Research Support

The Amsterdam UMC PHS FCOIP implements United States PHS regulations 42 CFR 50 Subpart F “Promoting objectivity in Research” and 42 CFR Part 94 “Responsible Prospective Contractors” (text of PHS regulation). Amsterdam UMC is responsible for ensuring implementation of these policies and may suspend all relevant activities until the financial conflict of interestis resolved or other actiondeemed appropriate by the Institutional official is implemented. Violation of any part of these policies may also constitute cause for disciplinary or other administrative action pursuant to Institutional policy.

Definitions

'Clinical Trial' means any PHS-sponsored research study that involves interaction with human subjects and the concurrent investigative use of drugs, biologics, devices or medical or other clinical procedures, such as surgery.

'Family' means any member of the Investigator’s immediate family, specifically, any dependent children and spouse.

'Financial Interest' means anything of monetary value received or held by an Investigator or an Investigator’s Family, whetheror not the value is readily ascertainable, including, but not limited to: salary or other paymentsfor services (e.g.,consulting fees, honoraria, or paid authorships for other than scholarly works);any equity interests(e.g., stocks, stock options, or other ownershipinterests); and intellectual property rights and interests (e.g., patents, trademarks, service marks, and copyrights), upon receipt of royalties or other income related to such intellectual property rights and interests.

'Financial Interest' does not include:

1. salary, royalties, or other remuneration from the Institution;
2. income from the authorship of academic or scholarly works;
3. income from seminars, lectures, or teaching engagements sponsored by or from advisory committees or review panels for U.S. Federal, state or local governmental agencies; U.S. institutions of higher education; research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers; or
4. equity interests or income from investment vehicles, such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions made in these vehicles.

For Investigators, 'Financial Interest' also includes any reimbursed or sponsored travel undertaken by the Investigator and related to his/her institutional responsibilities. This includes travel that is paid on behalf of the Investigator as well as travel that is reimbursed, even if the exact monetary value is not readilyavailable.

It excludes travel reimbursed or sponsored by U.S. Federal, state or local governmental agencies, U.S. institutions of higher education,research institutes affiliatedwith institutions of higher education, academic teachinghospitals, and medicalcenters.

'Significant Financial Interest' means a FinancialInterest that reasonably appears to be related to the Investigator’s Institutional Responsibilities, and:

1. if with a publicly traded entity, the aggregate value of any salary or other payments for services received during the 12 month period preceding the disclosure, and the value of any equity interest during the 12 month period preceding or as of the date of disclosure, exceeds $5,000; or
2. if with a non-publicly traded entity, the aggregate value of any salary or other payments for services received during the 12 month period preceding the disclosure exceeds $5,000; or
3. if with a non-publicly-traded company, is an equity interest of any value during the 12 month period preceding or as of the date of disclosure; or
4. is income exceeding $5,000 related to intellectual property rights and interests not reimbursed through the Institution, or
5. is reimbursed or sponsored travel exceeding $5,000 related to their institutional responsibilities.

'Financial Conflict of Interest' means a Significant Financial Interest (or, where the Institutional officialrequires disclosure of other Financial Interests, a Financial Interest) that Amsterdam UMC reasonably determines could directly and significantly affectthe design, conductor reporting of PHS- sponsored research.

'Institutional official' means the individual within Amsterdam UMC that is responsible for the solicitation and review of disclosures of significant financialinterests including those of the Investigator’s Family related to the Investigator’s institutional responsibilities. For the purposes of this policy, the Institutional Official is designated as the Chair of the Department within Amsterdam UMCwhere the Research fundedby the United States PHS takes place.

'Institutional responsibilities' means the Investigator’s professional responsibilities associated with his or her Institutional appointment or position,such as research, teaching, clinicalactivities, administration, and institutional, internal and external professional committee service.

'Investigator' means any individual as indicated in the definition of “Investigator” in 42 CFR 50.603 and 42 CFR 94.3. This definition is not limited to those titled or budgeted as principal investigator or co-investigator on a particular proposal, and may include postdoctoral associates, senior scientists, or graduate students. The definition may also includecollaborators or consultants as appropriate.

