Federal regulations and ethical principals require that certain groups of human subjects shall be considered particularly vulnerable in a research setting. Those considered to be "vulnerable populations" are individuals who may have limited autonomy which precludes their full and free appreciation or participation in the consent process.
Particularly vulnerable populations must receive, in addition to the general requirements for review of research by the IRB, further protections which are consistent with federal regulations and specific for: a) pregnant women, human fetuses and neonates involved in research (45 CFR 46 Subpart B), prisoners (45 CFR 46 Subpart C), and children (45 CFR 46 Subpart D, 21 CFR 50 Subpart D). There are also additional federal regulations pertaining to “in vitro fertilization.”
Definitions applicable to these policies include:
- Neonate: a newborn
- Fetus: the product of conception from implantation until delivery
- Pregnancy: the time between implantation until delivery. A woman shall be assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy until the results of a pregnancy test are negative or until delivery
Although federal regulations pertain specifically to the vulnerable populations defined above, other populations, though not considered vulnerable according to regulations, may still be particularly subject to coercion. These populations, which should be considered vulnerable and deserving of special consideration by investigators and the IRB, include but are not limited to those with dementia or other cognitive impairments, students and employees of the Principal Investigator and key personnel, the elderly, terminally ill patients, hospitalized patients, prospective transplant recipients, and patients who can receive certain treatment(s) only through research protocols. Both the Principal Investigator and the IRB should recognize such subjects as vulnerable and should provide special protections as necessary.
While considering additional protections for vulnerable subjects, the IRB shall also require that members of these populations be permitted or encouraged to become human research subjects to ensure that they are adequately represented in research and have access to potential benefits of such research.
In its review of studies involving vulnerable populations, the IRB should carry out responsibilities additional to those described in other sections of these policies. For the vulnerable populations defined in Subparts B-D of 45 CFR 46 and Subpart D of 21 CFR 50, the additional responsibilities include following special procedures that ensure the safeguarding of the subjects' rights, safety and welfare. Policies associated with these specific vulnerable populations and for other populations not incorporated in the federal regulations are included in individual sections of this document (below). In general, the IRB review shall be particularly concerned with the rationale and details for the inclusion of vulnerable populations in studies, with procedures to ensure that risks are adequately addressed, with the consent process to ensure that it adequately addresses the needs and capabilities of vulnerable subjects and with the fulfilling of all necessary regulatory requirements.
To accomplish the above, the IRB membership must include one or more members qualified to represent each involved group of vulnerable subjects with knowledge, expertise and sensitivity gained from working with these subjects or from personal experience. At least one member qualified to represent the involved group of vulnerable subjects shall be present at the convened meeting when a study involving that group of vulnerable subjects is reviewed.
If the IRB believes that its expertise regarding a vulnerable population is insufficient to conduct an in-depth study review, the IRB may seek input from one or more internal or external consultants with appropriate scientific or scholarly expertise and knowledge of the vulnerable groups of subjects. The IRB has the authority to table its review until such consultant guidance/recommendation is received and presented pursuant to its policy on consultative support (SECTION 3.1).
Keys to the IRB review process for studies involving vulnerable populations include that the IRB ascertain that the inclusion of the vulnerable population is adequately justified in writing, that the Principal Investigator and the convened IRB have reviewed relevant federal regulations (45 CFR 46 Subparts B-D and/or 21 CFR 50 Subpart D) and that safeguards are implemented to minimize risks that are unique to each population. Research in vulnerable subjects shall not be performed unless all regulatory criteria are met.