Different Research Populations

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. NOTE: Research with minors rarely qualifies for exemption; plan accordingly.

For more information on NIH requirements for inclusion of children in research, see NIH Inclusion of Children Policy Implementation.

• Complete and submit Appendix B.Research with Minors Request with the protocol application.

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.

• Complete and submit Appendix C.Research with Prisoners Request Form with the protocol application.

All research protocols involving pregnant individuals or newborns must be reviewed by the fully convened board at one of its monthly meetings.

Individuals 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 individuals the same opportunities as non-pregnant individuals in research participation, unless the exclusion of pregnant individuals 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 volunteers and/or their fetuses, and whether involving pregnant individuals could yield any benefit that would outweigh such risks. In some cases, potential or suspected risks could justify excluding pregnant individuals 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 individuals 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.

• Complete and submit Appendix D.Research with Pregnant Individuals.Neonates Request with the protocol application. 

Individuals with decisional impairments may have diminished capacity to fully understand potential risks and benefits of a research project 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:

• whether the subject demonstrated the ability to understand the nature of the research procedures, the potential risks and benefits, the voluntary nature of the participation and to make a personal judgment about participation;
• use of any supplemental methods to enhance or evaluate decisional capacity;
• a summary of the matters discussed with the subject’s legally authorized representative.

For research involving persons with significant decisional impairment affecting their capacity to fully consent (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.

The National Institutes of Health has developed points to consider in working with this population. Topics include "consent capacity" vs "decision-making capacity," evaluating and consenting these individuals, and considerations in research in an ethical manner with this population.

• Complete and submit Appendix E.Research Involving Adults with Decisional Impairments with the protocol application.

Research involving international research may require prior approval from a appropriate local authority, organization, or IRB equivalent, if customary for that non-US setting. Where no equivalent board or group exists, investigators must identify local experts or community leaders who will be knowledgeable about the study and who can serve as consultants for that setting.

For international research, federal regulations also stipulate:

1. The researcher must provide the same or equivalent protections for participants, regardless of international setting.
2. The researcher must be familiar with and comply with local laws, regulations, political and socio-economic factors, and cultural context in all research locations.
3. The researcher must have sufficient knowledge of the local context, which may impact all aspects of the research design, and in particular, the protection of the rights and welfare of participants.

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 any 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.

• Complete and submit Appendix G.International Research with the protocol application.