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

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

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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

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Jeremy Sugarman, MD, MPH, MA September 16, 2011 Use with Permission Only 1 Using Data to Inform Policies about Disclosing Financial Conflicts of Interest in Research Interest in Research

Jeremy Sugarman, MD, MPH, MA Harvey M. Meyerhoff Professor of Bioethics & Medicine Department of Medicine Berman Institute of Bioethics Johns Hopkins University Baltimore, Maryland

Disclosure

I have/had bioethics advisory board or consulting relationships with Amgen, Genentech, and Merck Serono. All of my COI‐related research was sponsored by the National Institutes of Health

Objectives

  • To discuss the nature of financial conflicts of

interests in research

  • To review data related to the disclosure of

financial interests to potential research financial interests to potential research participants

  • To describe how such data can inform policies

and practices regarding disclosure

A Patient

  • 18 yo with diet‐controlled

OTC‐deficiency

  • Enrolled in a Phase I gene

transfer experiment at the University of Pennsylvania University of Pennsylvania

  • Transfected with adenovirus

vector via hepatic injection

  • Developed hepatic failure

and died

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SLIDE 2

Jeremy Sugarman, MD, MPH, MA September 16, 2011 Use with Permission Only 2

Spectrum of Conflicts

  • Initial considerations
  • Research design
  • Prospective review
  • In process

– Recruitment – Informed consent – Integrity of the data

  • Reporting

Selected Types of Financial Interests

  • Per capita payments
  • Money received outside the study
  • Investigator holds equity
  • Institution holds equity

Potential Solutions

  • Divest
  • Minimize
  • Disclose

“Please be aware that the University of Whentenwhistle, Dr. Joyce K. Hanson (the Director of the Center for Human Genome Study), and Acme, Inc. (a bioetchnology company in which Dr. Hanson holds an interest) have a financial interest in a successful

  • utcome from the research involved in this study.”

y

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SLIDE 3

Jeremy Sugarman, MD, MPH, MA September 16, 2011 Use with Permission Only 3

Important Empirical Questions Regarding Disclosures of COI

  • Who, What, When, Where, and How?
  • How will these data be used?
  • What are the effects on trust?
  • What are the effects on the research

enterprise?

Conflict of Interest Notifications Study

  • Duke

– Jennifer Allsbrook

  • Johns Hopkins

Jerem S garman

3

Jennifer Allsbrook – Joëlle Friedman – Alice Fortune‐Greeley – Chantelle Hardy – Li Lin – Kevin Schulman – Kevin Weinfurt – Jeremy Sugarman

  • Wake Forest

– Mark Hall – Nancy King – Jan Lawlor NHLBI Grant: 1 R01 HL075538‐01

Overview

Overview of COINS studies Potential goals of disclosure Recommendations

COINS Overview

Develop Model Disclosures Review COI Policies Obtain Stakeholder Input Evaluate Effects of Disclosure

6

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SLIDE 4

Jeremy Sugarman, MD, MPH, MA September 16, 2011 Use with Permission Only 4

COINS Overview

Develop Model Disclosures Review COI Policies Obtain Stakeholder Input Evaluate Effects of Disclosure

7

Expert Panel

Mark Barnes (Ropes & Gray) Rebecca Coleman (Theravance, Inc) Joseph DiCesare (Novartis) John M. Falletta (Duke University) Robert A. Gatter (Pennsylvania State University) Julie Gottlieb (The Johns Hopkins University) Jeffrey Kahn (University of Minnesota) Mary Faith Marshall (University of Minnesota)

  • S. Van McCrary (SUNY Stony Brook)

Erica Rose (GlaxoSmithKline) Michael B. Waitzkin (FoxKiser)

COINS Overview

Develop Model Disclosures Review COI Policies Obtain Stakeholder Input Evaluate Effects of Disclosure

8

Weinfurt et al. Policies of Academic Medical Centers for Disclosing Financial Conflicts of Interest to Potential Research Participants. Acad Med 2006;81:113‐118. Dinan et al. Comparison of Conflict of Interest Policies and Reported Practices in Academic Medical Centers in the United

  • States. Account Res 2006;13:1‐32.

COINS Overview

Develop Model Disclosures Review COI Policies Obtain Stakeholder Input Evaluate Effects of Disclosure

9

Potential Participants IRB Chairs COIC Chairs Investigators Research Coordinators

COINS Overview

Develop Model Disclosures Review COI Policies Obtain Stakeholder Input Evaluate Effects of Disclosure

10

Potential Participants IRB Chairs COIC Chairs Investigators Research Coordinators Weinfurt et al. Views of Potential Research Participants on Financial Conflicts of Interest. JGIM 2006;21:901‐906.

