Conflicts of interest Different types different contexts 1

Conflicts of interest Different types, different contexts 1

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 2

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 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 3

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 doctor’s colleagues 4

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 5

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 inhospital recruitment • A shortcoming is that this would require more financial means 6

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 7

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 8

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 9

Sponsors paying doctors • What’s 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 10

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

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 12

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 13

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