The safety and welfare of human subjects and the integrity of research involving human subjects should not be subordinated to, or compromised by, financial or other personal interests. Dartmouth-Hitchcock Clinic, Mary Hitchcock Memorial Hospital (collectively, "D-H") and Dartmouth College (the "College") have adopted this Conflict of Interest Policy for Human Subject Research (the "Policy") to ensure compliance with this fundamental principle.
This Policy supplements D-H's and the College's general institutional policies on conflicts of interest and conflicts of interest in research. It is intended to address the special conflict problems relating to Human Subject Research.
The overarching policy is one of full disclosure with subsequent review by an appropriate oversight process prior to final approval of the proposed research protocol by the Committee for the Protection of Human Subjects (D-H's and the College's unified institutional review board, hereinafter "IRB"). The intent of this Policy is to promote objectivity in Human Subject Research by establishing standards to avoid, to the greatest extent feasible, the possibility that the design, conduct or reporting of such research will be biased by any conflicting interest of a Principal Investigator or Other Key Personnel, thereby reducing the likelihood that such conflicting interest could adversely affect the rights and welfare of human subjects.
A potential conflict of interest occurs when an individual's personal or private interests might lead an independent observer reasonably to question whether the individual's professional actions or decisions are influenced by considerations of personal interest, financial or otherwise.
All Human Subject Research protocols submitted to the IRB will be reviewed according to the process set forth herein.
"Principal Investigator and Other Key Personnel" shall mean a Principal Investigator and any other person (including students) who is responsible for the design, conduct, or reporting of Human Subject Research. The Principal Investigator is responsible for the conduct of all individuals participating in the project, including disclosure requirements for all Other Key Personnel. Principal Investigators and Other Key Personnel may also be referred to herein as "Reporting Persons."
"Human Subject Research" shall mean systematic investigation relating to human subjects designed to develop or contribute to generalizable knowledge. This includes study design, testing, and evaluations involving a living individual about whom a Principal Investigator or Other Key Personnel obtains data, through intervention or interaction with the individual, or through the use of identifiable private information.
"Reportable Financial Interest" means anything of monetary value that would reasonably appear to affect or be affected by the research or related activities, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights), as further detailed in Section III below.
Reporting Persons must disclose "Reportable Financial Interests," as defined above, for themselves and for their spouse or domestic partner and dependent children. To the extent known by Reporting Persons, Reportable Financial Interests held by other family members must also be disclosed. Reportable Financial Interests include, but are not limited to:
"Reportable Financial Interests" do not include:
Attached hereto as Appendix A are examples of Reportable Financial Interests that must be disclosed. The Conflict Review Committee (the "Committee"), discussed in Section VI below, shall prepare and make available examples of conflicts of interest, methods of conflict management and decisions of the Committee, based upon prior cases referred to the Committee, in order to provide guidance to Principal Investigators and Other Key Personnel.
Reporting Persons must make annual financial disclosures to the College's Office for Sponsored Projects ("OSP"), on forms provided by OSP, consistent with the requirements of federal regulations. Additionally, Reporting Persons proposing Human Subject Research, in accordance with Federal, D-H and College policy, must, coincident with submission of the protocol to the IRB, either (1) disclose all Reportable Financial Interests as detailed herein to OSP, on forms provided by OSP, or (2) confirm to the IRB that a current disclosure of all Reportable Financial Interests as detailed herein is on file with OSP. All disclosures of Reportable Financial Interests should provide sufficient detail to permit an accurate and objective evaluation. Disclosure forms must be updated as new Reportable Financial Interests arise during the period of an award.
If D-H or the College carries out research through sub-grantees, contractors, or collaborators, D-H or the College shall require such sub-grantee, contractor, or collaborator to either comply with this Policy or provide assurances that its own policy substantially conforms to this Policy.
This Policy is based upon the principle of full disclosure of those Reportable Financial Interests that would reasonably appear to affect or be affected by the research or related activities. All persons subject to this Policy are expected to comply fully with it. Instances of non-compliance with, or deliberate breach of, this Policy, including without limitation failure to file or knowingly filing incomplete, erroneous, or misleading disclosure forms, or failure to comply with prescribed conflict management or monitoring procedures, will be reported to the Provost and CO.
