PURPOSE: Establishes an Institutional Review Board (IRB) to monitor clinical research for natural products and treatments used in the practice of indigenous medicine (“IM”).
INTENT: The Indigenous Medicine Institutional Review Board (“IMIRB”) is necessary to approve, modify, or reject research in IM. IM diagnostics, treatments, and substances will be studied in a consistent manner to provide documentation for validity and safety through statistical analysis.
ORGANIZATION: IMIRB is an organized board with members consisting of tribal practitioners, physicians (MDs and DOs), a tribal member, and a layperson. The board primarily reviews and monitors biomedical research involving subjects who are members of the “Turtle Healing Band.” Such review serves an important role in the protection of the rights and welfare of human research subjects.
ACCOUNTABLITY: IMIRB is accountable to an Indian Nation to whom it pays tribal tax and provides annual reports. Such Indian Nation will, in turn, communicate IMIRB’s findings to its tribal members and/or other tribes with whom it may be affiliated as part of a Banding Agreement. Duties of the IMIRB are outlined in its rules and regulations.
FUNDING: The IMIRB is affiliated with a 7871 non-profit entity established as part of a Tribal Banded Health Care Program and as such is a non-profit organization. IMIRB receives funding from clinical research applications, which is $750 per submission.
OBJECTIVES: IMIRB will assist the First Nation Medical Board and its Indian Tribe(s) in defining, clarifying, and understanding the scope of practice for IM. Through the administration of the IMIRB, the following objectives will be accomplished:
RESULTS: Indian Tribes and THB Members will have access to medical alternative devices, therapies, and substances that would otherwise be unavailable. As information becomes available tribal practitioners, tribal healers, tribal technicians will better understand IM as studies become more available from IMIRB activities. Industries supporting IM will seek to affiliate with IMIRB by establishing facilities on Indian Lands or on Indian Land Trusts and increase employment and/or income for Indian Tribe(s).
OUTCOME: IMIRB will establish model guidelines for efficacy, benefits, and safety of IM.