Background 

In accordance with Title 38 U.S.C., section 7303, the VA conducts medical research with 

a focus on areas that most directly address the diseases and conditions affecting veterans. 

Non-veterans may be enrolled in VA medical research only when there are insufficient 

numbers of veterans available. 

The Office of Research and Development (ORD) of the Veterans Health Administration 

(VHA) administers all VA research conducted at VA medical facilities nationwide. The 

VA Research and Development (R&D) program is an intramural program and allocates 

appropriated Medical and Prosthetic Research funds to VA medical facilities through its 

four services: (1) Laboratory Biomedical R&D, (2) Clinical Sciences R&D, (3) 

Rehabilitative R&D, and (4) Health Services R&D. 

The ORD allocates appropriated research funds to VA medical facilities for scientifically 

meritorious research related to the high priority health care needs of veterans. In addition 

to the appropriated Medical and Prosthetic Research funds, VA investigators may also 

obtain funding support for their research from extramural sources, such as other Federal 

agencies, private health organizations and foundations, and commercial entities. Unlike 

agencies such as the National Institutes of Health and the Department of Defense, VA 

does not have the statutory authority to make research grants to non-VA entities. 

However, contracts may be utilized to obtain special services not available in VA. VA 

medical R&D spending in 2008 was approximately $1,805 million and involved 3,250 

full-time employee equivalents (FTE). VA is anticipating $1,845 million and 3,201 FTE 

in 2009.1

 

VA is one of the 17 Federal departments and agencies that have agreed to follow the 

Federal Policy for the Protection of Human Subjects, known as the Common Rule, 

effective June 18, 1991 (56 Federal Register (FR) 28001). VA regulations pertaining to 

 

1

 Department of Veterans Affairs, FY 2009 Budget Submission, Vol. 2, Pg. 2A-7. 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

VA Office of Inspector General 2 

implementation of the Common Rule are incorporated in Title 38 Code of Federal 

Regulations Part 16 (38 CFR 16). In 1999, VA established an independent office of 

research compliance and assurance. In 2003, this office was succeeded by the Office of 

Research Oversight (ORO). The ORO is the primary office responsible for overseeing 

research compliance and assurance for human subjects protections, animal welfare, 

research safety, and research misconduct throughout the VA system. VHA 

Handbook 1200.05, Requirements for the Protection of Human Subjects in Research, 

details the procedures all VA research facilities must use to implement 38 CFR 16. Food 

and Drug Administration (FDA) regulations at 21 CFR 50 may also apply if the research 

involves a clinical investigation regulated by the FDA. 

Federalwide Assurance and Institutional Review Board for the Protection of Human 

Subjects. 

The Common Rule defines research as a systematic investigation, including research 

development, testing and evaluation, designed to develop or contribute to general 

knowledge (38 CFR 16.102(d)). All research conducted under VA auspices is considered 

to be Federally supported. Thus, each VA facility conducting or engaged in research 

involving human subjects must obtain an Assurance in accordance with 38 CFR 16.103. 

This Assurance, when granted, is called a Federalwide Assurance (FWA). It is a written 

commitment by research facilities that complies with the Common Rule and other 

applicable Federal and VA requirements for the protection of human subjects. Under 

38 CFR 16.102(f), a facility is engaged in human subjects research whenever its 

employees or agents (1) intervene or interact with living individuals for research purposes 

or (2) obtain individually identifiable, private information for research purposes. FWAs 

for VA facilities are filed with the Department of Health and Human Services’ (HHS) 

Office for Human Research Protections (OHRP) through the VA ORO. FWAs must be 

approved by both the ORO and the OHRP before any human subjects research is 

initiated. 

Each VA facility engaged in research involving human subjects or human biological 

specimens must hold an effective FWA approved by the OHRP with an effective VA 

FWA Addendum approved by the ORO. In rare cases and with the ORD’s concurrence, 

the ORO may negotiate special Assurances or recognize Assurances issued by other 

Common Rule departments and agencies in lieu of FWAs.2

 FWAs must be renewed at 

least every 3 years in order to remain active. FWAs are inactivated if a renewal has not 

been approved by both the ORO and the OHRP prior to the end of the FWA’s approval 

period. 

The institutional review board (IRB) designated under the FWA at each research facility 

is the committee charged with the oversight of all research activities involving human 

subjects for compliance with regulations within the facility. Every VA facility conducting 

 

2

 VHA Handbook 1058.03, Assurance of Protection for Human Subjects In Research, May 10, 2007, 5a(11). 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

research involving human subjects must establish an IRB or must secure the services of 

an IRB, as described in VHA Handbook 1200.05. The use of a commercial IRB is 

prohibited. IRBs must have at least five members with varied backgrounds to promote 

complete and adequate review of research activities. At least one member’s primary 

expertise must be scientific and at least one member’s must be non-scientific. Also, at 

least one member must not otherwise be affiliated with the VA medical center. No IRB 

may consist entirely of members of one profession. The IRB is a subcommittee of the 

R&D Committee at VA research facilities, which is the local committee charged with 

oversight of all R&D activities within a facility. The IRB must approve a research 

protocol before the R&D Committee considers its approval. 

All VA-covered human subjects research activities must be reviewed and prospectively 

approved and are subject to continuing review at least annually by the designated IRB(s). 

IRBs must approve, require modifications to (in order to secure approval), or disapprove 

the proposed human subjects research. Before approval, the IRB must review the full 

research proposal, the consent form, and all supplemental information to determine that 

the following requirements are satisfied: (1) risk must be minimized; (2) there must be a 

reasonable risk to benefit ratio; (3) subjects must be equitably selected; (4) informed 

consent forms must be valid; (5) the informed consent process for patients must be 

documented; (6) safety must be monitored; (7) privacy and confidentiality must be 

maintained; (8) vulnerable subjects must be protected; (9) conflicts of interest must be 

managed, reduced, or eliminated; and (10) investigators must meet education 

requirements for the protection of human subjects in research and for conducting the 

research. 

Research activities may be exempt from review by the IRB if the only involvement of 

human subjects is in one or more of the categories specified in 38 CFR 16.101(b) (or in 

Appendix A of VHA Handbook 1200.05). Investigators must submit the proposed 

research and the request for exemption to the IRB. Exemption status must be approved 

by the IRB Chair or an IRB member designated by the Chair, and the decision must be 

communicated in writing to the investigator and the IRB. 

VA Requirements for Obtaining Signed Informed Consent Forms from Research 

Subjects. 

