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 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: 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.