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1 Conflicts of interest Different types, different contexts.

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1 1 Conflicts of interest Different types, different contexts

2 2 Conflicts of interest There are many types of conflict, not all of which can be totally avoided Some people may not recognize that they have a conflict when one exists –Are definitions of COI needed? –Should there be educational efforts to inform and discuss COI However, there should be ways to minimize the conflict Are there some that are so serious that they cannot be managed? –In that case, they should not be permitted

3 3 Physicians As doctors and as researchers –Patients look on their physicians as people who will act in their best interest –Research participants may therefore experience the therapeutic misconception –Patients may agree to participate in research because when their doctor is the researcher, they do not recognize that it is not routine clinical care

4 4 Recruitment Solution of problem of doctors recruiting their own patients –One IRB requires that someone other than the physician doing research be the one to recruit patients Another problem is innovative treatment or off-label use of drugs; however, this is not for the REC but for the doctors colleagues

5 5 Witnessing informed consent One law requires two witnesses to the informed consent process A role of the witness in this situation is to determine that the participant really understands that it is research, not ordinary treatment –But who should the witness be? Another colleague could also be biased –A family member may not be the best person

6 6 Recruitment In phase III and IV, a CAB could be used for the recruitment process, in order to try to avoid conflicts of interest This could not work, of course, for in- hospital recruitment A shortcoming is that this would require more financial means

7 7 Incentives for participation Patients have a conflict in that they will get better care during research than they would outside of the research context Patients do not want to say no to their doctors seeking to recruit them When there is a long waiting time for clinical care, some patients seek to participate in research because they can be treated faster

8 8 Industrial sponsors Researchers receive money from sponsors yet must remain objective in conducting research –However, doctors salaries are very low and they seek money from elsewhere –Sponsors pay researchers a capitation fee for each patient recruited for research This is not permitted in at least one country by law or regulation

9 9 Conflicts arising from payments One way to minimize conflicts arising from researchers being paid by sponsors of research, is to put the money in a pool to be distributed to others in the institution, as well Regulations can preclude large gifts or payments by sponsors to researchers

10 10 Sponsors paying doctors Whats wrong with paying doctors a salary for their role as researchers? –Main problem is paying for each patient recruited –Doctors as researchers do need to be paid, however –Should be transparent; REC should know –Should be part of written procedures, including informed consent Studies reveal that some participants would want to know this, but others indicated they did not care about this

11 11 Studies of sponsored research Studies have shown that industrially sponsored research are biased in favor of the sponsors product –Sponsors product was shown to be superior by 38 % over the control –Ways that sponsors protocols could be regulated??

12 12 Institutional colleagues Reviewing and judging the research protocols of colleagues can involve a conflict between objectivity and institutional loyalty This problem occurs with institutional RECs –Could basically be addressed by using outside committees –In some places, the institutional model has been replaced by a regional one, in order to avoid this conflict –Could protocols be reviewed anonymously? Not possible within an institution by the REC

13 13 REC members conflicts Potential conflict may exist with a particular study Some REC members may have bias against certain types of research –Drug studies may be perceived as dangerous –Some members may disapprove of research on sexuality

14 14 Recommendations Minimizing conflicts of interest –As much transparency as possible –REC members from outside the institution –Widen the context of review in some circumstances

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