HUMAN SUBJECTS RESEARCH

Management Decision and Research Center

Health Services Research and Development Service

Office of Research and Development

Department of Veterans Affairs

A Primer

INFORMED CONSENT FOR

HUMAN SUBJECTS RESEARCH

A Primer

INFORMED CONSENT FOR

Management Decision and Research Center

Health Services Research and Development Service

Office of Research and Development

Department of Veterans Affairs
The Health Services Research and Development Service (HSR&D)

is a program within the Veterans Health Administration’s Office of

Research and Development. HSR&D provides expertise in health

services research, a field that examines the effects of organization,

financing, and management on a wide range of problems in health

care delivery – quality of care, access, cost, and patient outcomes. Its

programs span the continuum of health care research and delivery,

from basic research to the dissemination of research results, and ultimately to the application of these findings to clinical, managerial,

and policy decisions.

Informed Consent for Human Subjects Research

Boston, MA: Management Decision and Research Center;

Washington, DC: VA Health Services Research and

Development Service, Office of Research and Development,

Dept. of Veterans Affairs [2002].

iv; 23 leaves. 28 cm.

Includes bibliographic references. Primer.

DNLM: 1. Human Experimentation. 2. Informed Consent.

3. United States, Department of Veterans Affairs, Management

Decision and Research Center.

W 20.55 .H9 D213 2002
Informed Consent for Human Subjects Research

Purpose of Primer series:

To help bridge the gaps between health services researchers, policy

makers, managers, and clinicians in an effort to improve the quality

and cost-effectiveness of health care for veterans. The Primer series is

part of a larger set of dissemination initiatives developed by VHA’s

Office of Research and Development through the Management

Decision and Research Center, a program within the Health Services

Research and Development Service.

Purpose of the Informed Consent for Human Subjects 

Research Primer:

To provide an overview of informed consent for research within VA,

from regulations to the content and process of obtaining consent

from potential research participants. The Primer provides a framework for understanding the basics of informed consent, incorporating the responsibilities of everyone involved, from researchers to

senior managers. More in-depth readings and other resources are listed in the appendices.

Suggested audience: 

VA professionals, clinicians, managers, front line supervisors,

researchers, and staff involved in health care delivery in all parts of

the Veterans Health Administration.

Suggested uses:

Individual study, orientation for professional staff and health 

care providers, management training programs in Veterans Integrated

Service Networks and within VA facilities, and continuing 

medical education courses and other medical and health professional training programs.

November 2002

Contributors i

Preface iii

Introduction v

What is informed consent for research? 1

Why is informed consent important to VA? 1

What regulations govern informed consent? 2

What are the elements of informed consent? 3

Who is responsible for ensuring informed consent in VA research? 4

Is there a difference between informed consent in clinical 

research versus informed consent in standard medical treatment? 6

Are there subsets of patients with whom we need to 

be particularly careful when obtaining informed consent? 7

How is informed consent obtained? 7

What are some tips for providing prospective research participants 

with the information they need and ensuring that they understand it? 9

What documentation is required for informed consent? 11

What is the role of the IRB in informed consent? 11

How should VA managers work with their IRBs to ensure proper informed consent? 12

What data protection issues apply to informed consent for clinical research? 13

What training is required on informed consent and human subjects protection? 14

How is VA working to improve informed consent for research participants? 15

Conclusion 16

Appendix A: Elements of Informed Consent 17

Appendix B: Resources 19

Appendix C: Training Resources 24

Appendix D: Reading Materials 26

Appendix E: Glossary 28

Table of Contents

Contributors and Acknowledgements

i

The MDRC staff thanks the many managers and researchers who

participated in the development of this Primer. Mary Darby, editorial consultant, wrote the Primer with Gerry McGlynn and with input

from a number of researchers and others with experience in the

informed consent process. Special thanks go to the following individuals for their assistance: John R. Feussner, MD, MPH, Medical

University of South Carolina, Charleston, SC; James F. Burris, MD,

Deputy Chief Research and Development Officer, VACO; Brenda A.

Cuccherini, PhD, Office of Research and Development, VACO;

Ellen Fox, MD, Director, National Center for Ethics, VACO; Philip

Lavori, PhD, Director, Cooperative Studies Program Coordinating

Center, VA Palo Alto Health Care System, Palo Alto, CA; James A.

Tulsky, MD, HSR&D Investigator, Durham, NC; Michael J. Miller,

MD, PhD, Clinical Manager, VISN 1, Bedford, MA; Sheila C.

Gelman, MD, Clinical Manager, VISN 10, Cincinnati, OH.

We also extend our appreciation to colleagues throughout VA for

their thoughtful comments in reviewing an earlier draft of this

Primer: Frances M. Weaver, PhD, Deputy Director, Midwest Center

for Health Services and Policy Research, Hines IL; Gary Nugent,

Chief Executive Officer, VA Nebraska-Western Iowa Health Care

System, Omaha, NE; Larry Lehmann, MD, Chief Consultant for

Mental Health, VACO; Paulette Cournoyer, DNSc, Program

Director (decentralized), VACO Office of Nursing Services, VA

Boston Healthcare System, Boston, MA; David Lee, MD, Chief of

Staff, Boise VAMC, Boise, ID; Michael Simberkoff, MD, Chief of

Staff, New York VAMC, New York, NY; Joseph F. Collins, ScD,

Director, Cooperative Studies Program Coordinating Center, VA

Maryland Healthcare System, Perry Point, MD; Frederick Moolten,

MD, ACOS/R&D, Bedford VAMC, Bedford, MA; Charles M.

Clark, MD, ACOS/R&D, Roudebush VAMC, Indianapolis, IN;

Anne E. Sales, PhD, RN, HSR&D Investigator, VA Puget Sound

Health Care System, Seattle, WA; Sola Whitehead, CIP, IRB

Coordinator, Portland VAMC, Portland, OR.

Primer Development and Editing

Geraldine McGlynn, MEd; Karen Bossi, MA; Diane Hanks, MA;

and Patrick Morrissey, all from VA HSR&D Management Decision

and Research Center, Boston, MA.

Preface

iii

Providing veterans with the highest quality, most cost-effective health

care is the mission of the Veterans Health Administration (VHA).

Within VHA’s Office of Research and Development, we conduct

research that provides us with new knowledge or evidence we need to

make system decisions that insure best health care practices and outcomes. Veterans help us in this quest to continuously improve the

quality of the health care we provide through their willingness to participate in research studies. It is our honor and privilege to serve our

veterans, and it is our duty to protect their rights and guarantee their

safety in research.

