AHRQ 2009 Annual Conference Do Ask, Do Tell: Best Practices in Conflict of Interest Policies for Research, Publishing, and Recommendation-Making Non-Financial Conflicts of Interest Steve Knickrehm James Bell Associates

Project Team AHRQ Project: Best Practices in Conflict of Interest for Comparative Effectiveness Reviews and for Recommendation-Making Panels James Bell Associates: James Bell Steve Knickrehm Eastern Research Group: John Eyraud Andreas Lord Nyssa Ackerley

Definition of Conflict of Interest “A conflict of interest is a set of conditions in which professional judgment concerning a primary interest (such as a patient's welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain).” - D. F. Thompson, Understanding Financial Conflicts of Interest, 1993

Emphasis on Financial COI (FCOI)— 1993 COI rules focus on financial gain because money is:  more objective  more fungible  easier to regulate by impartial rules  generally useful for more purposes. “Just because we cannot do much about the other secondary interests, it does not follow that we should do little about financial gain.” - Thompson, 1993

The Two Horns of the Non-Financial COI (NFCOI) Dilemma 1. Medical and health care literature is clear that NFCOI can be as damaging to scientific integrity as financial interests. 2. Much of the literature assumes nothing can be done to manage nonfinancial interests and ignores its potentially damaging consequences.

Leading Organizations Increase Emphasis on NFCOI World Association of Medical Editors (WAME) Policy Statement World Association of Medical Editors (WAME) Policy Statement International Committee of Medical Journal Editors (ICMJE) Uniform Requirements International Committee of Medical Journal Editors (ICMJE) Uniform Requirements JAMA JAMA Lancet Lancet Implementation Science Implementation Science AHRQ AHRQ U.K. National Institute for Health and Clinical Excellence (NICE) U.K. National Institute for Health and Clinical Excellence (NICE)

 Academic Commitments  Intellectual Passion  Personal Relationships  Political or Ideological Beliefs  Institutional Affiliations  Religious Beliefs  Professional Conflicts  Professional Relationships  Recognition for Professional Achievement  Favors to Students, Friends, or Family  Professional Affiliations  Published Opinions or Advocacy Positions Positions * Compiled from WAME, ICMJE, JAMA, etc… Types of NFCOI*

NFCOI Example 1—Religious Beliefs Imagine you’re a peer reviewer who’s received a request to referee a paper. The paper reports the results of a study using cell lines derived from an aborted fetus as a diagnostic tool in identifying certain viral infections. You are also a member of a religious organization morally opposed to fetal cell research. In your review, you raise questions about the study’s validity and methodology that might undermine the paper’s chance of publication. Imagine you’re a peer reviewer who’s received a request to referee a paper. The paper reports the results of a study using cell lines derived from an aborted fetus as a diagnostic tool in identifying certain viral infections. You are also a member of a religious organization morally opposed to fetal cell research. In your review, you raise questions about the study’s validity and methodology that might undermine the paper’s chance of publication. - PLOS Medicine Editors, Making Sense of Non-Financial Competing Interests, 2008

NFCOI Example 2— Personal/Professional Associations Imagine you’re an editor and you receive a paper from the scientist who supervised your postdoctoral fellowship. It’s been a couple of years since you left his lab, but he has supported your career and you have warm feelings toward him; plus you still join your former lab mates occasionally at their monthly pub night. You select sympathetic reviewers and you fight hard for the paper at the editorial meeting. Imagine you’re an editor and you receive a paper from the scientist who supervised your postdoctoral fellowship. It’s been a couple of years since you left his lab, but he has supported your career and you have warm feelings toward him; plus you still join your former lab mates occasionally at their monthly pub night. You select sympathetic reviewers and you fight hard for the paper at the editorial meeting. - PLOS Medicine Editors, 2008

NFCOI Example 3—Published Opinions or Advocacy Positions Dietary Approaches to Stop Hypertension (DASH)-Sodium Trial funded by the National Heart, Lung, and Blood Institute (NHLBI) Dietary Approaches to Stop Hypertension (DASH)-Sodium Trial funded by the National Heart, Lung, and Blood Institute (NHLBI) Questions were raised about the lack of primary end points for all subgroups in the published results, despite repeated requests. Questions were raised about the lack of primary end points for all subgroups in the published results, despite repeated requests. “It is plausible to assume that the reluctance of NHLBI may be based in its own conflict of interest in this matter. Dr. Lenfant and his colleagues at NHLBI have spent the better part of the past two decades championing sodium restriction as the most important dietary adjustment for the prevention and treatment of hypertension. Without the data to justify this, we must ask whether the vested interests of the NHLBI might not have a role in apparent efforts to protect this policy.” “It is plausible to assume that the reluctance of NHLBI may be based in its own conflict of interest in this matter. Dr. Lenfant and his colleagues at NHLBI have spent the better part of the past two decades championing sodium restriction as the most important dietary adjustment for the prevention and treatment of hypertension. Without the data to justify this, we must ask whether the vested interests of the NHLBI might not have a role in apparent efforts to protect this policy.” - David A. McCarron, “NHLBI’s Conflict of Interest: Why We Need the Data Quality Act”, Editorial, American Journal of Hypertension, 2003

Addressing the NFCOI Dilemma “As with all competing interests, what’s in dispute is not that they exist, but how to manage them. The responsibility of journals and the wider research communities is to safeguard the credibility of the scientific and editorial processes. Three things are needed to start making sense of non-financial competing interests: 1. Disclose 2. More Policy Development 3. More Research” - PLOS Medicine Editors, 2008