Situation
A state health agency has asked Dr. Maggiano to assist in setting up a data base to monitor health risk behaviors among pregnant women. Data will be collected from centers across the state which provide nutritional support to pregnant low-income women. The agency director, Sam Klench, indicates that one requirement of the grant is that they over sample the Native American population of the state. However, the director informs Dr. Maggiano that they have been refused access to three reservation clinics by the Tribal Councils. The director wants to develop a strategy to attract Native American women to off-reservation clinics. This will allow them to meet the grant requirements and provide nutritional support.
Questions
- What are the federal guidelines for working with Native American research subjects? Is the direct consent of tribal representatives a barrier which can be circumvented? If so, under what circumstances?
- Do the nutritional needs of pregnant, low-income Native American women outweigh federal human subject guidelines or tribal authority?
- What would you recommend to this state health agency as a “next step” in research? How would you mediate the agency’s research interests and the concerns of the tribal councils?
Discussion
If you or the granting agency are unfamiliar with the human subject guidelines in relation to Native American populations, you will first need to consult with knowledgeable professionals. The reasons for the tribal council denial for agency access should be fully explored and perhaps mediated. If all efforts to comply with federal human subjects requirements and to meet tribal council concerns are unsuccessful, the grant agency should be informed that it is unlikely the agency can meet their guidelines.
