Disclosure I have/had bioethics advisory Using Data to Inform board - PDF document

Jeremy Sugarman, MD, MPH, MA September 16, 2011 Disclosure I have/had bioethics advisory Using Data to Inform board or consulting relationships Policies about Disclosing with Amgen, Genentech, and Financial Conflicts of Merck Serono. Interest in Research Interest in Research All of my COI ‐ related research Jeremy Sugarman, MD, MPH, MA was sponsored by the National Harvey M. Meyerhoff Professor of Bioethics & Medicine Department of Medicine Institutes of Health Berman Institute of Bioethics Johns Hopkins University Baltimore, Maryland Objectives A Patient • 18 yo with diet ‐ controlled • To discuss the nature of financial conflicts of OTC ‐ deficiency interests in research • Enrolled in a Phase I gene • To review data related to the disclosure of transfer experiment at the University of Pennsylvania University of Pennsylvania financial interests to potential research financial interests to potential research • Transfected with adenovirus participants vector via hepatic injection • To describe how such data can inform policies • Developed hepatic failure and practices regarding disclosure and died Use with Permission Only 1

Jeremy Sugarman, MD, MPH, MA September 16, 2011 Spectrum of Conflicts Selected Types of Financial Interests • Initial considerations • Per capita payments • Research design • Money received outside the study • Prospective review • Investigator holds equity • In process • Institution holds equity – Recruitment – Informed consent – Integrity of the data • Reporting Potential Solutions “Please be aware that the University of Whentenwhistle, Dr. • Divest Joyce K. Hanson (the Director of the Center for Human Genome • Minimize Study), and Acme, Inc. (a bioetchnology company in which Dr. Hanson holds an interest) have a financial interest in a successful • Disclose outcome from the research involved in this study.” y Use with Permission Only 2

Jeremy Sugarman, MD, MPH, MA September 16, 2011 Important Empirical Questions Regarding Disclosures of COI • Who, What, When, Where, and How? Conflict of Interest Notifications Study • How will these data be used? • What are the effects on trust? • Duke • Johns Hopkins – Jennifer Allsbrook Jennifer Allsbrook – Jeremy Sugarman Jerem S garman • What are the effects on the research – Joëlle Friedman – Alice Fortune ‐ Greeley enterprise? • Wake Forest – Chantelle Hardy – Mark Hall – Li Lin – Nancy King – Kevin Schulman – Jan Lawlor – Kevin Weinfurt NHLBI Grant: 1 R01 HL075538 ‐ 01 3 Overview COINS Overview Review COI Obtain Develop Evaluate Overview of COINS Policies Stakeholder Model Effects of Input Disclosures Disclosure studies Potential goals of disclosure Recommendations 6 Use with Permission Only 3

Jeremy Sugarman, MD, MPH, MA September 16, 2011 COINS Overview COINS Overview Review COI Obtain Develop Evaluate Review COI Obtain Develop Evaluate Policies Stakeholder Model Effects of Policies Stakeholder Model Effects of Input Disclosures Disclosure Input Disclosures Disclosure Weinfurt et al. Policies of Academic Medical Centers for Expert Panel Disclosing Financial Conflicts of Interest to Potential Research Participants. Acad Med 2006;81:113 ‐ 118. Mark Barnes (Ropes & Gray) Jeffrey Kahn (University of Minnesota) Rebecca Coleman (Theravance, Inc) Mary Faith Marshall (University of Minnesota) Joseph DiCesare (Novartis) S. Van McCrary (SUNY Stony Brook) Dinan et al. Comparison of Conflict of Interest Policies and John M. Falletta (Duke University) Erica Rose (GlaxoSmithKline) Reported Practices in Academic Medical Centers in the United Robert A. Gatter (Pennsylvania State University) Michael B. Waitzkin (FoxKiser) States. Account Res 2006;13:1 ‐ 32. Julie Gottlieb (The Johns Hopkins University) 7 8 COINS Overview COINS Overview Review COI Obtain Develop Evaluate Review COI Obtain Develop Evaluate Policies Stakeholder Model Effects of Policies Stakeholder Model Effects of Input Disclosures Disclosure Input Disclosures Disclosure Weinfurt et al. Views of Potential Research Potential Participants Potential Participants Participants on Financial Conflicts of Interest. JGIM 2006;21:901 ‐ 906. IRB Chairs IRB Chairs COIC Chairs COIC Chairs Investigators Investigators Research Coordinators Research Coordinators 9 10 Use with Permission Only 4

