PHS Addendum

This PHS Addendum implements the requirements of certain federal regulations, specifically 42 CFR 50 and 45 CFR 94, and applies to all projects funded, directly or indirectly through a subaward from another organization, by the PHS other than SBIR or STTR awards. This PHS Addendum supplements MIT’s Policy on Conflicts of Interest in Research. PHS regulations differ, in some respects, from MIT’s Policy. It is imperative, therefore, that every MIT Investigator that accepts PHS funding, whether directly or indirectly, becomes familiar with, and abides by, the provisions of this PHS Addendum. 

This policy also applies to projects funded by certain foundations that have elected to apply the PHS standards and requirements relating to financial conflicts of interest. A list of these foundations is available here.

Sections:

 

IDENTIFYING INVESTIGATORS

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.  

A matrix designed to assist Principal Investigators in identifying Investigators can be found here.

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TRAINING

MIT must provide training regarding MIT’s Policy and the regulations to Investigators. PHS Investigators must complete the training prior to MIT charging effort to the PHS award, and at least every four years thereafter. Investigators must also complete training within a period of time determined by the Institutional Official if (i) this PHS Addendum is substantively amended in a manner that affects the requirements of Investigators or (ii) MIT determines that the Investigator has not complied with this PHS Addendum or with a management plan related to his or her research.

Training will be provided through the Collaborative Institutional Training Initiative (CITI). More information can be found here.

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SPONSORED TRAVEL

PHS requires that Sponsored Travel be included in the determination of whether the Aggregate value of an Investigator’s financial interests rises to the level of a Significant Financial Interest. Sponsored Travel includes (a) travel expenses paid to an Investigator or travel paid on an Investigator’s behalf, 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, ONLY if such travel reasonably appears to be related to the Investigator’s Institutional Responsibilities. 

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.

In order to ensure compliance with PHS regulations, therefore, an Investigator must update his or her master COI disclosure to include Sponsored Travel if the Sponsored Travel equals or exceeds $5,000, alone or in combination with other Remuneration and Equity Interests:

  • at the time of submission of a proposal to PHS, looking back over the previous 12 months; 
  • thereafter, within 30 days following reimbursement or within 30 days following the completion of a trip, if the PHS Investigator has an active award or pending proposal with a PHS agency. 

An Investigator need not disclose Sponsored Travel paid for or reimbursed by:

  • MIT (e.g. paid from MIT funds or from sponsored awards funds managed at MIT)
  • U.S. Federal, state or local governmental agencies
  • U.S. Institutes of higher education
  • U.S. Research institutions affiliated with institutions of higher education 
  • U.S. Academic teaching hospitals and medical centers

The disclosure must include at a minimum, the purpose, cost of the trip (estimate if unknown), the identity of the organization or entity funding the travel, the destination, the duration of the trip (usually days), and the relationship between the trip and the PHS Investigator’s proposals and awards. The Designated Official may request additional information to determine whether the Sponsored Travel is related to the Investigator’s Institutional Responsibilities in accordance with the Review, Evaluation and Resolution section of this policy.

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REPORTING TO PHS

PHS agency funded Investigators are required to disclose a Significant Financial Interest within 30 days of identifying the Significant Financial Interest. MIT shall, within 60 days, review the disclosure, determine its relatedness, determine if it is a Financial Conflict of Interest and if so, implement a management plan. Within 60 days of determining whether an Significant Financial Interest is a Financial Conflict of Interest, MIT must report the Financial Conflict of Interest details, including details of the management plan, to the PHS funding agency.

The PHS regulations require MIT to provide the following information regarding Financial Conflicts of Interestt:  

  1. if the Financial Conflict of Interest existed prior to award, prior to expenditure of funds;
  2. if the Financial Conflicts of Interest arises during the term of the award, within 60 days of determining whether a Significant Financial Interest is a Financial Conflicts of Interest (see Disclosure Requirements above);
  3. as part of the annual progress report on the Research;
  4. as part of any requests for an extension of the award; and 
  5. following a retrospective review as discussed in more detail under RETROSPECTIVE REVIEW below.

Each report to PHS must include sufficient information to enable PHS to understand the nature and extent of the financial conflict and to assess the appropriateness of the management plan. The required information includes:

  1. project number;
  2. Principal Investigator or Contact Principal Investigator if there are multiple Principal Investigators on the project;
  3. name of the Investigator with the Financial Conflict of Interest;
  4. name of the entity with which the Investigator has a Financial Conflict of Interest;
  5. nature of the Significant Financial Interest (e.g., Equity, consulting fees, travel reimbursement, honorarium);
  6. value of the Significant Financial Interest, which value may be expressed as being within a range ($0– $4,999; $5,000–$9,999; $10,000– $19,999; amounts between $20,000– $100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000) 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;
  7. a description of the relationship of the Significant Financial Interest to the PHS-funded research and the basis for MIT’s determination that the Significant Financial Interest conflicts with the research; and
  8. a description of the key elements of the management plan, including:
    1. the role and principal duties of the conflicted Investigator in the research;
    2. the conditions of the management plan;
    3. how the management plan is designed to safeguard the objectivity of the research;
    4. confirmation of the Investigator’s agreement to the management plan;
    5. how the management plan will be monitored to ensure Investigator compliance; and
    6. other relevant information.

