December 2020

Research conducted at the Organization may involve inclusion of populations that are mentioned in federal regulations DHHS 45 CFR 46 and FDA 21 CFR 56 as possible “vulnerable populations.”   Both sets of regulations state an “IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.” FDA regulations also include in the list “handicapped” persons.  The IRBs are authorized by the Organization to review and approve research to be conducted in any of the mentioned possible vulnerable populations.  Federal regulations do not outline specific criteria to be applied by an IRB when a project will enroll adult mentally disabled persons, or adult economically or educationally disadvantaged persons, or handicapped persons.  The Organization authorizes the IRBs to review and make case-by-case determinations on when a proposed population may constitute a vulnerable population.  The IRBs’ decisions regarding a vulnerable population will take into account the specific mental illness diagnosis, handicap, educational and/or economic disadvantage, the specific recruitment setting, and the nature of the research study proposed when making this determination. Additionally, when the IRB regularly reviews research that involves vulnerable participants, the IRB membership will include one or more members who are knowledgeable about or experienced in working with such participants. 

When a study involves individuals who may lack the capacity to consent, the IRB will assess whether the plans articulated in the eIRB application for the assessment of the capacity to consent are adequate. The IRB will consider the level at which the participants are able to comprehend, the possible risks to participating, and whether the assessments are appropriate for that level of understanding. The type of research and setting for consent will also be considered when evaluating the assessments of understanding.

Consultants may be used if the IRB requires additional expertise to determine the appropriateness of an assessment for capacity to consent for a specific population where individuals may be unable to provide informed consent for themselves.

The same process will be utilized in assessing the appropriateness of the assent process when a study proposes to engage individuals who lack the capacity to consent in the consent process through a plan for assent.

Where use of a Legally Authorized Representative (LAR) is determined to be appropriate for individuals who may lack capacity to consent, the IRB will ensure that the investigator adheres to guidelines regarding use of LARs as outlined in the informed consent guidance.

The IRB may ask for a process to re-evaluate an individual’s capacity to consent if a disease process, situation or condition is likely to change over time.

When the IRB regularly reviews research that involves vulnerable participants, the IRB membership will include one or more members who are knowledgeable about or experienced in working with such participants.