Unless waived by the IRB under criteria at 38 CFR 16.116(c) or 16.116(d), Federal 

regulations and both VA regulations and VHA policies require that written informed 

consent be obtained from every subject participating in human research conducted under 

the auspices of the VA, and the consent form must be the most recent IRB-approved 

consent form. Regulations at 38 CFR 16.117(c) require specific findings on the part of 

the IRB for waiver of the requirement for the investigator to obtain a signed consent form 

from any subject. VHA Handbook 1200.05 further stipulates that only VA Form 10-

1086, “Research Consent Form,” be used as the consent form. Unless the IRB waives the 

requirement for the investigator to obtain a signed consent form from some or all subjects 

VA Office of Inspector General 3 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

in the research, the final page of each consent form must be signed and dated by the 

following three individuals: 

• The subject or the subject’s legally authorized representative. 

• A witness whose role is to witness the subject’s or the subject’s legally authorized 

representative’s signature. 

• The person obtaining the informed consent. 

The original signed consent form must be filed in the subject’s research case history as a 

part of the requirements for documentation of the informed consent. VHA 

Handbook 1200.05 further requires a written progress note in the subject’s medical 

record describing the consent process. Additionally, VHA Handbook 1907.01, Health 

Information Management and Health Records, August 25, 2006, requests that the signed 

and dated consent form be scanned into the medical record. 

Scope and Methodology 

We reviewed applicable laws, regulations, policies, procedures, and guidelines. Each of 

the 15 two-inspector teams visited 2 of the 30 statistically randomly selected VA research 

facilities to examine and retrieve pertinent documentation. Facility Directors were 

notified 2 business days prior to our visits. 

Study Populations. 

The study population consists of all enrollees of human subjects research projects 

conducted under VA auspices that were active and required informed consent, and had at 

least one enrollee as of August 20, 2008. 

To identify the study population, we first obtained a list from the HHS’s OHRP of all VA 

facilities holding an active FWA with the assistance of the ORO. As discussed in the 

Background section, each VA facility engaged in research involving human subjects or 

human biological specimens must hold an effective FWA registered with the OHRP. 

There were 114 VA facilities with current FWAs. 

We then requested from all 114 facilities a list of all human subjects research protocols 

that were active at their facilities as of August 20, 2008, which was the day our request 

was sent. We also requested identification of any protocols that had not enrolled any 

human subjects (no enrollees) as of August 20, 2008, and any that had obtained IRB 

approval of waiver from informed consent (waivers). We asked facilities to exclude 

protocols that were exempted from IRB review because an exemption preempts the 

requirement for an informed consent process. 

After receiving facility-specific protocol listings, we excluded 12 facilities that did not 

have any active protocols which required informed consent and had at least one enrollee. 

VA Office of Inspector General 4 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

Thus, 102 VA facilities had at least one applicable protocol for this review. The study 

population constitutes all subjects from whom informed consent was required for these 

active protocols at the 102 facilities. 

To estimate the extent of no enrollee and waiver protocols on facility-specific protocol 

listings, we statistically randomly sampled 15 protocols from each facility listing (if the 

listing included more than 15 protocols). We then sent the facility-specific list of 

15 protocols to the corresponding facility and asked for numbers of enrollees within each 

protocol. For facilities with 15 protocols or fewer, we sent the list of all protocols and 

asked for the numbers. 

Sample Design. 

The sample design consisted of three stages for selecting the probability-based random 

sample of subjects. With probability sampling, each subject in the study population has a 

known, positive probability of selection. This property of probability sampling avoids 

selection bias and enabled us to use statistical theory to make valid inferences from the 

sample to the study population. 

In the first stage, we statistically randomly selected 30 VA facilities from the universe of 

102 facilities, stratified by numbers of protocols within facilities. The stratification was 

used to ensure the inclusion of a spectrum of facilities with fewer and more protocols in 

our sample. The first stage of sampling resulted in 4 facilities with 10 or fewer protocols 

within each of them and 26 facilities with more than 10 protocols within each of them. 

For the second stage of sampling, we statistically randomly selected 10 protocols from 

each of the 26 sample facilities with more than 10 protocols. We included all protocols 

from the four sample facilities with 10 or fewer protocols. 

In the third stage, we statistically randomly selected 50 subjects from each of the sample 

protocols that had enrolled more than 50 subjects. We included all of the subjects if the 

protocol enrolled 50 subjects or fewer. All consent forms from an individual subject 

were collected for examination. This third stage of sampling was conducted by our 

inspectors onsite during their visits to the 30 sample facilities. 

This was a complex, multistage sample design that included stratification, clustering, and 

unequal probabilities of selection. 

Site Visits for Document Examination and Retrieval. 

Each of the 15 two-inspector teams visited 2 of the 30 randomly selected facilities during 

the week of September 29, 2008, (and the following week, if necessary) to examine and 

retrieve the pertinent documentation for the selected sample protocols within each 

facility. One facility was visited during the week of October 6, 2008. We notified 

facility Directors 2 business days prior to our inspectors’ visits. Facility Directors were 

VA Office of Inspector General 5 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

informed which of the 10 protocols were selected (all were selected if the facility had 

10 or fewer) and were requested to provide pertinent documentation for review. 

Onsite, the inspectors asked for the enrollee lists for the selected sample protocols, all 

consent forms for each subject on the protocol enrollee list, the IRB waiver document if 

the requirement to obtain an informed consent was waived for the protocol, and the most 

recent investigator progress report dated within the past year. If the selected protocol was 

granted a waiver for the requirement to obtain an informed consent under 38 CFR 

16.116(c) or 16.116(d), the IRB’s documentation of the waiver was examined for 

confirmation. These confirmed waivers were then excluded from consent form 

inspection. 

For the remaining protocols that required informed consent, the enrollee lists were 

checked against the number of subjects listed in the most current investigator progress 

report. For examination of consent forms, inspectors then used random number 

generation software to select a sample of 50 subjects from each of the protocols that had 

more than 50 subjects. For protocols with 50 subjects or fewer, all subject consent forms 

were included for review. 

Presence or Absence of Informed Consent Forms. 

We first verified whether there was at least one research consent form for each of the 

sample subjects. If no consent forms were located for any of the sample subjects during 

our site visit, the facility was notified to provide the opportunity to locate the forms 

and/or provide an explanation. If the facility was unable to provide the forms to our 

inspectors, we counted the forms as absent. 