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PUBLIC ACCESSIBILITY

PHS requires MIT to make information regarding Financial Conflict of Interest 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.

MIT may also disclose information regarding the management of the Financial Conflict of Interest.

Instructions for requesting information about a reported Financial Conflict of Interest can be found at /contact-us/fcoi-public-information-request-form.

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SUBAWARDS ISSUED BY MIT UNDER PHS FUNDED PRIME AWARDS

When MIT issues a subaward to another organization to carry out a portion of a PHS funded project, the subawardee must comply with the PHS conflict of interest regulations. MIT, therefore, will only issue subawards under PHS funded awards to institutions that have financial conflict of interest policies that comply with the PHS regulations. 

If a subawardee Investigator has a Financial Conflicts of Interest, MIT is responsible for reporting the Financial Conflict of Interest to the PHS on behalf of the subawardee. As a result, subawardees must report Financial Conflicts of Interest to MIT within 30 days of determining whether there is a Financial Conflict of Interest so that MIT may report it to PHS in a timely manner. In addition, MIT is required by PHS to make information regarding subawardeeFinancial Conflicts of Interest available to the public. MIT will report subawardee Financial Conflicts of Interest using the same method it uses to disclose its own Financial Conflicts of Interest, and will notify the subawardee of any requests for information. Questions regarding the specifics of subawardee Financial Conflicts of Interest are directed to the subawardee.

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SUBAWARDS ISSUED TO MIT UNDER PHS FUNDED PRIME AWARDS

When MIT makes a proposal for or receives a subaward from another organization to carry out a portion of a PHS funded project, MIT must comply with the PHS regulations regarding conflicts of interest. MIT’s Policy and this PHS Addendum apply to these proposals and awards rather than the policies of the subawarding organization. MIT provides reports of Financial Conflicts of Interest to the subawarding organization for reporting to PHS as specified in the PHS regulations.

Reports are provided in the same form and format as MIT uses in connection with its direct awards from PHS. The subawarding organization is also responsible for the public accessibility reporting (see above). The subawarding organization may choose to do so either by posting MIT’s report to a publicly available website or responding to written requests within 5 business days.

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INVESTIGATOR NON-COMPLIANCE - RETROSPECTIVE REVIEW

In cases where a Financial Conflict of Interest is not identified or managed in a timely manner, including due to

  1. failure by the Investigator to disclose a Significant Financial Interest that is determined by the Institution to constitute a Financial Conflict of Interest;
  2. failure by MIT to review or manage such a Financial Conflict of Interest; or
  3. failure by the Investigator to comply with a Financial Conflict of Interest management plan,

MIT must, within 120 days of its determination of noncompliance, complete a retrospective review of the Investigator’s activities and the PHS-funded research to determine whether the design, conduct, or reporting of the PHS-funded research, or any portion thereof, conducted during the period of noncompliance, was biased. Retrospective reviews will be conducted by the Office of the General Counsel or other MIT personnel, as determined by the Conflict of Interest Committee.

MIT is required to document the retrospective review and report detailed findings to PHS, including at least the following key elements:

  1. project number;
  2. project title;
  3. Principal Investigator or contact Principal Investigator if there are multiple Principal Investigators on the project;
  4. name of the Investigator with the Financial Conflict of Interest;
  5. name of the Entity with which the Investigator has a Financial Conflict of Interest;
  6. reason(s) for the retrospective review;
  7. detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);
  8. findings of the review; and
  9. conclusions of the review.

Based on the results of the retrospective review, MIT will update the previously submitted Financial Conflict of Interest report, if appropriate, specifying the actions that will be taken to manage the Financial Conflict of Interest. If bias is found, MIT must notify PHS promptly and submit a mitigation report. The mitigation report must include, at a minimum:

  1. the elements documented in the retrospective review above;
  2. a description of the impact of the bias on the research; and
  3. MIT’s plan of action or the actions taken to eliminate or mitigate the effect of the bias (e.g., extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research is salvageable).

Thereafter, MIT will submit Financial Conflict of Interest reports annually, as specified under the PHS regulations. Depending on the nature of the Financial Conflict of Interest, MIT may determine that additional interim measures are necessary with regard to the Investigator’s participation in the PHS- funded research between the date that the Financial Conflict of Interest or the Investigator’s noncompliance is determined and the completion of MIT’s retrospective review.

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RECORD RETENTION

The COI Officer will retain all disclosures, conflict management plans, and related documents for a period of at least three years following submission of the final expenditure report for the applicable project to the PHS or the prime PHS awardee, unless any litigation, claim or negotiation, audit, or other action involving the records is commenced before expiration of the three-year period, in which case, records will be retained until completion of the action and resolution of all issues.

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