Study Agreements

In a recent study at Duke University, Schulman and colleagues surveyed 108 U.S. medical schools that looked at clinical research and focused on their agreements with industry sponsors for multi-center studies.2 They found that these institutions rarely had requirements that ensured the examiner`s independence in the design, collection, analysis or interpretation of the data. They also found few provisions guaranteeing either adequate protection of the investigators` freedom of publication or the corresponding paternity of the manuscripts. The study concludes that academic institutions regularly enter into research contracts that do not meet appropriate ethical standards. This is an omission that can have serious consequences. An important guarantee would be the verification and authorization by the IRB or REB of all CSAs to review and approve The Institutional Ethics Review (IRB or REB) panels. During its development, when the characteristics of the tool became apparent, DreamApply decided to expand the scope of the new instrument by making it available as a tool in its own right, which can be used free of charge for each university, for the benefit of the entire Erasmus community. The tool has been made free, allowing all partner coordinators to share their agreements collaboratively. In addition, the tool also has an API that any university can use to simply integrate it into its study information system and automate its work in terms of learning agreements. While some aspects of the treaty do not affect the protection of the subject or ethical integrity, the issues raised are clearly within the purview of the institution`s ethics assessment committee.

If certain provisions of the treaty have ethical implications, the established ethics verification mechanism should take responsibility for them. The interests they are accustomed to protecting on behalf of investigators and institutions do not doubt the good intentions of members of the Office of Institutional Research Contracts or another body charged with negotiating these agreements are not identical to the interest of protecting human subjects and ensuring the integrity of research. Members of the institution`s contract office will rarely have the experience of thinking about the impact of different topics on human issues or on the integrity of research. Institutions have a conflict of interest in the CSAs because they benefit from the fact that sponsors conduct research there. Researchers who are interested in launching their research may not be familiar with these ethical issues or are not sufficiently cautious. The IRB is the primary responsibility for these matters and this obligation should not be transferred to another authority. The IRB should not hesitate to conduct a comprehensive review of research-related materials, including the research contract and budget, to ensure the protection of issues and the integrity of research. Outsourcing can be entrusted to funds within higher education or other major sources of funding, including federal grants/cooperation contracts, federal contracts, foundations and industry. 15 In a recent study, Blumenthal and colleagues found that 19.8% of a random sample of university life scientists from major research institutes delayed the publication of results on the sponsor`s application by more than six months.6 In 1990, a group of researchers at the University of California, San Francisco closed a study by Boots Pharmaceuticals Inc. (after the acquisition of the original sponsor Flint Laboratories) funded a study comparing the effectiveness of synthetic thyroid with competing preparations.