'Public Health Service' or 'PHS' means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority of the PHS may be delegated. The components of the PHS include, but are not limited to, the Administration for Children and Families, Administration on Aging, Agencyfor Healthcare Researchand Quality, Agency for Toxic Substances and Disease Registry,Centers for DiseaseControl and Prevention, Federal Occupational Health, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, and Substance Abuse and Mental Health Services Administration.

'Research' means a systematic investigation, study, or experiment designedto contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and appliedresearch (e.g., a published article,book or bookchapter) and product development (e.g., a diagnostic test or drug).

Conflict of interest

This policy is predicated on the expectation that Investigators should conduct their affairs so as to avoid or minimize conflicts of interest, and must respond appropriately when conflicts of interest arise. To that end, this policyinforms Investigators about situations that generate conflicts of interest related to research, provides mechanisms for Investigators and Amsterdam UMC to managethose conflicts of interest that arise, and describes situations that are prohibited. Every Investigator has an obligation to become familiar with, and abide by, the provisions of this policy. If a situation raising questions of conflict of interest arises, an Investigator should discuss the situation with the Institutional official.

1. Disclosure of Financial Interests

All Investigators are required to disclose their outside financial interests as defined above to Amsterdam UMC on an annual and on an ad hoc basis, as described below. The Institutional official is responsible for the distribution, receipt, processing, review and retention of disclosure forms.

1. Annual Disclosures: all Investigators must disclose their Significant Financial Interests that are related to the investigator’s institutional responsibilities to the Institution, throughthe Institutional Official, on an annual basis. All forms should be submitted to the Institutional official or designee by June 1 forthe previous calendaryear.

2. Ad hoc Disclosures: In addition to annual disclosure, certain situations require ad hoc disclosure.All Investigators must disclose their Significant Financial Interests to the Institution, through the Institutional Official, within30 days of their initialappointment or employment.
   
   Prior to entering into PHS-sponsored projects or applications for PHS-sponsored projects, where the Investigator has a Significant Financial Interest, the Investigator must affirmthe currency of the annualdisclosure or submitto the Institutional Official an ad hoc updated disclosure of his or her Significant Financial Interests with the outside entity. Amsterdam UMC will not submit a research proposal unless the Investigator(s) have submitted such ad hoc disclosures.
   
   In addition, all Investigators must submit to the Institutional official an ad hocdisclosure of any Significant Financial Interest they acquire or discover during the course of the year within thirty (30) days of discovering or acquiring the Significant Financial Interest.

3. Travel: investigators must also disclose reimbursed or sponsored travel related to their institutional responsibilities, as defined above in the definition of Financial Interestand Significant Financial Interest. Such disclosures must include, at a minimum, the purposeof the trip, the identityof the sponsor/organizer, the destination, the duration, and,if known, the monetary value.The Institutional Officialwill determine if additional information is needed (e.g.,the monetary value if not already disclosed) to determine whether the travel constitutes a Financial Conflict of Interest with the Investigator’s research.

2. Review and decision of the institutional official

If the disclosure form reveals a Significant Financial Interest, it will be reviewed promptly by the Institutional Official or designee for a determination of whether it constitutes a Financial Conflict of Interest.If a Financial Conflict of Interest exists, the Institutional Official will take action to manage the financial conflict of interest including the reductionor elimination of theconflict, as appropriate.

A Financial Conflict of Interestwill exist when the Institutional Officialor designee determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of PHS-sponsored research. If the Institutional Official determines that there is a Financial Conflict of Interest that can be managed, he or she must develop and implement a written management plan. The affected Investigator must formally agree to the proposed management strategies and sign the written management plan before any related PHS-sponsored research goes forward.

The Institutional Official will periodically review the ongoing activity, monitor the conduct of the activity (including use of studentsand postdoctoral appointees), to ensure open and timelydissemination of the research results,and to otherwise oversee compliance with the management plan.

3. Clinical Trials

Clinical trials involve particularly sensitive issues if the Investigator has a FinancialInterest related to the clinicaltrial. In the event of non-compliance with reporting and/or management of a financial conflict of interest involving a PHS-sponsored clinical research project whose purposeis to evaluate the safety or effectiveness of a drug, medical device,or treatment as required by this Policy,the investigator must disclose the financial conflicts of interest in each public presentation of the resultsof the affected PHS-sponsored researchand request an addendumto previously published presentations.

