Summary of Updates to the MIT Policies and Procedures on Conflicts of Interest in Research | Financial Conflicts of Interest in Research

Changes are effective late August 2013.

Policy Statement

Existing	Summary of Change	Rationale
A statement of what a conflict of interest is, and the need for Investigators to disclose their financial relationships.	Introduction paragraph talks more about what a COI is and the importance of disclosing to MIT.	Faculty Feedback suggested clarity and more information so people understand what a COI is and why it’s important to disclose.

Definitions

Existing	Summary of Change	Rationale
No specific definition of aggregate which lead to multiple interpretations and inconsistencies in reporting	New definition: Aggregate means the consolidated total of monies received from a single entity (i.e. through Remuneration, Sponsored Travel, Equity Interests, etc.)	Faculty feedback suggested a more comprehensive definition that would capture all of the different types of income or payments received from an entity.
No definition of Sponsored Travel; previously all travel by PHS investigators was required to be reported	New definition: Sponsored Travel (applies only to PHS Investigators) means (a) travel expenses paid to or on behalf of an Investigator, by a single entity in any 12-month period and (b) travel reimbursed to or paid on behalf of an Investigator’s Family by a single entity in any 12-month period, but ONLY if such travel reasonably appears to be related to the Investigator’s Institutional Responsibilities. See the PHS Addendum for more information.	ALL travel had to be reported prior to the NIH issued "clarification" on October 18, 2012, which suggested travel could be considered an SFI. Therefore, to reduce administrative burden for PHS investigators, the de-minimus threshold of $5000 in Aggregate from the same entity is now applied. For example, a $3000/year consulting project with Company A does not need to be disclosed, but, Company A also reimbursed you directly for a trip to tour their headquarters, value of $2500, now the Aggregate for Company A (consulting + travel) is greater than >$5K and both events must be reported.
Definition of Family did not include "domestic partner".	Updated definition: Family now includes "domestic partner".	This is now in keeping with HR’s definition of Family

Existing

Summary of Change

Rationale

No specific definition of aggregate which lead to multiple interpretations and inconsistencies in reporting

New definition: Aggregate means the consolidated total of monies received from a single entity (i.e. through Remuneration, Sponsored Travel, Equity Interests, etc.)

Faculty feedback suggested a more comprehensive definition that would capture all of the different types of income or payments received from an entity.

No definition of Sponsored Travel; previously all travel by PHS investigators was required to be reported

New definition: Sponsored Travel (applies only to PHS Investigators) means (a) travel expenses paid to or on behalf of an Investigator, by a single entity in any 12-month period and (b) travel reimbursed to or paid on behalf of an Investigator’s Family by a single entity in any 12-month period, but ONLY if such travel reasonably appears to be related to the Investigator’s Institutional Responsibilities. See the PHS Addendum for more information.

ALL travel had to be reported prior to the NIH issued "clarification" on October 18, 2012, which suggested travel could be considered an SFI. Therefore, to reduce administrative burden for PHS investigators, the de-minimus threshold of $5000 in Aggregate from the same entity is now applied.

For example, a $3000/year consulting project with Company A does not need to be disclosed, but, Company A also reimbursed you directly for a trip to tour their headquarters, value of $2500, now the Aggregate for Company A (consulting + travel) is greater than >$5K and both events must be reported.

Definition of Family did not include "domestic partner".

Updated definition: Family now includes "domestic partner".

This is now in keeping with HR’s definition of Family

Disclosure Requirements

Existing	Summary of Change	Rationale
Disclosures submitted in August during the "annual" disclosure process. Disclosures updated throughout the year, yet the "annual" disclosure was still required.	New "rolling" disclosure process is being implemented that recognizes significant revision, and resets the due date 12 months forward. Specific revision triggers defined.	The new process recognizes that Investigators are updating their disclosures more regularly when they disclose new SFIs. This change recognizes those substantial updates. The MyCOI module in Coeus will provide a more user friendly experience to support this change.

PHS addendum (affected sections are Sponsored Travel, Reporting to PHS)

Existing	Summary of Change	Rationale
No Sponsored Travel definition, all travel required to be reported.	Sponsored Travel is a newly defined term and is now considered an SFI under MIT’s COI policy. Only travel that meets the de minimis $5,000 threshold should be inclueee in our disclosure requirements. Travel must be disclosed at the time of proposal submission, including Sponsored Travel in the previous 12 months for the date of proposal submission. PHS Investigators must keep their Sponsored Travel updated as long as they have a pending proposal or active award.	On October 18, 2012 NIH issued a clarification concerning disclosure requirements for reimbursed and Sponsored Travel. This clarification caused MIT to change its policy. In the issued clarification, NIH states that looking back over the previous twelve-month period provides baseline information that allows MIT 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
Defined periods for determining and reporting to PHS unclear	Clarification of the timeline for reporting to PHS: All SFIs must be disclosed via MyCOI in Coeus within 30 days of identifying an SFI; within 60 days from disclosure, MIT shall review/determine if SFI is an FCOI and if so, implement a management plan; within 60 days of determining that an FCOI exists, report it to the PHS funding agency	The added text in the policy more clearly delineates the disclosure, review/determination, and reporting timelines.