HMS/HSDM Financial Conflicts of Interest in Sponsored Research - FAQ's

About HMS

More... Share to Twitter Share to Facebook
HMS/HSDM Financial Conflicts of Interest in Sponsored Research - Frequently Asked Questions

Who is an “Investigator”?

The project director (PD) or principal investigator (PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research.

•  Investigators may include any individual that leads, manages, or makes a substantial contribution to a significant research-related activity (e.g., proposal development, conduct of research procedures, and/or analysis or reporting of results).
• The Disclosure Statement will require PI to identify all Investigators. 
• All Investigators must complete a Disclosure Statement prior to grant submission.  Disclosure Statements will be included with a grant proposal and/or uploaded into GMAS as part of the proposal.

What do I need to report to HMS and when do I need to report it?

Under the 2011 revised regulation, Investigators are required to disclose their Significant Financial Interests (and those of the Investigator’s spouse/partner and dependent children) that reasonably appear to be related to the Investigator’s institutional responsibilities:

(1) no later than at the time of application for PHS-funded research;
(2) within thirty days (30) of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest or occurrence of sponsored or reimbursed travel; and
(3) at least annually, in accordance with the specific time period prescribed by the Institution, during the period of award.

To whom should I disclose my financial interests?

You must report your relevant outside activities and financial interests to HMS.  Please go to outsideactivities.hms.harvard.edu/OAR to access the Outside Activity Reporting portal.

When should I disclose my financial interests to HMS?

Investigators must update their Outside Activity Report annually during the period of the PHS award, as well as within thirty (30) days of discovering or acquiring a new Reviewable Interest or occurrence of sponsored or reimbursed travel.

What about financial interests acquired or discovered during the award period subsequent to the submission of the initial report?

Investigators have an ongoing obligation to disclose Significant Financial Interests throughout the awarded project period.  Under the 2011 revised Financial Conflict of Interest regulation, Investigators must update financial disclosures of Significant Financial Interests to HMS within thirty (30) days of acquiring or discovering (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest.  HMS designated official(s) will have sixty (60) days to review the Significant Financial Interest disclosure, determine whether the Significant Financial Interest is related to NIH-funded research, determine whether a Financial Conflict of Interest exists, and if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, or will be, taken to manage the Financial Conflict of Interest.  If a Financial Conflict of Interest exists, HMS must submit an FCOI report to the NIH within this same 60-day period.

What about payments to or assets held by my spouse/partner or dependent children? Must these financial interests to be disclosed?

Yes.  The financial interests that must be disclosed by the Investigator include the aggregated amounts or values of financial interests held by the Investigator and his/her spouse/partner and dependent children.

How long does an Investigator have to disclose a newly acquired or discovered Significant Financial Interest?

Under the 2011 revised regulation, each Investigator who is participating in the NIH-funded research must submit to HMS an updated disclosure of Significant Financial Interests within thirty (30) days of acquiring or discovering a new Significant Financial Interest or a Significant Financial Interest that was not disclosed timely.

What happens if my financial interests change during the award period?

The 2011 revised regulation requires each Investigator who is participating in NIH-funded research to submit an updated disclosure of Significant Financial Interest to the Institution’s designated official(s) within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest.  HMS designated official(s) are required to review the updated financial disclosure of Significant Financial Interest, determine whether the Significant Financial Interest is related to the NIH-funded research and, if so related, whether the Significant Financial Interest is a Financial Conflict of Interest and take appropriate action to manage any Financial Conflict of Interests and report such FCOI(s) to NIH.

Do I need to disclose salary paid to me by my Institution as an Investigator?

No.  Salary, royalties, or other remuneration from your employing or appointing Institution is not included.

Do I need to disclose the occurrence of any reimbursed or sponsored travel related to my institutional responsibilities?

Yes.   The regulation requires Investigators to disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to the Investigator’s institutional responsibilities.  However, the disclosure requirement does not apply to travel that is reimbursed or sponsored by the following:

o a federal, state, or local government agency,
o an Institution of higher education as defined at 20 U.S.C. 1001(a),

o an academic teaching hospital,
o a medical center,
o a research institute that is affiliated with an Institution of higher education, or
o under a sponsored award.

For any reimbursed and/or sponsored travel that is reportable under the new PHS regulations, you will need to report the following information within thirty (30) days of travel:

1. Purpose of the trip,
2. The identity of the sponsor/organizer,
3. The destination, and
4. The duration of travel.

Moreover, there is a $5,000 de minimis per entity.  This means that you only have to report sponsored or reimbursed travel if the travel was more than $5,000, you receive more than $5,000 from the entity for services or a combination of the two is more than $5,000.