Review of Executed Informed Consent Forms. 

We examined all the consent forms that were located to check for the existence of the 

following four elements: 

• Subject or the subject’s legally authorized representative signature. 

• Date of subject or subject’s legally authorized representative signature. 

• Witness signature. 

• Date of witness signature. 

Note that for this review, we examined only for the existence of signatures and their 

dates; we did not verify the authenticity of signatures. 

Since more than one consent form might be executed by an individual subject during the 

course of the research, we examined each of the consent forms from the same subject for 

the same study. 

VA Office of Inspector General 6 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

Statistical Analysis. 

We classified an executed research consent form as “compliant” for the purpose of this 

review if the form had all the following: 

• Subject or the subject’s legally authorized representative signature. 

• Date of subject or subject’s legally authorized representative signature. 

• Witness signature. 

• Date of witness signature. 

• Identical signature dates. 

If any of the above elements was missing from a consent form, the form was deemed 

noncompliant. A subject may have had more than one consent form for a given protocol. 

We defined a subject’s form as compliant if any of his/her multiple forms were 

compliant. Thus, a subject would be judged as not having a compliant form for a 

protocol only if all of the subject’s consent forms pertaining to that protocol were 

noncompliant. If more than one compliant form was located for a subject, we used the 

one with the earliest consent date in our data analyses. The consent date was defined as 

the date of the subject or subject’s legally authorized representative signature. If all 

consent forms for a subject of a given protocol were noncompliant, we also used the form 

with the earliest consent date in the analyses. 

It is possible for a veteran to participate in more than one VA research protocol. Because 

ensuring proper informed consent is the obligation of the investigators and not the 

responsibility of the subjects, we did not attempt to identify same subjects across 

different protocols. Therefore, we treat same subjects in different protocols, if any, as 

different subjects. 

We estimated the number and the percentage of research subjects whose consent forms 

were on file for all active research protocols in VA that required informed consent; and 

from among those subjects with research consent forms, we estimated the number and the 

percentage of subjects whose forms were compliant. Horvitz-Thompson sampling 

weights, which are the reciprocal of sampling probabilities, were used to account for our 

unequal probability sampling. To take into account the complexity of our multistage 

sample design, the jackknife replicate-based method was employed to obtain the 

sampling errors for the estimates. 

We also presented a 95 percent confidence interval for the true value (parameter) of the 

study population. A confidence interval gives an estimated range of values (being 

calculated from a given set of sample data) that is likely to include an unknown 

population parameter. The 95 percent confidence interval indicates that among all 

possible samples we could have selected of the same size and design, 95 percent of the 

time the population parameter would have been included in the computed intervals.

VA Office of Inspector General 7 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

Percentages can take only positive values from zero to 100, but their logits can have 

unrestricted range; hence, the normal approximation can be used to estimate the 

parameters. Thus, we calculated the confidence intervals for percentages on the logit 

scale and then transformed them back to the original scale to ensure that the calculated 

confidence intervals contained only the proper range of zero to 100 percent. 

All data analyses were performed using SAS statistical software (SAS Institute, Inc., 

Cary, NC), version 9.2 (TS1M0). Maps were produced using ArcGIS software 

(Environmental Systems Research Institute, Redlands, CA), version 9.2. 

This inspection was performed in accordance with Quality Standards for Inspections 

published by the President’s Council on Integrity and Efficiency. 

VA Office of Inspector General 8 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

VA Office of Inspector General 9 

Results and Conclusions 

As of August 20, 2008, 102 out of the 114 VA facilities holding active FWAs had active 

protocols that required informed consent and had at least one subject. From the 

102 facilities, we statistically randomly selected 30 (29.4 percent) facilities for our 

review. Appendix A lists the 30 sample facilities where we conducted onsite inspections. 

Figure 1 depicts geographically the 114 VHA facilities with active FWAs and the 

30 facilities we inspected. It shows that we visited 19 of the 21 Veterans Integrated 

Service Networks. 

Ten research protocols were statistically randomly selected from each of the 26 sample 

facilities with more than 10 protocols, and all protocols from each of the 4 sample 

facilities with 10 or fewer protocols were included in our protocol sample. In total, we 

obtained 289 sample protocols from the 30 sample facilities (Figure 2). One protocol 

was for a serum repository that was an auxiliary study of a treatment protocol initiated in 

1991. Originally, the informed consent for the auxiliary study was incorporated into the 

approved treatment protocol consent. In 1996, the informed consent document for the 

repository was separated from the treatment protocol. Since these two protocol titles 

were different, our inspectors did not accept copies of these treatment consent forms. 

The copies were shredded as they contained confidential information. Also, because 

these subjects were non-veterans at a university affiliate and it would take considerable 

effort for the facility to get copies of these treatment consent forms, we excluded this 

protocol from our data analysis. 

Of the remaining 288 sample protocols, 24 did not have any subjects. Hence, a total of 

264 protocols were included in our protocol sample for further review. Of these 

264 protocols, 33 were waived from informed consent, leaving a total of 231 protocols 

that had at least one subject and required informed consent. 
Review of Informed Consent in the Department of Veteran

Figure 1. 114 VA Research Facilities with an Active Federalw

Alaska Hawaii 

0 2 125 50 500

Miles

0 5 295 90

Miles

Assurance as of August 20, 2008 

Legend

ADMINISTRATIVE 

VISN

State

INSPECTION STAT

Visited (30 

Not visited Without app

VA Office of Inspector General 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

Figure 2. Sampling flowchart. 

VA Office of Inspector General 11 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

Findings 

Part I. Protocols Exempt from Informed Consent

Issue 1: Insufficient Institutional Review Board Waiver 

Documentation 

The Common Rule and VA regulations at 38 CFR 16.116 mandate that no investigator 

may involve a human being as a subject in research covered by the regulations unless 

(a) the investigator has obtained the legally effective informed consent of the subject or 

the subject’s legally authorized representative, or (b) the IRB has waived the 

requirements to obtain informed consent in accordance with 38 CFR 16.116(c) or (d). 

