CONFLICT OF INTEREST POLICY: RESEARCH
Background
A situation may occur in which, an individual who is officially associated with research that is sponsored in whole or in part by START Treatment & Recovery Centers, Inc. (“START”), has more than an arms-length interest in the outcome of such research. This interest may be a professional, proprietary, or pecuniary one, or may be due to other circumstances.
The scientific credibility and the general acceptance of the results of research clearly depend on the integrity and objectivity of the individuals involved. Even the perception that an individual has a bias may cast doubt on the validity of the results. START has established this Conflict of Interest Policy (the “Policy”) to address issues of conflict of interest that may arise in the context of START sponsored research.
The Policy defines areas of actual and potential conflicts of interest and identifies when disclosure must be provided. Following disclosure, the START Institutional Review Board (the “IRB”) or an ad hoc committee of the IRB will determine on a case-by-case basis, whether any limitations will be placed on an individual’s participation in START sponsored research. The Treatment, Research and EvaluationCommittee of the Board of Trustees will be notified of any actual or potential conflict of interest.
Applicability
The Policy is applicable to research that is sponsored in whole or in part by START (“START Sponsored Research”) and to the following individuals, hereafter called “participating individuals”:
a. All scientists, including advisory scientists and principal investigators, including deputy and co-principal investigators involved in START sponsored research, and
b. Other individuals who have a substantial decision-making or a direct supervisory responsibility for the design, implementation, and analysis of START Sponsored Research, including the
following:
1. START’s IRB members,
2. START’s Chief Executive Officer, other C-Level Officers, and Vice President, Research & Evaluation,
3. Any other individuals who are officially involved with the Protocol/Concept Reviews,Protocol Design, Implementation, and Data Analysis, and
4. Any other individual who the Principal Investigator identifies as being subject to the disclosure reporting requirements of the Policy.
The Public Health Service (“PHS”) regulations 42 CFR part 50, subpart F, “Promoting Objectivity in Research” for which PHS funding is sought, requires that grantee institutions have written policy guidelines on conflict of interest. In the event another funding or granting organization also has conflict of interest policies, those policies will also apply. The Treatment, Research and Evaluation Committee of
the Board of Trustees, the IRB, or an ad hoc committee of the IRB will resolve any conflicts between the Policy and the conflict of interest policies of other relevant funding or granting organizations.
Definitions
1. Research Product. A research product includes a drug, technique, or technology and the ancillary materials produced under the aegis of START such as training materials or published and unpublished articles, in support of the drug, technique, or technology.
2. Immediate Family Member. Immediate Family Member includes a spouse, children, and siblings.
3. Conflict of Interest. There are several types of situations that could constitute an actual or potential conflict of interest:
A. Professional Interest
a.1 The participating individual or an immediate family member has played a substantial role in the prior development of a product or technology (such as behavioral manuals or drug products) that is being utilized or studied by START or currently receives a financial or other material benefit from such product or technology.
a.2 The participating individual or an immediate family member has an ongoing affiliation with an organization having a role in the development or sale of a product or technology that was investigated by, developed by or is being utilized by START, including organizations holding patents to or licenses for the development or sale of research products. That would include instances in which the individual serves as an officer, director, trustee, general partner, or employee for such an organization regardless of whether the participating individual is currently being compensated for that position. Such organizations would also include those with which the individual is negotiating for or has an arrangement concerning prospective employment or affiliation, or those from which the participating individual receives or expects to receive any compensation for honoraria, consultative services, or other activities (such as educational grants). The significance of the conflict will depend, to some degree, on whether reimbursement for professional activities involves compensation limited to that normally required to support the scientific process, or is substantially larger, leading to actual or potential personal financial gain to the investigator or an immediate family member.
B. Proprietary Interest
b.1 The participating individual has a financial interest in the research product being studied because the individual or an immediate family member has an interest in the product or technology that may result in financial gain, e.g., where the individual may receive royalties or other compensation following the commercial sale of the product or technology. Such royalties may be in the form of personal compensation to the individual or may be used in support of the individual’s research.
b.2 The participating individual has a financial interest in the research product being studied because the individual or an immediate family member has an equity interest, including but not limited to shares, or option in an enterprise that will benefit from the sale of the product or technology.
C. Miscellaneous
There may be other instances in which a participating individual or an immediate family member has an affiliation or relationship such that objective impartiality could be questioned. The standard that a participating individual should use in determining whether or not to disclose a actual or potential conflict of interest is how the conduct in question would look if reported in the media.
The intent of the Policy is to err on the side of full disclosure. Thus, the participating individuals may need to disclose any other interests, affiliations, arrangements or relationships that could lead to questions about the motives in connection with their work on behalf of START if such interest, etc. were known or made public.
