JEFF WARNER CONTRACT AND GRANT OFFICER FEDERAL UPDATE

Prior NIH Approval of Human Subjects Research in Active Awards Initially Submitted without Definitive Plans for Human Subjects Involvement NOT-OD Delayed Onset Human Subjects Research - Research applications may be submitted with the knowledge that human subjects will be involved during the period of support, but definite plans for this involvement cannot be described in the application. Delayed Onset awards generally fall into one of three categories:  Single Project Awards – results from initial pre-clinical research are needed before the human subjects research can be fully planned.  Clinical Research Networks – often funded as cooperative agreements or multi-project awards, that plan to add new protocols over the course of the award.  Awardee Funded Small Projects – pilot project programs and may be used to support new or junior faculty or to stimulate new research areas at the awardee institution and its collaborators. Process for Submitting Prior Approval Requests: After award and prior to the involvement of human subjects, the grantee must submit to the NIH awarding Institute/Center (IC) for approval, a detailed human subjects section.

Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval NOT-OD Any change in research procedures in an active award that would result in an increased risk to human subjects now requires NIH approval before implementation. Process for Submitting Prior Approval Requests: NIH strongly encourages PD/PI’s to discuss any potential changes in human subjects research under consideration with their Program Officer. Prior approval requests must be submitted in writing (including submission by ) by the Authorized Organization Representative (AOR) to the GMO of the funding IC no later than 30 days before the proposed change. *Although proposed changes may be addressed in the annual progress report, the formal prior approval request must be submitted as a separate request.

Clarification - Time Limit on NIH Resubmission Applications NOT-OD NIH policy allows a thirty-seven month window for resubmissions (A1 applications) following the submission of a New, Renewal, or Revision application (A0 application). After thirty-seven months, NIH views a submission as a new application, regardless of whether an unsuccessful resubmission (A1) was submitted during the thirty-seven month time period. The policy was implemented to stimulate new research directions for projects that were not successful initially and may have become outdated over the course of several years. Clarification - The initial submission of a new, renewal or revision application constitutes the starting point for the thirty-seven month policy.

Notice of Pilot Processes for Submitting of Post-Award Relinquishing Statements to NIH NOT-OD A pilot process for electronic submission of the Official Statement Relinquishing Interests and Rights in a Public Health Service Research Grant is now available through the eRA Commons. Under the pilot system, the original institution will be able to submit a relinquishing statement through the Change of Institution module in the eRA Commons. The "new" institution will then be able to view this relinquishing statement through the same module. *The relinquishing statement may be submitted electronically even if the corresponding application is submitted on paper.

Notice of Pilot Processes for Post-Award Change of Grantee Organization Applications to NIH NOT-OD A pilot process for electronic submission of post-award Change of Grantee Organization applications is now available through Grants.gov. All electronic requests must be submitted through the parent FOA for Change of Grantee Organization Applications (PA ). The pilot is only available for post-award Change of Grantee Organization applications for activity codes currently submitted electronically through Grants.gov. Additionally, Change of Grantee Organization requests for applications pending review and for applications pending award are not included in the pilot.

Research Performance Progress Report (RPPR) Module and Training Webinar Available to NIH Grantees NOT-OD All grantee institutions will have access to the NIH Research Performance Progress Report (RPPR) for most Streamlined Non-competing Award Process (SNAP) and Fellowship awards, starting October 19, The Research Performance Progress Report (RPPR) is an initiative to establish a uniform format for interim performance reporting on Federally-funded research. The use of the RPPR is not required at this time and grantees may continue to use eSNAP or paper submissions as appropriate. On October 17, 2012, the NIH Office of Extramural Research will provide training for grantees on use of the NIH RPPR eRA module. This webinar is designed for those who are responsible for completing and/or submitting progress reports to NIH through the eRA Commons. SPA will arrange a meeting place for the webinar. The details and location will be communicated through the SPA listserv. *Training materials and other resources are posted on the NIH RPPR webpage.

Contract and Grant Officers Should you have any questions, please feel free to contact your Contract and Grant Officer. Jonathan Lew: or Alison Yeung: or Leighsa Washington: or Jeff Warner: or