The regulations give IRBs authority to waive the required research consent under two 

circumstances. The first waiver authority is applicable only to research activities 

designed to study certain aspects of public benefit or service programs, which cannot be 

carried out without a waiver. The conditions under which this waiver may be authorized 

by an IRB are detailed at 38 CFR 16.116(c). The second waiver authority is described at 

38 CFR 16.116(d) as follows: 

An IRB may approve a consent procedure which does not include, or which 

alters, some or all of the elements of informed consent set forth in this 

section, or waive the requirements to obtain informed consent provided the 

IRB finds and documents that: 

(1) The research involves no more than minimal risk to the subjects; 

(2) The waiver or alteration will not adversely affect the rights and 

welfare of the subjects; 

(3) The research could not practicably be carried out without the waiver 

or alteration; and 

(4) Whenever appropriate, the subjects will be provided with additional 

information after participation. 

The waiving of informed consent using a method other than that requiring the IRB 

findings and IRB documentation specified at 38 CFR 16.116(c) or (d), is not in 

compliance with the regulations. VHA Handbook 1200.05, Appendix C 2, stipulates the 

same requirement of “the IRB finds and documents” for waiving the requirement to 

obtain an informed consent. 

We examined IRB documentation for each of the 33 waivers. All but two waivers had 

the IRB written decision of the waiver. One facility was unable to provide our inspectors 

with the IRB waiver documentation. Rather, they supplied the IRB meeting minutes for 

the initial approval of the research. The “new research registration” section of the 

VA Office of Inspector General 12 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

minutes contained “ADMINISTRATIVELY APPROVED (data collection)” for the 

protocol. This fails to satisfy the regulations at 38 CFR 16.116(c) and (d) requiring that 

the IRB find and document specific criteria when approving waiver or alteration of some 

or all of the required elements of informed consent. 

Another facility was also unable to provide us with the IRB written decision to the 

investigator approving a waiver of informed consent for the study subjects. Instead, we 

were offered a printed copy of the computerized Project Summary and the 

IRB-approved consent form effective from July 17, 2008 to July 17, 2009. The Project 

Summary shows that the investigator asked for a waiver of consent for some subjects in 

the Description of Subject Population section. However, the investigator’s answer was 

“No” to the question “Are you requesting a waiver of documentation of consent (either no 

subject signature or no written document)?” In the section “Provide a description of the 

enrollment and consent process for adult subjects,” the investigator detailed the 

procedure and included the sentence “The subject will be instructed to keep a copy of the 

consent document and to send the other to me using the included stamped addressed 

envelope.” Thus, it seems that the investigator only asked for a waiver of consent for 

some special subjects. However, the Administrative Codes section of the Project 

Summary indicates that the IRB approved waiver of documentation of consent. Without 

IRB written documentation to the investigator, it is uncertain exactly what the IRB 

approved the waiver for since the IRB contradictorily approved the consent form for the 

informed consent documentation. 

Part II. Protocols That Required Informed Consent

Table 1 shows the distribution of informed consent forms per subject of the sampled 

subjects (Table 1). A total of 5,993 subjects were sampled from the 231 protocols that 

required informed consent and had at least one subject. Consent forms could not be 

located for 43 (0.7 percent) subjects. Of the remaining 5,950 subjects with at least one 

consent form located, 90 percent had one consent form, 6 percent had two forms, and 

2 percent had three forms; and 15 subjects had six forms in a protocol. 

Table 1: Distribution of number of forms per subject (including

those with no forms) in sampled research protocols.

Forms Per Subject # of Subjects Percent

0 43 0.7

1 5,394 90.0

2 352 5.9

3 107 1.8

4 55 0.9

5 27 0.5

6 15 0.3

Total 5,993 100.0

VA Office of Inspector General 13 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

The consent dates ranged from March 24, 1987, to September 30, 2008. In our following 

data analyses, for subjects with more than one consent form for a same protocol, we used 

the earliest compliant consent form if more than one compliant form existed or the 

earliest noncompliant form if all a subject’s forms were noncompliant. Table 2 gives the 

year distribution of these 5,950 forms (one form per subject). The consent date was 

missing for 20 forms. Over 55 percent of the consent forms had a consent date in 2006 or 

later. The median consent date was April 30, 2006 (not shown in Table 2), which means 

that half of our sampled forms were signed before May 1, 2006, and half were signed on 

or after that date. 

Table 2: Yearly distribution of consent dates

for the sampled consent forms.

Consent  

Year

Sampled

Forms

Percent

. 20 0.34

1987 1 0.02

1990 1 0.02

1992 1 0.02

1993 1 0.02

1994 3 0.05

1995 5 0.08

1996 17 0.29

1997 48 0.81

1998 32 0.54

1999 75 1.3

2000 159 2.7

2001 282 4.7

2002 397 6.7

2003 453 7.6

2004 490 8.2

2005 675 11.3

2006 916 15.4

2007 1,226 20.6

2008 1,148 19.3

Total 5,950 100.0

Issue 2: Absence of Informed Consent Forms 

Table 3 reports the presence/absence of consent forms for the 5,993 sampled subjects. It 

also gives the estimated number (and the percent) of VA subjects whose consent forms 

were present/absent, based on our sample data. Of the 5,993 sampled subjects from the 

enrollee lists, 43 subjects’ consent forms could not be located. After taking into account 

the complexity of our sample design, we estimated that 367,103 subjects were under VA 

VA Office of Inspector General 14 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

VA Office of Inspector General 15 

active research protocols as of August 20, 2008; and that 98 percent (361,042) of their 

forms were able to be located, and we are 95 percent confident that the true percent value 

is somewhere from 95.5 percent to 99.4 percent. 

Table 3: Presence/absence research consent forms for the 5,993 sampled and the estimated VA subjects.

Form Sampled VA Estimates

Located Subjects # of Subjects (95% Confidence Interval) Percent (95% Confidence Interval)

No 43 6,061 (2,169.9, 16,613.8) 1.7 (0.6, 4.5)

Yes 5,950 361,042 (350,489.1, 364,933.0) 98.3 (95.5, 99.4)

Total 5,993    367,103       100.0      

Forty-three sampled consent forms could not be located. Regulations at 38 CFR 

16.117(c) require specific findings on the part of the IRB for waiver of the requirement 

for the investigator to obtain a signed consent form from any subject. As a part of the 

requirements for informed consent documentation, the original signed consent form must 

be filed in the subject’s research case history. VHA Handbook 1200.05 further demands 

that a written progress note be placed in the subject’s medical record describing the 

consent process, and in addition, VHA Handbook 1907.01 requests that the signed and 

dated consent form be scanned into the medical record. 

Explanations provided to us for the missing forms indicated that none of these forms 

were from protocols that obtained the IRB waiver of obtaining a signed consent form. 