Informed consent is the cornerstone for providing protections for

human subjects in research studies. By law, participants recruited

into research studies must be informed about the risks and benefits

of the study and voluntarily consent to participate. While this sounds

logical and easy enough to implement, there are many potential hurdles in achieving true informed consent. For example, what if a

prospective research participant is very ill or homeless and vulnerable? How does one decide if a research candidate is competent to

provide voluntary consent? And who is ultimately responsible for

insuring appropriate and meaningful consent in VHA? 

VHA is committed to conducting the highest quality research in

areas that are important to veterans’ health. Our research efforts must

follow all federal regulations and meet exemplary ethical standards.

This Primer is designed as an educational tool for VHA managers,

clinicians, researchers, and others who are responsible for obtaining

or overseeing appropriate informed consent, or are in some other way

involved in the process. It provides an overview and informational

resources for learning more about this very important topic. 

Robert H. Roswell, MD

Under Secretary for Health

v

Introduction

During the 1990’s, public interest focused on several well-publicized

cases that illustrated some significant gaps in research study safety

and administration, some with tragic results. These cases raised questions about the processes used to insure the rights and safety of

research participants. 

Informed consent, the major tenet for insuring understanding and

voluntariness of participation in research, justifiably came under

intense scrutiny. One important consideration is whether a research

participant’s signature on a consent form provides enough assurance

that the participant truly understands the risks and benefits of a

study and is competent to voluntarily agree to participate. There is

also the issue of impartiality and responsibility of those obtaining

consent from the participants. Informed consent is intended to protect the dignity and safety of research participants, but how best to

confidently implement it in today’s fast-paced, high technology

health care environment can be complex.

Within VA this is of particular importance because the agency bears

a public trust to provide the best possible care for veterans.

Accordingly, VA took quick action to shore up all aspects of compliance, safety, and protections of research participants as well as

improvements in the administration of research studies. VA’s compliance structures and research policies were reviewed and updated, 

and new systems were developed to improve education and accountability. VA’s Office of Research and Development initiated a State of

the Art Conference (SOTA) on “Making Informed Consent

Meaningful” that brought together VA and non-VA clinicians,

researchers, ethicists, and managers with the goal of identifying 

what could be done to improve the theory and practice of informed

consent.

This Primer is an outgrowth of the Informed Consent SOTA 

conference. It was developed to provide a broad audience within and

outside of VA with a clear definition of informed consent and the

regulations that govern it, as well as the roles and responsibilities of

all those involved, directly or indirectly, in the consent process in VA.

It is presented in a question and answer format for easy reading and

accessibility. The appendices provide definitions, further reading, 

and other training and informational resources. 

What is informed consent for research?

Informed consent is the process through which the research team

obtains – and maintains – the legally effective permission of a person

or a person’s authorized representative to participate in a research

study. Informed consent is achieved when a prospective subject

receives full disclosure of the research plan and intent, understands

all of the information that is disclosed to him or her, voluntarily consents to participate in the study, and is competent to do so. 

The concept of informed consent originated in the clinical care setting, and has become a cornerstone for the ethical conduct of human

subjects research. Although sometimes thought of as a rote reading of

rights ending in the participant’s signature on the dotted line of a

consent form, informed consent is not merely a formality. Nor is it

simply a bureaucratic policy. Informed consent is a legal and moral

responsibility to uphold the individual autonomy and personal dignity of all people who consider participating in research.

The Belmont Report of the National Commission for the Protection

of Human Subjects of Biomedical and Behavioral Research identifies

three basic ethical principles that should serve as guideposts for

human subjects research: respect for persons, beneficence, and justice. Truly informed consent upholds all three of these basic ethical

principles.

Why is informed consent important to VA?

1

The concept of informed

consent originated in the

clinical care setting, and 

has become a cornerstone 

for the ethical conduct of 

human subjects research.

VA is a world leader in research, and, as such, is committed to

upholding the principles for the ethical conduct of research. VA’s

clinical research enterprise depends on the voluntary and informed

participation of thousands of human subjects who deserve to be

treated with respect and dignity.

Because it is the right thing to do, and VA is subject to federal regulations for the protection of all human research participants, no VA

research may involve a person as a participant without first obtaining
2

his or her legally effective informed consent. The only exceptions 

are those cases in which the Institutional Review Board (IRB), with

oversight responsibility for a given study, approves a waiver of

informed consent. 

In addition, VA patients tend to be very trusting of their clinicians,

particularly their nurses. Many VA patients who are candidates for

research participation are quite sick; still others are vulnerable

because they are demented, mentally ill, or substance-abusing. As a

result, these patients may give their consent to participate without

fully understanding the intent, risks, and other aspects of the research

study. In these circumstances, research team members have an even

greater responsibility to fully explain research opportunities to

patients or their legally authorized representatives in an impartial

manner and to ensure that they understand the explanation.

What regulations govern informed consent?

An array of laws, regulations, and policy statements emphasize the

need for obtaining meaningful informed consent and address how

this should be done in accordance with the basic ethical principles of

human subjects research. The federal government has developed uniform standards on informed consent for federally funded research.

However, some groups, such as the National Bioethics Advisory

Commission, have cited a need to develop uniform standards on

informed consent for research that is not federally funded as well.

VA is one of 17 federal departments and agencies that have agreed to

follow the Federal Policy for the Protection of Human Subjects, more

familiarly known as the Common Rule, effective June 18, 1991. This

policy is described in the Code of Federal Regulations (CFR), Title 45,

Part 46 (http://ohrp.osophs.dhhs.gov/humansubjects/guidance/

45cfr46.htm). VA’s incorporation of this policy can be found at 

38 CFR 16. 

Investigators receiving support from other federal agencies, such as

the National Institutes of Health, must meet the human subjects

requirements of those funding sources in addition to those of VA.

VA...agreed to follow the

...Common Rule. VA 

facilities are responsible 

for developing their own

standard operating

procedures for addressing 

all aspects of human subjects

protection, including 

informed consent.
Generally, the requirements are similar, because those agencies are

also governed by the Common Rule. Where Food and Drug

Administration (FDA) regulated test articles are used, FDA

regulations also apply, regardless of funding source

(http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfr50_00.html).

Finally, investigators must meet applicable local and state regulations. 

VA facilities are responsible for developing their own standard operating procedures for addressing all aspects of human subjects protection, including informed consent. The Institutional Review Board

(IRB) with oversight responsibility for a given study may toughen a

research protocol, making the informed consent process more rigorous if it feels this is necessary to protect the rights and welfare of subjects. (See “Who is responsible for ensuring informed consent in VA

research?” on page 4.) VA’s policies and procedures for informed consent may be found in VHA Handbook 1200.5, Appendix C:

The Informed Consent (http://www.va.gov/resdev/directive/

RevisedHandbookProtectionHumanSubjectsInResearch.doc). 

What are the elements of informed consent?

