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Faculty Disclosure for Federal Funding Agencies

October 29, 2021

Harvard University’s process for NIH submissions has been updated to align with new requirements and directives set by the National Defense Authorization Act (NDAA) Section 223 and the National Security Presidential Memorandum (NSPM) 33.  These two documents outline changes in federal research guidelines that aim to enhance national security, research integrity, safety and productivity within the research environment, and reducing the administrative burden on federal grantees.  These new requirements were developed in response to perceived violations of existing disclosure policies that has led to the sanctioning, firing, or arrest of several U.S.-based scientists.

As a result, full and transparent disclosures have become increasingly important for evaluating the proposed work for risks to national security and intellectual capital, exploitation by foreign governments, conflicts of interest and commitment, and assessing the qualifications of participants.  In order to assist PIs in their disclosure, new tools and processes have been created so that PIs can gather information they need to disclose.  In the short term, there will be additional effort from PIs, Grant Managers, and Central Administration to ensure the disclosures are complete and accurate; but, we anticipate that the long term benefit will be realized with the implementation of uniform policies across the federal research agencies as directed in both NDAA Section 233 and NSPM 33.

 

Informational Module for Faculty Available on HTP

Highlights of NDAA Section 223 and NSPM 33

NDAA Section 223: Disclosure of Funding Sources in Applications for Federal Research and Development Awards

Disclosure Requirement:
For each covered individual listed on the application

  • Disclose the amount, type, and source of all current and pending research support received by or expected to be received by the individual as of the time of the disclosure
  • Certify that the disclosure is current, accurate, and complete
  • That any entity (organization) certify that all Key personnel employed by the organization has been made aware of the requirements above.

National Security Presidential Memorandum 33: Supported Research and Development National Security Policy 

Strengthen Disclosure Requirements and Processes

  • Requires disclosure of information related to potential conflicts of interest and commitment from participants in Federally funded research.
  • Outlines key information to disclose to federal agencies

Enhance Awareness of Research Security Risks and Protections

  • Development of guidance and educational outreach from OSTP and DNI on the threats to the research community from foreign governments and the federal policies available to mitigate risks to research security and integrity
  • Establishment of federal department and agency with roles and responsibilities related to research security
  • Require research institutions to establish a research security program for institutions receiving excess of 50 million dollars per year in federal funding

Reducing Administrative Burdens on Researchers

  • Directs departments and agencies to standardize disclosure processes, definition, and forms related to research security across funding agencies to the maximum extent practicable
Submission Process

Submissions of proposals and progress reports are due to your School’s submitting office according to their deadline policy for review and authorization.  Submission deadlines vary by the submitting office; for Harvard Chan SPA submit 7 business days before the sponsor’s due date; for OSP and HMS ORA submit 5 business days before the sponsor’s due date.  Please use the links listed below for more information on each submitting office’s deadline policies:

 

New Disclosure Guidelines for NIH submissions due on or after January 25, 2022

Biosketch (at proposal stage)

    1. All positions, scientific appointments, and affiliations with both domestic and foreign entities or governments must be included.
    2. Use of SciENcv is strongly encouraged for Biosketch preparation and updates.  For assistance with SciENcv, please refer to the manual or the instructional videos below.
    1. Changes to Biosketch include revisions to Section A, B, and D.  Details on changes to the Biosketch format (rev 12/2020) can be found on the Biosketch NIH Format pages, Instructions, and Sample and Other Support.
      • Section A incorporates the previous Section D: Research Support.  This section may include ongoing and completed projects from the past three years that the applicant wishes to highlight.
      • Section B has been renamed “Positions, Scientific Appointments, and Honors.”  The NIH specifies that the list must include the following, whether or not remuneration is received and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary):
        1. All positions, both domestic and foreign
        2. All scientific appointments, both domestic and foreign
        3. All affiliations with foreign entities or governments
        4. All titled academic, professional, or institutional appointments
        5. Any relevant academic and professional achievements and honors.
      • With the reorganization of Research Support to Section A, Section D has been reduced to Scholastic Performance and is solely present on the fellowship version of the Biosketch.

Preparation of Agreements for Other Support (at Proposal stage)

Preparing and uploading your agreements ahead of time will facilitate and expedite the submission of your Other Support for Just-in-Time and RPPR.

    1. Locate and compile contracts or agreements with a foreign organization, government, or individual (excepting sponsored agreements that are in GMAS) for any of the following
      • Conducting research as part of consulting;
      • Providing support for individual’s research;
      • An appointment, affiliation, or employment.
    1. See the NIH Agreements Decision Tree to help identify which contract need to be submitted as supporting documentation.
    2. Retain these agreements (a copy of the original document as well as the English translation).  Further guidance will be provided on this page on the appropriate steps for deposition into GMAS.

