New York University School of Medicine
Institutional Review Board
Continuing Education
Who is a Vulnerable Subject?
November 2008
Definition of Vulnerable
Vulnerability is one of the least examined concepts in research ethics. The Belmont Report links
Vulnerability to questions of justice in the selection of subjects. The term ‘Vulnerable’ is applied in
human subjects research to define individuals who are unable to give informed consent or who
are susceptible to harm. Harm can be a social, economic, legal, psychological, or physical.
To say that subjects are vulnerable means that they are likely to have compromised autonomy to
a degree that demands extra protection. Certain individuals require ongoing protections as
established in the regulations (45 CFR 46 Subparts B-D and 21 CFR 50 Subpart D. However, IRBs
must also focus on characteristics of a research protocol and environment that may present a different
type of vulnerable population that is not identified in the regulations.
 Vulnerable Subjects in the Regulations
(1) Pregnant Women, Human Fetuses and Neonates (See Sub Part B 45 CFR 46)
(2) Prisoners (See Sub Part C 45 CFR 46)
(3) Children (See Sub Part D 45 CFR 46)
IRB Review Requirements:
The above regulatory citation must be presented and agreed upon during a fully convened
meeting. The IRB must always make sure to identify: 1. Risks to subjects are; minimized and
reasonable in relation to anticipated benefits. 2. Selection of subjects is equitable. The IRB
should take into account; the purposes of the research, the setting in which the research will
be conducted, special problems of research involving vulnerable populations.
NOTE: Do not make Subpart findings for populations not recognized in the regulations as a
vulnerable population
Example:
Research involving pregnant women, placenta after delivery and neonates of an uncertain
viability or viable neonates requires the IRB must make findings consistent with 45 CFR 46
Subpart B. [Note: For viable neonates the IRB must also make Subpart D findings].
 Vulnerable Subjects in the NYUMC IRB Policies and Procedures
NYU SoM IRB Policies and Procedures identify the three vulnerable populations from the
regulatory subparts but also includes the following:
(1) Adults who lack the ability to consent,
(2) Students,
(3) Employees,
(4) Homeless persons.
IRB Review Requirements:
For these four groups, the IRB must make findings consistent with the NYU SoM IRB Policies
under Section-10.4 for Persons with Mental Disabilities or Persons with Impaired decision-Making
Capacity and Section 16.3 for NYU SoM Students and Employees as Subjects.
The policy and procedures identify additional safeguards to be included in studies involving these
types of subjects. IRB members should become familiar with these safeguards.
Note: NYU SoM IRB policies must be identified and evidenced in meeting correspondence or
review materials.
Example:
Research involving students requires the IRB make sure that the researchers emphasize that
neither their academic status or grades, or the subjects employment, will be affected by their
participation.
 Vulnerable Populations not found in the Federal Regulations or IRB Policies and
Procedures:
There are other types of vulnerable populations not considered by the regulations or IRB Policies.
An individual who may not normally appear vulnerable may be susceptible to harm at the time
they present for possible inclusion in a research study. These individuals are vulnerable because
they are more susceptible to harm in the research given their present circumstance. The Belmont
Report provides examples of harmful exploitation in low status populations (ethnic group
members, children, the poor, women) or subject populations (soldiers, prisoners) in medical
research. Others that may be susceptible to harm are persons who are:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
Physically handicapped
Mentally disabled
Economically disadvantaged
Educationally disadvantaged
Racial minorities
Very sick or terminally ill
Temporarily impaired
Institutionalized
A community or country
IRB Review Requirements:
Common sense tells us that not all vulnerable subjects are at the same risk level for
vulnerability. What may protect one may hinder others from a beneficial involvement in the
research. The IRB should look for provisions in the proposed protocol that address the risk of
vulnerability and susceptibility to harm or coercion. These provisions may include: Identifying
potential for capacity loss and possible influence of others on decision making process, making
sure information provided is understandable, written in simple English, and the protocol
describes who will be involved in the consent process, what will be discussed, where the
consent process will take place, when the consent process will be done and how will subjects
be asked to consent.
Example:
Research involving individuals who have survived a man made or natural disaster requires the
IRB ensure the researchers identify the potential susceptibility coercion and develop a plan to
handle the possible inability of subjects to make decisions shortly after the disaster by specifically
addressing how the consent process will be handled during recruitment.
References:
Levine, C., R. Faden, C. Grady, 2004. The Limitations of “Vulnerability” as a Protection for Human Research
Participants
The American Journal of Bioethics, 4(3): 44–49, 2004,
IRB Member Handbook (Second Edition)- Amdur and Bankert
NYU Langone Medical Center IRB Policies and Procedures
http://www.med.nyu.edu/irb
Office for Human Research Protection IRB Guidebook
http://www.hhs.gov/ohrp/irb/irb_guidebook.htm