Suchergebnisse

The effects of conflicts of interest on the conduct of human research have been roundly debated, but less attention has been paid to the role of Institutional Review Boards (IRBs) in their identification and management. Government and private policy recommendations disagree about IRBs' responsibility in this area. A survey focusing on respondents' attitudes and behaviors regarding consideration of investigator and institutional financial relationships with industry when reviewing research protocols was mailed to a random sample of 893 IRB members and 316 IRB chairs at 115 academic institutions (response rates of 67% and 72%, respectively). More than half of IRB members and chairs felt that industry relationships posed a moderate or big problem for research integrity nationally, and about one-third thought such relationships were a problem at their own institution. Approximately two-thirds felt that investigator-industry relationships should be considered when reviewing protocols regardless of whether they are deemed to be conflicts of interest. While more than 90% of IRB members and chairs believed that investigators' relationships should be disclosed to research participants, 61% of members and chairs reported that these relationships were not always disclosed to participants. While more than 80% believed that institutional relationships should be disclosed to research participants, only 39% of members and chairs said this happened all the time. Some beliefs of IRB members and chairs are at odds with recommendations to limit the role of IRBs in the management of potential investigator conflicts. Lack of unambiguous guidelines has led to inconsistent practices among IRBs.

Patient-centered outcomes research (PCOR) is becoming increasingly common. However, there is little evidence regarding what novel ethical challenges, if any, are posed by PCOR with relevance to institutional review board (IRB) oversight and human subjects protections. This article reports the results of a national survey of all IRB chairpersons from research-intensive institutions in the United States. Findings address the responsibilities of IRBs and the challenges associated with PCOR review and oversight. IRB chairpersons varied in their judgment of PCOR's overall value to the scientific enterprise and to research at their institution. Furthermore, 27% of respondents considered patients serving in nontraditional roles to be research subjects even when they are not enrolled in research. There was also variation in the training and safeguards their IRBs require for patient partners. Our results suggest that guidance should be developed around ethical and regulatory issues associated with PCOR oversight.