MANAGING CONFLICTS OF INTEREST

IN UM/JHS HUMAN SUBJECT RESEARCH

1. GENERAL PRINCIPALS AND PROCEDURES

2. REGULATIONS, POLICIES AND UM PROCESS

Human Subjects Research Office1500 NW 12th Avenue, Ste. 1000, Miami, FL 33136Tel. 305-243-3195

www.hsro.miami.edu

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Investigator Resources Ancillary Committee Information

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www.hsro.miami.edu• Human Subjects Research Office• The Human Subjects Research Office (HSRO) provides administrative

support for the University of Miami Institutional Review Boards….

• Recent Updates

• REMINDER:

• The HSRO is continually reviewing and revising its written Policies and Procedures…

• During the month of April, 2007, the following Policies were updated:– General Principles of Informed Consent– Lapse in IRB Approval– CIRB

• TABLE OF CONTENTS•  

• Preface   • Background Topics •             A. History  Approved 11/30/05•             B. Ethical Principles   Approved 11/30/05  •             C. Federal Regulations   Approved 11/30/05   •             D. Federal Wide Assurance (FWA)   Approved 11/30/05 •             E. Does a Project Constitute Human Subjects Research  Approved 7/24/06 •     F. Medical Case Reports Approved 2/22/07

G. Retrospective Chart Reviews Approved 2/22/07

H.  Off-Label Use of Marketed Drugs, Biologics or Medical Devices Approved 2/22/07

• Definitions   Approved 2/8/05

• Authorities and Responsibilities•            A. IRB Authority   Approved 7/24/06•            B. HSRO Responsibility  Approved 2/13/06•            C. IRB Policy and Procedures Committee  Approved 10/11/05•            D. Responsibility of Principal Investigators  Approved 2/13/06•            E. Responsibilities of UM Deans/Department Chairs   Approved 2/13/06•            F. Responsibilities of Students and Faculty Advisors   Approved 2/13/06  

•         •           

Institutional Review Boards        A. IRB Membership and Structure Approved 2/23/06B. IRB Chairs and Vice-Chairs Approved 2/23/06C. IRB Members Approved 2/23/06

• Conflict of Interest •           A. General Principles Approved 10/27/06•             B. IRB Members, Alternate Members, Ad Hoc Members and Guests

Approved 10/27/06•             C. Principal Investigators and Key Personnel Approved 10/27/06•             D. Human Subject Conflict of Interest Committee Approved 10/27/06•             E. IRB Review and Approval of Conflict Management Approved 10/27/06

• IRB Meetings •            A. Agenda Approved 3/14/06

•             B. Minutes Approved 3/14/06

•             C. Reviewer Assignments Approved 3/14/06

•             D. Consultants and Ad Hoc Reviewers Approved 3/14/06

•             E. Confidentiality of IRB Meetings and Guest Policy Approved 3/14/06

•             F. Meetings and Quorum Approved 3/14/06

•             G. Voting Approved 3/14/06

General Principles for IRB Reviews             A. Submission of New or Continuing Studies  Approved 3/14/06            B. Recommendations for Review Category  Approved 3/14/06            C. Criteria for IRB Approval  Approved 3/14/06            D. Approval Duration  Approved 3/14/06

Definition of IRB Review Types             A. Exempt Studies  Approved 3/31/06             B. Expedited Reviews  Approved 3/31/06             C. Reviews Requiring The Convened IRB  Approved 3/31/06 IRB Review Of Initial Studies             A. Initial Studies-Exempt  Approved 3/31/06             B. Initial Studies-Expedited  Approved 3/31/06             C. Initial Studies-Convened IRB Review  Approved 7/24/06 IRB Review of Continuing Studies             A. General Principles For Review Of Continuing Studies  Approved 3/31/06             B. Continuing Studies-Expedited  Approved 3/31/06             C. Continuing Studies-Convened IRB Review  Approved 7/24/06

Unanticipated Problems and Adverse Events            A. Problems and Events that Require Prompt Reporting  Approved 4/27/06

            B. Definitions  Approved 4/27/06

            C. Review of Problems or Events that Require Prompt Reporting  Approved 4/27/06            D. Reportable Problems/Events at Continuing Review  Approved 4/27/06

