NIH Foreign Subawards FAQs


 

Proposal Stage

It is recommended that before including proposed subrecipients in proposals, the PI should explain if the proposal is awarded the subrecipient will be required to meet the following requirements:

  • What: provide access to copies of all lab notebooks, all data, and all documentation that supports the research outcomes as described in the progress report, to the PI
  • When: such access will need to be provided no less than once per year, in alignment with the timing requirements for Research Performance Progress Report (RPPR) submission.
  • How:  using a Columbia University-supported repository. Information that is not in English, it will have need to be translated.

If the subrecipient expresses concerns at this stage about their ability to comply with these requirements, encourage them to speak with their respective institutional officials about the NIH policy.

NIH’s policy will also communicated to the subrecipient on the Subrecipient Letter of Intent (LOI), a required form to be signed by the subrecipient’s institutional official, to be submitted to Sponsored Projects Administration (SPA) at the time of proposal review in SPA.

Yes, you may include the first page only of the Subrecipient LOI in the “Consortium/Contractual Arrangements” attachment in the Research Plan of the NIH proposal. The second page of the Subrecipient LOI is for internal use only. Both pages must be submitted to the SPA Project Officer during proposal review.

No, but it is a good idea to relay to the subrecipient that if awarded, they must provide access to all related documentation using a Columbia-supported platform. See Research Data Storage Options (updated 4/17/24) for possible options, and see FAQs below for more information.

While not required at the proposal stage, the electronic platform must be provided to SPA in Rascal Proposal Tracking (PT) for non-competing continuations.

It depends on whether the platform is solely being used to meet the requirements NIH’s Policy Guidance for Subaward/Consortium Written Agreements (NOT-OD-23-182). If the platform is used for general administrative purposes or serves multiple projects and cannot be directly allocated to one specific NIH grant without a reasonable allocation method, then it cannot be charged to the grant. If it can be reasonably allocated and directly applied, then this should be detailed and explained in the proposal budget justification.

Electronic Platforms

No, researchers must use a Columbia-supported electronic platform, including those managed by departmental IT staff (such as RedCAP). The Columbia-supported platform must have an RSAM System ID#.  Researchers cannot use personal electronic platforms (such as Dropbox, etc.). It is important that Columbia institutional representatives, in addition to researchers, have the ability to access documentation to provide to NIH upon request. The following chart includes examples of Columbia-supported options with RSAM System ID#s. See See Research Data Storage Options (updated 4/17/24).

No, the fees are considered facilities and administration (F&A)/indirect costs and should not be directly charged to a grant. As stated in the FAQ above concerning proposal budgeting, it depends on whether the platform is solely being used to meet the requirements NIH’s Policy Guidance for Subaward/Consortium Written Agreements (NOT-OD-23-182). If the platform is used for general administrative purposes or serves multiple projects and cannot be directly allocated to one specific NIH grant without a reasonable allocation method, then it cannot be charged to the grant.

Consider Columbia Data Platform (CDP), which is also protected health information (PHI) and personally identifiable information (PII) secure. See https://dataplatform.cuit.columbia.edu/ for more information. CDP allows you to collaborate with others, can accommodate very large data sets and cold storage, and is relatively low cost but it depends on the size and nature of the data. You can email [email protected] for more information. Subrecipients must provide access to copies of all lab notebooks, all data, and all documentation that supports the research outcomes as described in the progress report, regardless of file size.

Any platform listed as ‘sharable’ in the Research Data Storage Options gives the subrecipient the ability to share their data with the Columbia PI. The platform selected must have a RSAM#. Each platform will have its own mechanism for the subrecipient to be able to share its documentation. For more information, refer to the platform’s instructions to allow for external collaboration.

Human Subjects

The following language should be used:

“The following individuals and/or agencies will be able to look at and copy your research records [REMOVE ANY THAT ARE NOT APPLICABLE]:

- The investigator, study staff, Columbia University staff, [INSERT IF APPLICABLE: NewYork-Presbyterian Hospital staff] and medical professionals who may be evaluating the study or providing services for the study

- Authorities from Columbia University [INSERT IF APPLICABLE: and NewYork-Presbyterian Hospital], including the Institutional Review Board ('IRB')

- The Office for Human Research Protections ('OHRP') [INSERT IF APPLICABLE: and the United States Food and Drug Administration ('FDA');

- If this study is sponsored (money or supplies are being provided), the sponsor of this study, [NAME SPONSOR], including persons or organizations working with or owned by the sponsor

- Other government regulatory agencies (including agencies in other countries) if the sponsor is seeking marketing approval for new products resulting from this research.”

Yes. Columbia is responsible for the conduct of the research at subrecipient sites and should provide a model/template consent form that is approved by the Columbia IRB to subrecipient sites. If there is a proposal to revise the consent form at a subrecipient site, the Columbia PI should be apprised before the changes are made and should consult with the Columbia Human Research Protection Office if necessary.  Consent form changes for the subrecipient site that are approved by the foreign local IRB or ethics board must be communicated to and documented by the Columbia PI. Subrecipient site consent forms should be submitted to the Columbia IRB at the time of continuing review.

Yes.

RPPRs

PI’s should continue to review all subaward documentation to confirm that the performance outcomes that are reported in the RPPR are accurate, complete, and properly reflect the programmatic goals of the approved award. Rascal Proposal Tracking (PT) will include an additional certification for PIs that they have access to copies of all lab notebooks, all data, and all documentation that supports the research outcomes as described in the progress report.

In addition, PIs must identify the electronic platform used to access the subrecipients documentation in Rascal Proposal Tracking at the time a non-competing continuation needs review in SPA.

Yes, all data and supporting documentation must be translated into English, so that it is available to NIH, upon request. Machine-translation of the documents is acceptable (i.e., Google translate, etc).

The subrecipient should scan and upload their supporting documentation in the selected Columbia-supported electronic platform. See NIH’s FAQs for additional information.