PROTECTION OF VOLUNTEERS

NAMI members strongly support severe mental illness research, including research involving human subjects, as this is the basis for all future advances in treatment. However, research involving human subjects must be in accord with the highest scientific, medical, and ethical standards and must protect and honor the individuals and families who make this contribution to scientific progress. Specifically, NAMI demands that:

1) research subjects give truly informed consent and that they and their families fully understand the protocols and risks and benefits of the research;
2) researchers perform independent and ongoing evaluations of research-subject capacity to consent;
3) IRBs include consumers and family members:
4) consumers may withdraw from a study at any time without penalty;
5) at the end of the study, or if a consumer terminates participation prematurely, ongoing effective treatment and aftercare are ensured as is feedback on the study results.

Below is a list of resources that provide information about the protection of research volunteers:

* National Institutes of Health Bioethics Resources: A variety of resources made available by the NIH related to research ethics, both within the NIH and outside the NIH.

* Public Responsibility in Medicine and Research (PRIM&R): A private, not-for-profit organization providing educational materials on research ethics.

* Association for the Accreditation of Human Research Protection Programs, Inc.: A recently formed organization to accredit IRBs.

* Partnership for Human Research Protection, Inc.: A recently formed collaborative to accredit IRBs.

* Responsible Research: A Systems Approach to Protecting Research Participants: Landmark report published by the Institute of Medicine in 2002.