Does an Investigator need to disclose all reimbursed or sponsored travel, no matter the dollar level, if it is reimbursed or sponsored by sources other than those excluded from disclosure (i.e., Federal, state, or local government agency; an U.S. Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an U.S. institution of higher education; or under a sponsored award)?

HMS imposes a $5,000 de minimis threshold to reporting of reimbursed or sponsored travel (when aggregated per entity).  Investigators must disclose their Significant Financial Interests, including reimbursed or sponsored travel, no later than at the time of application over the previous twelve-month period (initial disclosure), which is also the same disclosure requirement that applies to all other Significant Financial Interests. The initial disclosure of Significant Financial Interests over the previous twelve-month period provides baseline information that allows HMS to take into account whether Investigators have an ongoing financial relationship with an entity providing a payment or reimbursement or whether the payment or reimbursement was limited in duration.

The 2011 revised regulation requires disclosure of basic information about reimbursed or sponsored travel including, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination and the duration.  As provided in the regulation, the Institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.  The regulation does not specify the process to be used by Institutions for review of Investigator travel disclosures; however, the Institution is responsible for determining whether such travel constitutes a Financial Conflict of Interest with PHS-funded research.  Travel to scientific meetings and to present Investigator’s research to colleagues and other interested parties is an integral part of the scientific research enterprise and affords many important opportunities for forging relationships and collaborations among researchers.  The provisions in the revised regulations are not intended to discourage this type of travel but require the disclosure of the occurrence of any reimbursed or sponsored travel related to the Investigator’s institutional responsibilities provided the travel is not sponsored or reimbursed by those identified sources excluded in the Final Rule.  NIH recently announced that institutions have the discretion to apply the $5,000 de minimis threshold for disclosure to reimbursed or sponsored travel (when aggregated per entity).  HMS is applying the de minimis.

I am an Investigator in an NIH-supported clinical trial network. My network has developed a study-wide policy for the trial that requires me to disclose my Significant Financial Interests to my network’s steering committee/operations office on an annual basis. Do I need to disclose my Significant Financial Interests to HMS as well?

Yes.  If you are an Investigator as defined by the regulation on an NIH-supported grant award, then you must disclose your Significant Financial Interests to HMS in accordance with the Financial Conflict of Interest policy.

Is income from all non-profit institutions excluded from the definition of Significant Financial Interest?

No.  The 2011 revised regulation states that income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education is excluded from the definition of Significant Financial Interest.   Such income from all other sources is included in the definition of Significant Financial Interest and, accordingly, must be disclosed.

What must be disclosed when an Investigator is employed by HMS and has equity in a for-profit company?

It depends.  The Investigator must disclose the equity interest in the for-profit company to HMS  if the Significant Financial Interest is related to the Investigator’s institutional responsibilities.  If the for-profit company is unrelated to the Investigator’s institutional responsibilities, the Investigator does not need to disclose the equity interest to HMS.

Am I required to disclose interests in mutual funds or retirement accounts?

No, you do not need to disclose interests held in mutual funds, pensions, institutional investments, or other investment vehicles where you have no ability to control what shares you buy and sell.

What about stock and stock options?

You need to disclose equity interests that are relevant to your institutional role which would include stock, options, and warrants. However, you do not have to report stock held in mutual funds, pensions, institutional investments, or other investment vehicles where you have no ability to control what shares you buy and sell.

Are foreign investments (e.g., shares in a foreign corporation) covered by the financial disclosure requirement?

Yes.  Financial interests are defined as anything of monetary value, whether or not the value is readily ascertainable.  Any financial interest that meets the definition of Significant Financial Interest under the regulation must be disclosed.  Foreign investments are covered financial interests under the regulation, if the investments satisfy the definition of Significant Financial Interest.  The Investigator must disclose Significant Financial Interests (and those of the Investigator’s spouse and dependent children).

What about “blind trusts?”

No, you do not need to disclose interests held in investment vehicles where you have no ability to control what shares you buy and sell such as a blind trust. 

Sponsored Travel - FAQ's

What is the definition of sponsored travel?

Sponsored travel is any travel related to your institutional responsibilities paid on your behalf by an outside entity, regardless of dollar amount. Excluded from this definition is any travel reimbursed or sponsored from teaching engagements/talks sponsored by or service on advisory or review panels for federal, state or local government agency, U.S. institution of higher education, academic teaching hospital, medical center or research institute affiliated with an U.S. institution of higher education or under a sponsored award.

