The CSS IRB will assure that additional protections are implemented, as necessary, to protect vulnerable research subjects (such as those with impaired decision-making capacity, neurological, developmental or psychiatric disorders; educational disadvantages; medical, social, or economic conditions; or other circumstances that might restrict the individual’s capacity to provide inform). The extent of additional protection afforded should depend upon the risk of harm and the likelihood of benefit.

Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 23
Effective Date: 10/8/2021

CFR 45 §46 Subpart B,C and D

Policy

The CSS IRB will assure that additional protections are implemented, as necessary, to protect vulnerable research subjects. The extent of additional protection afforded should depend upon the risk of harm and the likelihood of benefit. See, CFR 45 §46 Subpart B (Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in research), Subpart C (Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects), and D (Additional Protections for Children Involved as Subjects in Research).

Purpose

The purpose of this Standard Operating Procedure (SOP) is to describe the review of research involving individuals or groups that could be potentially vulnerable to coercion or undue influence because of impaired decision-making capacity, neurological, developmental or psychiatric disorders; educational disadvantages; medical, social, or economic conditions; or other circumstances that might restrict the individual’s capacity to provide informed consent or to protect their own interests.

When participants in research conducted under the auspices of The College of St. Scholastica are likely to be vulnerable to coercion or undue influence or have diminished decision-making capacity, the research must include additional safeguards to protect the rights and welfare of these participants. The CSS IRB must ensure that all of the regulatory requirements for the protection of vulnerable subjects are met and that appropriate additional protections for vulnerable subjects are in place.

Please note that the existence of additional protections should not discourage research with vulnerable populations or those requiring special considerations. National Institute of Health (NIH)  policies state that studies should not be designed to exclude women, minorities, and individuals based on age unless there is a scientific or ethical reason not to include them.

Definitions

Vulnerable Adult - As stated by the Presidential Commission for the Study of Bioethical Issues, Determining which individuals or groups should be considered vulnerable and in need of additional protections as research participants is an ongoing challenge for researchers and IRBs. There are different approaches to defining vulnerable populations that might be appropriate in different contexts. These include the categorical (or subgroup) approach, and the contextual approach.

Categorical Vulnerability - The categorical (or subgroup) approach defines vulnerable populations as those groups in society whose members share features that might make them vulnerable. For example, the U.S. Code of Federal Regulations lists “children, prisoners, pregnant women, mentally disabled persons, [and] economically or educationally disadvantaged persons” as vulnerable groups. The categorical approach is most applicable when all members of a particular group are vulnerable for the same reason.

Contextual Vulnerability - In its 2001 report, Ethical and Policy Issues in Research Involving Human Participants, the National Bioethics Advisory Commission (NBAC) proposed an alternative to the categorical definition of vulnerability, highlighting the extent to which vulnerability in research subjects is sensitive to context. NBAC described six types of vulnerability that could apply to research participants in different circumstances:

1. Cognitive or communicative vulnerability: the inability to understand information and make decisions, either due to capacity (e.g., young children), or circumstances (e.g., a stressful emergency or language barrier).
2. Institutional vulnerability: being subject to an authority relationship in a formal hierarchical structure (e.g., prisoners or military personnel).
3. Deferential vulnerability: being subject to the authority of others (e.g., children or military personnel).
4. Medical vulnerability: having a serious health condition for which there is no satisfactory standard treatment.
5. Economic vulnerability: being disadvantaged in the distribution of social goods and services such as income, housing, or health care.
6. Social vulnerability: being a member of an undervalued or disenfranchised social group.

NBAC recommends that guidance for review of research be oriented around “how to identify and avoid situations that render some participants or groups vulnerable to harm or coercion” and argued that this approach, in which vulnerability is understood in terms of a person’s context, better expresses the ethical principle of respect for persons by treating people as individuals rather than solely as members of a group.

Vulnerable Populations

The Presidential Commission for the Study of Bioethical Issues defines vulnerable populations as “Groups of individuals who are potentially unable to exercise control over how their interests are represented and pursued.”

Minnesota Law – Minnesota defines a vulnerable adult as a person 18 years of age or older who meets at least one of the following criteria:

• Is a resident of a facility;
• Receives services from a provider required to be licensed by the Minnesota Department of Human Services (DHS), with certain exceptions;
• Receives services from a home care provider, person, or organization that offers, provides, or arranges personal care assistance services;
• Has a physical or mental disability that impairs the person’s ability to adequately care for himself or herself without assistance, and as a result, has an impaired ability to protect himself or herself from maltreatment (Minn. Stat. § 626.5572, subd. 21).

Legally Authorized Representative (LAR) - The individual or judicial or other body with the legal authority to provide proxy consent for a person who lacks the capacity or legal status to function autonomously. Except for individuals under a civil commitment order (Minnesota Statutes 253B.095, subd. 1), there is no law in Minnesota that specifically creates a hierarchy of legally authorized representatives for research purposes. It is generally accepted that surrogates have the same authority in research as in the clinical setting.  If the individual has appointed a health care agent (sometimes referred to as a health care power of attorney), or if there is a judicially appointed guardian, that individual would generally be considered the legally authorized representative.  In the absence of a health care surrogate or judicially appointed guardian, the closest adult relative would generally be considered the legally authorized representative. If there is more than one individual with the same degree of kinship, it is recommended that all such individuals jointly serve the role.

