Institutional Review Board

Saint Francis Hospital and Medical Center (SFHMC) promotes objectivity in research and has established standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research to be performed will be biased by any conflicting financial interest of an Investigator.  Financial interests in human subjects research are distinct from other interests in institutional life, because their existence may entail special risks.  Specifically, opportunities to profit from research may affect – or appear to affect – the judgment or decisions of an investigator.  At SFHMC, all significant financial conflicts of interest in human subjects research are regarded as potentially problematic, and therefore, require close scrutiny.  It is the purpose of this policy to set forth the principle for identifying the potential for conflicts and the procedures for reviewing and addressing those potential conflicts that occur.  This is done to ensure that the research may be performed in a manner consistent with preserving the safety and welfare of human subjects that participate in such research, as well as ensure the overall integrity of the research.

The specific purpose of the policy is:

·         To identify actual or potential conflicts of interest in research, and to eliminate, reduce or manage such conflicts;

·         To maintain the integrity of research endeavors;

·         To ensure compliance with federal and state laws and regulations regarding conflict of interest as it relates to research.

Guidelines recommended by the American Association of Medical Colleges (AAMC) Task Force on Financial Conflicts of Interest in Clinical Research (Oct. 2002), and federal laws and regulations that include, but are not limited to, 21 CFR Parts 54, 312, 314, 320, 330, 601, 807, 812, 814 and 860, 42 CFR 50, Subpart F, and 45 CFR part 94.

This policy applies to all individuals affiliated with the hospital in some manner who, on behalf of SFHMC, are responsible for, or are in the position to influence, the design, conduct, or reporting of the research or other scholarly activity.  This includes:

·         Full or part-time employees at SFHMC

·         Members of the Medical/Dental and Nursing Staff at SFHMC

·         Trainees, and medical, nursing, pharmacy and dietary students

DEFINITIONS                                                                                                                               

·         SFHMC means Woodland Physicians Associates, Asylum Hill Family Medicine Center, and Collaborative Laboratory Services, where a research study is conducted, whether it is initiated by an investigator or by an outside entity.

·         Investigator means the principal investigator and any other person who is responsible for the design, conduct, or reporting of a research project.  For purposes of this policy, “Investigator” includes the Investigator’s family members: spouse, children, and any other person living in the same household.

·         Research means a systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social sciences research.  The term encompasses basic and applied research and product development.

·         Significant Financial Interest means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interest (e.g., stocks, stock options or other ownership interest); and intellectual property rights (e.g., patents, copyrights and royalties from such rights).  For the purposes of this policy, Disclosable Financial Arrangements are:

·         Compensation made to the investigator in which the value of compensation could be affected by study outcome.

·         A proprietary interest in the tested product, including but not limited to: a patent, trademark, copyright or licensing agreement.

·         Any equity interest in the sponsor of a covered study, i.e., any ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices.

·         Any equity interest in a publicly held company that exceeds $10,000 in value.

·         Significant payments of other sorts, which are payments that have a cumulative monetary value of $10,000 or more made by the sponsor of a covered study to the investigator or the investigator’s institution to support activities of the investigator exclusive of the costs of conducting the clinical study or other clinical studies (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria) during the time the clinical investigator is carrying out the study and for 1 year following completion of the study.

The term does not include:

o        Salary, royalties, or other remuneration from SFHMC;

o        Income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities;

o        Income from service on advisory committees or review panels for public or non-profit entities;

o        An equity interest that when aggregated for the Investigator and the Investigator’s spouse and dependent children, meets both of the following tests: Does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a 5% ownership interest in any single entity;

o       Salary, royalties or other payments that when aggregated for the Investigator and the Investigator’s spouse and dependent children over the next twelve months, are not reasonably expected to exceed $10,000.

Saint Francis Hospital and Medical Center will:

1)      Maintain an appropriate written, enforced policy on conflict of interest that complies with state and federal guidelines and regulations, and inform each Investigator of that policy, the Investigator’s reporting responsibilities, and of these regulations.  If SFHMC carries out research through subcontractors, or collaborators, SFHMC must take reasonable steps to ensure that Investigators working for such entities comply with this policy, either by requiring those Investigators to comply with SFHMC’s policy or by requiring the entities to provide assurances to SFHMC that will enable SFHMC to comply with this policy.

2)      Require that all financial disclosures be made at the time of application to the Institutional Review Board (IRB) of a research project, and on an annual basis thereafter, or as new reportable Significant Financial Interests are obtained.

3)      Provide guidelines consistent with this policy for the designated official(s) to identify conflicting interests and take such actions as necessary to ensure that such conflicting interest will be managed, reduced, or eliminated.

4)      Maintain records of all financial disclosures and all actions taken by SFHMC with respect to each conflicting interest for three years.

Disclosure Procedures and Review

Research Financial Disclosure Forms will be completed and on file prior to the approval of a research project by the IRB.  Forms must be completed by Principal Investigators and all Co-Investigators for each funded research project.  Forms will be updated at the time of renewal of a protocol, or if there is a new reportable Significant Financial Interest obtained by the Investigator.  All forms will be forwarded to the IRB for review. 

Review of the Financial Disclosure Forms will be conducted by the office of the IRB.  All forms indicating potential conflict of interest, along with the research proposal in question will be reviewed by the IRB and it will establish whether a financial conflict exists, and determine if the Investigator may be permitted to conduct the outlined research.

Resolution and Management of Conflicts of Interest

The IRB will review all financial disclosures, and determine whether a conflict of interest exists, and if so, what actions should be taken by SFHMC to manage, reduce or eliminate such conflict of interest.  A conflict of interest exists when the IRB reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the proposed research.  If a conflict of interest has been identified as a result of the procedures as outlined above, the IRB will be responsible for taking the appropriate actions(s):

1)      Determine if there are compelling circumstances which are sufficient to allow the research to proceed in the face of the conflict.

2)      For projects that are allowed, review of the nature of the conflict at a fully convened IRB meeting, with recommendations made to manage the conflict.

3)      Determine the appropriate strategies to properly oversee and manage potential conflict(s), taking into consideration the possible remedies as outlined below.

4)      Inform the investigator of the actions and decisions of the IRB, including restrictions.

Restrictions that might be imposed to manage conflicts of interest include, but are not limited to:

1)      Public disclosure of significant financial interests;

2)      Monitoring of the research by independent reviewers;

3)      Modification of the research plan;

4)      Disqualification from participation in all or a portion of the research;

5)      Divestiture of significant financial interests, or;

6)      Severance of relationships that create actual or potential conflicts.

SANCTIONS:                                                                                                                                           

If the failure of an Investigator to comply with the conflict of interest in research policy of SFHMC has biased the design, conduct, or reporting of the research, SFHMC will consider the situation, and as necessary, take appropriate action.  Sanctions will include, but are limited to:

1)      Letter of reprimand

2)      Notification to funding agencies and/or professional journals or societies

3)      Termination of research project

4)      Suspension

5)      Termination

Privacy Policy  |  Policies and Ownership Saint Francis Care 114 Woodland Street Hartford, Connecticut 06105 (860) 714-4000