Do I need to disclose the occurrence of any reimbursed or sponsored travel related to my institutional responsibilities?

Yes.   The regulation requires you to disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to your institutional responsibilities.  However, the disclosure requirement does not apply to travel that is reimbursed or sponsored by the following:

• a federal, state, or local government agency;
• an Institution of higher education as defined at 20 U.S.C. 1001(a);
• an academic teaching hospital;
• a medical center; or
• a research institute that is affiliated with an Institution of higher education.

Additionally, a $5,000 de minimis when aggregated per entity applies.  This means that you only have to report travel if the travel is more than $5,000, you receive more than $5,000 in services from the entity or a combination of the two exceeds $5,000.

Pursuant to the federal regulations, you must disclose the following:

• purpose of the trip;
• the identity of the sponsor/organizer;
• the destination; and
• the duration.

Moreover, the regulations do not exclude foundations and other non-profits from the disclosure requirements.  As such, you are required to disclose travel reimbursed or sponsored by those entities.

What exactly do I need to report to HMS in connection with reimbursed or sponsored travel?

For any reimbursed and/or sponsored travel that is reportable under the new Public Health Service (PHS) regulations, you will need to report the following information within thirty (30) days of travel:

1. Purpose of the trip,
2. The identity of the sponsor/organizer,
3. The destination, and
4. The duration.

We also request that you provide an approximate date of the travel so we know what occurred within the last twelve (12) months.  In general, we do not require that you provide us with the exact amount of the sponsored travel or travel reimbursement. In some certain instances, such as very lengthy stays or exotic/unusual travel destinations, we may ask for further details relating to the trip, including approximate reimbursed or sponsored amounts. It is therefore advisable that you keep some documentation about the amount of reimbursed and the approximate amount of sponsored travel for each trip undertaken.  This does not mean, however, that we will ask for or that you will need to keep individual travel-related receipts, such as taxi receipts or airline tickets, though you may want to keep those for tax reporting or other personal purposes.

I am combining a trip to an advisory board meeting of a company I consult for, and which is paid for by the company, with a family vacation for which I am paying myself. What do I need to report to as reimbursed/sponsored travel?

It is not uncommon to combine a business trip with a personal vacation. And it is fine to do so as long as the vacation part of the trip is paid for by personal funds and not by the company that is paying for the business trip. For the purposes of the reporting requirement, you will need to disclose the following to HMS within thirty (30) days of the travel:

1. Purpose of the trip,
2. The identity of the sponsor/organizer,
3. The destination, and
4. The duration (excluding the subsequent family vacation).

Public Accessibility - FAQ's

Is HMS required to make my Financial Conflict of Interest publicly accessible?

Yes.  To comply with the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought [(42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94)], HMS will ensure public accessibility of identified financial conflicts of interest held by senior/key personnel, via a written response within five (5) business days upon receipt of a request.

What are the requirements for making information regarding an identified Financial Conflict of Interest of senior/key personnel publicly accessible?

HMS will ensure public accessibility, via a written response within five (5) business days upon receipt of a request as detailed below, of information concerning Significant Financial Interest (SFI) disclosed to HMS that meets the following criteria:

• The individual for whom information is sought, is identified by HMS in the grant application, progress report, or any other required report submitted to the NIH as a senior/key personnel on an NIH grant or cooperative agreement for which a notice of award was issued on or after August 24, 2012;
• The SFI is still held by the senior/key personnel for the NIH-funded research project;
• A determination has been made that the SFI is related to the PHS-funded research; and
• A determination has been made that the SFI is a Financial Conflict of Interest (FCOI).

What information regarding an identified Financial Conflict of Interest of senior/key personnel is HMS required to make publicly accessible?

HMs must provide the following information: Investigator name, Investigator title and role with respect to the research, the name of the entity in which the significant financial interest is held and the approximate dollar value of the significant financial interest (in a dollar range) or a statement that the interest is one whose value is not readily ascertainable by reference to the public price or other reasonable measure of fair market value. 

Subcontracts/Subawards - FAQ's

What are the responsibilities of HMS for subrecipients (e.g., subcontractors or consortium members)?

HMS is responsible for ensuring that any sub-recipient's institution affirms that the institution has a PHS compliant COI policy and will report any FCOIs identified to HMS in a timely manner.  HMS will be responsible for reporting it to PHS prior to any spending on subaward (or prior to commencement of new investigator participation).  If sub-recipient institution does not have a COI policy, HMS will provide a PHS compliant COI policy and related disclosure form for the sub-recipient institution to consider.  Standard language will be incorporated into subawards.