In any such instance, the participating individual should disclose the nature and extent of such affiliation or relationship using the procedures discussed below.
4. Potential conflicts. A potential conflict refers to a situation that does not necessarily constitute or appear to constitute a conflict of interest but where there is a reasonable possibility of an actual orapparent conflict of interest coming into play.
Proper Procedure
The purpose of the Policy is to ensure that participating individuals make full disclosure of a actual or potential conflict of interest so that an informed decision is made that balances the interests of the disclosing individual with the needs of START. It is not the purpose of the Policy to limit or exclude an individual from participating in research, where the conflict of interest is remote or insignificant.
Participating individuals having a potential conflict of interest as outlined above may be allowed to take part in research investigation after providing formal disclosure. However, in some instances certain activities will be prohibited. On an ad hoc basis, the IRB will convene a committee to review possible
conflicts of interest to determine whether there is a sufficient basis to apply the prohibition described below. Additionally, the Treatment, Research and Evaluation Committee of the Board of Trustees may review the possible conflict and may take its own, independent actions.
Because of the potential that an actual or potential conflict of interest could bias conclusions, and because even the perception by others of a conflict of interest could compromise research credibility, START researchers and participating individuals should make reasonable efforts to avoid the occurrence of such conflicts.
Following completion of a trial or other study, individuals directly involved in the design, performance, or conduct of the study should refrain from activities primarily targeted at commercial marketing of the product. Scientific activities such as authorship of scientific articles or book chapters, and presentations at academic institutions or professional meetings do not require disclosure unless compensation, such as honoraria and travel expenses is given.
Disclosure
Each participating individual is expected to complete and file a Conflict of Interest Disclosure, using the form attached to the Policy, for any START Sponsored Research, where such research is designed, performed, or conducted at the request of an outside party, such as a pharmaceutical company, an educational institution, or a governmental entity, or in connection with the products of an outside party. The forms must be filed with the IRB, and presented semi-annually to the Treatment, Research and Evaluation Committee of the Board of Trustees, including the number of persons completing a disclosure and the number of persons for which there is a potential or actual conflict of interest. In addition, at the beginning of any presentation of the results of a clinical trial or other study through either oral presentation or publication, the participating individuals must disclose, if applicable, private sources of funding provided specifically for design, performance, or conduct of the START Sponsored Research or reporting of results.
Prohibited Activities
If, in the view of the Treatment, Research and Evaluation Committee of the Board of Trustees, the IRB, or an ad hoc committee of the IRB, a participating individual has an actual conflict of interest, that individual may not assist in the development of any protocol involving the research product for which there is such a conflict of interest.
The Treatment, Research and Evaluation Committee of the Board of Trustees, the IRB, or an ad hoc committee of the IRB, will consider on a case-by-case basis, whether a participating individual might also be prohibited from other activities involving the investigation of the research product or the presentation of results for which there is a potential or actual conflict of interest.
Sanctions
Failure to disclose a potential or actual conflict of interest as required above under the Policy or participation in prohibited activities as determined according to the Policy, may result in the loss of privilege to participate in the research activities of START as well as other sanctions including the termination ofemployment.
Conflict of Interest Disclosure Form: Research
To: Participating Individual
From: START Treatment & Recovery Centers, Inc.
Because of your role as an IRB member, Chief Executive Officer, other C-Level Officer, or Vice President,
Research & Evaluation at START Treatment & Recovery Centers, Inc. (“START”), or as an individual who is
officially involved with the Protocol/Concept Reviews, Protocol Design, Implementation, and Data
Analysis, or other individual identified by a Principal Investigator, in research that is sponsored in whole
or in part by START, you have been designated a participating individual under the Research Conflict of
Interest policy (the “Policy”) of START. As a participating individual, START requests that you carefully
read the attached Policy, with particular attention to the definitions of Conflict of Interest set forth
under Paragraph 3, Definitions, and then respond to the questions set forth below based upon the best
information that is available to you.
3. Are you or an immediate family member negotiating for employment or have an arrangement
concerning prospective employment or affiliation with an organization having a role in the
development or sale of a research product that was investigated by developed by or is being utilized
by START? (See 3Aa.2 of the Policy)
4. Have you or an immediate family member received during the past 12 months or expect to receive
compensation from an organization having a role in the development or sale of a research product
that was investigated by, developed by or is being utilized by START? (See 3Aa.2 of the Policy)
6. Do you or an immediate family member have an interest in the research product being studied due
to an equity interest or option in an enterprise that will benefit from the sale of the research
product? Holdings in mutual funds need not be disclosed. (See 3Bb.2 of the Policy)
7. Do you or an immediate family member have any other interest, affiliations, arrangements or
relationships that you believe could lead to questions about your motives in connection with your
work on behalf of START if such interest, etc. were known or made public? (See 3C of the Policy)