            E. Safety Notice/Report from Sponsor or Central Site  Approved 4/27/06

SOURCES OF CONFLICTS

1. IRB MEMBERS2. IRB STAFF (WHOSE RECOMMENDATIONS

MAY INFLUENCE MEMBERS)

3. PRINCIPAL INVESTIGATORS

4. KEY PERSONNEL

5. DSMB MEMBERS

6. INSTITUTIONAL

EACH COI SOURCE HAS THE POTENTIAL TO:

1. Introduce bias into research design, conduct or reporting

2. Place human subjects at greater risk or decrease research benefits to them

3. Compromise investigators’ or students’ academic pursuit

4. Misuse University resources

IRB MEMBERS AND STAFF

• 1. apply regulations and UM policies

• 2. apply UM ethical standards

• 3. question: might a COI challenge the integrity of a reasonable individual

• 4. question: might a situation appear to a reasonable member of the public to be a `conflict that could challenge the integrity of the conflicted party

INVESTIGATORS

• 1. most investigators deny that funding or other putative COIs would

compromise their findings• 2. media have raised issues of ‘funding

effects’ biasing results toward sponsors• 3. perceptions vs realities

INSTITUTIONAL CONFLICTScomplicating factors

• 1. institutions seek financial gains from faculty discoveries

• 2. COI must be defined independently from investigator COIs

• 3. all investigators, IRB members and staff are involved

• 4. COI is potential rather than real. COI cannot be defined quantitatively

UM-JHS PROCESS• 1. Investigator indicates COI• 2. UM Contracts and Compliance `

Committee• 3. [JHS Clinical Research Review

Committee]• 4. IRB Conflict of Interest Committee• 5. IRB

                                                                                                                 

CONFLICT OF INTEREST COMMITTEE

UNDERSTANDS CONFLICTS ARE INEVITABLE

REQUIRES DISCLOSURE AND TRANSPARENCY

RECOMMENDS TO IRB A) SHOULD THE CONFLICT BE

PERMITTEDB) IS THE CONFLICT MANAGEABLEC) HOW SHOULD THE CONFLICT BE

MANAGED

SUMMARY

• 1. managing COIs is complex

• 2. COI management requires disclosure and transparency

• 3. thoughtful policies and strict compliance are required

• 4. science is not broken

BUT…

Importance of Public Trust

Kelly Insignares, Ph.D., MBA, CIP

Regulations

• Public Health Service Act - DHHS– 42 CFR 50.604(b), 45 CFR 94.4 (b)– 42 CFR 50.603, 45 CFR 94.3– 42 CFR 50.605(a), 54 CFR 94.5 (a)– 45 CFR 46.107 (e)

• FDA– 21 CFR 54, 21 CFR 56.107 (e)

When in doubt, disclose!

• Mechanisms for disclosure– Outside consulting form – annual Faculty Affairs – HSRO / IRB application and notifications – disclosure is

required on a per study basis– Contracts and Compliance Committee / CRIS

• Updates if a new conflict arises or an existing conflict changes within 10 days after onset– Submit notification to the HSRO with COI disclosure form

Current Thresholds

• SFI $10,000 or more in any preceding or anticipated 12 month period

• 5% or greater ownership equity interest

• Serving in a management position such as director, officer or partner

• Intellectual property rights – patents, licensing agreements, copyright or royalties

Institutional Conflicts

• Disclosure of institutional conflict– Research involves a drug, device or other

invention created at UM by the PI, or by anyone employed at UM who may derive financial benefit

– UM may gain financially by the research

• Compelling circumstances (research could not be conducted as safely or effectively anywhere else)

HSRO Procedures for COI• COI submitted by PI and key personnel• PI recommendation on managing the COI• Reviewed by the HSCOIC

– Includes community representative

• HSCOIC recommendation sent to the IRB• Final conflict management plan

– Determined by the IRB

• Communication to the PI and Department Chair

Conflict Management Plans

• Disclosure of the financial interest– COI ICF template language

• Independent external monitoring

• Modification of the study

• Divestiture of the financial interest

• Severance of conflicting relationship

Conclusion

• Conflicts of Interest in research are not illegal but they can influence decisions and actions

• Let’s be proactive and address these situations in a collaborative manner as they arise

• Protect the rights and well being of our research subjects – disclose!