Participants in this breakout session discussed key points from several of the presentations given in the plenary session. Much of the conversation focused on data integrity and authorship issues as important areas that would benefit from additional discussion and understanding of international approaches. The group was especially interested in problems facing the three sectors—government, universities, and industry—and ways they could be addressed.

Individual participants made a number of points during the discussion. This is a non-exhaustive list, and is not intended to represent consensus views of the workshop or the breakout session:


  • Possible Issues for Industry. Industry-supported research is moving offshore, particularly clinical trials in the pharmaceutical industry. Cost is an important factor driving this. Also, the incidence of some diseases is overwhelmingly in developing countries. Industry may need to takes steps to avoid the perception of being self-serving in the host country. When there is documentation of biased reporting, who is responsible? Do the researchers in developing countries know what they are supposed to do? There are complexities in managing the roles of contract research organizations (CROs), site management organizations (SMOs), study coordinators and investigators.
  • Possible Actions by Industry. Good communication with the public by companies in the host country is helpful. Steps have been taken to increase transparency, such as establishing the clinical trial portal, but industry could better clarify responsibility and accountability in clinical trial roles. Industry could also get more involved in education and training in areas where companies have expertise, such as data integrity.
  • Possible Issues for the U.S. Government. U.S. government agencies have regulations related to responsible conduct of research (RCR) training by grantees. Some government regulations related to research may not be applicable to modern research operations. Institutions may not take responsible conduct or research (RCR) seriously and only require some online courses.

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