Marshall University

Huntington, WV

  

SUBJECT:  Vulnerable Human Subjects

 

PURPOSE:  To ensure that potentially vulnerable subject groups are equitably recruited, selected, and protected during research activities.

 

POLICY:  To give special consideration to protecting the welfare of vulnerable subjects, such as children, prisoners, pregnant women, mentally disabled persons, economically, or educationally disadvantaged persons. 

 

SCOPE:  This policy covers all human subjects that are or may be considered potentially vulnerable subjects, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons who may potentially be enrolled in research activities.

 

RESPONSIBILITIES:

 

Principal Investigator (PI) is responsible for ensuring that all vulnerable human subjects are protected and participate voluntarily in an environment free from coercion or undue influence.  The PI has the responsibility to ensure the informed consent has sufficient information about the research and its risks and benefits for the subject to reach an informed decision as to whether they will voluntarily participate and that the subject understands the informed consent.  The investigator is responsible for explaining to the subject his/her rights including the protection of the subject’s privacy and confidentiality of information.

 

Institutional Review Board Chairperson and members are responsible for ensuring that the rights and welfare of research subjects are protected.   They are responsible for ensuring recruitment and selection of human subjects are performed in a manner free from coercion and undue influence.  The IRB is responsible for ensuring that the informed consent contains information sufficient for the subject to assess risks and benefits and that the language utilized is at the vulnerable subject’s level of understanding.  The IRB must ensure that it has adequate representation on the Board to consider specific kinds of research involving these vulnerable populations in a competent manner.  The IRB must carefully consider group characteristics, such as economic, social, physical, and environmental conditions, to ensure that the research incorporates additional safeguards for vulnerable subjects.

 

DEFINITIONS:

(a)    "Children" are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.

(b)   "Assent" means a child's oral or written affirmative agreement to participate in research. Every effort should be made to obtain assent even in small children, (i.e., 3 years of age or younger); however, assent must be documented in children who are 7 years of age or older. Mere failure to object should not, absent affirmative agreement, be construed as assent.

(c)    "Permission" means the agreement of parent(s) or guardian to the participation of their child or ward in research.

(d)   “Parent" means a child's biological or adoptive parent.

(e)    "Guardian" means an individual who is authorized under applicable State or local law to consent on behalf of a child.

(f)      “Prisoner” is an individual involuntarily confined or detained in a penal institution.

 

PROCEDURE:

 

The IRB carefully considers the following specific elements of the research plan when reviewing research involving vulnerable subjects:

 

(1)   Strategic issues include inclusion and exclusion criteria for selecting and recruiting subjects; informed consent and willingness to volunteer; coercion and undue influence; and confidentiality of data.

 

(2)   Group characteristics, such as economic, social, physical, and environmental conditions, to ensure that the research incorporates additional safeguards for vulnerable subjects.

 

(3)   Investigators are not permitted to over-select or exclude certain groups based on perceived limitations or complexities associated with those groups.  For example, it is not appropriate to target prisoners as research subjects merely because they are a readily available “captive” population.

 

(4)   The IRB is knowledgeable about applicable state or local laws that bear on the decision-making abilities of potentially vulnerable populations.  State statutes often address issues related to competency to consent for research, emancipated minors, legally authorized representatives, the age of majority for research consent, and the waiver of parental permission for research. 

 

(5)   Research studies that plan to involve any potentially vulnerable populations must have adequate procedures in place for assessing and ensuring subjects’ capacity, understanding, and informed consent or assent.  When weighing the decision whether to approve or disapprove research involving vulnerable subjects, the IRB ensures and requires that such procedures are a part of the research plan.  It may be possible for researchers to enhance the understanding for potentially vulnerable subjects.  Examples include, having someone not involved in the research to obtain the consent, the inclusion of a consent monitor, a subject advocate, interpreter for hearing-impaired subjects, translation of informed consent forms into languages the subjects understand, and reading the consent form to subjects slowly and ensuring their understanding paragraph by paragraph.

 

(6)   The IRB may require additional safeguards to protect potentially vulnerable populations. For instance, the IRB may require that the investigator submit each signed informed consent form to the IRB, that someone from the IRB oversee the consent process, or that a waiting period be established between initial contact and enrollment to allow time for family discussion and questions.

 

When research involves prisoners or pregnant women, the chair will bring a copy of the regulations (45 CFR 46 Subparts B and C) to the IRB meeting. The regulations are reviewed and minutes will document each required determination with protocol specific findings the IRB members provide to justify each determination.

 

I.  Pregnant Women, Human Fetuses, and Neonates. 

For information concerning this topic refer to the Code of Federal Regulations (45 CFR 46 Subpart B)

 

 

II.  Research Involving Prisoners.

For information concerning this topic refer to the Code of Federal Regulations (45 CFR 46 Subpart C)

 

 

III.  Research Involving Children

For information concerning this topic refer to the Code of Federal Regulations (45 CFR 46 Subpart D)

 

  

IV.  Research Involving Decisionally Impaired Subjects. 

For information concerning this topic refer to the VHA Handbook 1200.5 regulations.

 

 

V.  Research Involving Other Potentially Vulnerable Adult Subjects.

 

Employees, students, and trainees at Marshall University also may be considered vulnerable subjects.  Thus, the IRB upholds the same standards in approving research involving these groups as other vulnerable subjects research.  The context of the research is an important consideration for the IRB to have in mind when reviewing research that involves other potentially vulnerable subjects.  Research involving homeless persons, members of particular minority groups, or the economically or educationally disadvantaged pose significant challenges.  Research involving significant follow-up procedures or offering significant monetary compensation may unduly influence certain types of subjects, and the IRB must take such considerations into account.  Nevertheless, research involving these subjects is socially important for understanding and eventually improving adverse health in these populations.

 

Research Involving Deceased Persons.  Research involving deceased persons is not covered by the FDA human subject regulations or the Common Rule. 

 

VAMC Research

For VA research involving:

 

 

FOLLOW-UP RESPONSIBILITY:  Director, Office of Research Integrity

 

REFERENCES:   45 CFR 46

                               38 CFR 16.107

                               45 CFR 46.101(i)

 

 

 

 

 Revised 5-1-2007