3

Federal regulations and VA policy govern the content of informed

consent for VA-approved research, defining a number of basic

elements that must be explained to the prospective subject as part of

the informed consent process. Depending on the nature of the

research, several additional elements may also be required. 

Following is a brief description of the basic elements of informed

consent. A more detailed description of both the basic and additional elements of informed consent may be found in Appendix A of 

this primer.

Basic Elements of Informed Consent

Purpose and Description: Explain the purpose of the study,

the length of time expected for the subjects’ participation, the

process to be followed during the study, and any experimental

procedures. 

Risks: Describe any reasonably foreseeable harms, inconvenience, or discomforts to the participant. 

Federal regulations and 

VA policy govern the content

of informed consent for 

VA-approved research, 

defining a number of 

basic elements that must be

explained to the prospective

subject as part of the

informed consent process.
4

Benefits: Describe any benefits to the prospective participant or

to others that may reasonably be expected to result from

the research. 

Alternatives: Disclose any appropriate alternative treatments

that might benefit the prospective participant. 

Confidentiality: Tell the prospective participant whether his or

her individual record will be kept confidential and explain the

level of confidentiality to be maintained. 

Greater Than Minimal Risk: For research involving more

than minimal risk, provide an explanation of whether any compensation is available and whether medical treatments are available if injury occurs. 

Contact Information: Provide information about whom the

subject may contact with questions about the research. 

Voluntary Participation: Explain that participation is

voluntary. 

No Payment Required: Inform the prospective participant

that he or she will not be required to pay for treatment received

as a subject in a VA research project. 

Who is responsible for ensuring informed consent in VA research?

There are several layers of responsibility for ensuring informed

consent in VA research. VA leaders, including facility and network

directors, chiefs of staff, service chiefs, associate chiefs of staff for

research and development, and other managers, clinicians, investigators, and research staff all share responsibility for maintaining

proper informed consent procedures. 

Within the VA system, the facility director has oversight responsibility for all research conducted at that facility and for ensuring that all

human subjects protection regulations are implemented correctly.

Part of that responsibility has to do with fostering an institutional

culture of respect for human subjects protection, assuring access to

information on human subjects protection, and seeing to it that

investigators fulfill their responsibilities. The facility director is also

responsible for ensuring that the facility has its own written standard

operating procedures (SOPs) for human subjects protection,

There are several layers 

of responsibility for 

ensuring informed 

consent in VA research.
5

including the manner in which informed consent sessions are to

be conducted, and that all SOPs are followed.

The facility director also establishes oversight to ensure compliance

with regulations and effective administration of the facility’s human

subjects research protection program. The facility director appoints

IRB members upon recommendation from the R&D Committee,

provides the IRB with needed resources and staff, and supports the

IRB’s authority and decisions.

In facilities with sizable research programs, the facility director

delegates responsibility to administer the program to the Research

Service, headed by the associate chief of staff for research and

development (ACOS for R&D). In smaller facilities, a research

and development coordinator replaces the ACOS. The IRB is a subcommittee of the R&D Committee, and the ACOS for R&D is the

executive secretary of the R&D Committee. For a study involving

human subjects to proceed, the study protocol, including the consent

forms, must be approved by both the IRB and the parent R&D

Committee. Neither committee can overturn a disapproval by the

other, providing a double layer of protection to research subjects.

At the research study level, the principal investigator is responsible

for ensuring that effective informed consent is obtained and

documented correctly for all study participants before participants

may enter a study. In some instances, the principal investigator does

not personally obtain informed consent from prospective participants, but delegates that responsibility to another member of the

research team (usually a research nurse or a research assistant).

However, the principal investigator still bears responsibility for

ensuring that informed consent is obtained properly. In addition, the

principal investigator must make sure that the person obtaining

informed consent fully understands what needs to be done and

has adequate training to carry out this task.

... the principal investigator 

still bears responsibility 

for ensuring that informed 

consent is obtained properly.
6

As mentioned, the concept of informed consent originated and

developed in the clinical care setting before becoming an important

issue in the research setting. As a result, the conceptual and ethical

framework of informed consent for medical treatment is similar in

many ways to that of informed consent for research. There is one

major difference, though. Whereas medical treatment has as its

primary and overriding goal the successful treatment of the individual patient, the primary goal of research is to produce generalizable

knowledge. This new knowledge may or may not help the individual

research participant.

Sometimes, a prospective research participant may not understand

this key difference in goals between research and treatment, and may

enter a research trial believing that the research intervention

will help him or her directly. The prospective participant views

participation in the research study as a form of treatment and expects

better health as a result. Frequently, research participants in this situation assume that they have the same relationship with the study

researchers as they would with their own doctors. But these expectations and assumptions are simply not true. When a research participant confuses the goals of research with those of treatment, this

gives rise to what is called “therapeutic misconception.”

Therapeutic misconception can seriously impair the ability of an

otherwise competent person to give legally effective informed consent. As a result, researchers must be careful to ensure that prospective participants fully understand the goals of research, as well as the

difference between receiving medical care in a research study versus

receiving medical care from a personal physician. 

Is there a difference between informed consent in clinical research versus

informed consent in standard medical treatment?

When a research participant

confuses the goals of research

with those of treatment, this

gives rise to what is called

“therapeutic misconception.”
Are there subsets of patients with whom we need to be particularly 

careful when obtaining informed consent?

There are several subsets of patients who have characteristics or problems that may make them particularly vulnerable to decision-making

that is not fully competent or voluntary. Research team members

must make special efforts to recognize these vulnerable patients and

assure that when they give consent to participate in research, their

decisions are fully competent and voluntary.

These subsets of vulnerable patients include:

• Some people with mental illness, including certain elderly

patients suffering from dementia. These patients may need a

legally authorized surrogate decision-maker – usually a family

member – to act on their behalf.

• Substance abusers, who may be vulnerable to coercion.

• Homeless patients, who may perceive a benefit to participating

in a research study, such as being able to sleep in a hospital.

• Patients who are desperately ill and particularly vulnerable to

therapeutic misconception.

How is informed consent obtained?

7

Meaningful informed consent is obtained by having a conversation

with the prospective participant. Once obtained, informed consent is

maintained through an ongoing process to keep the participant

informed of any developments that may affect his or her decision to

continue in the study. 

Several things need to happen during the initial conversation. First,

the research team member obtaining consent must disclose to the

prospective participant everything he or she needs to know about the

research study in order to make a fully informed decision about

whether to participate. The consent form spells out the information

Meaningful informed 

consent is obtained by having

a conversation with the

prospective participant.
8

that must be disclosed – including the purpose of the study,

risks, benefits, alternative treatments, and other elements of

informed consent. 