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Jeremy Sugarman, MD, MPH, MA September 16, 2011 Use with Permission Only 5

COINS Overview

Develop Model Disclosures Review COI Policies Obtain Stakeholder Input Evaluate Effects of Disclosure

11

Potential Participants IRB Chairs COIC Chairs Investigators Research Coordinators Weinfurt et al. Disclosing Conflicts of Interest in Clinical Research: Views of Institutional Review Boards, Conflict of Interest Committees, and

  • Investigators. J Law Med Ethics 2006;Fall:581‐591.

COINS Overview

Develop Model Disclosures Review COI Policies Obtain Stakeholder Input Evaluate Effects of Disclosure

12

Potential Participants IRB Chairs COIC Chairs Investigators Research Coordinators Friedman et al. Perspectives of Clinical Research Coordinators on Disclosing Financial Conflicts of Interest to Potential Research Participants. Clinical Trials 2007; 4: 272‐278.

COINS Overview

Develop Model Disclosures Review COI Policies Obtain Stakeholder Input Evaluate Effects of Disclosure

13

Weinfurt et al. Developing Model Language for Disclosing Financial Interests to Potential Clinical Research Participants. IRB 2007;29:1‐5.

COINS Overview

Develop Model Disclosures Review COI Policies Obtain Stakeholder Input Evaluate Effects of Disclosure

40

Hall et al. Measuring trust in medical

  • researchers. Med Care 2006;44:1048‐

1053.

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SLIDE 6

Jeremy Sugarman, MD, MPH, MA September 16, 2011 Use with Permission Only 6

COINS Overview

Develop Model Disclosures Review COI Policies Obtain Stakeholder Input Evaluate Effects of Disclosure

43

Weinfurt et al. Effects of disclosing financial interests on attitudes toward clinical research. J Gen Intern Med 2008;23:860‐866. Weinfurt et al. Effects of disclosing financial interests on participation in medical research: A randomized vignette trial. AHJ 2008;156:689‐687.

Overview

Overview of COINS studies Potential goals of disclosure Recommendations

  • 1. Promote informed

decision making

Challenges

  • Differing views on what should be disclosed
  • People have trouble understanding
  • Can exacerbate therapeutic misconception
  • Study coordinators often lack information
  • Artificially increasing salience of financial

disclosure?

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Jeremy Sugarman, MD, MPH, MA September 16, 2011 Use with Permission Only 7

  • 2. Honor Participants’ Perceived

Right to Know

  • Disclosures make a difference to some

people, especially of equity relationships.

  • Di

l d t ff t t l

  • Disclosures do not affect most people.
  • People still want to know

What is material to the decision?

  • 3. Establish or Maintain

T t Trust

  • Disclosure could increase trust
  • Disclos re can decrease tr st
  • Disclosure can decrease trust

★ Especially for equity relationships

  • Overall, most disclosures do not

undermine trust

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Jeremy Sugarman, MD, MPH, MA September 16, 2011 Use with Permission Only 8

  • 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. Joyce K. Hanson (the Director of the Center for Human Genome Study), and Acme, Inc. (a bioetchnology company in which Dr. Hanson holds an interest) have a financial interest in a successful

  • utcome from the research involved in this study.”

y “Please be aware that the University of Pennsylvania, Dr. James M. Wilson (the Director of the Institute for Human Genome Therapy), and Genovo, Inc. (a gene therapy company in which Dr. Wilson holds an interest) have a financial interest in a successful

  • utcome from the research involved in this study.”

y

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Jeremy Sugarman, MD, MPH, MA September 16, 2011 Use with Permission Only 9

  • 5. Deter Troubling

Financial Relationships

  • Assumes investigators dislike

disclosing.

  • No data to support this.
  • Others usually do the disclosing.
  • Could create moral license (caveat

emptor)

  • 6. Protect Research Participants’

Welfare

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Jeremy Sugarman, MD, MPH, MA September 16, 2011 Use with Permission Only 10

  • No systematic evidence to suggest

harm

  • Any protection would have to result

from . . .

  • improving informed decision making
  • deterring investigators from dangerous

financial relationships

Overview

Overview of COINS studies Potential goals of disclosure Recommendations

  • 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.