| (C) If more than one recruitment Grant Application
is reviewed by the Scientific Review Council during the Grant Review
Cycle, then the Scientific Review Council shall assign a Numerical
Ranking Score to each Grant Application to convey its prioritization
ranking.
(D) If the Scientific Review Council recommends a change
to the Grant Award funds requested by the Grant Application, then
the recommended change and explanation shall be recorded at the time
the final Overall Evaluation Score is set.
(E) The Scientific Review Council's recommendations
shall be provided to the presiding officer of the Program Integration
Committee and to the Oversight Committee pursuant to the process described
in subsection (d) of this section.
(3) The Institute may assign continuation Grant Applications
to the appropriate Review Council.
(A) The Review Council members review all components
of the Grant Application, evaluate the merits according to explicit
criteria published in the Request for Applications, and, after discussion
by the Review Council members, provide an individual Overall Evaluation
Score that conveys the Review Council member's recommendation related
to the progress and continued funding.
(B) The individual Overall Evaluation Scores are averaged
together for a final Overall Evaluation Score for the Application.
(C) If more than one continuation Grant Application
is reviewed by the Review Council during the Grant Review Cycle, then
the Review Council shall assign a Numerical Ranking Score to each
continuation Grant Application to convey its prioritization ranking.
(D) If the Review Council recommends a change to the
Grant Award funds or to the Scope of Work requested by the continuation
Grant Application, then the recommended change and explanation shall
be recorded at the time the final Overall Evaluation Score is set.
(E) The Review Council's recommendations shall be provided
to the presiding officer of the Program Integration Committee and
to the Oversight Committee pursuant to the process described in subsection
(d) of this section.
(4) The Institute's Peer Review process described in
subsections (c) and (d) of this section may include the following
additional process steps for Product Development of Cancer Research
Grant Applications:
(A) A Grant Applicant may be invited to deliver an
in-person presentation to the Peer Review Panel. The Product Development
Review Council chairperson is responsible for deciding which Grant
Applicants will make in-person presentations. The decision is based
upon the initial Overall Evaluation Scores of the primary reviewers
following a discussion with Peer Review Panel members, as well as
explicit criteria published in the Request for Applications.
(i) Peer Review Panel members may submit questions
to be addressed by the Grant Applicant at the in-person presentation.
(ii) A Grant Application that is not presented in-person
will not be considered further. The average of the primary reviewers'
initial Overall Evaluation Scores will be the final Overall Evaluation
Score for the Grant Application.
(iii) Following the in-person presentation, each Peer
Review Panel member submits a score for the Grant Application based
on the panel member's general impression of the Grant Application's
merit and accounting for the explicit criteria published in the Request
for Applications. The submitted scores are averaged together to produce
the final Overall Evaluation Score for the Grant Application.
(B) A Grant Application may undergo business operations
and management due diligence review and an intellectual property review.
The Peer Review Panel submits a list of applications recommended for
due diligence review to the Product Development Review Council. The
Product Development Review Council decides which Grant Applications
submitted by the Peer Review Panel will undergo business operations
and management due diligence and intellectual property review. The
decision is based upon the Grant Application's final Overall Evaluation
Score, but also takes into consideration how well the Grant Application
achieves program priorities set by the Oversight Committee, the overall
Program portfolio balance, and any other criteria described in the
Request for Applications. A Grant Application that is not recommended
for due diligence and intellectual property review will not be considered
further.
(i) Business operations and management due diligence
may be conducted by an outside vendor, contracted by the Institute
or by members of the Product Development Review Council.
(ii) It will be at the Institute's discretion as to
who to use to perform business operations and management due diligence;
factors may include volume of work and expertise required.
(C) After receipt of the business operations and management
due diligence and intellectual property reviews for a Grant Application,
the Product Development Review Council and the Primary Reviewers meet
to determine whether to recommend the Grant Application for a Grant
Award based upon the information set forth in the due diligence and
intellectual property reviews. The Product Development Review Council
may recommend changes to the Grant Award budget and Scope of Work.
(D) The Product Development Review Council assigns
a Numerical Ranking Score to each Grant Application recommended for
a Grant Award.
(f) Institute Employees and Oversight Committee members
may attend Peer Review Panel and Review Council meetings. If an Institute
Employee or an Oversight Committee member attends a Peer Review Panel
meeting or a Review Council meeting, the attendance shall be recorded
and the Institute Employee or Oversight Committee member shall certify
in writing compliance with the Institute's Conflict of Interest rules.
The Institute Employee's and Oversight Committee member's attendance
at the Peer Review Panel meeting or Review Council meeting is subject
to the following restrictions:
(1) Unless waived pursuant to the process described
in Chapter 702, §702.17 of this title (relating to Exceptional
Circumstances Requiring Participation), Institute Employees and Oversight
Committee members shall not be present for any discussion, vote, or
other action taken related to a Grant Applicant if the Institute Employee
or Oversight Committee member has a Conflict of Interest with that
Grant Applicant; and
(2) The Institute Employee or Oversight Committee member
shall not participate in a discussion of the merits, vote, or other
action taken related to a Grant Application, except to answer technical
or administrative questions unrelated to the merits of the Grant Application
and to provide input on the Institute's Grant Review Process.
(g) The Institute's Chief Compliance Officer shall
observe meetings of the Peer Review Panel and Review Council where
Grant Applications are discussed.
(1) The Chief Compliance Officer shall document that
the Institute's Grant Review Process is consistently followed, including
observance of the Institute's established Conflict of Interest rules,
and that participation by Institute employees, if any, is limited
to providing input on the Institute's Grant Review Process and responding
to committee questions unrelated to the merits of the Grant Application.
Institute Program staff shall not participate in a discussion of the
merits, vote, or any other action taken related to a Grant Application.
(2) The Chief Compliance Officer shall report to the
Oversight Committee prior to a vote on the award recommendations specifying
issues, if any, that are inconsistent with the Institute's established
Grant Review Process.
(3) Nothing herein shall prevent the Institute from
contracting with an independent third party to serve as a neutral
observer of meetings of the Peer Review Panel and/or the Review Council
where Grant Applications are discussed and to assume the reporting
responsibilities of the Chief Compliance Officer described in this
subsection. In the event that the independent third party observes
the meeting of the Peer Review Panel and/or the Review Council, then
the independent third party reviewer shall issue a report to the Chief
Compliance Officer specifying issues, if any, that are inconsistent
with the Institute's established Grant Review Process.
(h) Excepting a finding of an undisclosed Conflict
of Interest as set forth in §703.9 of this chapter (relating
to Limitation on Review of Grant Process), the Review Council's decision
to not include a Grant Application on the prioritized list of Grant
Applications submitted to the Program Integration Committee and the
Oversight Committee is final. A Grant Application not included on
the prioritized list created by the Review Council shall not be considered
further during the Grant Review Cycle.
Cont'd... |