Training Requirement – FAQ’s

Does the regulation require Investigator training?

Yes.  Each Investigator (as defined by the regulation), including subrecipient Investigator(s), must complete training prior to engaging in PHS-funded research and at least every four years, and immediately under the designated circumstances:

o Institutional Financial Conflict of Interest policies change in a manner that affects Investigator requirements
o An Investigator is new to an Institution
o An Institution finds that an Investigator is not in compliance with the Institution’s Financial Conflict of Interest policy or management plan.

Please go to www.citiprogram.org to access the Conflict of Interest CITI Training.

 Instructions:

1)    Log-in:
A CITI account is required to access the training, and you should use your existing account.  If you do not have an account, this link will also allow you to create an account.   Please register with your HMS email address and provide your HUID.

When registering, please select Harvard Medical School and Harvard School of Dental Medicine from the list of participating institutions.

2)  You will need to enroll in the CITI Conflict of Interest Course. To enroll:
•         Please select “Conflicts of Interest” when it asks which category or categories of courses you need to take

3)  The “Conflict of Interest – Stage 1” Course will be displayed in the “My Courses” section. Click on “Enter” to begin.

4)  To access the course content, you will need to sign the Integrity Assurance Statement. Once acknowledged, you’re now able to begin the Conflict of Interest Training modules.

5)  Complete all three COI Training modules:
a) Financial Conflicts of Interests
b) Institutional Responsibilities
c) Mandatory PHS Required Training on Research Conflicts of Interest at Harvard Medical School.

You will need a score of 80% or higher on Modules 1 and 2, to successfully complete the training and receive credit. If you do not score 80% or higher, you will need to re-take the quiz portion of the relevant module until you reach 80%. There is no quiz for module 3.

To confirm you have completed each module, you can find your results by clicking on “See a list of all modules completed” located in the main menu.

Why This Training is Important:
Individuals who are currently participating in PHS-funded projects or cooperative agreements, and who do not complete the mandatory training by August 24, will become ineligible to work on those projects at the next progress report. Individuals who have submitted a new application for funding will not be able to participate, or receive any funds, until the training is completed. Individuals who are not currently participating in a PHS-funded project will be ineligible to join such a project until the training is completed.

When is an Investigator required to complete Financial Conflict of Interest training if they are currently funded under a PHS grant or cooperative agreement at the time the HMS FCOI policy is implemented and posted?

Investigators are required to complete FCOI training at least once before engaging in PHS-funded research and every four years thereafter.  If you are currently funded, you will be required to complete the training prior to a notice of award (renewal or new award).  Additionally, FCOI Training must occur immediately if (i) Institutional FCOI policies change in a manner affecting investigator requirements; (ii) Investigator is new to institution; or (iii) institution finds an investigator noncompliant with policy or existing management plan.

Retrospective Review - FAQ's

What is a retrospective review and when is it required? 

Whenever a Financial Conflict of Interest is not identified or managed in a timely manner, including:

• Failure by the Investigator to disclose a Significant Financial Interest that is determined by the Institution to constitute a Financial Conflict of Interest;
• Failure by the Institution to review or manage such a Financial Conflict of Interest; or
• Failure by the Investigator to comply with a Financial Conflict of Interest management plan;

HMS must, within 120 days of the Institution’s determination of noncompliance, complete a “retrospective review” of the Investigator’s activities and the NIH-funded research project to determine whether any NIH-funded research, or portion thereof, conducted during the time period of the noncompliance was biased in the design, conduct, or reporting of such research.

What are the key elements for documenting the retrospective review? 

HMS is required to document the retrospective review which must include at least the following key elements:

A. Project number;
B. Project title;
C. PD/PI or contact PD/PI if a multiple PD/PI model is used;
D. Name of the Investigator with the FCOI;
E. Name of the entity with which the Investigator has a financial conflict of interest
F. Reason(s) for the retrospective review;
G. Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed, etc.);
H. Findings of the review; and
I. Conclusions of the review.

What will HMS do if bias is found during the retrospective review?

If bias is found, HMS must notify NIH promptly and submit a mitigation report to the NIH.  The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and HMS’ plan of action or actions taken to eliminate or mitigate the effect of the bias (i.e., impact on the research project, extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable).  Thereafter, HMS will submit FCOI reports annually as prescribed by the regulation.