FEDERAL UPDATE
J E F F WAR N E R
CONTRACT AND GRANT OFFICER
Prior NIH Approval of Human Subjects Research in Active Awards Initially Submitted without
Definitive Plans for Human Subjects Involvement
NOT-OD-12-130

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-12-129
 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 e-mail) 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-12-128

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-12-132

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-12-134

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-12-270).
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-12-142

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, 2012.

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: 949-824-3029 or jlew@uci.edu
 Alison Yeung: 949-824-2644 or alison.yeung@research.uci.edu
 Leighsa Washington: 949-824-2460 or lrwashin@uci.edu
 Jeff Warner: 949-824-4781 or warnerj@uci.edu