However, the research team member must be careful not to focus

exclusively on the consent form. The consent form is a tool. It serves

as a guide for how to conduct the conversation and as a receipt, once

it has been signed by the participant, that the participant has given

informed consent to be in the study. 

The consent form is not the only means for the research team member to inform the prospective participant. Informed consent is

obtained through a thoughtful dialogue that respects the individuality of each prospective participant and allows ample opportunity for

the prospective participant to ask questions, which the research team

member must answer fully. The goal is to ensure that the prospective

participant truly understands everything he or she needs to know

about the study before making a decision, that the decision to

participate is completely voluntary, and that he or she is competent

to make this decision. 

This may actually require more than one conversation, depending

on the nature of the research. In fact, some researchers believe that,

especially for more complicated studies or those with unusual risks,

prospective participants should be informed in stages on several occasions, so that they have time to reflect on what they have been told

before receiving more information. 

In addition, research team members may want to encourage prospective participants to talk with their families before reaching a decision.

They may also want to give prospective participants written materials on the study and on participation in VA research to help guide

their decisions. (See the Office of Research Compliance and

Assurance web site at www.va.gov/orca for the brochure, “I’m a veteran. Should I participate in research?”)

There is no single best way to obtain informed consent. Research

studies vary widely – obtaining informed consent for a trial of a

The consent form spells 

out the information that 

must be disclosed – 

including the purpose 

of the study, risks, 

benefits, alternative 

treatments, and 

other elements of 

informed consent.
highly experimental therapy is a very different matter from obtaining

informed consent for a survey study. Researchers are experimenting

with different tools for administering informed consent. For example, some studies indicate that informational videotapes or audiotapes may help improve prospective participants’ understanding of a

research study. Other researchers have focused on ways to simplify

the language used to inform prospective participants so that complex

information is more easily understood. 

It is very important for research team members to keep in mind that

informed consent is a process, not something obtained simply by

having a prospective participant sign a consent form. And getting a

participant’s signature on the consent form does not end the process.

The research team must keep participants informed of any significant

new findings developed during the study that may affect participants’

willingness to continue in the study.

What are some tips for providing prospective research participants with 

the information they need and ensuring that they understand it?

9

Plain speaking – both verbally and in writing – is critical to obtaining informed consent. Prospective participants must understand the

nature of their involvement in a study before they can give meaningful informed consent. Because VA patients tend to be very trusting of

their clinicians, they may give their consent without fully understanding what they are doing. For this reason, research team members must make a special effort to communicate simply and directly

with prospective participants and ensure their understanding. Here

are some tips for doing this:

Write to your audience. When developing a consent form or an

oral script, write at a level that matches the reading ability of your

prospective participants, generally at or below the 8th grade level. 

Use active voice, short words. Whether in writing or in conversation with a prospective participant, use active voice and short, simple

words. For example, “we note” is better than “it is noted,” and “pay”

or “repay” is better than “compensate.” 

It is very important for 

research team members to 

keep in mind that informed

consent is a process, not 

something obtained 

simply by having a 

prospective participant 

sign a consent form.
10

Speak plainly. Get rid of jargon and use descriptive phrases to

convey information. For example, instead of “researchers,” use the

phrase “people doing the study.” 

Make it simple. Keep your sentences short. Limit your ideas to one

per sentence.

Don’t dictate. When developing a consent form, don’t put words in

patients’ mouths by using the first person singular construction.

Consent forms that read along the lines of “I understand that I will

be asked...” or “I recognize that I may be at some risk for...” may be

intimidating to prospective participants. In fact, many IRB experts

view this construction as coercive. It is better to write to your

prospective participants. “You will be asked to...” or “You may be at

risk for...” are good constructions.

Break it down. Organize the information you are providing into

discrete “chunks” that are easier for people to understand. The

elements of informed consent (see Appendix A) provide a good

framework for organizing your information.

Be straightforward. Do not overstate the possible benefits of your

research. On the flip side, do not understate the risks. The information you present must be full and objective, if true informed consent

is to be obtained.

Quiz the patient. Ask the prospective participant several times

during the conversation whether he or she remembers and understands what you have just told him. Ask the person to explain that

information back to you in his or her own words.

Don’t rush a decision. Give the person time to think the matter

over. You may need to have several conversations over a period of

days. Encourage the prospective participant to talk with his or her

family members before reaching a decision.

nt 

Prospective participants 

must understand the 

nature of their involveme

in a study before they 

can give meaningful 

informed consent.
What documentation is required for informed consent?

A written consent form that embodies the required elements of

informed consent serves as documentation that informed consent

was obtained prior to a subject’s enrollment in a study. Both the IRB

and the R&D Committee of the institution where the research is

being conducted must approve this form before any prospective

research participants are approached. 

When a prospective participant has agreed to give informed consent

to participate in a study, he or she or a legally authorized representative signs and dates the consent form. A witness to the participant’s

signature must also sign and date the form. The original signed

consent form is then filed in the participant’s case history. A copy of

the signed form must be provided to the participant or their legal

representative. 

Under some conditions, the IRB may approve a short form written

consent. The content of this informed consent form may be presented orally to prospective participants who can’t read. A written summary of what is to be said to the prospective participant must be

approved in advance by the IRB. In addition, there must be a witness

to the oral presentation. After the presentation, the participant signs

a short written statement attesting that the elements of informed

consent have been presented to him or her orally. The witness and

the person obtaining the consent must also sign this statement, as

well as a copy of the summary that was read to the participant.

What is the role of the IRB in informed consent? 

11

The IRB is a subcommittee of the R&D Committee. For a study

involving human subjects to proceed, both these committees must

approve the study protocol, including the informed consent form.

Neither committee can overturn a disapproval by the other. 

Prior to reviewing the informed consent form, the IRB examines the

research protocol closely, particularly with respect to the potential

risks and benefits, to ensure that the risk-benefit ratio is acceptable.

A written consent form 

that embodies the required 

elements of informed consent

serves as documentation 

that informed consent was

obtained prior to a subject’s

enrollment in a study.
12

This becomes an important issue when the IRB assesses the consent

form, which must accurately reflect the study’s risks and benefits and

provide the prospective participant with all the information needed

to give fully informed consent.

Once the IRB has approved an informed consent form, the form

must be used to obtain legally effective informed consent for the

study. It cannot be modified without approval from the IRB.

IRB meeting minutes, including approval of consent forms, are

reviewed by the R&D Committee, which must approve the minutes

before they are sent to the facility director for final concurrence.

Although approval by the R&D Committee is generally routine, they

may flag controversial issues regarding research protocols or consent

forms and ask the IRB to review them again. The R&D Committee,

as well as higher authorities (facility director, ORD) may also add

other modifications or strengthen requirements that must be met

before approval of the protocol or consent form.

