Conducting research with certain populations may require additional considerations and protections. For a research study that includes any of the populations below, please read through the corresponding SU IRB policy and include any required appendices with your protocol submission.
Additionally, other populations not included below may require special considerations with regard to recruitment, data collection, and consent: persons who are homeless, persons with disabilities, elderly individuals, undocumented citizens, and non-English language speakers. If you have questions or concerns about how best to ensure protections for these populations, please consult with the IRB at email@example.com or 206-296-2585.
In Washington State, “minor” (children) refers to persons under 18 years old and not emancipated (except with respect to special circumstances such as research about sexually-transmitted diseases). Minors are a special group of research participants, classified as a “vulnerable population” and protected under the Common Rule 45 CFR 46 Subpart D and 21 CFR 50 Subpart D.
Depending on risk level, certain research protocols involving minors may require full board review.
For more information on NIH requirements for inclusion of children in research, see NIH Inclusion of Children Policy Implementation.
All research protocols involving prisoners must be reviewed by the fully convened board at one of its monthly meetings.
Prisoners are a special group of research participants, classified as a “vulnerable population” and protected under the Common Rule 45 CFR 46 Subpart C. “Prisoner” means any individuals in any kind of penal institution, such as a prison, jail, or juvenile offender facility, and their ability to leave the institution is restricted.
Additionally, the SU IRB includes in this vulnerable population any individual on parole or under ongoing legal supervision, such that his/her capacity to freely consent or voluntarily could be influenced (or perceived by the individual to be influenced) by figures of authority or supervision.
All research protocols involving pregnant women or newborns must be reviewed by the fully convened board at one of its monthly meetings.
Women who are or may become pregnant during a research study are considered by Federal Regulations and SU IRB policy to be a "vulnerable population" that requires additional considerations to avoid unnecessary risk to the fetus. The SU IRB supports providing pregnant women the same opportunities as non-pregnant women in research participation, unless the exclusion of pregnant women is appropriately justified due to risk concerns.
The IRB must review a protocol to determine whether participation as a research subject could pose potential risks to pregnant female volunteers and/or their fetuses, and whether involving pregnant women could yield any benefit that would outweigh such risks. In some cases, potential or suspected risks could justify excluding pregnant women from the research or require consultation from a primary care physician or other qualified health-care provider before being permitted to participate in the research.
If pregnant women will be included, the IRB must assess whether subjects who are or suspect they are pregnant should be advised to consult with a primary care physician when considering whether or not to participate.
Persons with decisional impairments often have a diminished capacity to understand potential risks and benefits of a research study and thus may have limited ability to provide autonomous informed consent. Decisional impairment could result from a psychiatric, organic, developmental or other disorder that affects cognitive or emotional functions, or may result from the effect of drugs or alcohol. The impairment may be temporary, permanent or may fluctuate.
In studies in which some or all participants may have decisional impairment, the investigator should document (in notes) the following during the consent process:
For research studies involving persons with decisional impairment (whether permanent or temporary), each individual's legally authorized representative (LAR) must provide permission for the individual to participate in the research project. An LAR is an individual or judicial or other body authorized by law to consent on behalf of a potential subject to the subject's participation in the research.
Protocol submissions involving international research should receive prior approval from the appropriate local authority, organization, or IRB equivalent. Where no equivalent board or group exists, investigators must obtain "local approval" from local experts or community leaders.
Federal regulations also make the following stipulations with regard to international research:
Level of knowledge about the local context and local law required for approval is based on the degree of risk to potential participants. For higher risk studies, the IRB may request consultation with experts in the particular international setting.
Researchers should also review the US Department of Health and Human Service International Compilation of Human Subjects Protections.
NOTE: If you are or will be conducting research in an international setting, check the SU Education Abroad website for international travel policy that involves approval for student/faculty/staff travel to areas of high risk. Please refer to the Seattle University Education Abroad Health and Safety site for more details, and to see whether your travel requires additional review.