The Goals and Principles of
Human Participant
Protection
Part 4:
Vulnerable Populations
Acknowledgements
 We thank the University of Texas at Austin
for permission to adapt and use their IRB
training materials.
 Much of the material in this presentation
was taken from the Code of Federal
Regulations, Title 45, part 46; Protection of
Human Subjects.
 Other material came from the Food and
Drug Administration Regulations, 21 CFR,
parts 50 & 56.
Objective
 The purpose of this presentation is to
raise the level of understanding of all
Tarleton State University faculty,
students, and staff regarding the
regulations governing research involving
human subjects, and
 Enable them to apply these regulations
to specific research studies.
Vulnerable Populations
 Vulnerable research participants are those
persons who are relatively or absolutely
incapable of protecting their own interests.
 The lead researcher and research team
must be aware of the special problems
surrounding research involving vulnerable
populations.
 The proposed involvement of vulnerable
populations in research requires detailed
justification and additional safeguards to
protect their welfare and safety.
Vulnerable Populations
 Vulnerable populations include:
 Children
 Individuals whose capacity to give
consent is questionable
 Prisoners
 Fetuses and pregnant women
 Terminally ill persons
 Students and employees
 Comatose patients
Vulnerable Populations: Children
 A child is a person less than 18 years
of age unless emancipated or
married.
 Children cannot legally give consent.
 Any study involving children requires
IRB review and approval.
 Parental consent must be obtained in
all cases; a parent is the child’s legal
parent or guardian.
Vulnerable Populations: Children,
Assent of Child
 In addition to the parent or guardian’s written
consent, research involving children should not
proceed without the child’s written assent to
participate.
 The child’s signed assent is required.
 An assent form is a simplified, single page version of
the consent form signed by the parent or guardian;
the assent explains to the child what will happen
should they agree to participate in the research.
 Federal guidelines recommend children 7-12 be given
a separate assent form; children 13-17 may be given
the same consent form given to their parent or
guardian.
Vulnerable Populations:
Questionable Capacity to Consent
Capacity to consent means a person
has sufficient mental capacity to
understand the information provided,
to appreciate how it is relevant to
their circumstances, and to make a
reasoned decision about participation
in the study.
Vulnerable Populations:
Questionable Capacity to Consent
 Vulnerable populations may include
persons with:
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Psychiatric disorders
Neurological conditions
Substance abuse
Various metabolic disorders
Vulnerable Populations:
Questionable Capacity to Consent
 If a person is unable to provide
consent, in some cases a legally
authorized representative may grant
permission for participation in the
research.
 A legally authorized representative is
a legal guardian or person with validly
designated power of attorney.
Vulnerable Populations:
Questionable Capacity to Consent
 Research involving persons whose capacity
to consent is questionable requires careful
consideration to ensure such persons are
provided additional safeguards for their
safety and welfare.
 In some cases, individuals who are not able
to give informed consent may receive
permission to participate from a legally
authorized representative and then give
their own assent.
Vulnerable Populations:
Questionable Capacity to Consent
 Special precautions:
 Additional use of witnesses for consent
 Use of patient advocates
 Renewing consent at specific stages of
the research
 Limiting time period for approval
Vulnerable Populations: Prisoners
 A prisoner is any person, adult or child,
involuntarily confined pursuant to
involvement with the criminal or juvenile
justice system.
 This includes a person who enters into a
study and at a later time during their
participation in the study becomes a
prisoner.
 Federal rules regarding research involving
prisoners are designed to prevent coercion
(intentional or not) of such persons into
agreeing to participate.
Vulnerable Populations: Prisoners
 Any study involving any prisoner
must be given full review by the IRB.
 Potential advantages to the prisoner
for his or her participation must not
interfere with the ability to make a
voluntary choice by outweighing the
risks (for example, participation in
the study cannot be used to influence
sentencing or parole decisions).
Vulnerable Populations: Prisoners
 The risks of participating must be as
acceptable to non-prisoner participants as
to prisoners.
 Selection of prisoners as subjects must be
fair.
 Adequate follow-up care must be provided
if needed.
 IRB membership must include a prisoner
representative, that is, someone who is
knowledgeable of prison inmate life.
Vulnerable Populations: Pregnant
Women
 Pregnant women may only be involved in
bio-medical research if the study regards
the health needs of the mother and the
fetus will be placed at risk only to the
minimal extent to meet the health needs of
the mother or risk to the fetus is minimal.
 The father’s signature is required unless:
 The purpose of the study is to meet the
mother’s health needs, or
 The father is not reasonably available, or
 The pregnancy was the result of sexual assault
Vulnerable Populations: Students
 Students have traditionally served as
research subjects for a variety of
academic disciplines.
 The concern is that student
participation in research may not be
truly voluntary for numerous reasons
including the student’s desire to
appear cooperative or motivated.
Vulnerable Populations: Students
 Various procedures may be used to reduce
the possibility of unintentional coercion:
 Posting IRB approved advertisements
throughout the campus to recruit from a broad
base of students
 Avoiding personal solicitations of students by
any person
 Providing a number of research projects from
which to choose if participating as a research
subject is used a course requirement
 Providing alternative and equal methods for
meeting course requirements other than
participating as a research subject.
Disclosure
 Deception refers to
 Covert observation of behavior
 Failing to fully inform subjects when
obtaining consent
 Subjects should be given the
opportunity to be debriefed after the
study and given the option to
withdraw from the study and/or have
their data removed.