Clinical Research

The results from research have been known to produce harms to members of the sampled population who do not actually participate in the research study. An example of the type of research that could result in group harms is:

A study of the genetic links between DNA samples found at a prehistoric central Asian archeological site and west coast Native American tribes.

Which of the following practices can be effective in minimizing group harms?

Community consultation is used with the community of interest to make sure that potential harms are recognized and understood, and that the study is designed to provide benefits to the community. Collaborative IRB review with tribal IRB's will also maximize the likelihood that group harms are minimized. On-going consultation ensures that group leaders are provided with accurate information about the research as it progresses. By planning disclosure of the research, the researcher informs the community about how the research results will be disclosed early on in the process to reduce the possibility of harms to the group as the research is published or presented.

Which of the following studies has the LEAST potential to create group harm?

Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer.