Beth Israel Deaconess Medical Center

Beth Israel Deaconess Medical Center

BIDMC Manual
Title: Conflict of Interest Policy for Research
Policy #: ADM-19
Purpose:
The purpose of this policy is to identify, manage, and resolve conflicts of interest that may affect the research decisions, transactions, and operations of Beth Israel Deaconess Medical Center, Inc. This policy is also intended to comply with Harvard University Faculty of Medicine’s Policy on Conflicts of Interest and Commitment (“HMS COI Policy”)[1], as well as the requirements set forth in the HHS Final Rule, Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors (August 25, 2011).[2]
This policy shall be subject to any appropriate modifications required from time to time to conform to applicable governmental regulations and to policies of the Harvard University Faculty of Medicine.
Policy Statement:
The mission of Beth Israel Deaconess Medical Center (BIDMC) is to provide extraordinary care, where the patient comes first, supported by world-class education and research.[3] All individuals who serve BIDMC and its patients are expected to put this mission first and foremost whenever conducting activities relating to BIDMC.
Translating scientific and medical discovery into improved clinical care requires open collaboration and synergies achieved through thoughtful and complex partnerships with industry, government, academia, and others. These partnerships are consistent with the mission of BIDMC. However, it is important that such relationships do not create conflicts of interest that might undermine the validity of the research, or the safety of research participants. Such concerns arise when an individual’s own interests have the potential to affect the design, conduct or reporting of research, or when an institution’s interests have the potential to undermine its oversight of research activities.
For these reasons, BIDMC has established the following Conflict of Interest Policy for Research. The policy outlines unacceptable practices, and guides individuals in identifying and disclosing relationships with outside Organizations. The disclosures will assist BIDMC in identifying and managing conflicts so that these important collaborations can be undertaken without compromising integrity.
All individuals who are participating in research at or under the auspices of BIDMC are required to comply with this Policy, relevant procedures and guidelines established to carry out this policy, and with any additional requirements imposed by the BIDMC Committee on Clinical Investigations (CCI), the BIDMC Conflicts of Interest Committee (COIC), or other IRB or oversight body with jurisdiction over their research.
Other related policies:
·  ADM-18 Conflict of Interest Policy for Institutional Transactions
·  ADM-17A Personal Gifts, Travel, Meals, and Entertainment
·  ADM-17B Industry-Supported Speaking, Programs, Fellowships, and Preceptorships
·  ADM-15 Supplier Contact and Negotiation

I.  Individual Interests and Activities Related to Research

Investigators conducting Research at or under the auspices of BIDMC must ensure that personal financial interests and outside positions that may conflict with the best interests of patients, Research, and BIDMC are disclosed and addressed to maintain the integrity of not only Research, but also decision-making in all transactions. All Investigators conducting Research, or proposing to conduct Research, at or under the auspices of BIDMC, will disclose all outside interests or relationships, and gifts from an Organization, and intellectual property rights held by the Investigator or the Investigator’s Family. The Investigator will also comply with any management plan or transparency requirements imposed by BIDMC.
Certain Income Interests, Equity Interests, and activities are prohibited in the context of Clinical Research and Sponsored Research to protect against the introduction of bias or unnecessary risk in the Research. Any exceptions to the prohibitions outlined in this policy pertaining to Clinical Research are subject to approval by the BIDMC Committee on Clinical Investigations.
A.  Disclosure Obligations
1.  Disclosure to BIDMC. Investigators are required to disclose to BIDMC the financial interests, outside activities, intellectual property, and gifts of:
·  the Investigator;
·  the Investigator’s Family; and
·  an Organization in which the Investigator (either alone or with a Family member) exercises a controlling interest;
that reasonably appear to be related to the Investigator’s institutional responsibilities.
Disclosure must be made at the time and format specified by BIDMC. Examples include:
·  Research funding submissions;
·  Human subjects research protocol submissions;
·  Annual disclosure
2.  Disclosure to Research Subjects and Research Community. BIDMC may require individual interests and activities to be disclosed:
·  In CCI-approved consent forms;
·  To the Research personnel working on the Research project;
·  To the sponsor of multi-center trials; and
·  To Institutional Review Boards of other participating institutions.
3.  Disclosure to Trainees.[4] Investigators are responsible for ensuring that those who conduct Research under their supervision do so with full information about the nature of any relationships with industry that may be impacted positively or negatively by the work. An Investigator’s outside activities should not adversely influence the instruction, guidance or supervision of trainees. Academic assignments should principally serve the interests of the trainees in their academic advancement. To that end, Investigators should not assign trainees to participate in projects that could constrain their ability to freely discuss, defend and publish their research. Additionally, no Investigator may assign any trainee to any project in which the Investigator has an Income or Equity Interest, either directly or through an outside entity.
a.  General Disclosure to All Trainees. Investigators must disclose to all individuals whose job description includes assisting with the Investigator’s research any Income Interests, Equity Interests, or activities of the Investigator in any Organization that (i) provides Sponsored Research support to the Investigator’s Research or (ii) whose Technology is being investigated in the Investigator’s Research. The individuals to whom such disclosure must be made may include, but are not limited to, students, trainees, and other Investigators. Such disclosure must be made prior to or at the time an individual is offered a position or collaboration with the Investigator’s Research team or Research laboratory, or any other job that may encompass assisting with the Investigator’s Research.
b.  Project-specific Disclosures. Before a trainee may be involved in any specific Research project, the Investigator must provide a clear description of the following:
·  the source of funding (industry or otherwise) of the specific research project;
·  any Income or Equity Interests or activities of the Investigator in an Organization:
-  that provides Sponsored Research support to the project; or
-  whose Technology is being investigated in the Research; and
·  any restrictions that may be imposed on the timing of the scientific communication of data.
4.  Disclosure in Publications, Public Comments, or Presentations. Investigators are required to disclose financial interests in related outside entities and sources of support related to a presentation, public comment, including online, or publication of research results, the provision of expert testimony on a subject, or if members of an audience would give weight to those interests in assessing the opinions, advice, or work they are receiving. This includes the disclosure of a financial interest (by entity name) in an Organization which owns or has a contractual relationship to the Technology being reported or discussed or which sponsors the research being reported or discussed.
B.  Clinical Research Rule
Investigators who Participate in Clinical Research (as defined below), and members of their Families, may not have the following interests in an Organization whose Technology is being investigated:
·  Income Interest (other than Post-market Royalties);
·  Equity Interest;
·  Fiduciary role[5] to a for-profit Organization; or
·  Executive Position[6] at a for-profit Organization.
An Investigator “Participates in Clinical Research” if they fall within the criteria listed in either paragraphs 1 or 2 below:
1.  Design, Conduct, or Reporting of an IRB-approved Study. Investigators who are responsible for the design, conduct, or reporting of an IRB-approved study (excluding those studies determined to be Nominal Risk Clinical Research by the Committee on Clinical Investigations or Conflicts of Interest Committee) and, as part of that IRB-approved study:
a.  have access to information about living individuals by intervening or interacting with them for research purposes; and/or
b.  have access to identifiable private information about living individuals for research purposes; and/or
c.  obtain the voluntary informed consent of individuals to be subjects in research; and/or
d.  study, interpret, or analyze identifiable private information or identifiable data for research purposes; and/or
e.  have access to the study treatment assignment made through, for example, a randomization process.
2.  Primary Author. Investigators who serve as a primary author of a publication reporting the results of an IRB-approved study (excluding those studies determined to be Nominal Risk clinical Research by an IRB or BIDMC COI Committee). A primary author of a publication is the individual who, in compliance with HMS Authorship Guidelines[7] and ICMJE Authorship Guidelines,[8] takes primary responsibility for the integrity of the work as a whole even if he or she does not have an in-depth understanding of every part of the work.[9] There may be more than one primary author and this rule applies to all primary authors of a publication. Moreover, in situations where Investigators are not subject to the Clinical Research Rule but will be authors, those investigators must fully disclose in presentations and publications related financial interest(s) and should include a statement regarding the faculty member’s role on the study.[10]
Duration of Restriction. When triggered, this Rule applies until the later of the following to occur:
a.  twelve (12) months following the last day that a human study participant completes the Clinical Research (e.g., data lock plus 12 months); or
b.  first publication, or the decision not to publish, of data derived from the Clinical Research.