Based on these explanations, it seems that some investigators utilized consent procedure 

as “deferred consent” or “ratification” rather than the required prospectively obtained 

consent. Subjects should not be added to the enrollee list or counted as enrollees in the 

annual progress report for IRB continuing review until after the informed consent. Below 

are some of the explanations provided to us for the missing forms. 

• Explanation: A patient on the enrollee list was offered entry into the study but 

never returned to sign an informed consent document and thus, never officially 

enrolled. 

However, based on further information we requested from the facility, we found 

out that this patient was a screen failure and that all screen failures we sampled 

from the enrollee list had signed a consent form except for this particular patient. 

• Explanation: Consent forms have been found for all subjects who entered the 

protocol and received clinical treatment. The missing forms for subjects on the 

enrollee list and listed in progress reports to the IRB were believed not to have 

been saved by the prior investigator because the subjects volunteered to be 

screened but did not actually enter treatment.

• Explanation: A patient was deemed ineligible to participate in the study after 

review of his medical record. The patient was not invited to participate in the 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

study and never signed the consent form. The patient’s name was placed on the 

annual report in error. 

• Explanation: The number of enrollees in annual progress reports to the VA IRB 

was over-reported due to the inclusion of non-veteran subjects. 

We requested consent forms for these non-veteran subjects because all regulations 

pertaining to veteran research subjects also apply to non-veteran subjects enrolled 

in VA-approved research (VHA Handbook 1200.05). The facility reported later 

that the investigator was unable to locate these remaining consent forms. 

• Explanation: The investigator mixed up subjects in different protocols, and these 

subjects were incorrectly included on the enrollee list. 

However, we found that the investigator could not locate another consent form for 

one of the remaining three subjects in the study even though it was confirmed that 

he/she should be on the enrollee list. 

Issue 3: Noncompliance of Consent Forms 

Table 4 shows the distribution of compliant consent forms among the located forms. Of 

the 5,950 sampled subjects with a located consent form, 4,887 subjects’ forms were 

compliant. We estimated that throughout VA, about 69 percent of the 361,042 subjects’ 

located forms were compliant, and we are 95 percent confident that the actual compliant 

form percent is somewhere from 39.9 to 88.6. 

Table 4:  Compliance of research consent forms for the 5,950 sampled and the estimated VA subjects whose forms

were on file.

Compliance Sampled VA Estimates

of Form Subjects # of Subjects (95% Confidence Interval) Percent (95% Confidence Interval)

Compliant   4,887 250,811 (144,123.7, 319,976.3) 69.5 (39.9, 88.6)

Noncompliant   1,063 110,231 (41,065.2, 216,917.8) 30.5 (11.4, 60.1)

Total 5,950    361,042       100.0      

We further looked into the categories for classifying these forms as noncompliant. The 

five noncompliant categories were defined as follows: 

1. No signature of the subject or the subject’s legally authorized representative. 

2. No date of subject (or the subject’s legally authorized representative) signature but 

subject or the subject’s legally authorized representative signature present. 

3. No witness signature but form signed and dated by subject or the subject’s legally 

authorized representative. 

4. No date of witness signature but witness signature and subject (or the subject’s 

legally authorized representative)signature and date present. 

VA Office of Inspector General 16 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

VA Office of Inspector General 17 

5. Different dates of subject (or the subject’s legally authorized representative) and 

witness signatures. 

These categories are listed in the hierarchical order. Thus, each noncompliant form was 

sorted into only one category although some noncompliant forms may have contained 

more than one noncompliant element. For example, if a form lacked both subject (or the 

subject’s legally authorized representative) signature and date of witness signature, the 

form was placed only into the category “no subject signature” and was not counted in the 

category “no witness date.” 

Table 5 shows the distribution of the categories for classifying these forms as 

noncompliant. It indicates that most noncompliant forms were due to no witness 

signature. The estimated percent attributable to “no witness signature” from among the 

110,231 noncompliant VA forms is 97.2 percent, and we are 95 percent confident that the 

actual percent of “no witness signature” is somewhere from 84.8 percent to 99.5 percent. 

We observed that more than 60 percent of the noncompliant consent forms in our sample 

did not contain a witness signature and date block. Three out of four of these with no 

witness block consent forms had a consent date after July 15, 2003. Thus, the witness 

part of the consent could easily be missed during the informed consent process. It is 

unclear why IRBs approved consent forms without a witness block. We also found that 

during annual continuing reviews for a same protocol in different years, IRBs approved 

consent forms that did not consistently contain witness blocks. It is perplexing that 

consent forms used in an earlier year contained witness blocks while those in a later year 

did not. 

Table 5:   Distribution of Noncompliance research consent forms for the 1,063 sampled and the estimated VA subjects whose

forms were noncompliant.

   Sampled    VA Estimates

Noncompliance Category Subjects

# of

Subjects3 (95% Confidence Interval) Percent (95% Confidence Interval)

No subject signature 16 1,023 (96.2, 10,062.9) 0.9 (0.1, 9.1)

Subject signature, but no date         20 1,350 (243.8, 7,151.3) 1.2 (0.2, 6.5)

No witness signature 994 107,178 (93,480.8, 109,734.2) 97.2 (84.8, 99.5)

Witness signature, but no  

        witness Date 20 507 (77.7, 3,241.8) 0.5 (0.1, 2.9)

Dates different 13 172 (25.2, 1,162.4) 0.2 (0.02, 1.1)

Total 1,063    110,230       100.0      

 

3

 Total is different from 110,231 in Table 4 due to rounding errors. 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

The following are some examples illustrating the inconsistency of excluding witness 

blocks in IRB-approved consent forms. 

• The IRB-approved consent form used in 2003 had a witness block, but the block 

was omitted in the approved form used in 2005. All these consent forms are not 

the VA Form 10-1086, VA Research Consent Form. 

• The IRB approved the VA consent form (Form 10-1086) used in 2000 with no 

witness block; the approved VA consent form used in 2001 had a witness block. 

• The IRB approved the consent form (in lieu of VA Form 10-1086) used in 2005 

without a witness block; the approved consent form (in lieu of VA Form 10-1086) 

used in 2006 had a witness block. 

• The IRB-approved non-VA consent form used from June 14, 2007, through 

February 21, 2008, did not have a witness block; the approved VA consent form 

on July 26, 2007 had a witness block. 

• The IRB-approved VA consent form (Form 10-1086) used in 1999 had a witness 

block; the approved VA consent form used in 2006 did not have a witness block. 

