Institutional Financial Conflict of Interest in Research

Effective date: October 2013

Purpose

This policy is intended to protect patient safety and welfare, safeguard the reputation and integrity of the Institution as well as preserve the integrity of affiliated research, while fulfilling the mission of Baptist Memorial Health Care Corporation (BMHCC) and each of the entities in which it is the sole corporate member (hereinafter referred to as "BMHCC Affiliate"). BMHCC and BMHCC Affiliate may be collectively referred to as "Baptist."

Definition

Institutional Financial Conflict of Interest: An Institution may have a conflict of interest in Human Subjects Research whenever the financial interests of the Institution or of Institutional Official acting within his or her authority on behalf of the Institution, might affect or reasonably appear to affect Institutional Processes for the conduct, review or oversight of Human Subjects Research.

Policy

1. Institutional Financial Conflicts of Interest in research will be identified, analyzed and managed.
2. Potential Sources of Institutional Financial Conflict of Interest in Research.
   1. A licensing agreement may present a conflict when intellectual property developed by Baptist employees and owned by Baptist is licensed to a company that proposes to conduct clinical research at Baptist using the licensed property.
   2. A conflict might arise if Baptist holds equity interest in a company that proposes to sponsor clinical research at Baptist.
   3. A conflict would arise if a potential donor conditioned a gift on being involved in the design or conduct of a clinical research study or the analysis of results, or being able to influence the review or oversight of a study.
   4. A conflict might arise if a senior member of the administrative or medical staff had a significant financial interest in a company sponsoring clinical research at Baptist.

Procedures

1. The Research Oversight Committee (ROC) is responsible for determining whether contracts might present Institutional Financial Conflicts of Interest in clinical research. The ROC will send questionable contracts to the Corporate Compliance Office (CCO) for analysis as further outlined in this Policy.
2. The occasion may arise in which a senior administrator or physician has an investment in a company proposing to sponsor clinical research at a Baptist entity. Such a person must make relevant disclosures under Institutional Policy on Conflict of Interest Disclosure, which applies. The disclosures would be reviewed by the CCO, who may confer with the Corporate Compliance Committee. If relevant information is revealed, the CCO will refer the matter to the Corporate Compliance Committee, who may give clear instructions to the CCO on how to proceed, or refer the matter to Corporate Legal Counsel for advice.
3. A situation may arise when Baptist is contacted directly to discuss gifts, donations, or contracts for activities that might involve clinical research, even peripherally. In such cases, all discussions about conditions for accepting the gift should be coordinated with the CCO. If an Institutional Financial Conflict of Interest is identified, the organizational representatives who negotiate terms of acceptance of gifts will indicate that donors may not participate in conduct, review or oversight of Human Subjects Research.
4. Other matters involving a potential Institutional Financial Conflict of Interest will be referred by the CCO to the Corporate Compliance Committee for analysis and disposition.
5. Decisions about whether to manage or Institutional Financial Conflicts of Interest in clinical research are guided by the following principles:
   1. The rights and welfare of Human Subjects must be protected.
   2. The reputation and financial and integrity of Baptist must be preserved.
   3. Examples of procedures to manage an Institutional Financial Conflict of Interest include but are not limited to:
      1. Disclosing Baptist's interest in the research to potential research subjects.
      2. Not allowing the research to be conducted at a Baptist facility.
      3. Organizing an ad hoc committee with no professional or financial ties to the sponsor to oversee the research.
      4. Having the research reviewed by an external IRB rather than a Baptist IRB.
   4. The CCO is responsible for ensuring that all reporting requirements for funding or regulatory agencies are met.
6. Noncompliance with procedures for managing conflicts of interest will be referred to the CCO who will present the matter to the Corporate Compliance Committee for evaluation and resolution. Findings are also to be communicated to the chair of the IRB and the IRB may supplement the proposed course of remediation.