Safeguarding the Ethical Conduct of Biomedical Research in Israel against Conflict of Interest

Abstract

The global entrepreneurialism of biomedical research and its close ties with the private sector have introduced strong financial incentives into the public arena. In Israel, powerful forces of privatization have strengthened the enterprise of competitive research. A pivotal concern is whether an increasingly competitive research environment will create conflicts of interest (COI) impacting researchers and research institutions' ability to protect research validity and research participants' health and safety. In Israel, scandals have raised concerns about whether those responsible for conducting and evaluating research are committed to ethical standards. In response, the government has introduced regulatory mechanisms aimed at limiting the negative influence of commercial COI. The regulatory scheme imposes upon the hospitals and the Israeli Ministry of Health (MOH) the responsibility to identify and eliminate COI arising from the relationships between commercial sponsors and investigators. The scheme also calls for screening to determine eligibility of government advisors used for scientific input in the review of new trial applications. This dissertation evaluates whether government-created mechanisms are adequate responses to commercial incentives in the otherwise self-regulated research landscape in Israel. The collection and analysis of empirical data reveals practical interpretations and implementation of the regulatory mechanisms. The U.S. regulatory model illuminates a comparative model for attending to similar COI challenges. This dissertation suggests that current Israeli regulatory safeguards are lacking crucial standards and norms. The lack of standardized objectives and responsibilities, and the substantial variations found in institutional interpretation and implementation, require further regulatory intervention by the Israeli government. The objectives of this dissertation are to promote transparency and accountability within the Israeli biomedical scheme. The analysis is premised on the assumption that the protection of human subjects and the preservation of integrity within the context of medical research must evolve in tandem with the changing world of innovation and creative technologies. Securing legitimate standards and norms will benefit not only the research community, but also the welfare of the general public and those who contribute to scientific inquiry as clinical trial participants.