Other Support (at JIT and RPPR stages)

    1. Changes to Other Support include reorganization of the format page, electronic signatures, and supporting documentation for foreign activities and resources.  Additional details can be found on the NIH Other Support website including changes to the Other Support form (rev 12/2020), as well as instructions and FAQs.
    2. For further guidance use the following Harvard documents: Other Support Template (1/25/2022), Other Support Guide (1/25/2022), and FAQs for the new changes effective January 25, 2022.
    3. Consulting activities when research is conducted as part of the consultation must be included in Other Support.  For more information, see NIH Other Support FAQ 4.
    4. An electronic signature is required for each PI or Key Personnel to certify that their Other Support form is complete and accurate.  This signature may not be delegated to an administrator, lab member, or Grant Manager.
    5. Supporting documentation for foreign activities and resources that are reported in Other Support must be attached to the submitted application.  This includes:
      • unredacted copies of contracts, grants, or any other agreements specific to foreign appointments and/or employment of PI or Key Personnel.
      • An English translation must also be provided if the original document is in a foreign language.
      • Non-certified translations as well as machine read translations, such as Google Translate are acceptable for submission to NIH, see NIH Other Support FAQ 6.
New Disclosure Guidelines for NSF submissions due on or after October 4, 2021

Biosketch

    1. All academic, professional, or institutional appointments, beginning with the current appointment” (in reverse chronology). All current domestic or foreign professional appointments outside of the individual’s academic, professional, or institutional appointments at Harvard.

Current and Pending Support

Roles and Responsibilities Pertaining to NIH grant Disclosure

Principal Investigators and Key Personnel are expected to be forthright and transparent about relationships, resources, and activities.  Investigators and Key Personnel will provide a complete and accurate disclosure on their Biosketch and Other Support.  This includes:

    1. Collecting their disclosure information from GMAS, OAIR, and the DUA Agreements Module.
    1. For NIH Other Support disclosures: providing any required unredacted agreements, with English translation if the original is in a foreign language.
    2. Working with their Grant Manager to complete your submission
    3. Certifying with their electronic signature the completeness and accuracy of the final Other Support document with your electronic signature prior to submission to NIH

Grant Managers will assist PIs and Key Personnel in organizing, formatting, and completing their submission.  This includes:

    1. Obtaining the disclosure information from the PI or Key Personnel.
    2. Working with the PI or Key Personnel to complete the form.
    3. Formatting and reviewing for completeness and accuracy.
    4. For NIH Other Support disclosures: ensuring required supporting documentation, including original agreements and English translations, is attached.

School or Central Reviewers will coordinate with Grant Managers and PIs or Key Personnel to ensure the accuracy and completeness of the submission.  This includes:

    1. Reviewing Biosketch and Other Support for completeness and accuracy.
    2. Reviewing Contracts/Agreements submitted by the PIs and other Key Personnel for inclusion on Other Support.
    3. For NIH Other Support disclosures: Ensuring required supporting documentation, including original agreements and English translations, is attached.
    4. Maintaining original signed (certified) copies of Other Support.
    5. Submitting finalized Biosketch and Other Support to NIH.
School Contacts

Use the links below to contact your Research Administrator:

Definitions

NIH and NSF Definition of Research:

A systematic study directed toward fuller scientific knowledge or understanding of the subject studied.

Harvard University Definition of Scientific Appointment:

Any academic or research appointment, including visiting, adjunct or temporary academic appointments, with a university, college, governmental or non-profit research institution and any fiduciary or executive level appointment with a for-profit entity engaged in commercial or research activities of a biomedical nature.

Harvard University Definition of Research:

Adheres to the Federal Policy for the Protection of Human Subjects (known as the “Common Rule”).  Teaching/training in research methods may also constitute Research for the purposes of NIH’s definition.

Harvard University Definition of Conducting Research:

To be a Project Director, Principal Investigator or to otherwise be responsible for the design, conduct or reporting of research regardless of title or position (e.g., an Investigator). This definition does not normally include service on scientific or clinical advisory boards or more general scientific consulting unless it is anticipated that the individual will make a direct and significant intellectual contribution to a specific research project for the entity.

Harvard University Definition of Research as Part of Consulting:

To be responsible for the design, conduct or reporting of Research regardless of title or position.  This does not normally include service on scientific or clinical advisory boards or more general scientific consulting, unless the Principle Investigator or Senior/Key Personnel is anticipated to make a direct and significant intellectual contribution to a specific Research project for the entity.  Such an activity may result in earning authorship on a publication describing or supporting a research activity, or any consulting activity that otherwise meets the definition of Research.

Harvard University Definition of Support:

Any resources (i.e., financial, in-kind, personnel, provision of high-value materials that are not freely available) made available to a Principle Investigator or Key Personnel for use by this individual to pursue their Research. This includes in-kind resources directly provided to the individual (e.g., office/laboratory space, equipment, supplies or employees or students funded by outside sources). This does not include institutional resources, such as core facilities or shared equipment, that are made broadly available.

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