The Provost and CO will consult with the Committee regarding possible sanctions to be imposed, which may include, but are not limited to, recommendation of the following:
The Provost and CO will then recommend an appropriate sanction to the Presidents of the College and the appropriate D-H component organization, who will make the final decision, which decision will be implemented through the appropriate institutional mechanisms. Matters under this Policy concerning Trustees shall be reported to the Chair of the Board of Trustees, of the College or the appropriate D-H component organization, for appropriate action.
In addition, the College and D-H shall follow Federal regulations regarding the notification of the sponsoring agency in the event a Reporting Person has failed to comply with this Policy. The sponsor may take its own action, as it deems appropriate, including the suspension of funding for the Reporting Person until the matter is resolved.
After twelve (12) months of operation under this Policy, the Committee shall compile and prepare a synopsis of the cases referred to it and resolution of same (the "Synopsis"), for review by the Provost and CO or their designee(s). The Provost and CO or their designee(s) shall review the Synopsis, any other material they deem appropriate for their review, solicit input from Principal Investigators and Other Key Personnel involved in Committee proceedings over the course of the prior twelve (12) months, and make any recommendations they deem appropriate concerning this Policy and/or the Committee's proceedings.
Professor Summers proposes to serve as the principal investigator ("PI") on a research project involving human subjects sponsored by Company XYZ. Over the past year, Professor Summers's consulting fees from Company XYZ have totaled $3,000. Professor Summers anticipates doing roughly the same amount of consulting for Company XYZ during the coming year.
The Conflict Review Committee ("CRC") decides that Professor Summers may serve as PI but recommends to the IRB that the conflict be managed by including the following statement in the patient consent form:
" Please note Dr. Summers receives consulting fees from the company providing funding for this research project, Company XYZ."
The Committee for the Protection of Human Subjects ("IRB") accepts the CRC's recommendation.
A Phase II randomized, double-blind, placebo-controlled clinical trial is proposed to be conducted at Dartmouth. The drug that is being tested is based on technology developed at Dartmouth and licensed to a for-profit company that will provide the drug for the clinical trial. Dr. Winter, the Co-Investigator on the project, developed the intellectual property that Dartmouth licensed to the above-referenced for-profit company. Dartmouth will receive fees and royalties from the company at various benchmarks set forth in the license agreement, and Dr. Winter will receive a portion of those payments pursuant to Dartmouth's royalty-sharing policy.
Based on the nature of this study and future anticipated uses for this drug, and the fact that the anticipated financial benefits to Dr. Winter are not significant, the CRC recommends that the conflict be managed, as follows:
The IRB accepts the recommended management plan and also requires the following sentence in the Patient Consent Form:
"Please note that the Co-Investigator of this research project, Dr. Winter, developed the drug being tested in this research study. If the drug proves beneficial and becomes commercially available, Dr. Winter and Dartmouth College may benefit financially through a licensing agreement with the company funding this study. Dr. Winter will not recruit or enroll patients into this study. The Principal Investigator, Dr. Spring, will supervise enrollment for the study. In addition, an external data monitoring board has been created to review the study safety data."
Dr. Princi, a physicist from the Center for Cognitive Neuroscience, currently owns 40% of the stock in Company ABC. The primary mission of Company ABC is to create a new means to image an MRI. Dr. Princi is a co-founder of Company ABC and currently serves as Chief Scientific Officer. Company ABC wants to provide funds to Dartmouth College in order to conduct a research study with the goal of improving the imaging of an MRI scan. Company ABC holds a license for the patented technology to be used in the research study. In addition, under the terms of the research agreement, Company ABC will have an option to negotiate a license to any new technology arising out of the research.