Jeremy Sugarman, MD, MPH, MA September 16, 2011 COINS Overview COINS Overview Review COI Obtain Develop Evaluate Review COI Obtain Develop Evaluate Policies Stakeholder Model Effects of Policies Stakeholder Model Effects of Input Disclosures Disclosure Input Disclosures Disclosure Potential Participants Potential Participants Weinfurt et al. Disclosing Conflicts of Interest in IRB Chairs Clinical Research: Views of Institutional Review IRB Chairs Friedman et al. Perspectives of Clinical Research COIC Chairs Boards, Conflict of Interest Committees, and COIC Chairs Coordinators on Disclosing Financial Conflicts of Investigators Investigators. J Law Med Ethics 2006;Fall:581 ‐ 591. Investigators Interest to Potential Research Participants. Clinical Trials 2007; 4: 272 ‐ 278. Research Coordinators Research Coordinators 11 12 COINS Overview COINS Overview Review COI Obtain Develop Evaluate Review COI Obtain Develop Evaluate Policies Stakeholder Model Effects of Policies Stakeholder Model Effects of Input Disclosures Disclosure Input Disclosures Disclosure Weinfurt et al. Developing Model Language for Hall et al. Measuring trust in medical Disclosing Financial Interests to Potential Clinical researchers. Med Care 2006;44:1048 ‐ Research Participants. IRB 2007;29:1 ‐ 5. 1053. 13 40 Use with Permission Only 5

Jeremy Sugarman, MD, MPH, MA September 16, 2011 COINS Overview Overview Review COI Obtain Develop Evaluate Overview of COINS Policies Stakeholder Model Effects of Input Disclosures Disclosure studies Potential goals of Weinfurt et al. Effects of disclosing financial interests on disclosure attitudes toward clinical research. J Gen Intern Med 2008;23:860 ‐ 866. Weinfurt et al. Effects of disclosing financial interests on Recommendations participation in medical research: A randomized vignette trial. AHJ 2008;156:689 ‐ 687. 43 Challenges • Differing views on what should be disclosed • People have trouble understanding 1. Promote informed • Can exacerbate therapeutic misconception decision making • Study coordinators often lack information • Artificially increasing salience of financial disclosure? Use with Permission Only 6

Jeremy Sugarman, MD, MPH, MA September 16, 2011 • Disclosures make a difference to some people, especially of equity relationships. • • Di Disclosures do not affect most people. l d t ff t t l • 2. Honor Participants’ Perceived People still want to know Right to Know What is material to the decision? • 3. Establish or Maintain Disclosure could increase trust • • T Trust t Disclos re can decrease tr st Disclosure can decrease trust ★ Especially for equity relationships • Overall, most disclosures do not undermine trust Use with Permission Only 7

Jeremy Sugarman, MD, MPH, MA September 16, 2011 4. Minimize Legal Risk for Research Institution/Investigator • In some states, no liability risk for failing to disclose • No precedent for a disclosure being sufficiently thorough “Please be aware that the University of Whentenwhistle, Dr. “Please be aware that the University of Pennsylvania, Dr. Joyce K. Hanson (the Director of the Center for Human Genome James M. Wilson (the Director of the Institute for Human Genome Study), and Acme, Inc. (a bioetchnology company in which Dr. Therapy), and Genovo, Inc. (a gene therapy company in which Dr. Hanson holds an interest) have a financial interest in a successful Wilson holds an interest) have a financial interest in a successful outcome from the research involved in this study.” y outcome from the research involved in this study.” y Use with Permission Only 8

Jeremy Sugarman, MD, MPH, MA September 16, 2011 5. Deter Troubling Financial Relationships 6. Protect Research Participants’ Welfare • Assumes investigators dislike disclosing. • No data to support this. • Others usually do the disclosing. • Could create moral license ( caveat emptor ) Use with Permission Only 9

Jeremy Sugarman, MD, MPH, MA September 16, 2011 Overview Overview of COINS • No systematic evidence to suggest studies harm • Any protection would have to result Potential goals of disclosure from . . . • improving informed decision making • deterring investigators from dangerous Recommendations financial relationships 1. Participants should not be sole decision makers about risks of financial relationships. 2. Disclosures should be brief and simple, with opportunity to ask questions questions. 3. Equity relationships should be discouraged, not simply disclosed. 4. Study personnel should receive training they need. 5. Be explicit about goals of disclosure. Use with Permission Only 10