Appendix H: Native American or
Indigenous Research
A project includes Native American or Indigenous research participants when:
- The research takes place in Indian Country, and/or on land under the control or jurisdiction of a sovereign tribe or among International Indigenous populations; or
- Human research is conducted in Indian Health Service (HIS) facilities or involving IHS staff or resources, or
- The research involves participation by members of a sovereign tribe or Indigenous community and that may foreseeably result in research results with implications specific to a tribe or to individuals as members of a tribe or Indigenous community, and the proposed publication or dissemination of that research; or
- The research actively recruits Native Americans or International Indigenous populations for enrollment or participation; or
- The research involves human subjects, including genetic testing or testing of blood, tissue, or other biological materials if the individual’s membership in or affiliation with a tribe or Indigenous community is identified, and that is intended to or that may foreseeably result in conclusions or generalizations about a tribe or individuals as members of a tribe or Indigenous community.
Project Information
IRB Project No.:
Project Title:
Investigator:
Investigator's Contact Information: / Phone/Official University Email:
Alternate Contact:
Alternate Contact's Information: / Phone/Official University Email:
Section 1 (Complete this section for EACH specific Native Nation or Indigenous population)
Name of Native Nation or Indigenous Group:
The researcher has consulted with the Native Nation or Indigenous Group and has obtained approval documentation: Yes No
If no, please explain the reason for which approval is not able to be obtained:
Describe, ifany, specific local laws or nation/state rules and regulations governing the proposed research activity:
Describe any specific recruitment, consent issues and additional risk factors for this population that the IRB needs to take into consideration:
Will data or information remain with the researcher once the study is complete: Yes No
If yes, please explain:
Will biological specimens be collected from this population (e.g. saliva, blood, or tissue): Yes No
If yes, please explain what will be collected and how it will be used:
*If genetic research may be done, include in the informed consent required language that can be found in the guidance, Native Americans or International Indigenous Population
Will biological specimens from this population be placed in a repository: Yes No
If yes, please explain what repository and who willhaveaccess to it:
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