Review of Studies Involving Vulnerable Populations
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. For studies requiring full board review, a member or consultant who is knowledgeable about or experienced in working with vulnerable populations may be asked to review all material and be present (in person or via teleconference) at the meeting. Consultants may participate in the discussion but may not vote. For studies requiring full board review, any decision made by a convened board will supersede the opinion of an individual reviewer. The minutes will reflect the determinations of the convened board regarding the required findings.
Vulnerable populations include those defined 45 CFR 46 Subparts B (Pregnant Women), Subpart C (Prisoners), andSubpart 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 in this policy but determined to be vulnerable by the IRB. For example, depending on the nature of the study, the IRB also considers refugees and Boise State students and employees to be vulnerable populations.
Proposed studies involving pregnant women may qualify for exempt or expedited review when no more than minimal risk is involved. The Chair or an IRB member will make the final determination. Studies requiring full board review will be reviewed and approved in accordance with the criteria of 45 CFR 46 Subparts A and B.
Note: For social/behavioral research involving pregnant women, the IRB determined that it will allow pregnant women to be enrolled in research involving interview, focus group, survey or similar procedures without any additional safeguards. These studies will be reviewed by the IRB following equivalent standards as set forth in the Common Rule.
If pregnant women are involved in a study involving more than minimal risk or invasive procedures, then additional safeguards may be required, and the IRB will ensure the research is in accordance with the criteria of 45 CFR 46 Subpart B.
The full board must initially review all studies involving prisoners. Research involving prisoners will be reviewed and approved in accordance with the criteria of 45 CFR 46 Subparts C. The membership of the board will be such that the majority of members have no association with the prisons involved and at least one member will be a prisoner, or 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. The Chair will make the final determination regarding approval status and categories.
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:
- the risk is justified by the anticipated benefit to the participants;
- the relation of the anticipated benefit to the risk is at least as favorable to the participant as that presented by available alternative approaches; and
- 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 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:
- the risk represents a minor increase over minimal risk;
- the intervention or procedure presents experiences to participants that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;
- the intervention or procedure is likely to yield generalizable knowledge about the participant’s disorder or condition which is of vital importance for the understanding or amelioration of the participant’s disorder or condition; and
- that adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians.
- The IRB must determine that adequate provisions are made for soliciting the assent of the children aged 11 and above.
Economically or Educationally Disadvantaged
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 must 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 income 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.
Boise State Students
Studies that focus on Boise State 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 a PI may use his/her own students as participants, it is preferable for the PI 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 (e.g., research on teaching methods or curriculum development) the study must be designed in such a way that any element of undue influence or coercion is minimized. (See our guidelines on using students as research subjects.)
Boise State Employees
Studies that focus on Boise State 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 PI must outline procedures to ensure that the employees will not be subject to undue influence or coercion and to ensure that the employee’s privacy will be respected. While a PI/supervisor may use his/her own direct report employees as participants, the preference of the IRB is that the PI recruit employees with whom the PI does not have a direct relationship. For example, if the research study is an analysis of the performance evaluation process, the PI may recruit employees from the general population of the institution as opposed to employees from the PI’s department. If colleagues or subordinates will be recruited the PI must provide a rationale for their recruitment other than for convenience sake.
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 IRB will follow these same policies and procedures when it reviews research studies that seek to enroll non-Boise State employees in research.
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 PI to determine on an individual basis whether an individual is capable of providing consent, e.g., the IRB may require that the PI 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).
The IRB may impose additional protections. For example, the IRB may require the use of a witness to the consent process or videotaping the consent process.
Non-English Speaking Individuals
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.
Non-English speaking participants, who meet enrollment criteria, may not be excluded because they cannot understand or read English. Non-English speaking participants may not be excluded from research that may have direct potential benefits. If non-English speaking participants will be specifically excluded from research, the PI must provide an ethical and scientific explanation for doing so.
Investigators must be aware of the cultural differences when using this population. Subjects may not speak English, and their language may not be in written form. These and other cultural differences will need to be taken into consideration for data collection methods, recruitment, and consent processes. In general, the PI should follow the guidelines for non-English speaking individuals above, as many refugees have English as a second language.