Because of the significant involvement of Dr. Princi in Company ABC, the CRC recommends allowing the research to be conducted at Dartmouth only under the management of faculty other than Dr. Princi. Dr. Princi will not be allowed to serve as a researcher on the study and will be required to remove himself from all aspects of the project. Another faculty member will carry out the role of principal investigator and manager of the project.
The IRB accepts the CRC's management plan and adds a sentence to the consent form, as follows:
"Please note that a member of the Dartmouth College faculty is co-founder and owns equity in the company sponsoring this project and therefore he may benefit financially if the techniques being tested are successful. The faculty member is not involved in the management of the research project."
Blue Drug Company wants to sponsor a clinical trial testing whether its existing soft-tumor drug is effective in treating certain atypical forms of solid tumors. Blue Drug Company is conducting this study at multiple sites throughout the country. The budget provided by Blue Drug Company is based on average costs incurred at all sites. At DHMC, the cost of conducting the study is less than the budget offered by the company. The projected cost per patient is $1,000 and the budgeted amount provided by the company is $5,000 per patient. It is anticipated that there will be funds remaining at the completion of the protocol, and that these funds will be available to support research by Dr. Jones, the faculty member directing the study at DHMC.
The CRC recommends a conflict management plan requiring a physician not involved with the research to validate that eligibility criteria are met, prior to the enrollment of a patient into this research study. The IRB accepts the CRC management plan and adds the following sentences to the consent form:
"Please note that in order to conduct this study, DHMC receives funds from Blue Drug Company. It is anticipated there will be extra funds remaining at the completion of the study. Any funds remaining will be used by Dr. Jones at DHMC for future educational or research purposes."
This form is issued in accordance with the Conflict of Interest Policy for Human Subject Research adopted by Dartmouth-Hitchcock Clinic, Mary Hitchcock Memorial Hospital, and Dartmouth College. Copies of the policy may be obtained from the Committee for the Protection of Human Subjects ("CPHS") or from the Dartmouth College web site.
This form should be completed by individuals with respect to whom a financial interest that could reasonably appear to affect or be affected by proposed human subject research has been listed in Section 29 of a CPHS Study Plan.
With regard to the research study referenced below, please describe financial interests held by the Principal Investigator, Other Key Personnel, or any of their spouses, domestic partners, or dependent children. You do not need to include: salary and benefits from Dartmouth-Hitchcock Clinic, Mary Hitchcock Memorial Hospital, or Dartmouth College; income from seminars, lectures, teaching engagements or publishing sponsored by Federal, state, or local entities or from non-profit academic institutions, where the origin of the funds is not from corporate sources; income from service on advisory committees or review panels for governmental or non-profit entities; investments in publicly-traded mutual funds; or gifts and promotional items of nominal value, and meals and lodging for participation in professional meetings.
Title of Study: __________________________________________________________
PI of Study: __________________________________________________________
CPHS #: _______________________________________
Compensation for services (e.g., consulting fees or honoraria), or in-kind payments, other than from the Reporting Person's primary employer, in the prior calendar year or projected over the next twelve months
___YES ____NO
Royalty income or the right to receive future royalties under a patent license or copyright, where the research is directly related to the licensed technology or work
___YES ____NO
Equity interests (e.g. stocks, stock options or other ownership interests, including equity holdings where the value cannot readily be determined by reference to public prices)
___YES ____NO
Intellectual property rights (e.g., patents, copyrights and royalties from such rights)
___YES ____NO
Gifts or funds available to the researcher from this sponsor beyond the current research project
___YES ____NO
Funding expected to significantly exceed the projected costs of conducting the current research project
___YES ____NO
The above is an accurate and current statement.
| Signature | Date | 200 |
| Printed Name | Title | |
| Please, sign and return the completed form in envelope marked "Confidential," to Nancy Wray, Director of the Office of Sponsored Projects, Hinman Box 6210. |
_____ There is no actual or potential conflict of interest. The Director of the OSP shall so inform the CPHS and the reporting person.
_____ There is an actual or potential conflict that could affect the objectivity of research, the reporting of results, or human subjects. The matter shall be referred to the Conflict Review Committee.
Comments:
| Signature | Date | 200 |