4. Reporting to PHS

The institutional official will report financial conflicts of interest or non-compliance to PHS in accordance with PHS regulations. If the fundingfor the Researchis made available from a prime PHS-awardee, such reports shall be made to the prime awardee prior to the expenditure of any funds and within60 days of any subsequently identified financial conflictof interest such that the prime awardee may fulfill their reporting obligations to the PHS.

5. Investigator non-compliance

1. Disciplinary Action: In the event of an Investigator’s failure to comply with this Policy, the Institutional official may suspend all relevant activities or take other disciplinary action until the matter is resolved or other action deemed appropriate by the Institutional official is implemented.
   
   A Institutional Official’s decision to impose sanctions on an Investigator because of failure to comply with this Policy, or failure to comply with the decision of the Institutional official, will be described in a written explanation of the decision to the investigator, and, where applicable, the IRB, and will notify the individual of the right to appeal the decision. Amsterdam UMC will promptly notify the PHS Awarding Component of the actiontaken or to be taken.If the funding for the research is made available from a prime PHS awardee, such notification shall be made promptly to theprime awardee for reporting to PHS.
2. Retrospective Review: in addition, if the Institutional Official determines that a Financial Conflict of Interest was not identified or managed in a timely manner, including but not limited to an Investigator’s failure to disclose a Significant Financial Interest that is determined to be a Financial Conflict of Interest, or failure by an Investigator to materially comply with a management plan for a Financial Conflict of Interest, an ad hoc committee appointed by the Institutional Official will complete a retrospective review of the Investigator’s activities and the PHS-sponsored researchproject to determine whether the researchconducted during the period of non-compliance was biased in the design,conduct or reporting of the research.
   
   Documentation of the retrospective review shall include the project number, project title, PI, name of Investigator with the Financial Conflict of Interest,name of the entity with which the Investigator has the Financial Conflict of Interest, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review.
   
   The Institutional official will update any previously submitted report to the PHS or the prime PHS-awardee relating to the research, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward. This retrospective review will be completed in the manner and within 120 days of the institution’s determination of noncompliance with the PHS regulations and this policy. If bias is found, Amsterdam UMC will promptly notify the PHS Awarding Component and submit a mitigation report in accordance with the PHS regulations. The mitigation report will identifyelements documented in the retrospective review, a description of the impact of the bias on the research project and the planof action to eliminate or mitigate the effect of the bias.

6. Training

Each Investigator must complete training on this Policy, the investigator’s responsibilities regarding disclosure and the PHS regulations prior to engagingin research fundedby PHS, and at least every four years thereafter. They must also complete training within a reasonable period of time as determined by the Institutional Official in the event that this Policy is substantively amended in a manner that affects the requirements of Investigators, if the investigator is new to the institution, or if it is determined that the Investigator has not complied with this policy or with a management plan related to their activities.

7. Record retention

The Institutional Official will retain all disclosure forms, conflict management plans, and relateddocuments for a period of three years from the date, as applicable, (i) the final expenditure reportis submitted to the PHS or to the prime PHS awardee or (ii) of final payment, unless the exceptions of 45 CFR 75.361 (a) through (f) or 48 CFR 4.705 apply and in such case the retention periods in those subsections will be followed by the Institutional Official.

8. Confidentiality

To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be confidential. However, Amsterdam UMC may be required to make such information availableto the PHS Awarding Componentand/or HHS, to a requestor of information concerning financial conflict of interest related to PHS funding or to the primary entity who made the funding available to the Institution, if requested or required. If Amsterdam UMC is requested to provide disclosure forms, conflict management plans, and related information to an outside entity, the Investigator will beinformed of this disclosure.

9. Public accessibility

Prior to the expenditure of funds, Amsterdam UMC will respond to any requestor within five business days of the request, information concerning any Significant Financial Interest that meets the following criteria:

1. The Significant Financial Interest was disclosed and is still held by the senior and key personnel;
2. A determination has been made that the Significant Financial Interest is related to the PHS-funded research; and
3. A determination has been made that the Significant Financial Interest is a Financial Conflict of Interest.

10. Regulatory authority

This policy implements the requirements of 42 CFR 50 Subpart F and 45 CFR 94; where there are substantive differences between this policy and the requirements, the requirements shall take precedence.