In recent years, privacy and confidentiality, and conflicts of interest have become increasingly complex and contentious. The growth of genetics testing and research, proliferation of databanks, and use of the Internet and computers by investigators threaten individual and group privacy. The expansion of university industry partnerships continues to raise major and troubling questions regarding conflicts of interest for individual researchers, IRB members and institutions. While new regulations and guidance have been proposed and enacted (e.g., HIPAA), many in the research community remain ill informed about recent developments and new responsibilities that arise for protecting the rights and welfare of study participants. Using several innovative approaches, we have designed the """"""""Current Issues in Research Ethics,"""""""" (CIRE) Program, to fill gaps in knowledge and understanding among: researchers, research staff, IRB members, and administrators.
We aim to advance awareness of these major topics, and stimulate new reflection and insight into their ethical, legal, and policy implications. Given tensions between researchers and IRB members, the ClRE Program will bring these two groups together to explore difficult issues collaboratively. We will examine critical aspects of privacy such as ramifications of HIPAA and other new regulations, third party consent, genetic privacy, use of the Internet for research, and conflicts of interest at varied levels. Over the three years of the proposed project, we will develop, implement and evaluate four day long university-hospital courses -- three times at Columbia University and once at our affiliate, Harlem Hospital Center. We will also partner with PRIM&R (Public Responsibility in Medicine and Research) to present a state-of-the-art two-day national conference addressing these areas in a broader format for a broader audience. We will focus on how issues of privacy arise with vulnerable populations (e.g., HIV, mental illness, genetic disorders) and underserved groups. Before each daylong course, we will conduct focus groups to assess the needs of future attendees. Comprehensive evaluations at the end of each course will help further develop and refine it. We will disseminate outcome products widely, including an ongoing """"""""Ethics Challenge of the Month"""""""" on the CIRE Website. In Year Three, we will put a model syllabus (with resource materials and bibliography) on line using a technologically advanced e-seminar.
