Externally sponsored research is an important part of supporting faculty scholarly research and fulfilling the college's mission. As this activity grows in sophistication and complexity it may intersect increasingly with industrial explorations and entrepreneurial ventures, creating for investigators the potential for conflicting interests. A conflict of interest exists when it can be reasonably determined that an investigator's personal financial concerns could directly and significantly influence the design, conduct, or reporting of sponsored research activities. Faculty and staff of the college have an obligation to scrupulously maintain the objectivity of their research, avoiding any conflict of interest.
Saint Anselm College has developed this policy to protect the integrity of sponsored research and to comply with federal regulations. These regulations require that any faculty and staff member in a position to influence the outcome of a funded project asserts that he or she has no financial conflict of interest with regard to the project, or report any conflict that does exist. It is the intent and policy of the college, as an institution of higher education in receipt of federal research support, to comply with present and future regulations.
Specifically, the intent of this policy is to identify and eliminate or manage any possible threat to research objectivity at Saint Anselm College. The main components are disclosure of investigators' financial interests that might be affected by the research, and application of methods to minimize or eliminate the risks associated with such connections. It is not meant to discourage, but rather to safeguard the pursuit and dissemination of knowledge.
This policy becomes effective July 1, 2010 and applies to any employee of Saint Anselm College who is responsible for the design, conduct, or reporting of research activities funded or proposed for funding by external sources. The policy also includes the investigator's immediate family, which is defined as his/her spouse or domestic partner and dependent children. Project directors are responsible for ensuring that all participants in a project who are responsible for the design, conduct, or reporting of the research disclose any significant financial interests that would reasonably appear to be affected by the research. Individuals who come to work on an established project through reallocation of effort, hiring, transfer, promotion, etc., and thereby take on a responsible position in a project, must also disclose any such significant financial interests.
Collaborators, subcontractors, sub-recipients, and visiting scientists must either comply with this policy or provide a certification to the college Grant Officer that their institutions are in compliance with pertinent federal policies and that they in turn are in compliance with their own institutional policies. Subcontractors from commercial firms need make a certification only when the prime award is from the Public Health Service.
Significant Financial Interests
Any Saint Anselm College employee responsible for the design, conduct, or reporting of research activities funded or proposed for funding by external sources must reveal all current significant financial interests that would reasonably appear to be affected by the research. Significant financial interest is defined as any current financial interest of the investigator and his/her immediate family that could reasonably appear to be affected by the activities proposed for funding; or any interest held by the investigator and his/her immediate family in a business entity (company, corporation, or other enterprise) whose financial interests might reasonably appear to be affected by such activities.
Specifically, significant financial interests might include, but are not limited to, any of the following:
- Anything of significant monetary value, including salary or other payments for services, such as consulting fees or honoraria;
- Direct equity interests, such as stock, stock options, or ownership interests;
- Intellectual property rights owned by the investigator, such as patents, copyrights, and royalties from such rights.
The term does not include:
- Financial interests in business enterprises or entities that when aggregated for the investigator and his/her immediate family meet both of the following tests:
- the financial interest does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and
- the financial interest does not represent more than a five percent ownership interest in any single entity.
- Salary, royalties, or other remuneration from Saint Anselm College
- Salary, royalties, or other payments that when aggregated for the investigator and his/her immediate family, are not expected to exceed $10,000 during the next twelve month period;
- Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
- Income from service on advisory committees or review panels for public or non-profit entities.
An investigator may choose to disclose any other financial or related interest that might present an actual, potential, or perceived conflict of interest. Disclosure can be a key factor in protecting an individual's reputation and career from potentially harmful allegations of misconduct.
All Disclosure Statements and related documents are considered sensitive information and only those persons involved in the implementation of this policy will have access to such records.
Each investigator who has significant financial interests possibly affected by the research must complete a Saint Anselm College Financial Disclosure Statement (Word) and attach all required supporting documentation. In addition, the investigator must submit a proposed conflict of interest management plan that details steps that could be taken to manage, reduce, or eliminate any conflict of interest. The form, documentation, and plan should be submitted in a sealed envelope marked confidential to the Grants Officer.
All significant financial interests must be disclosed prior to the time a proposal is submitted. All financial disclosures must be updated by investigators during the period of the award as new reportable significant financial interests are obtained.
Review of Disclosures
The Vice President of Finance will review all disclosure statements to determine whether the significant financial interests of the investigator could reasonably be expected to affect the design, schedule, conduct, or reporting of the activities funded or proposed for funding. The Vice President of Finance may request additional clarifying information from the individual which will be treated as non-public information to the extent allowed by law.
Management Plans for Conflict
The Vice President of Finance may propose a conflict management plan and approve it or add conditions or restrictions to ensure that any conflict is managed, reduced, or eliminated. Such conditions or restrictions may include, but are not limited to, the following:
- Public disclosure of significant financial interests
- Monitoring of the research by independent reviewers
- Modification of the planned activities (possibly subject to sponsor approval)
- Disqualification from participation in all or part of the project
- Divestiture of significant financial interests
- Severance of relationships creating conflict.
In all cases, resolution of the conflict or establishment of an acceptable conflict management plan must be achieved before expenditure of any funds under an award.
If a conflict cannot be resolved to the investigators satisfaction, an appeal may be made to the college's Executive Vice President or President, who will consult with the investigator and the Vice President of Finance and make a binding decision.
As part of the Financial Disclosure Statement each investigator must certify that if the Vice President of Finance determines a conflict exists, the investigator will adhere to all conditions or restrictions imposed upon the project and will cooperate fully with the individual(s) assigned to monitor compliance.
Failure to properly disclose relevant financial interests or to adhere to conditions or restriction imposed by the Vice President of Finance will be considered a deviation from accepted standards of conducting research at Saint Anselm College.
Alleged violations of this policy will be investigated by the Vice President of Finance which will make recommendations for action to the Executive Vice President or President. Breaches of policy include failure to file the necessary disclosure statements; knowingly filing incomplete, erroneous, or misleading disclosure forms; or failure to comply with prescribed procedures. If a determination has been made that the policy has been violated, he/she may impose sanctions including notification of sponsor and termination of award; formal admonition; a letter to the investigator's personnel file; and suspension of the privilege to apply for external funding and/or to seek IRB approval.
The Business Office will maintain records of all disclosures and associated activities securely and confidentially. All records will be maintained for three years following the letter of termination or completion of the project or resolution of any government action involving the records. Records will not be routinely provided to sponsors unless such is an agency requirement, the agency submits a written request, or Saint Anselm College is unable to satisfactorily manage an actual or potential conflict of interest. The Grant/Contract Administrator will be responsible for communications with sponsors. Disclosure statements and associated information will not be released without notifying the investigator.
Federal Policy: The National Science Foundation (NSF) Investigator Financial Disclosure Policy and the U.S. Public Health Service (PHS) regulations in 42 CFR Part 50, and 45 CFR part 94, under the heading of Objectivity in Research are effective as of October 1, 1995, and carry the weight of federal regulation. The federal policies stipulate requirements for:
- annual financial disclosures on the part of ALL research investigators supported by NSF or PHS (defined in Section 3 with required form as Attachment 1)
- institutional certification that all proposed and ongoing NIH/NSF sponsored research is either free of conflicts of interest, or that such conflicts are adequately managed (detailed in Section 4)
- the implementation of an institutional mechanism for managing conflicts of interest in research
- keeping NIH/NSF informed if the College is unable to satisfactorily manage actual or potential conflicts of interest
- sanctions where appropriate (Section 7); and
- maintenance of records relating to this policy, for at least three years following the termination of a given project.