NIH guidance on consortium F & A indirects

typically consortium FA does not apply to direct cost cap.


see attached for guidance from version D


policy_subaward_IDC_supplemental guide


nih era commons interim RPPR- new product for 2017

here is the scenario of how the Interim RPPR will be used.(They are RPPR’s that you file when you are planning a competing renewal)

If you opt NOT to apply for Competing Renewal, complete the Final RPPR as you normally would within 120 days of the project end date.

If you are going to complete a Competing Renewal application (or have already submitted such an application), you will submit an Interim RPPR. This must be submitted within 120 days of the project end date.

NIH policy on effort adjustments during no cost extension periods

During a NCE, is there a minimum effort requirement for key personnel named in the NOA, other than the PI?

The short answer is “NO”

With the exception of grant programs that have an effort requirement, or where terms and conditions prohibit such reductions, NIH will not require prior approval for the reduction in effort for Senior/key personnel named in the Notice of Award (NoA) during a no-cost extension. However, consistent with the NIH Grants Policy Statement Chapter, recipients are reminded that for active NIH awards, the PD/PI and other Senior/key personnel named in the NoA must devote a measurable level of effort.

NIH details for data safety monitoring plan (2016)

Located At: NIH guidance for 424, forms D, Section II, 4.1.5 “Data and Safety Monitoring Plan”

The NIH Data and Safety Monitoring Policy is described and referenced in Part II Section 5.3.

If the proposed research includes a clinical trial (See definition of “clinical trial” under Part III Section 3), create a document entitled “Data and Safety Monitoring Plan.” For all clinical trials, NIH requires a data and safety monitoring plan (DSMP) that is commensurate with the risks of the trial and its size and complexity. In this attachment, you must provide a description of the DSMP that you are proposing to establish for each clinical trial proposed, including:

  • The overall framework for safety monitoring and what information will be monitored.
  • The frequency of monitoring, including any plans for interim analysis and stopping rules (if applicable).
  • The process by which Adverse Events (AEs), including Serious Adverse Events (SAEs) such as deaths,hospitalizations, and life threatening events and Unanticipated Problems (UPs), will be managed and reported as required to the Institutional Review Board (IRB), the person or group responsible for monitoring, the funding IC, the NIH Office of Biotechnology Activities (OBA;, and the Food and DrugAdministration (FDA;
  • The individual(s) or group that will be responsible for trial monitoring and advising the appointing entity. Because the monitoring plan will depend on potential risks, complexity, and the nature of the trial, a number of options for monitoring are possible. These include, but are not limited to, monitoring by a: §PD/PI: While the PD/PI must ensure that the trial is conducted according to the protocol, in some cases (e.g., low risk trials, not blinded), it may be acceptable for the PD/PI to also be responsible for carrying out the DSMP. (some option below)
    • Independent safety monitor/Designated medical monitor: a physician or other expert who isindependent of the study.
    • Independent Monitoring Committee or Safety Monitoring Committee: A small group ofindependent investigators and biostatisticians.
    • Data and Safety Monitoring Board (DSMB): a formal independent board of experts includinginvestigators and biostatisticians. As noted in Part II Section 5.3, NIH requires the establishmentof DSMBs for multi-site clinical trials involving interventions that entail potential risk to the

Supplemental Grant Application Instructions II-11

participants, and generally for Phase III clinical trials. Although Phase I and Phase II clinical trials may also need DSMBs, smaller clinical trials may not require this oversight format, and alternative monitoring plans may be appropriate. •If a DSMB is used, please describe the general composition of the Boardwithout naming specific individuals.