Guidance on Appeals and Requests for Reconsideration of Grants Working Group Funding Recommendations

Guidance on Appeals and Requests for Reconsideration of Grants Working Group Funding Recommendations

This page summarizes CIRM’s policies governing appeals and requests for reconsideration of funding recommendations by the Grants Working Group (GWG).  Please note that CIRM’s Extraordinary Petition and Additional Analysis Option policies have been repealed and are no longer in effect.  For complete information about appeals and requests for reconsideration, you should consult:

Appeals and Requests for Reconsideration of GWG Funding Recommendations” (http://www.cirm.ca.gov/sites/default/files/files/funding_page/Appeal_Request_for_Reconsideration_Policy_3-19-13.pdf) and
CIRM Grants Administration Policy (http://www.cirm.ca.gov/sites/default/files/files/funding_page/NPGAP_11012012.pdf).

Any questions about these policies should be directed to the CIRM Review Office (RO) via Dr. Gil Sambrano, Associate Director for Review (gsambrano@cirm.ca.gov).

Applicants for CIRM funding may appeal a GWG funding recommendation on the basis of a “conflict of interest” or a “material dispute of fact”.  Additionally, applicants with Translational Applications may seek reconsideration of a GWG funding recommendation based on “material new information”.

After the GWG has met, each applicant will receive a report summarizing key strengths and weaknesses cited by the GWG in their evaluation. You should carefully examine that report.  Before filing an appeal or request for reconsideration, you are required to raise any questions or concerns about the GWG’s recommendation with the CIRM Review Office (RO) via Dr. Gil Sambrano, Associate Director for Review (gsambrano@cirm.ca.gov).  Failure to confer with the RO before filing an appeal or request for reconsideration may result in an appeal or request for reconsideration being denied.

All appeals and requests for reconsideration must be made in writing, must be a maximum of three pages long (excluding attachments), and must be submitted to the CIRM RO no later than ten (10) days after the review report was provided in writing to the PI/PD.  An untimely appeal or request for reconsideration may be denied.

Grounds for an Appeal

Grounds for an appeal are limited to the following:

  1. Conflict of Interest. An applicant may appeal on the grounds that a demonstrable financial or scientific conflict of interest had a negative impact on the review process and resulted in a flawed review. For the definition of “conflict of interest,” see: http://www.cirm.ca.gov/sites/default/files/files/funding_page/Reg100003_Conflict_of_Interest.pdf. Differences of scientific opinion between or among PIs and reviewers are not grounds for appeal. Appeals based on a claimed conflict of interest are further described in Section II.F of the CIRM Grants Administration Policy available via this link: http://www.cirm.ca.gov/sites/default/files/files/funding_page/NPGAP_11012012.pdf

  2. Material Dispute of Fact.  An applicant may appeal on the grounds that the GWG incorrectly determined one or more facts bearing on the funding recommendation, and that the GWG’s recommendation would have been different but for that incorrect determination.  The dispute must pertain to an objectively verifiable fact, rather than a matter of scientific judgment or opinion. There are other important limitations that apply, and you should carefully read the appeals policy for complete details. 

Request for Reconsideration Based on Material New Information -
Translational Applications ONLY

Grounds for requesting reconsideration are strictly limited to “material new information” in connection with a Translational Application.  A “Translational Application” means an application where the goal is to achieve a Development Candidate, an IND filing, or to complete a clinical trial (such as Disease Team or Strategic Partnership RFAs).  Requests for reconsideration based on material new information will not be entertained in connection with other applications for funding.  Further, only certain kinds of new information will qualify.  They include, for example, approval by a regulatory body, such as the Food and Drug Administration, to initiate or continue a clinical trial, or a documented, enforceable agreement between the applicant and a commercial partner.  The new information must also respond directly to a specific criticism or question addressed in the review report, and must not have been available to the applicant before the GWG meeting at which the application was reviewed.  You should consult the policy for complete details.

Review of an Appeal or Request for Reconsideration

CIRM staff will make an initial determination whether an appeal or request for reconsideration has potential merit.  If staff determines that the PI/PD has set forth clear grounds for an appeal or request for reconsideration, consideration of the application by the Application Review Subcommittee (the subcommittee of the ICOC which is charged with making funding decisions) will be deferred until a resolution is reached.  After investigation, CIRM’s president will make the final decision whether to grant an appeal or request for reconsideration.  If granted, the matter will be referred to the full GWG for a new review (for appeals based on a conflict of interest), or to a GWG subcommittee for further scientific review (for appeals based on a dispute of fact, and for requests for reconsideration based on a material dispute of fact).  The GWG’s further recommendations will then be presented to the Application Review Subcommittee, which will make the final decision on funding the application in question.

 

© 2013 California Institute for Regenerative Medicine