• The IRB-approved consent form (in lieu of VA Form 10-1086) used from 

August 1, 2005, through April 3, 2006, did not contain a witness block; the one 

used from March 5, 2007, through March 4, 2008, had a witness block. However, 

these forms showed the same form version number and the same revision date 

even though they were clearly different versions. 

• Both versions of consent forms approved by the IRB in March 2002 and in 

January 2003 did not have a witness block. However, the later version of the 

executed forms contained witness signatures and dates even though the forms did 

not have witness blocks. 

Another explanation for the high percent of no witness signature is the likelihood that 

investigators mistakenly thought the witness was an option rather than a requirement. 

For example, an investigator sent a memo to the IRB to clarify the consenting procedure 

after our inspector examined the consent forms for his/her research project. In the memo, 

the investigator noted that he/she mistakenly understood that witnesses were not 

absolutely necessary and that the only instance in which a witness was necessary was if 

the subject was somehow compromised. 

38 CFR 16.117(a) stipulates that informed consent be documented by the use of a written 

consent form approved by the IRB and signed by the subject or the subject's legally 

authorized representative. Sixteen sampled subject consent forms were unsigned. Four 

(25 percent) of these unsigned forms were incomplete or had missing pages. From 

VA Office of Inspector General 18 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

among the rest of the sampled consent forms, an additional 20 were undated by the 

subjects, an extra 20 were undated by the witnesses, and 13 more had different subject 

and witness signature dates. 

Figure 3 shows the estimated percent of compliance forms for each facility sorted by the 

percent compliant. The percent of facility compliance ranged from 15 to 100, with half 

of the facilities having a compliant percent of over 93 percent and the other half having a 

compliant percent below that. 

Figure 4 charts the estimated percent of compliance for each sampled protocol within a 

facility. It shows that some facilities performed much better than others. 

Figure 3. Estimated percent of compliant forms for each facility. 

VA Office of Inspector General 19 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

Figure 4. Estimated percent of compliant forms for each sampled protocol within a facility. 

VA Office of Inspector General 20 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

Conclusions 

The Common Rule and VA regulations authorize IRBs to waive the required informed 

consent if they find and document specific criteria when approving the waiver. We found 

insufficient IRB documentation for the waiver of informed consent for two of the 

33 sampled research protocols that were waived from the required informed consent 

process. 

We estimated that 1.7 percent of the 367,103 VA research subject consent forms could 

not be located, and we are 95 percent confident that the true percent value is somewhere 

from 0.6 percent to 4.5 percent. It appears that some investigators utilized consent 

procedure as “deferred consent” or “ratification” since research subjects were added to 

the enrollee list before completing the informed consent. The requirement to obtain the 

legally effective informed consent of individuals before involving them in research is one 

of the central protections provided for under the Common Rule. Any informed consent 

procedures other than the required prospectively obtained consent, fail to constitute 

informed consent under the regulations for the protection of human research subjects. 

Subjects should not be added to the enrollee list or counted as enrollees in the annual 

progress report to the IRB for continuing review until their informed consents are 

prospectively executed. 

Thirty-one percent (110,231) of the 361,042 VA research subject consent forms on file 

were estimated to be noncompliant; most (97 percent) lacked witness signature. We 

found that (annual) IRB-approved consent forms for particular protocols did not 

consistently include witness blocks over the course of the research, which likely 

contributed to the high percent of missing witnesses. In addition, investigators may have 

mistakenly taken the required witness as an option. 

We estimated that nearly 1 percent (1,023) of the 110,231 VA noncompliant forms 

lacked subject or subject’s authorized representative signature. As mandated by the 

Common Rule and VA regulations, consent forms without subject signature are not 

“legally effective.” 

Recommendations 

Recommendation 1: We recommended that the Under Secretary for Health require that 

facility Directors ensure sufficient IRB written documentation of waiver from informed 

consent. 

Recommendation 2: We recommended that the Under Secretary for Health establish 

procedures requiring facility Directors to ensure signed informed consent forms are on 

file. 

VA Office of Inspector General 21 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

VA Office of Inspector General 22 

Recommendation 3: We recommended that the Under Secretary for Health establish 

procedures requiring facility Directors to ensure that informed consents are prospectively 

obtained, which includes adding subjects to enrollee lists and/or to annual research 

progress reports only after obtaining the informed consent. 

Recommendation 4: We recommended that the Under Secretary for Health require 

facility Directors to ensure that witnesses are obtained for all VA consent forms as 

required. 

Recommendation 5: We recommended that the Under Secretary for Health establish 

procedures requiring facility Directors to ensure that IRB-approved informed consent 

forms consistently contain witness blocks or ensure sufficient IRB written documentation 

of waiver from the witness requirement. 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 

Appendix A 

Thirty Sampled VA Research Facilities 

Visited by Inspectors 

VA New Jersey Health Care System – East Orange Campus 

James J. Peters VA Medical Center – Bronx, NY 

Edward Hines Jr. VA Hospital – Hines, IL 

Clement J. Zablocki Veterans Affairs Medical Center – Madison, WI 

Edith Nourse Rogers Memorial Veterans Hospital – Bedford, MA 

Overton Brooks VA Medical Center – Shreveport, LA 

VA Medical Center – Canandaigua, NY 

VA Connecticut Healthcare System – West Haven Campus 

Manchester VA Medical Center – Manchester, NH 

VA North Texas Health Care System – Dallas VA Medical Center 

VA Nebraska Western Iowa Health Care System – Omaha Division 

VA Boston Healthcare System – Boston, MA 

VA Medical Center – Providence, RI 

VA Health Care System – Albuquerque, NM 

VA Pittsburgh Healthcare System – University Drive Division 

Richard L. Roudebush VA Medical Center – Indianapolis VA Medical Center 

VA Maryland Health Care System – Baltimore VA Medical Center 

VA Medical Center – Iowa City, IA 

William S. Middleton Memorial Veterans Hospital – Milwaukee, WI 

VA Puget Sound Health Care System – Seattle, WA 

VA Medical Center – Asheville, NC 

VA Palo Alto Health Care System – Palo Alto, CA 

VA Greater Los Angeles Healthcare System – Los Angeles, CA 

VA Medical Center – Atlanta, GA 

VA Medical Center – Coatesville, PA 

Charlie Norwood VA Medical Center – Augusta, GA 

VA Healthcare System – Bay Pines, FL 

VA Gulf Coast Veterans Health Care System – Biloxi, MS 

VA Medical Center – Minneapolis, MN 

VA Salt Lake City Health Care System – Salt Lake City, UT

VA Office of Inspector General 23 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research

