Research with Vulnerable Populations

It is the responsibility of the Florida Atlantic University (FAU) IRB to ensure that procedures are in place in a research activity to protect the subjects taking part. This is especially true when a research activity involves a vulnerable population group as research subjects.

Special circumstances are sometimes necessary and special protections must be put in place to adequately protect vulnerable populations. This includes the categories of vulnerable subjects categorized by the Federal regulations and those which might be vulnerable due to other considerations or the circumstances of the research activity itself.

The purpose of this policy is to set forth the definitions and regulations which define vulnerable populations, and to codify FAU’s position that any human subjects research involving vulnerable populations conducted under its auspices, regardless of funding mechanism, must undergo regulatory review and adhere to the principles outlined in the Belmont Report.

A “vulnerable population” is any population at risk for coercion or undue influence that may require special protections. A vulnerable population may have a limited ability to make a free and uninfluenced decision to provide consent to participate in research. There are some groups who have been identified by the federal regulations as vulnerable populations: pregnant women and fetuses, minors, prisoners, persons with impaired decision making capacity, and those who are educationally or economically disadvantaged. Pregnant women, prisoners, and minors have specific sections in the federal regulations that provide additional rules for studying these participants. Inability to consent does not limit participation in a study but instead requires that additional safeguards and consent procedures are followed.

Definitions

Economically or Educationally Disadvantaged Persons: those persons placed at special risk by socioeconomic and educational background.

1. Economically disadvantaged persons include those persons who struggle to provide basic necessities for themselves and their families or communities.
2. Educationally disadvantaged persons may have educational deficits, learning disabilities, or cultural backgrounds that limit communication and understanding with a researcher.

Individuals With Impaired Decision-Making Capacity: those persons having a psychiatric or developmental disorder that affects cognitive or emotional functions to the extent that the capacity for judgment and reason is significantly diminished. Other persons, including those under the influence of or dependent on alcohol or drugs, those affected by degenerative brain diseases, those who are terminally ill, and those who have severe physically disabling handicaps, may be compromised in their ability to make decisions in their best interests.

Passive Consent: A process in which consent or parental permission requirements have been altered or waived, or for which the requirement to document consent or parental permission has been waived. Sometimes this practice is referred to as an opt out procedure “Passive” or “Implied” consent are not referenced in the HHS regulations and are not consistent with the regulatory requirement for seeking consent or parental permission.

The following definitions are reflective of Federal law (45CFR46; 21CFR50).

Research Involving Pregnant Women, Human Fetuses, and Neonates (45CFR46.202)

Dead Fetus: a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.

Delivery means complete separation of the fetus from the woman by expulsion or extraction or any other means.

Fetus: the product of conception from implantation until delivery.

Neonate: a newborn.

Nonviable Neonate: a neonate after delivery that, although living, is not viable (defined herein).

Pregnancy: encompasses the period of time from implantation until delivery. A woman shall be assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery.

Viable: as it pertains to the neonate, means being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration.

Research Involving Prisoners (45CFR46.303)

Prisoner: any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.

Research Involving Minors (45CFR46.402)

Children: 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.

Assent: a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

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

Parent: a child’s biological or adoptive parent.

Guardian: an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.

Ward: a child who is placed in the legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, State, or local law.

Any research involving a vulnerable population as defined in this policy, and is conducted under the auspices of FAU, must be submitted to the FAU Institutional Review Board, or other appropriate IRB, for review prior to initiation.

Unless the IRB has waived the requirement to obtain consent, when research involves adults unable to consent, permission must be obtained from a Legally Authorized Representative.

For research involving health care procedures, consent may be sought from the following individuals for purposes of enrolling a subject with limited autonomy into a human research study, provided the Principal Investigator obtains documentation from the participant’s attending physician, clinician, therapist or counselor, or an impartial third party, that the subject is not capable of giving informed consent, and obtains consent from a designated Health Care Surrogate as defined in Florida Statute §765.202.

In the absence of a Health Care Surrogate, the following individuals in the following order of priority:

1. The judicially appointed guardian of the subject or the guardian advocate of the person having a developmental disability as defined in Florida Statute 393.063, who has been authorized to consent to medical treatment;
2. The subject’s spouse;
3. An adult child of the subject, or if the subject has more than one adult child, a majority of the adult children who are reasonably available for consultation;
4. A parent of the subject;
5. The adult sibling of the subject or, if the subject has more than one sibling, a majority of the adult siblings who are reasonably available for consultation;
6. An adult relative of the subject who has exhibited special care and concern for the subject and who has maintained regular contact with the subject and who is familiar with the subject’s activities, health, and religious or moral beliefs; or
7. A close friend of the subject.
8. A clinical social worker licensed pursuant to chapter 491, or who is a graduate of a court-approved guardianship program. Such a proxy must be selected by the provider’s bioethics committee and must not be employed by the provider. If the provider does not have a bioethics committee, then such a proxy may be chosen through an arrangement with the bioethics committee of another provider. The proxy will be notified that, upon request, the provider shall make available a second physician, not involved in the subject’s care to assist the proxy in evaluating treatment. Decisions to withhold or withdraw life-prolonging procedures will be reviewed by the facility’s bioethics committee.

Documentation of efforts to locate proxies from prior classes must be recorded in the subject record.

For all other research:

• An attorney under durable power of attorney. [Florida Statute §765.204]
• The judicially appointed guardian of the subject who has been authorized to consent to research.

For research outside Florida, a determination of who is a Legally Authorized Representative is to be made with consultation from general counsel.

The Principal Investigator (PI) will be responsible for:

• Ensuring that any proposed study that includes vulnerable populations is submitted to the FAU IRB, or other appropriate IRB, in a timely fashion for review, prior to initiating the study.
• Following all FAU policy, procedure, and guidance related to the conduct of research with vulnerable populations.

For procedures and guidance on conducting research with vulnerable populations, refer to the applicable Investigator Guidance:

• 405 Investigator Guidance- Research Involving Pregnant Women, Fetuses, and Neonates
• 406 Investigator Guidance- Research Involving Prisoners
• 407 Investigator Guidance- Research Involving Children
• 408 Investigator Guidance- Classroom Research
• 409 Investigator Guidance- Research Involving Other Vulnerable Populations

45 CFR 46.202

45 CFR 46.303

45CFR 46.402

21 CFR 50