The IRB must also ensure that the informed consent process, as 

performed by the research staff, has been properly documented,

including filing the original executed informed consent form in the

subject’s case history. In addition, IRB members may choose 

to observe the process of obtaining consent, to ensure that prospective participants are being adequately and effectively informed.

Under certain circumstances, the IRB may approve an amended 

consent procedure or waive the requirements for documentation of

informed consent. 

How should VA managers work with their IRBs to ensure 

proper informed consent?

VA managers should keep in mind that protection of human research

subjects is a shared responsibility and make sure that the lines of

communication are always open between the IRB and others

involved in informed consent. In particular, facility directors should

maintain an ongoing dialogue with their IRBs, R&D committees,

The IRB must also ensure 

that the informed consent

process, as performed by 

the research staff, has been

properly documented...
ACOS for R&D, and others involved in ensuring and maintaining

informed consent. 

Facility directors have ultimate responsibility to and for their facilities’ IRBs. They must ensure that investigators conducting research at

their facilities comply with the IRBs’ rulings, as well as ensuring that

the IRB does its job properly, carries the required accreditation, and

operates in compliance with the facility’s standard operating procedures for human subjects protection. Facility directors must also see

to it that IRB members have adequate training in informed consent

procedures and requirements. Finally, they must ensure that adequate

administrative support, including personnel and space sufficient to

provide privacy for conducting sensitive duties and storing records, is

provided for IRB activities.

What data protection issues apply to informed consent 

for clinical research?

13

Ensuring the privacy and confidentiality of all patient data used 

for human subjects research is of paramount importance to VA. Key

here is whether individual patients whose data are being used in

research will be identifiable as a result of the research. The IRB examines this issue when reviewing the study protocol. If concerns arise

over patient privacy and confidentiality, the IRB will direct the

research team to strengthen the protocol so that it addresses these

concerns appropriately.

In addition, effective in April 2003 are new patient privacy protections under the Health Insurance Portability and Accountability Act

(HIPAA) of 1996. These rules guide uses and disclosures of protected health information at health care facilities that are covered under

HIPAA, including VA facilities. Researchers and others involved

in human subjects research should familiarize themselves with

the new HIPAA privacy rules. Good resources include the Health

Privacy Project at the Georgetown University Institute for Health

Care Research and Policy (www.healthprivacy.org), and the

Department of Health and Human Services Office of Civil Rights
14

(www.hhs.gov/ocr/index.html). VA privacy regulations can be found

in VA Manual M-1, Part 1, Chapter 9.

The Institute of Medicine recommends that all research organizations work with their IRBs to develop specific guidance and examples for interpreting and applying key aspects of the new federal

regulations and make such guidance and examples available to all

investigators submitting proposals for review. VA managers may want

to consider working with their IRBs to identify and develop best

practices for protecting privacy and confidentiality in research. (See

“Protecting Data Privacy in Health Services Research,” Committee

on the Role of Institutional Review Boards in Health Services

Research Data Privacy Protection, Institute of Medicine, National

Academy Press 2000, http://www.nap.edu/catalog/9952.html.)

What training is required on informed consent and 

human subjects protection? 

Both the federal Office for Human Research Protections (OHRP)

and VA strongly recommend training related to human subjects

research. All who are involved in the informed consent process must

be sufficiently knowledgeable, either through training or experience.

Within VA, network directors, facility managers, IRB chairs, human

research protection administrators, and research investigators all

should have appropriate training in human subjects protection,

including informed consent. Investigators, in particular, must provide documentation of completion of approved training to the local

research office prior to conducting any research in VA. The Office of

Research Compliance and Assurance (ORCA) has arranged for VA

system-wide access to a comprehensive web-based training program

on the protection of human research subjects. The CITI

(Collaborative IRB Training Initiative) Course in the Protection of

Human Research Subjects was developed by a multi-institutional

collaboration that includes VHA participation through ORCA. This

is an optional training vehicle that will assist facility managers, IRB

members and staff, research administrative staff, and investigators to

Ensuring the privacy and 

confidentiality of all patient

data used for human subjects

research is of paramount

importance to VA.
15

fulfill training and education requirements. VA employees wishing

to use the module should go to the CITI-VA registration site at

www.miami.edu/bb/vareg. 

For more information on VA training and education regarding

informed consent, visit ORCA’s web site, www.va.gov/orca/. Also, see

Appendix C for a list of training resources for research staff and 

IRB members. 

How is VA working to improve informed consent for research participants?

The CITI training module is one example of how VA is working to

improve informed consent by training and educating VA managers

and research staff.

In addition, VA is working with the National Committee for Quality

Assurance (NCQA), a private, non-profit accreditation organization,

to establish an accreditation program for human subjects research. In

2000, VA signed a 5-year contract with NCQA to develop accreditation standards, survey all VA facilities conducting research with

human subjects every three years, and determine the accreditation

status for each facility. In creating this accreditation program, VA is

raising the bar for protecting human subjects enrolled in research and

setting an example for the rest of the research community to follow.

For details, visit www.ncqa.org/pages/programs/QSG/VAHRPAP/

vahrpap.htm.

Finally, VA is looking to its own research for insights on how to

improve informed consent. For example, a VA Cooperative Studies

Program project – Enhancing the Quality of Informed Consent,

otherwise known as EQUIC, is underway to test innovations in

informed consent. VA researchers will conduct structured interviews

with VA research participants to determine whether key elements of

informed consent were achieved, how satisfied they were with the

process, how much information they retained, and whether they

understood the information they were given. EQUIC will try to

identify ways that the process can be improved. VA’s Office of

Research and Development also expects to fund additional research

in the area of informed consent.

. . . VA is raising the bar 

for protecting human 

subjects enrolled in research

and setting an example for 

the rest of the research 

community to follow. 
16

Conclusion

People who participate in clinical research make a tremendous contribution to medical science. The VA research enterprise has both a

moral and a legal obligation to respect the rights and autonomy of all

people who consider participating in VA research. VA is a world

leader in research, striving for excellence in all its research programs.

Key to achieving that goal is ensuring the protection of all VA

research participants through a thoughtful and deliberate informed

consent process.

Many questions remain to be answered about how best to achieve

fully informed consent. VA will continue to explore innovations in

informed consent, and will adopt and disseminate those techniques

that improve patient protection.
Appendix A: Elements of Informed Consent

17

What are the elements of informed consent?

Following are the basic elements of informed consent. For more detail, please refer to VHA

Handbook 1200.5, Appendix C.