Appendix B 

Under Secretary for Health Comments 

VA Office of Inspector General 24 

Department of 

Veterans Affairs Memorandum

Date: May 7, 2009

From: Under Secretary for Health

Subject: Healthcare Inspection – Review of Informed Consent in the 

Department of Veterans Affairs Human Subjects Research, 

(WebCIMS 427012)

To: Assistant Inspector General for Healthcare Inspections (54)

1. I have reviewed the draft report, and I concur with the report and its 

recommendations. While I am pleased that VHA requires additional human 

subject protections beyond those afforded under the Common Rule, it is 

disturbing that some of our institutional review boards (IRBs) and investigators 

are not implementing the additional protections that VHA requires. These 

protections include requiring a witness signature on the informed consent form 

and specific IRB responsibilities in approving and documenting waivers 

related to the informed consent process. 

2. VHA Directive 2008-064, “Research Compliance Officers and the Auditing 

of VHA Human Subjects Research to Determine Compliance with Applicable 

Laws, Regulations, and Policies,” requires Research Compliance Officers 

(RCOs) to conduct annual audits of informed consent forms for all active 

research protocols. These audits include verifying that prospective informed 

consent was obtained and that the informed consent form contains the dated 

signatures of the subject and a witness. The requirement for a witness 

signature is one of the additional safeguards for VHA research subjects. 

3. It is extremely disappointing that some of our IRBs were unaware of the 

responsibility to approve and document waivers related to the informed 

consent process. The VHA Office of Research Oversight (ORO) will, 

therefore, immediately require that the annual informed consent audits 

conducted by each facility’s RCO include a review of the justifications and IRB 

documentation of such waivers. 

4. To strengthen IRB understanding of VA requirements concerning the roles 

and responsibilities of IRBs and investigators, the Office of Research and 
 Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research

VA Office of Inspector General 25 

Page 2 

OIG Draft Report, Healthcare Inspection, Review of Informed Consent in the 

Department of Veterans Affairs Human Subjects Research, (WebCIMS 

427012) 

Development (ORD) will develop training for IRB chairs and members. This 

training will address requirements for waivers related to the informed consent 

process, the requirement for a witness signature on the consent form, and IRB 

assessment of investigator compliance at the time of continuing review. This 

assessment will include verifying that investigators are obtaining informed 

consent prospectively, prior to initiating screening procedures or research 

interventions, and that the signatures of both the subject and the witness are 

being obtained properly. In addition, ORO is developing mechanisms to 

assist facility RCOs in conducting effective audits, in reporting findings related 

to informed consent deficiencies, and in helping investigators develop and 

implement responsive remedial action plans. RCOs will continue to report 

annual audit findings to the facility Director and the IRB with recommendations 

for corrective actions where noncompliance is identified. The combination of 

new training and the new procedures for annual RCO informed consent audits 

of all VA studies will help to ensure compliance with both VHA policy and 

Common Rule regulations concerning informed consent in human subject 

research. 

5. Thank you for the opportunity to review the draft report and for 

incorporating our technical comments in the final report. A detailed action 

plan to implement all report recommendations is attached. If you have any 

questions, please contact Margaret M. Seleski, Director, Management Review 

Service (10B5) at (202) 461-8470. 

(original signed by:) 

Michael J. Kussman, MD, MS, MACP 

Attachment 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research

Under Secretary for Health’s Comments 

to Office of Inspector General’s Report 

The following comments are submitted in response to recommendations 

in the Office of Inspector General’s report: 

OIG Recommendations

Recommendations/ Status Completion 

Actions Date______

Recommendation 1: We recommended that the Under Secretary for 

Health establish procedures requiring facility Directors to ensure 

sufficient IRB written documentation of waiver from informed consent. 

Concur 

a. The Office of Research and Development (ORD) will strengthen its 

policies on the IRB’s responsibility related to the requirements for waiver of 

the requirement to obtain informed consent as found in 38 CFR 16.116(c) 

and (d) and the IRB’s requirement to appropriately document its findings. 

b. The Office of Research Oversight (ORO) will require that the mandatory 

annual informed consent audits conducted by each facility’s Research 

Compliance Officer (RCO) include a review of (i) the justifications for such 

waivers relative to applicable regulatory criteria, and (ii) the adequacy of IRB 

documentation that all such criteria were satisfied. 

c. Per VHA Directive 2008-064 “Research Compliance Officers and the 

Auditing of VHA Human Subjects Research to Determine Compliance with 

Applicable Laws, Regulations, and Policies,” dated October 16, 2008, the 

RCO is required to report the finding of audits to the facility Director with a 

recommendation for corrective actions if the audits reveal any 

noncompliance. Audit results related to waivers of informed consent, the 

justifications for such waivers relative to applicable regulatory criteria, and 

the adequacy of the IRB’s documentation of its determinations regarding 

such criteria will be reported to the facility Director and others as required by 

the policy. 

d. The new policy requirements, the RCO audits, and the reporting to the 

facility Director will assist the facility Director in ensuring that the IRB 

appropriately documents the approval of a waiver to obtain the informed 

consent. 

VA Office of Inspector General 26 
 Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research

VA Office of Inspector General 27 

In process November 2009 

Recommendation 2: We recommended that the Under Secretary for 

Health establish procedures requiring facility Directors to ensure 

signed informed consent forms are on file. 

Concur 

a. The Office of Research and Development (ORD) will strengthen its 

policies in the new version of VHA Handbook 1200.05 on the investigator’s 

responsibility to maintain signed informed consent forms for all subjects 

entered into the investigator’s protocol if the IRB has not waived the 

requirement for obtaining informed consent or to obtain a signed informed 

consent. ORD will also strengthen its policies related to the role of the 

facility Research Compliance Officer (RCO) as a non-voting member of the 

IRB related to assessing the investigator’s compliance with the requirement 

to ensure signed informed consent forms are on file when the investigator 

submits his or her research protocols for continuing review. 

b. ORD will develop a training program for IRB chairs and members that will 

include the IRB’s role in ensuring that the investigator’s records contain all 

signed informed consents when the IRB conducts continuing review of the 

protocol. 

c. The Office of Research Oversight (ORO) is currently developing 

procedures for facility RCOs related to the auditing process, developing 

corrective action plans, and the reporting of all findings related to failure of 

investigators to maintain signed informed consents in the investigator’s 

protocol files. 

d. The new policy requirements, the RCO audits, and the reporting to the 

facility Director will assist the facility Director in ensuring that signed informed 

consent forms are found in the investigators’ records. 

