Research with Culturally or Medically Vulnerable Groups

1. 4/22/2012 1 Research with Culturally or Medically Vulnerable Groups

2. 4/22/2012 2 What does culturally or medically vulnerable mean: have suffered and continue to suffer discrimination those who may have less access to education, social services, and health care those who may be behaviorally or politically stigmatized In some cases, the harms may fall, not necessarily on the subjects of the research, but on the group as a whole � including those who did not take part in the research itself

3. 4/22/2012 3 Harms include: include stigmatization loss of status genetic determinism violation of cultural or group norms and values

4. 4/22/2012 4 Ways to minimize these risks of group harms: Community consultation, receive input from the community that will be researched Plan on-going consultation and review Ensure there is a plan of disclosure of research results ahead of time Though researchers must evaluate whether or not their research could result in group harms and, if this is a possibility, take appropriate steps to minimize this risk; the IRB will ultimately evaluate if the research is harmful.

5. 4/22/2012 5 Which of the following studies has the LEAST potential to create group harm? a) A study that surveys the perceptions of nurses and other health care workers about illegal drug use among cardiovascular surgeons in New York City. b) A genetic study to identify ancestral relationships between DNA obtained from a Cherokee Indian burial site and members of a Central Asian community. c) An anonymous survey of state high school teachers, athletic directors, and administrators that, among other things, asks for perceptions about the sexual preferences of their high school coaches. d) Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer.

6. 4/22/2012 6 d) Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer A Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer is unlikely to cause group harms. Although the patient population is women and women are specifically recognized as a vulnerable population, the subjects will likely come from all walks of life. It is thus unlikely that such a study will be harmful to women with breast cancer or to women in general who do not participate in the study. The results from other hypothetical studies listed have the potential to be distressful, to stigmatize or in another way harm individual members of the Group who did not actively participate in the research.