Purpose and Description: Tell the prospective participant that the study involves research,

explain the purpose of the study and the length of time expected for participation, describe

the process to be followed during the study, and identify any experimental procedures or

other procedures being done only for the research. For example, the researcher should say

whether the study involves a new drug, extra tests, separate research records, or nonstandard

means of management, such as random assignment. VA policy specifies that the following

information must be provided to the prospective participant:

• Name of the study

• Name of the principal investigator

• A statement that the study involves research

• An explanation of the purposes of the research and expected duration of the 

subject’s participation

• A description of the procedures to be followed and identification of those being done 

for research purposes

• Identification of any procedures that are experimental

Risks: Describe any reasonably foreseeable harms, inconvenience, or discomforts to the 

participant. If additional risks are identified during the study, the consent process and 

documentation will require revision to inform continuing, as well as new participants of

these risks.

Benefits: Describe any benefits to the prospective participant or to others that may reasonably be expected to result from the research. There may be none, other than a sense of helping society at large. 

Alternatives: Disclose any appropriate alternative treatments that might benefit the prospective participant. For example, a medication in a drug study may be available through the 

participant’s family doctor or clinic.

Confidentiality: Tell the prospective participant whether his individual record will be 

kept confidential and explain the level of confidentiality to be maintained. For example,

some studies require disclosure of information to study sponsors, the FDA, or other 

federal agencies.
18

Greater Than Minimal Risk: For research involving more than minimal risk, provide an

explanation of whether any compensation is available and whether medical treatments are

available if injury occurs, and, if so, what they consist of and where further information may

be obtained. 

Contact Information: Tell the prospective participant whom to contact if he has questions

about the research and his rights as a study participant, and whom to contact if he has an

injury that may be related to the research.

Voluntary Participation: Explain that participation is voluntary, that refusal to participate

will result in no penalty or loss of benefits to which the prospective participant would otherwise be entitled, and that the participant may withdraw from participating in the study at

any time without penalty.

No Payment Required: Inform the prospective participant that he or she will not be

required to pay for treatment received as a subject in a VA research project. However, he or

she may be required to pay usual co-payments for VA care and services that are not part of

the study. 

When appropriate, the following additional elements of consent should be included:

Unforeseeable Risk: Explain that the study treatment or procedures may have risks for the

prospective participant (or to an embryo or fetus, if the participant is or may become pregnant) that the researcher cannot currently foresee.

Termination of Participation Without Consent: State the circumstances under which

the participant’s further involvement in the study may be terminated without that person’s

consent.

Additional Costs: Disclose any additional costs to the prospective participant that may

result from participation in the study.

Consequences and Process of Withdrawal: Explain how a participant can leave the study

and what may happen to him if he chooses to withdraw.

Impact of Significant New Findings: Tell the participant that he will be informed of any

significant new findings developed during the research that may relate to his willingness to

continue in the study.

Number of Participants: Inform the prospective participant of the approximate number of

people involved in the study.

Human Biologic Specimens: Follow the VHA Handbook on Banking of Human

Biological Specimens, if specimens obtained in the study might lead to the development of

a valuable product or will be retained after the study ends. 

Payment: Include a statement regarding any payment the participant is to receive and how

payment will be made. If payment is given to participants, it must not be coercive in amount

or method of distribution. (VA permits payment to human research participants under specific circumstances; payment must be approved in advance by the IRB.)
19

Appendix B: Resources

What VA and non-VA resources are available to managers, investigators, and other

research staff?

There is an abundance of bioethics, research compliance, and other human subjects protection information available from government, academic, and private sources, much of it accessible via the Internet. A sampling of several different types of resources is presented here.

These resources can provide information and assistance in a variety of ethics, policy, and

compliance areas. Many of the resources listed here also provide extensive additional resource

listings on their web sites. First are listed some important VA offices and contacts for guidance on a variety of issues related to informed consent. Next is a listing of other government

resources, as well as some additional non-government sites of interest. 

WITHIN VA

National Center for Ethics

The National Center for Ethics is VHA's primary office for addressing the complex ethical

issues that arise in patient care, health care management, and research. It is distinctive in serving the nation's largest integrated health care delivery system and supports the development

of integrated ethics programs at the local, regional, and national levels. The Center's mission

is to clarify and promote ethical health care practices within VHA and beyond, and it serves

as the primary advisor on ethical issues to the Under Secretary for Health. 

Telephone: (802) 296-5145 

Email: vhaethics@med.va.gov 

Web Link

http://www.va.gov/vhaethics/index.cfm

Office of Research Compliance and Assurance (ORCA)

The Office of Research Compliance and Assurance serves as the primary Veterans Health

Administration component in advising the Under Secretary for Health on all matters affecting the integrity of research in the protection of human subjects and the welfare of laboratory animals. ORCA promotes enhancements in the ethical conduct of research in

conformance with regulations and policies, and investigates any allegations of research

improprieties and scientific misconduct. 

Telephone: (202) 565-9080

Web Link

http://www.va.gov/orca/
20

Office of Research and Development

The Office of Research and Development is committed to ensuring that VA funded research

and all VA researchers comply with statutory and regulatory requirements for the protection

of human research participants. As such, it is continually reviewing its research policies, 

issuing appropriate guidance, and developing new systems to improve education, accountability, and adherence to the research assurance requirements.

Telephone: (202) 565-8440

Web Link

http://www.va.gov/resdev/default.cfm

O THER GOVERNMENT RESOURCES

Office for Human Research Protections (OHRP)

The Office for Human Research Protections, part of the Department of Health and Human

Services (DHHS), monitors programs for the protections of human subjects at universities,

hospitals, and other medical and behavioral research institutions in the United States and

abroad. OHRP is responsible for leading efforts to protect human subjects in biomedical and

behavioral research and carrying out patient protection initiatives issued by DHHS.

Web Link

http://ohrp.osophs.dhhs.gov/

U.S. Food and Drug Administration (FDA)

FDA's mission is to promote and protect the public health by helping safe and effective

products reach the market in a timely way, and monitoring products for continued safety

after they are in use. It maintains enforcement authority to ensure that researchers carrying

out FDA-authorized drug and medical device clinical trials are complying with Department

of Health and Human Services patient protection and consent requirements through its

inspection and auditing of the conduct and reporting of clinical trials. 

•Information Sheets: Guidance for Institutional Review Boards and Clinical

Investigators

http://www.fda.gov/oc/ohrt/irbs/default.htm

•Center for Drug Evaluation and Research

http://www.fda.gov/cder/about/smallbiz/clinical_investigator.htm
21

National Institutes of Health (NIH)

NIH is committed to the ethical conduct of research and the protection of human subjects.

As part of this commitment, it has produced documents to provide guidance for researchers

and IRB members who have an obligation to safeguard the rights and welfare of research participants and has developed a bioethics resource web site. Bioethics Resources on the Web is

designed to facilitate research, scholarly activities, and training. The web site provides information about bioethics initiatives at NIH Institutes and Centers and other government

offices and programs, publications, reports, guidelines, and regulations related to bioethics. 