In process December 2009 
 Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research

VA Office of Inspector General 28 

Recommendation 3: We recommended that the Under Secretary for 

Health establish procedures requiring facility Directors to ensure that 

informed consent forms are prospectively obtained, which includes 

adding subjects to participant lists and/or to annual research progress 

reports only after obtaining the informed consent. 

Concur 

a. The Office of Research and Development (ORD) will develop a training 

program for IRB chairs and members that will include the IRB’s 

responsibilities in ensuring that informed consent forms are prospectively 

obtained prior to screening procedures or before research procedures are 

begun. It will also address: 

• The use of participant lists and when it is appropriate to add names of 

subjects to such lists. 

• The IRB’s role in ensuring that the annual research report submitted at the 

time of continuing review only includes subjects who have provided 

prospective informed consent. The IRB may review the list or require 

materials from the investigator to document that the participant list is in 

compliance with all requirements. 

b. The Office of Research Oversight (ORO) will assist all facility Research 

Compliance Officers (RCOs) in developing procedures to audit and reconcile 

participant lists with signed informed consent documents and procedures for 

reporting any noncompliance with recommendations for corrective actions to 

the facility Director. 

Note: Under VHA Directive 2008-064, dated October 16, 2008, facility RCOs 

are already required to audit the consent forms for all active research 

protocols each year and to develop procedures for notifying the facility 

Director, the IRB, and the investigator. ORO has developed audit criteria 

and audit tools for use in satisfying this requirement. One of the elements for 

such audits is determining if informed consent has been prospectively 

obtained. 

c. The combination of the new educational program, the RCO audits, and the 

reporting to the facility Director will assist the facility Director in ensuring that 

informed consent is prospectively obtained, which includes adding subjects 

to participant lists and annual research progress reports only after obtaining 

the subjects’ informed consent. 

In process December 2009 
 Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research

VA Office of Inspector General 29 

Recommendation 4: We recommended that the Under Secretary for 

Health require facility Directors to ensure that witnesses are obtained 

for all VA consent forms as required. 

Concur 

Note: The Federal Policy for the Protection of Human Subjects (the Common 

Rule) does not require there be a witness to the subjects or the subject’s 

Legally Authorized Representative’s signature. This is an added protection 

that VHA implemented to ensure that the informed consent is prospectively 

obtained. 

a. The Office of Research and Development (ORD) will develop a training 

program for IRB chairs and members that will include the IRB’s responsibilities in 

ensuring that the informed consent form contains the appropriate signature block 

for a witness’ signature and that at the time of continuing review of all protocols 

ensuring that all informed consent forms obtained by the investigator contain the 

signature of a witness as required by policy. The IRB or the Research 

Compliance Officer (RCO) may conduct the audits to ensure the witness’ 

signatures have been obtained as required by policy. 

b. Under a directive developed by ORD (VHA Directive 2008-064, “Research 

Compliance Officers and the Auditing of VHA Human Subjects Research to 

Determine Compliance with Applicable Laws, Regulations, and Policies,” dated 

October 16, 2008) facility RCOs are required to audit informed consent forms for 

all active research protocols each year and to develop procedures for notifying 

the facility Director, the IRB, and the investigator. Auditing of informed consent 

forms includes documenting that the signature of the witness was obtained. The 

signature of the witness is one of the elements in the audit tool developed by the 

Office of Research Oversight (ORO). 

 

c. These audit processes, the reporting of the audit results, and the development 

of corrective action plans have been put in place to allow the facility Director to 

ensure that the signature is obtained as required. 

In process December 2009 

Recommendation 5: We recommended that the Under Secretary for Health 

establish procedures requiring facility Directors to ensure that IRBapproved informed consent forms consistently contain witness blocks or 

ensure sufficient IRB written documentation of waiver from the witness 

requirement. 

Concur 
 Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research

VA Office of Inspector General 30 

a. The Office of Research and Development (ORD) will develop new policy 

requirements that will allow the IRB to waive the signature of a witness if specific 

criteria are met and that the IRB documents that the criteria are met in its 

minutes. The new policy requirement will be found in a revised version of VHA 

Handbook 1200.05. 

b. ORD will develop a training program for IRB chairs and members that will 

address this new policy including the criteria for waiver and the required 

documentation. 

c. The Office of Research Oversight (ORO) will require that the annual informed 

consent form audits conducted by facility Research Compliance Officers (RCO) 

will include elements related to the IRB’s documentation of: 

• Its review of the informed consent forms including documentation that the IRB 

found that all required criteria for an informed consent were met including the 

block for the signature of a witness 

• Its determination that all required criteria for waiver of the signature of a 

witness to the subject’s signature have been met. 

These audit processes, the reporting of the audit results, and the development of 

corrective action plans have been put in place to allow the facility Director to 

ensure that the IRB approved informed consent form contains the signature 

block for a witness or, if the IRB waived the requirement, that the IRB 

appropriately documented this requirement. 

In process November 2009 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research

Appendix C 

OIG Contact and Staff Acknowledgments 

OIG Contact Limin X. Clegg, Ph.D. 

Director, Biostatistics 

202.461.4661 

Acknowledgments Patrick Smith 

Nathan McClafferty 

Yurong Tan, Ph.D. 

Nancy Albaladejo 

Lisa Barnes 

Verena Briley-Hudson 

Judy Brown 

Elizabeth A. Bullock 

Andrea Buck, M.D. 

Shirley Carlile 

Pat Christ 

Audrey Collins-Mack 

Melanie Cool 

Sheila Cooley 

Dorothy Duncan 

Donna Giroux 

Louise Graham 

David Griffith 

Kathy Gudgell 

Wachita Haywood 

Jerome Herbers, M.D. 

Debbie Howard 

Jeff Joppie 

Jeanne Martin 

Tish McCutchen 

Nelson Miranda 

Karen Moore 

Rayda Nadal 

Katherine Owens 

Wilma Reyes 

Annette Robinson 

Jim Seitz 

Christa Sisterhen 

Randy Snow 

Virginia Solana 

Roberta Thompson 

Carol Torczon 

Marilyn Walls 

Sue Zarter 

VA Office of Inspector General 31 
Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research

Appendix D 

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 32