Studies proposing the involvement of vulnerable populations are reviewed to ensure that inclusion of these participants is justified and, if so, that adequate procedures are in place to minimize the risks related to physical harm, psychological harm and breach of privacy and confidentiality. The research must be relevant to the vulnerable population and not otherwise capable of being carried out with a non-vulnerable population.
The IRB will fulfill the additional duties required by Federal Regulations outlined in Subparts B, C and D of 45 CFR 46 regardless of the source of funding for initial and continuing review by expedited or full board proceedings.
Vulnerable populations include those defined 45 CFR 46 Subparts B (Pregnant Women), Subpart C (Prisoners), and Subpart D (Children), and those mentioned in 45 CFR 46.111(b): mentally disabled persons, or economically or educationally disadvantaged persons. The IRB may also require additional protections for any other group not specified but determined, by the IRB, to be vulnerable.
Proposed studies involving pregnant women may qualify for exempt or expedited review when no more than minimal risk is involved. All Studies will be reviewed and approved in accordance with the criteria of 45 CFR 46 Subparts A and B.
Research involving prisoners will be reviewed and approved in accordance with the criteria of 45 CFR 46 Subparts C. At least one member of the IRB reviewing the application must be a prisoner representative.
Research that involves children is subject to the additional requirements of Subpart D. Under DHHS and FDA regulations “children” are 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.
Proposed studies involving children may qualify for exempt or expedited review if the study falls into one of the federally-approved categories defined in 45 CFR 46.101. Exemption categories 1-5 do not apply to FDA regulated studies. Also, the exemption noted at 45 CFR 46.101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research involving children unless the research involves the observation of public behavior and the investigator(s) do not participate in the activities being observed.
For research not involving greater than minimal risk, the IRB must find and document that adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians.
For research involving greater than minimal risk but presenting the prospect of direct benefit to the individual participants the IRB must find and document:
For research involving greater than minimal risk and no prospect of direct benefit to individual participants, but likely to yield generalizable knowledge about the participant’s disorder or condition the IRB must find and document:
Economically or educationally disadvantaged individuals may be particularly vulnerable to the risks of research. The IRB may require additional protections. For example, the IRB may require the use of a witness to the consent process or videotaping the consent process.
Educationally disadvantaged participants may not be able to fully understand the concepts presented by the research and the investigator may have to take extra precautions to ensure that the participants fully understand what is being asked of them. Similarly, economically disadvantaged participants may be easily persuaded to participate in research if the economic compensation is so great that it would result in the participant ignoring or disregarding the research risks because of the compensation offered by the study. In such cases investigators must be careful to set economic compensation at a meaningful level that compensates the participant for her/his time, but it not so great that it unduly influences a participant’s decision to enroll. It is also important in such cases that the risks to the participants be made clear to the participants.
Studies that focus on students as participants may raise concerns with issues of coercion, undue influence and privacy. While these studies may qualify for exempt or expedited review, the Chair or authorized designee reserves the right to require full board review.
Each application that involves students as participants must outline procedures to ensure that the students will not be subject to undue influence or coercion and to ensure that the student’s privacy will be respected. While an investigator may use his/her own students as participants, it is preferable for the investigator to recruit students with whom he/she does not have a direct relationship. If it is not possible or practical to recruit from the general population of students due to the nature of the research the study must be designed in such a way that any element of undue influence or coercion is minimized if not removed.
Studies that focus on employees as participants may raise concerns of coercion, undue influence and privacy. While these studies may qualify for exempt or expedited review, the Chair or authorized designee reserves the right to require full board review. The IRB may consult with employees when considering approval of a study that involves them as participants.
Within each application that involves employees as participants, the investigator must outline procedures to ensure that employees will not be subject to undue influence or coercion and to ensure that the employee’s privacy will be respected. While an investigator may use his/her own direct report employees as participants, the preference of the IRB is that the investigator recruit employees with whom there is no direct relationship.
Additional suggestions to minimize concerns of coercion, undue influence and privacy include the general recruitment of participants through IRB approved advertisements, collection of data in an anonymous method, the use of an independent third party to recruit, consent and/or collect data. The IRB will also closely review how study data is reported back to management.
The employee’s participation must be voluntary and based on disclosure of complete and accurate information. Employees should not be asked to participate in any study that will interfere with their job obligations. An employee’s decision to participate or not participate cannot have any bearing on the employee’s performance evaluation.
The involvement of non-English speaking individuals in research studies raise concerns with issues of informed consent as well as their inclusion and exclusion in research. While these studies may qualify for exempt or expedited review, the Chair or authorized designee reserves the right to require full board review.
Investigators must be aware that individual participants, and sometimes significant portions of the potential participant population, may not speak English. Investigators must plan for populations that are likely to be recruited into the research and incorporate translations into the study design to allow for appropriate recruitment and enrollment. When applicable, the PI must outline in the protocol application procedures to recruit non-English speaking participants as well as procedures to translate study material and consent documents. The protocol must also describe procedures for ensuring that informed consent is presented to participants in a language understandable to them.
Individuals considered to be decisionally impaired may include those with psychiatric, cognitive or developmental disorders, substance abuse problems or individuals in chronic pain. Studies involving decisionally impaired participants may qualify for exempt or expedited review. However, the Chair or designee reserves the right to require full board review. Individuals who are decisionally impaired may still be capable of providing consent. If evidence is present that they are incapable of providing informed consent, for example, due to the incapacity to understand, an individual who is legally authorized to consent for them must sign and date the consent document. The IRB will make a determination as to whether the target participant population is capable of providing consent or whether a legally authorized representative must provide consent. The IRB may also require additional protections such as a witness to the consent process or requiring the investigator to determine on an individual basis whether an individual is capable of providing consent, e.g., the IRB may require the investigator to ask the participant to articulate in his/her own words the purpose of the study, the risks involved with the study, the benefits of the study and may request that those responses be documented. If the participant cannot answer such questions, consent from a legally authorized representative must be obtained.
When reviewing protocols that focus on decisionally impaired participants as the target population, the IRB must find that they are an appropriate participant population for the study, that the research question focuses on an issue unique to this population, that the level of risk is appropriate to the study and that, unless a waiver or alteration of consent has been approved, the provisions for obtaining informed consent from a legally authorized representative and the assent of the participant are adequate.
The provisions for obtaining the assent of an individual with impaired decision making ability are based on those set forth in subpart D. The IRB shall determine that adequate provisions are made for soliciting the assent of the decisionally impaired individual, when in the judgment of the IRB the individuals are capable of providing assent. In determining whether the individuals are capable of assenting, the IRB shall take into account the maturity and psychological state of the individual involved. This judgment may be made for all individuals to be involved in research under a particular protocol, or for each individual, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the individuals is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the individual and is available only in the context of the research, the assent of the individual is not a necessary condition for proceeding with the research. Even where the IRB determines that the participants are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with 46.116(d)(1-4).