(a) The Institute uses a Program Review process undertaken
by the Institute's Program Integration Committee to identify and recommend
for funding a final list of meritorious Cancer Research projects,
including those projects with Cancer Research Product Development
prospects, and evidence-based Cancer Prevention and Control Program
projects that are in the best overall interest of the State.
(b) Program Review shall be conducted pursuant to the
requirements set forth in Chapter 702 of this title (relating to Institute
Standards on Ethics and Conflicts, Including the Acceptance of Gifts
and Donations to the Institute) and Chapter 102, Texas Health and
Safety Code.
(c) The Program Integration Committee shall meet pursuant
to a schedule established by the Chief Executive Officer, who serves
as the Committee's presiding officer, to consider the prioritized
list of Grant Applications submitted by the Prevention Review Council,
the Product Development Review Council, or the Scientific Review Council.
(d) The Program Integration Committee shall approve
by a majority vote a final list of Grant Applications recommended
for Grant Awards to be provided to the Oversight Committee, including
a list of Grant Applications, if any, that have been deferred until
a future meeting of the Program Integration Committee. In composing
the final list of Grant Applications recommended for Grant Award funding,
the Program Integration Committee shall:
(1) Substantially base the list upon the Grant Award
recommendations submitted by the Review Council.
(2) To the extent possible, give priority for funding
to Grant Applications that:
(A) Could lead to immediate or long-term medical and
scientific breakthroughs in the area of Cancer Prevention or cures
for cancer;
(B) Strengthen and enhance fundamental science in Cancer
Research;
(C) Ensure a comprehensive coordinated approach to
Cancer Research and Cancer Prevention;
(D) Are interdisciplinary or interinstitutional;
(E) Address federal or other major research sponsors'
priorities in emerging scientific or Technology fields in the area
of Cancer Prevention, or cures for cancer;
(F) Are matched with funds available by a private or
nonprofit entity and institution or institutions of higher education;
(G) Are collaborative between any combination of private
and nonprofit entities, public or private agencies or institutions
in this state, and public or private institutions outside this state;
(H) Have a demonstrable economic development benefit
to this state;
(I) Enhance research superiority at institutions of
higher education in this state by creating new research superiority,
attracting existing research superiority from institutions not located
in this state and other research entities, or enhancing existing research
superiority by attracting from outside this state additional researchers
and resources;
(J) Expedite innovation and commercialization, attract,
create, or expand private sector entities that will drive a substantial
increase in high-quality jobs, and increase higher education applied
science or Technology research capabilities; and
(K) Address the goals of the Texas Cancer Plan.
(3) Document the factors considered in making the Grant
Award recommendations, including any factors not listed in paragraph
(2) of this subsection;
(4) Explain in writing the reasons for not recommending
a Grant Application that was recommended for a Grant Award by the
Review Council or for deferring a Grant Application recommendation
until a future meeting date;
(5) Specify the amount of Grant Award funding for each
Grant Application.
(A) Unless otherwise specifically stated, the Program
Integration Committee adopts the changes to the Grant Award amount
recommended by the Review Council.
(B) If the Program Integration Committee approves a
change in the Grant Award amount that was not recommended by the Review
Council, then the Grant Award amount and a written explanation for
the change shall be provided.
(6) Specify changes, if any, to the Grant Application's
Scope of Work recommended for a Grant Award and provide an explanation
for the changes made;
(7) Address how the funding recommendations meet the
annual priorities for Cancer Prevention, Cancer Research and Product
Development programs and affect the Institute's overall Grant Award
portfolio established by the Oversight Committee; and
(8) Provide a list of deferred Grant Applications,
if any.
(e) In the event that the Program Integration Committee's
vote on the final list of Grant Award recommendations or deferrals
is not unanimous, then the Program Integration Committee Member or
Members not voting with the majority may submit a written explanation
to the Oversight Committee for the vote against the final list of
Grant Award recommendations or deferrals. The explanation may include
the Program Integration Committee Member or Members' recommended prioritized
list of Grant Award recommendations or deferrals.
(f) The Program Integration Committee's decision to
not include a Grant Application on the prioritized list of Grant Applications
submitted to the Oversight Committee is final. A Grant Application
not included on the prioritized list created by the Program Integration
Committee shall not be considered further during the Grant Review
Cycle, except for the following:
(1) In the event that the Program Integration Committee's
vote on the final list of Grant Award recommendations is not unanimous,
then, upon a motion of an Oversight Committee Member, the Oversight
Committee may also consider the Grant Award recommendations submitted
by the non-majority Program Integration Committee Member or Members;
(2) 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); or
(3) A decision by the Program Integration Committee
to defer a decision to include a Grant Application on the prioritized
list of Grant Applications submitted to the Oversight Committee until
a future meeting of the Program Integration Committee, subject to
subsection (k) of this section.
(g) The Chief Compliance Officer shall attend and observe
Program Integration Committee meetings to document compliance with
Chapter 102, Texas Health and Safety Code and the Institute's administrative
rules.
(h) At the time that the Program Integration Committee's
final Grant Award recommendations are formally submitted to the Oversight
Committee, the Chief Executive Officer shall prepare a written affidavit
for each Grant Application recommended by the Program Integration
Committee containing relevant information related to the Grant Application
recommendation.
(1) Information to be provided in the Chief Executive
Officer's affidavit may include:
(A) The Peer Review process for the recommended Grant
Application, including:
(i) The Request for Applications applicable to the
Grant Application;
(ii) The number of Grant Applications submitted in
response to the Request for Applications;
(iii) The name of the Peer Review Panel reviewing the
Grant Application;
(iv) Whether a preliminary review process was used
by the Peer Review Panel for the Grant Mechanism in the Grant Review
Cycle;
(v) An overview of the Conflict of Interest process
applicable to the Grant Review Cycle noting any waivers granted; and
(vi) A list of all final Overall Evaluation Scores
for all Grant Applications submitted pursuant to the same Grant Mechanism,
de-identified by Grant Applicant;
(B) The final Overall Evaluation Score and Numerical
Ranking Score assigned for the Grant Applications recommended during
the Peer Review process; and
(C) A high-level summary of the business operations
and management due diligence and intellectual property reviews, if
applicable, conducted for a Cancer Research Product Development Grant
Application.
(2) In the event that the Program Integration Committee's
final Grant Award recommendations are not unanimous and the Program
Integration Committee Member or Members in the non-majority recommend
Grant Applications not included on the final list of Grant Award recommendations,
then the Chief Executive Officer shall also prepare a written affidavit
for each Grant Application recommended by the non-majority Program
Integration Committee Member or Members.
(i) To the extent that the information or documentation
for one Grant Application is the same for all Grant Applications recommended
for Grant Award funding pursuant to the same Grant Mechanism, it shall
be sufficient for the Chief Executive Officer to provide the information
or documentation once and incorporate by reference in each subsequent
affidavit.
Cont'd... |