If an Investigator Participates in Clinical Research, such participation shall be considered to apply for the entire duration of the study (one cannot elect to terminate participation prior to the end of the study). An Investigator must be free of all conflicting interests under this Policy in a relevant Organization prior to commencing the Clinical Research.
De Minimis Threshold: Faculty may receive $10,000 or less annually from a Business in the form of Income Financial Interests (e.g., consulting fees or other remuneration for services) and still Participate in Clinical Research on the Business’ Technology.[11] Furthermore, Faculty may have an Equity Financial Interest of $30,000 or less in a publicly-traded Business and continue to Participate in Clinical Research on the Business’ Technology so long as the equity was not given in connection with the Clinical Research at issue. The de minimis threshold for equity does not apply to privately held companies.
Dual-Career Family Exception. If an Investigator has an Income Interest or an Equity Interest that would be in violation of either the Clinical Research Rule or the Research Support Rule solely due to the career pursuits of the Investigator’s spouse or domestic partner, the Investigator may petition the BIDMC COI Committee for a limited exception under this policy.[12] The COI Committee has the authority, in its discretion, to grant a limited exception to the Clinical Research Rule or the Research Support Rule if the following circumstances are found to exist:
a.  the Investigator is subject to either or both of the Rules solely by virtue of the career pursuits of his or her spouse or partner;
b.  the CCI or COIC determines, in its discretion, that strict application of one or both of the Rules under the circumstances would unduly inhibit scientific progress; and
c.  any potential conflict of interest is one that the CCI or COIC finds, in its discretion, can be managed adequately through a formal management plan.
The decision of the COIC may be subject to the approval of the Harvard Medical School Standing Committee on Conflicts of Interest and Commitment (“HMS Standing Committee”).
Institutional License/Royalty Sharing Agreement Exception: Faculty Members shall continue to disclose all financial interests, including income received through institutional license agreements and institutional royalty sharing agreements (as defined by the policy). The BIDMC Conflicts of Interest Committee shall have the authority to grant limited exceptions to the Clinical Research Rule if:
a.  A faculty member is subject to the Clinical Research Rule solely because of income received through an institutional license or royalty sharing agreement;
b.  The Standing Committee determines, in its discretion, that strict application of the rule under the circumstances presented is unduly restrictive after weighing the merits of allowing the research to go forward and the risks of the potential conflict of interest; and
c.  The potential conflict arising by reason of the income received through the institutional agreement can be managed through a formal management plan.
Such exceptions are subject to case-by-case assessment by the BIDMC COI Committee, following a formal petition by the individual faculty member. The decision of the BIDMC COI Committee may be subject to approval by the HMS Standing Committee. BIDMC strongly encourages the faculty member to petition prior to an executed institutional license or royalty sharing agreement. If, however, such an agreement is reached prior to or during the Committee Petition period, BIDMC may establish an escrow account for the faculty member where the income can be held pending determination of the COI Committees.
The Committees will consider the following factors:
1.  Nature of the clinical research;
2.  Whether the clinical research is on the technology subject to the institutional license or royalty sharing agreement;
3.  Type of license/royalty sharing income received (i.e. one time signing fee, success based milestone, non-success based milestone);
4.  Role in institutional negotiations;
5.  Role in development of the intellectual property;
6.  Nature of the business licensing the technology including business size, diversity of product areas, corporate structure (private vs. public), and market share;
7.  Terms of the license or royalty sharing agreement including but not limited to factors such as total commitment of resources by the Business to technology development and percentage of total entity research budget.
C.  Research Support Rule
It is presumed that Investigators (and the members of their Families) who have any one of the following interests in an Organization may not receive Sponsored Research support from that Organization for Research.