•Bioethics Resources on the Web

http://www.nih.gov/sigs/bioethics/

The President’s Council on Bioethics

The newly established President’s Council on Bioethics advises the President on bioethical

issues that may emerge as a consequence of advances in biomedical science and technology.

The Council’s web site also includes a link to the archived site of the National Bioethics

Advisory Commission, established by the previous administration. 

Web Link

http://www.bioethics.gov/

NON-GOVERNMENT RESOURCES

National Committee for Quality Assurance (NCQA)

NCQA is a not-for-profit organization dedicated to improving health quality. Working 

with VA, it is operating an accreditation program to ensure that VA medical centers are 

complying with VA and other relevant federal regulations designed to protect human subjects of research. 

Web Link

http://www.ncqa.org/programs/accreditation/vahrpap/vahrpap.htm

Association for the Accreditation of Human Research Protection Programs, Inc.

(AAHRPP)

AAHRPP is a nonprofit organization working to protect the rights and welfare of research

participants by fostering and advancing the ethical and professional conduct of persons and

organizations that engage in research with human participants. It offers accreditation to institutions engaged in research involving human participants using a voluntary, peer-driven 

educational model. 

Web Link

http://www.aahrpp.org/
22

Association of American Medical Colleges (AAMC)

The AAMC has as its purpose the improvement of the nation’s health through the 

advancement of medical schools and teaching hospitals. As an association of medical schools,

teaching hospitals, and academic societies, the AAMC works with its members to set a

national agenda for medical education, biomedical research, and health care, and assists its

members by providing services at the national level that facilitate the accomplishment of

their missions.

Web Link

http://www.aamc.org/research/start.htm

•AAMC Research Compliance Resources

http://www.aamc.org/research/dbr/compliance/startcom.htm

Public Responsibility in Medicine & Research (PRIM&R)

PRIM&R is committed to the advancement of strong research programs and to the consistent application of ethical precepts in both medicine and research. Through national 

conferences and published reports, it has addressed a broad range of issues in research, 

clinical practice, ethics, and the law.

Web Link

http://www.primr.org/index.html

Applied Research Ethics National Association (ARENA)

ARENA is a national service organization for professionals interested in bioethics,

researchers, administrators, and members of Institutional Review Boards, hospital ethics

committees, patient advocacy groups, and Institutional Animal Care and Use Committees.

Its function is to promote educational activities, networking, resolution and/or amelioration

of mutual problems, and the professional advancement of its members. 

Web Link

http://www.primr.org/arena.html

The Hastings Center

The Hastings Center is an independent, nonpartisan, interdisciplinary research institute that

addresses fundamental ethical issues in the areas of health, medicine, and the environment as

they affect individuals, communities, and societies. Their publications include the Hastings

Center Report (and special supplements to this journal), IRB: Ethics & Human Research, and

other publications addressing issues related to human subjects research. 

Web Link

http://www.thehastingscenter.org/
RESOURCES FOR SIMPLIFYING INFORMED

CONSENT LANGUAGE AND FORMS

University of Michigan

Medical School Institutional Review Board: Simplification Guide to Medical Terms

http://www.med.umich.edu/irbmed/InformationalDocuments/consent/synonym.html

University of California-Davis

Office of Human Research Protection: Glossary of Human Subjects Terminology (Glossary

of Lay Terms for Use in Preparing Consent Forms for Human Subjects)

http://ovcr.ucdavis.edu/HumanSubjects/HSDefinitions/HSGlossary.htm

23
24

Appendix C: Training Resources

What training resources are available for investigators, IRB members, and other

research staff?

Training and certification in human subjects protection is a requirement for all VA investigators, and training is equally important for IRB members and research staff. A selection of

online training resources is provided here, as well as contact information for organizations

providing more formal training courses. Numerous other resources exist, and local medical

schools and academic medical centers can also be excellent resources for training in a variety

of areas of human subjects protection and informed consent.

CITI (Collaborative IRB Training Initiative) Course: The Protection of Human 

Research Subjects

Includes special registration site and training module for VA staff

www.miami.edu/bb/vareg

Association of American Medical Colleges (AAMC)

AAMC Research Compliance Resources: Computer-Based Instruction and On-Line Resources for

Human Subjects Protection

http://www.aamc.org/research/dbr/compliance/curricula.htm

Public Responsibility in Medicine & Research (PRIM&R)

http://www.primr.org/training.html

National Institutes of Health

Tutorials, Case Studies and Courses

http://www.nih.gov/sigs/bioethics/casestudies.html

Office for Human Research Protections (OHRP)

Educational Materials

http://ohrp.osophs.dhhs.gov/educmat.htm

Workshops

http://ohrp.osophs.dhhs.gov/wrkshp.htm
25

VA New Jersey Health Care System

Protection of Human Research Subjects Training Module

http://pws.prserv.net/vanjhcs_research/VAT1/first.htm

Dunn CM and Chadwick G.

Protecting Study Volunteers in Research: a comprehensive manual designed to assist clinical

research professionals in providing the highest standards of safety and ethical treatment for

their study volunteers. Developed in accordance with ACCME standards, readers can apply

for CME credits and Nursing Contact Hours. An exam is provided with each manual.

http://www.centerwatch.com/bookstore/pubs_profs_protect.html
26

Appendix D: Reading Materials

What reading materials are available to provide more information on informed

consent, research ethics, and the protection of human subjects in research?

Informed consent has been the subject of numerous publications, from entire books and

journals devoted to the topic to individual articles and literature reviews. The list below provides an extensive, but by no means complete guide to a variety of published articles and

journals covering research ethics and human subjects protection, as well as specific aspects of

informed consent and the regulations which govern it. 

JOURNALS

IRB: Ethics & Human Research

Includes articles and features that help clarify fundamental ethical concerns, explore regulatory developments, and share insights and experiences, as resources not only for IRB 

members, but also for investigators, sponsors, research administrators, participant-subjects,

and others actively involved in research with human subjects.

http://www.thehastingscenter.org/Membership/IRBdefault.asp

The Hastings Center Report

The premiere publication of the Hastings Center, the Hastings Center Report was the first

periodical devoted specifically to ethical issues in medicine, the life sciences, and the professions. This journal offers a public forum in which the many disciplines and professions that

contribute to bioethics - philosophy, medicine, law, the natural and social sciences, theology

- can join in mutually enriching discussion. Its goal is to stimulate the moral imagination of

its diverse readers in articles that are both intellectually rigorous and generally accessible. 

http://www.thehastingscenter.org/Membership/memberdefault.asp

REGULATIONS/CODES

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

(The Belmont Report). The National Commission for the Protection of Human Subjects of

Biomedical and Behavioral Research. April 18, 1979.

http://www.fda.gov/oc/ohrt/irbs/belmont.html

Federal Policy for the Protection of Human Subjects (Common Rule)

http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm

VHA Handbook 1200.5: Requirements for the Protection of 

Human Subjects in Research

http://www.va.gov/resdev/directive/RevisedHandbookProtectionHumanSubjects

InResearch.doc
27

VA Human Research Protection Accreditation Program Accreditation Standards

National Committee for Quality Assurance (NCQA)

http://www.ncqa.org/Programs/QSG/VAHRPAP/vahrpap.htm

BOOKS

Berg JW, Appelbaum PS, Parker LS, Lidz CW. Informed Consent: Legal Theory and

Clinical Practice. 2nd ed. New York: Oxford University Press;2001.