Because these guidelines are analogous to the guidelines that apply in the clinical setting, it is advised that they be utilized only in situations where the research holds out a prospect of direct benefit to the subject. For other situations, consult with the IRB or Legal Department.  A person under civil commitment is prohibited from giving consent to participate in a psychiatric clinical drug trial unless the court allows the patient to give consent to participate in a specific psychiatric clinical drug trial. (Minnesota Statutes 253B.095, subd. 1)

The Minnesota Commitment and Treatment Act (MN Stat. §253B) establishes the priority order of individuals who may serve as the LAR in situations where the incompetent individual has not designated a LAR. MN Stat. § 253B.03 Subd. 6(c) -  (Rights of Patients) states that,

(c) If the head of the treatment facility determines that the patient is not competent to consent to the treatment and the patient has not been adjudicated incompetent, written, informed consent for the surgery or medical treatment shall be obtained from the nearest proper relative. For this purpose, the following persons are proper relatives, in the order listed: the patient's spouse, parent, adult child, or adult sibling. If the nearest proper relatives cannot be located, refuse to consent to the procedure, or are unable to consent, the head of the treatment facility or an interested person may petition the committing court for approval for the treatment or may petition a court of competent jurisdiction for the appointment of a guardian. The determination that the patient is not competent, and the reasons for the determination, shall be documented in the patient's clinical record.

Procedure A. Review, Revision, Approval of Research Involving Vulnerable Subjects

1. When prisoners will participate in the research, or subjects who participate have a reasonable likelihood of being incarcerated at some time point during the study, the procedures outlined in CSS IRB SOP #34 Research Involving Prisoners will be followed. Research Involving Prisoners will also be followed for approved studies proposing to enroll a prisoner or continued participation of a subject who becomes a prisoner (e.g. change in status).
2. When pregnant women, fetuses, neonates who are either non-viable or of uncertain viability will participate in the research, or when the research will involve fetal materials or products of conception, the procedures outlined in CSS IRB SOP #35 Research Involving Pregnant Women and Reviewer Checklist will be followed.
3. When children will participate in the research, the procedures outlined in CSS IRB SOP #33 Research Involving Children and Investigator/Reviewer Checklist will be followed.
4. When minors who do not meet the definition of “children” will participate in the research, the procedures outlined in SOP #33 will be followed.
5. When there is a reasonable possibility that Wards and Foster Children will participate in the research,the procedures outlined in SOP #33 will be followed.
6. When adults with limited capacity for self-determination are identified for recruitment, the IRB will determine whether or not it is appropriate to enroll them into the research. (a) The decision will be based on the objectives and the potential risks of the research.

(b) When adults with limited capacity for self-determination are permitted to enroll, the IRB will determine whether or not additional protections are required and whether or not there are adequate procedures for ensuring that an appropriate assessment of capacity is performed and valid consent (subject or subject’s legally authorized representative) will be obtained (CSS IRB SOP #16 Informed Consent w/ Checklist and Templates).

7. When there is a reasonable possibility that individuals with limited English proficiency will participate in the research, the procedures outlined in the CSS IRB SOP #16 Informed Consent w/ Checklist and Templates will be followed to ensure that adequate procedures are in place to obtain valid consent (unless a waiver of consent is issued).
8. Employees, students and trainees who are under the supervision of the investigator(s), hospital volunteers and the non-adult immediate families of the investigators, are potentially vulnerable in the research context. Potential vulnerability is due to the possibility that refusal to participate might adversely affect the prospective subject’s position, performance evaluation or future employment status. Pressures to participate may be real or perceived.
   • Except in unusual circumstances, investigators should not enroll these individuals when the research involves greater than minimal risk without the prospect of direct benefit. Such studies should proceed only where the IRB determines that adequate provisions have been made to minimize the possibility of coercion, and the research is significant and cannot be conducted without the enrollment of these individuals. This caution may be extended to family members and relatives.
   • A waiver may be granted by the CSS IRB Chair or his/her designee for studies in which employees, students, trainees, volunteers and NTPs are by design the subject of the research (e.g. educational interventions directed at teacher’s students). The decision will be based on the objectives, potential benefits and the potential risks of the research.
   • Non-adult immediate family members of investigators may not participate in research studies conducted by investigators, unless it is a therapeutic or treatment study (i.e. a study for which the IRB has determined that there is a prospect for direct benefit), and a physician unaffiliated with the study has confirmed that it is the best therapeutic option available for the child.  (See, CSS IRB SOP #33 Research Involving Children and Investigator/Reviewer Checklist.)
9. When the proposed research may involve subjects that are potentially vulnerable, the IRB may choose to apply additional protections to ensure that the subjects’ rights and welfare are adequately protected. Examples of additional protections include having a third party observe the consent process, having a subject advocate assist the subject, engaging consultant reviewers or requiring additional monitoring of the research.

Resources

Presidential Commission for the Study of Bioethical Issues (PCSBI). (2016, September).

Vulnerable Subjects Background. Last Updated September 30, 2016.

National Bioethics Advisory Commission (NBAC), (2001) Ethical and Policy Issues in Research Involving

Human Subjects. Volume I, Report and Recommendations of the National Bioethics Advisory

Commission. P. 87. https://scholarworks.iupui.edu/handle/1805/25

National Institutes of Health Vulnerable and Other Populations Requiring Additional

Protections/grants.nih.gov

https://grants.nih.gov/policy/humansubjects/policies-and-regulations/vulnerable-populations.htm

Children’s Hospital of Philadelphia (CHOP) - https://irb.research.chop.edu/policies

Allina Health HRPP/IRB SOPs -

https://www.allinahealth.org/-/media/allina-health/files/for-medical-professionals/research/allina-r esearch-administration-home/hrpp-irb-sop-manual.pdf?la=en&hash=50A1A5F7B07CC65A86FB9F9B 34718003

This is a new policy per the 2018 Common Rule Requirements.