Eimantas Peicius Kaunas regional REC, Lithuania CONFLICT OF INTERESTS IN THE INDUSTRY SPONSORED RESEARCH: WHAT RECs SHOULD KNOW AND WHAT THEY REALLY KNOW ABOUT FINANCIAL ASPECTS OF THE RESEARCH PROJECTS? Eimantas Peicius Kaunas regional REC, Lithuania

WHAT IS CONFLICT OF INTERESTS (CoInt) INTRODUCTION WHAT IS CONFLICT OF INTERESTS (CoInt) CoInt constitutes the contradiction between primary interests (i.e. professional) and secondary - private or personal interests, attributed to the same subject (researcher, scientist, officer etc.) Primary interests of researcher: Professional duties, realization of scientific goals, representation of public interest, legal norms etc. Secondary individual interests of researcher: Personal financial interests, personal comfort, prestige, power, academic advancement etc.

RECs ROLE IDENTIFYING CONFLICTS OF INTERETS IN RESEARCH In research, the conflict of interests may induce the problem of scientific misconduct, threaten the rights and welfare of research participants or even public. Problem of dual duties (double loyalty) - researcher and physician in one person (better payment for research reduce the attention to patient needs potentially etc. ) Should REC manage the conflict of interests in research, and take into account in the review? YES

INTERNATIONAL RECCOMENDATIONS FOR RECs The judgement of a researcher concerning the research must not be influenced, by financial, personal, academic, political, or other interests at any stage. In the application the researcher should therefore set out any circumstances that might lead to a conflict of interest. Investigators should not enter into agreements that interfere unduly with their access to the data or their ability to analyse the data independently... Investigators must also disclose potential or apparent conflicts of interest on their part to the ethical review committee or to other institutional committees designed to evaluate and manage such conflicts. Ethical review committees should therefore ensure that these conditions are met (CIOMS, 2001). In preparing its opinion, the Ethics Committee shall consider… (j) the amounts and, where appropriate, the arrangements for rewarding or compensating investigators and trial subjects and the relevant aspects of any agreement between the sponsor and the site (EC Directive 2001, 6.3).

INTERNATIONAL RECCOMENDATIONS FOR RECs Explanatory Report to Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research: 58. Indent xvi addresses payments and rewards to be made to participants, researchers or institutions in the context of the research project. Such information is important to ethics committees in the interests of transparency and for proper evaluation of the research project. For example, unusually large payments or rewards might influence decisions on the risks that participants are willing to undertake, and could influence the behaviour of researchers in regard to such risks.   Guide for Research Ethics Committee Members (CDBI, 2011) 6.C.22.2 Researchers* Researchers should give details of any payments, rewards or material goods that will be provided to them or their institution in return for the research so that the REC can judge whether they are appropriate. (http://www.coe.int/t/dg3/healthbioethic/source/INF%282011%29_en.pdf)

Optional cases of potential conflicts of interests The same investigators/organizations are always involved in the most of clinical drug trials or overloaded with too many trials Certain investigators/organizations are almost always related to the research projects in the area Certain investigators/organizations are exploiting their research participants in different research projects (in similar or related studies) The leading status of certain principal investigators remains almost the same for years IS IT FOR BETTER INTERESTS OF RESEARCH PARTICIPANTS OR NOT?

RECs role in dealing with CoInt: sharing experience How often potential conflicts of interests of researchers are observed in your REC? Is this problem was ever discussed or actually dealt? Is it the role and obligation of REC to inquiry the commercial agreements between research funders and researchers (how much they are paid etc.)? Do REC has such authority legally in your country? What are the limits of REC proceeding such functions in reality?

Questions for round table discussion What documents and what information related to financial issues are required and reviewed by your RECs? How to evaluate the adequate amount to be paid to the investigator or institution? What are the ways to “minimize” local researchers’ financial interest in participating in research (e.g. restrict the number of clinical trials (or patients) per investigator)?