Conflict of Interest and PHS (Public Health Science) Sponsored Specific Requirements

Researchers at the MBL are subject to the Institute’s Conflict of Interest Policy (No. K.1.3) which supports compliance with Federal and sponsor specific conflict of interest (COI) disclosure requirements. Acceptance of sponsored research funds puts specific obligations on the MBL to indicate the conditions under which outside activities and financial interests are proper or improper, to provide for notification of conflict of interest, and to have a sound policy for dealing with violations. Anyone submitting a proposal for sponsored research should read the MBL Conflict of Interest Policy MBL Policy No. K.1.3  MBL Conflict of Interest Policy

The NSF requires conflict of interest disclosures from all investigators, who are defined as “the principal investigator, co- principal investigators/co-project directors, and any other person at the organization who is responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding by the NSF”.  Subawardee investigators should make their disclosures to the organization that will accept the subaward.

It is the policy of the MBL that each Investigator must disclose a Significant Financial Interest (SFI) (and those of the Investigator’s spouse and dependent children) related to the Investigator’s institutional responsibilities that meets or exceeds the regulatory definition of SFI:

a. No later than at the time of application for PHS-funded research
b. At least annually during the period of the award (August 15th, per MBL policy)
c. Within 30 days of discovering or acquiring a new SFI

MBL Conflict of Interest; Annual Disclosure and CITI Training  In addition to completing an annual Conflict of Interest Disclosure, scientists at the MBL receiving funds from Public Health Services (PHS) agencies, must complete a Conflict of Interest on-line tutorial every four years. Training is provided through the Collaborative Institutional Training Initiative (CITI) https://www.citiprogram.org/

The Conflict of Interest Training consists of three modules; (1.) Financial Conflicts of Interest: Overview, Investigator Responsibilities, and COI Rules, (2.) Institutional Responsibilities as They Affect Investigators, and (3.) Conflicts of Commitment, Conscience, and Institutional Conflicts of Interest.

Federal PHS Sponsors: National Institutes of Health (NIH), the Administration for Children and Families, Administration on Aging, Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Federal Occupational Health, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, and Substance Abuse and Mental Health Services Administration. The most current list can be found here.

Foundations following PHS COI Guidelines: Alfred P. Sloan Foundation, Alliance for Lupus Research (ALR), American Cancer Society (ACS), American Heart Association (AHA), Arthritis Foundation (AF), California Breast Cancer Research Program (CBCRP), California HIV/AIDS Research Program (CHRP), Lupus Foundation of America (LFA) and Susan G. Komen for the Cure

Conflict of Interest Training through CITI must be taken:
a. Prior to engaging in research related to any PHS-funded grant
b. At least every 4 years
c. Immediately, if : (1.) Institution revises its FCOI policy that affects requirements of Investigators (2.) An Investigator is new to any Institution (3.) An Investigator is not in compliance with the policy or management plan

Who is an Investigator?  Investigator means the individual or individuals who are independently responsible for the design, conduct, or reporting of the research project. This is typically the principal investigator and any co-principal investigator (i.e. the project leadership), though in some cases the principal investigator may determine that others are independently responsible for the project. While a title alone cannot determine who is an Investigator, postdoctoral appointees and graduate students are rarely considered independently responsible for a project. For NIH projects, the individuals identified in the proposal as “key personnel” may be Investigators.

The PHS Conflict of Interest regulations apply to all Investigators.  An Investigator is the principal investigator, co-principal investigator or any other individual who is independently responsible for the design, conduct, or reporting of PHS funded research.

Principal Investigators are responsible for appropriately identifying individuals who meet this definition for each proposal and award.  The NIH definition of senior/key personnel and Investigator are closely related.

PUBLIC ACCESSIBILITY  PHS requires MBL to make information regarding Financial Conflict of Interests reported to PHS, available to the public upon request. The minimum amount of information that must be made available includes the following:

1. Investigator’s name;
2. Investigator’s title and role with respect to the research;
3. Name of the entity in which the Significant Financial Interest is held or from which it is received;
4. Nature of the Significant Financial Interest; and
5. Approximate value of the Significant Financial Interest, which value may be expressed as being within a range as described above or if the value of the interest cannot be readily determined through reference to public prices or other reasonable measures of fair market value, a statement confirming that fact.

Information request should be submitted in writing to the following address:

Marine Biological Laboratory
Office of Human Resources
7 MBL Street
Woods Hole  MA 02543

For more information on specific federal policies:

NIH Conflict of Interest Policy

NSF Conflict of Interest Policy