Doyal L, Tobias JS, editors. Informed Consent in Medical Research. London: BMJ

Books;2001.

Dunn CM, Chadwick G. Protecting Study Volunteers in Research: A comprehensive

manual designed to assist clinical research professionals in providing the highest standards of

safety and ethical treatment for their study volunteers.

http://www.centerwatch.com/bookstore/pubs_profs_protect.html

Faden R, Beauchamp TL; in collaboration with: King NMP. A History and Theory of

Informed Consent. New York: Oxford University Press;1986.

Hartnett T, editor. The Complete Guide to Informed Consent in Clinical Trials.

Springfield (VA): PharmSource Information Services, Inc.;2000.

Kahn JP, Mastroianni AC, Sugarman J, editors. Beyond Consent: Seeking Justice in

Research. New York: Oxford University Press;1998.

Levine RJ. Ethics and Regulation of Clinical Research. 2nd ed. New Haven: Yale

University Press;1988. 

Mazur DJ. Medical Risk and the Right to an Informed Consent in Clinical Care and

Clinical Research. Tampa (FL): American College of Physician Executives;1998.

ARTICLES

VA’s Office of Research and Development, in collaboration with the Hastings Center, has

made available on the web a searchable annotated bibliography of empirical research on

informed consent. 

http://www.va.gov/resdev/fr/informed_consent
28

Appendix E: Glossary

Glossary of Informed Consent Terms

Adverse Event (AE): Any untoward physical or psychological occurrence in a human subject participating in research. An adverse event does not

necessarily have a causal relationship with the

research treatment or intervention. See also Serious

Adverse Event and Unexpected Adverse Event.

Assurance: Also called an Assurance of Compliance

or Federalwide Assurance (FWA). It is obtained

from the Office for Human Research Protections

(OHRP) and constitutes a written commitment by

an institution to protect human subjects participating in research. Any institution conducting or

engaged in federally supported research involving

human subjects must obtain an Assurance.

Belmont Report: A statement of basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human

subjects, and guidelines to assure that this research is

conducted in accordance with such principles. 

Case History: A record of all observations and other

data pertinent to the investigation on each research

subject. Case histories include the case report forms

and supporting data, including the original signed

and dated consent form documenting that informed consent was obtained prior to participation

in the study.

Common Rule: The Federal Policy for the

Protection of Human Subjects which VA and 16

other federal agencies and departments have agreed

to follow. It is described in the Code of Federal

Regulations (CFR) at 45 CFR 46, and VA has

incorporated its subscription to this policy at 38

CFR 16. 

Consent Form: An Institutional Review Board

(IRB) approved document containing all relevant

information to be communicated to potential

research participants; a participant’s signature on

this form is intended to document their voluntary

consent to participate in a research study. In VA

research, VA form 10-1086 must be used as the consent form. The consent form is only one part of the

consent process.

Human Subject: A living individual about whom a

research investigator obtains data. Data may be

obtained through intervention or interaction with

the individual, or through identifiable private 

information.

Institutional Review Board (IRB): A committee of

scientific and non-scientific individuals, established

according to federal requirements, with responsibility for review and approval of human subjects

research protocols and consent forms used in those

protocols.

Institutional Review Board Records: These may

include but are not limited to all minutes of IRB

meetings, a copy of all proposals reviewed including

all amendments, investigator brochures, supplemental information, consent forms, information submitted for continuing review, all correspondence,

and IRB membership, including a resume for each

member.
29

Investigator: An individual who conducts some or

all aspects of a research investigation. 

Legally Authorized Representative: An individual

or body authorized under applicable law to consent

on behalf of a prospective subject to the subject’s

participation in a procedure(s) involved in research,

when the subject is incapable of providing consent.

Principal Investigator: An individual with primary

responsibility for the design and conduct of an

investigation, and under whose immediate direction

research is conducted. In the event of an investigation conducted by a team of individuals, the principal investigator is the responsible leader of the team.

Research Records: Records that consist of both

IRB records and case histories, or any data gathered

for research purposes.

Researcher: A principal investigator and/or

investigator.

Serious Adverse Event (SAE): Death, a life threatening experience, hospitalization (for a person not

already hospitalized), prolongation of hospitalization (for a patient already hospitalized), persistent or

significant disability/incapacity, congenital anomaly/birth defects, or other event that jeopardizes the

research subject and may require medical or surgical

treatment to prevent one of the above outcomes.

Unexpected Adverse Event (UAE): Any adverse

event/reaction, the specificity or severity of which is

not consistent with the informed consent, current

investigator brochure, product labeling, or the risk

information described in the general investigational

plan or proposal.

Vulnerable Subjects: Individuals whose willingness

to volunteer for a research study may be more easily

influenced or coerced, or who may be less able to

make an informed decision to participate. These

individuals may include: pregnant women and

fetuses, prisoners, the mentally ill and those with

impaired decision-making capacity, children, and

economically and/or educationally disadvantaged

persons.
Notes
Notes
Notes
Informed Consent for Human Subjects Research: A Primer is available in electronic

and printed formats. Additional copies may be obtained from the sources listed below.

Electronic copies (PDF format) can be downloaded from the VA HSR&D web site.

Point your browser to http://www.hsrd.research.va.gov/publications/primer/

Print copies may be requested from:

Special Projects Office (512A5/152)

VA Maryland Health Care System

Telephone: (410) 642-1092

Email: rainelle.holcomb@med.va.gov

Other primers in the series include:

Primary Care in VA

Health Technology Assessment in VA

Using Outcomes to Improve Healthcare Decision Making

Program Evaluation for Managers

Risk Adjustment: A Tool for Leveling the Playing Field

Clinical Practice Guidelines

Organizational Change
Office of Research and Development

Veterans Health Administration

Department of Veterans Affairs

Produced by the Information Dissemination Program

Management Decision and Resource Center

VA Boston Health Care System (152-M)

150 South Huntington Avenue

Boston, MA 02130

617-278-4433

MDRC.Boston@med.va.gov

http://www.hsrd.research.va.gov