Transcript www.lsuhsc.edu

LSU School of Medicine-New Orleans (LSUSOM-NO) is
the provider of Continuing Medical Education for this
activity. The planning and presentation of all LSUSOMNO activities ensure balance, independence, objectivity
and scientific rigor.
The LSU School of Medicine-New Orleans
designates this educational activity for a maximum
of 1.5 AMA PRA Category 1 Credit(s) ™. Physicians
should claim only the credit commensurate with the
extent of their participation in the activity.
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Disclosure
I do not have any relationship(s) with commercial
interests.
A commercial interest is any entity producing,
marketing, re-selling, or distributing health care
goods or services consumed by, or used on, patients.
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The NIH Peer Review Process
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Welcome
– Presenter:
• Nicole G. Hammill, MBA
• Coordinator of Grants and Development
• Office of Research Services
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433 Bolivar Street, Room 206E, New Orleans, LA 70112
[email protected]
(504) 568-4970 tel
(504) 568-8808 fax
http:
http://www.lsuhsc.edu/administration/academic/ors/grant
s_contracts_processing.aspx
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Office of Research Services
Director:
Dr. Kenneth E. Kratz
Staff:
Nicole G. Hammill – Pre-award (Grants and Contracts)
Rose Castay – IACUC and IBC
Dyan Melson – IRB
Lynn Arnold – IRB
Amy Tassin – IRB
Anissa McDougle – Conflicts of Interest
Responsibilities:
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Pre-award, sponsored project activity; this includes evaluation and routing for signatures all grant
applications, research agreements, and clinical trial agreements.
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Conflict of Interest Program based upon Chancellor’s Memorandum #35 “Individual and Institutional
COI in Sponsored Projects”.
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The AAHRPP “Fully Accredited” Human Research Protection Program and Institutional Review
Board (IRB) which provides oversight for the protection of human subjects participating in research.
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The Institutional Animal Care and Use Committee (IACUC) which provides oversight for the welfare of
animals used in research.
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The Institutional Bio-safety Committee (IBC) which in collaboration with the Office of Environmental
Health and Safety provides oversight of bio-safety issues and recombinant DNA research.
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Helpful Administrative Information
• Most of the numbers, dates, names, and
titles commonly needed for the completion
of grant applications can be found here:
http://www.lsuhsc.edu/administration/academic/ors/d
ocs/Helpful_Administrative_%20Information.pdf
Updated frequently!
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Two-Tiered Process
• Mandated by law – PHS Health Act
• Defined in federal regulation – 42 CFR
52h
• Further defined in NIH policy
• Per year:
– Nearly 80,000 applications
– Over 18,000 reviewers
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Two-Tiered Process
• First Tier: Initial peer review
– Recommendations on scientific and technical merit
– Scientific Review Groups (“SRGs” or “Study Sections”)
• Second Tier: Advisory Council or Board
– Recommendations to the Institutes/Centers (“ICs”) on
funding, appeals, program priorities
– “Council”
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Final funding decisions – IC Director
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Referral of Application
• Application is received at the NIH Center
for Scientific Review (“CSR”).
• First Tier assignments include:
– Scientific Review Group (SRG)
– Study Section
– Institute/Center (IC)
– Scientific Review Officer
• Second Tier assignments include:
– Advisory Council or Board
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Referral of Application, con’t.
• Funding considerations include:
– Specific ICs (each IC has its own budget,
priorities, and paylines)
– Dual assignment (to more than one IC) is
possible
– Input from Program Officer
• Funding decisions
– Ultimately made by the director of the IC
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Referral to a Scientific Review Group
CSR Review
IC Review
• Most R01s, fellowships, and
small business applications
• IC-specific features
• Program projects
• Some Program Announcements
(PAs, PARs)
• Training grants
• Some Requests for Applications • Career development awards
(RFAs)
• RFAs
The review locus is stated in the Funding Opportunity Announcement (“FOA”)
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Sample Review Loci
U54 - IC REVIEW
http://grants1.nih.gov/grants/guide/rfafiles/RFA-CA-11-003.html
R01 - CSR REVIEW
http://grants.nih.gov/grants/guide/pafiles/PA-10-067.html
Applications that are complete and responsive to the FOA
will be evaluated for scientific and technical merit by an
appropriate peer review group convened by the National
Cancer Institute and in accordance with NIH peer review
procedures (http://grants1.nih.gov/grants/peer/), using
the review criteria stated below.
Applications submitted for this funding opportunity will be
assigned on the basis of established PHS referral guidelines
to the ICs for funding consideration.
As part of the scientific peer review, all applications will:
Undergo a selection process in which only those applications deemed
to have the highest scientific and technical merit, generally the top half
of applications under review, will be discussed and assigned an
impact/priority score;
Receive a written critique; and
Receive a second level of review by National Cancer
Advisory Board.
Applications that are complete will be evaluated for
scientific and technical merit by (an) appropriate scientific
review group(s) in accordance with NIH peer review
procedures (http://grants.nih.gov/grants/peer/) using the
review criteria stated below.
As part of the scientific peer review, all applications will:
Undergo a selection process in which only those applications deemed
to have the highest scientific and technical merit, generally the top half
of applications under review, will be discussed and assigned an
impact/priority score;
Receive a written critique; and
Receive a second level of review by appropriate national
advisory council or Board.
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Requesting Referral to a Specific SRG
• Include in the application’s Cover letter:
– Application title
– FOA # and title
– Request:
• Assignment to particular SRG or study section
– SRG rosters are posted 30 days before the SRG meeting:
» http://era.nih.gov/roster/index.cfm
» http://www.csr.nih.gov/committees/rosterindex.asp
• Assignment to particular IC for funding consideration
– Provide:
• Disciplines involved, if multidisciplinary
• Explanation for late application, if necessary
Not all requests can be honored
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The Scientific Review Officer (SRO)
• First level of peer review
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Designated Federal Official
Extramural scientist administrator
Identifies and recruits reviewers
Manages conflicts of interest
Oversees arrangements for review meetings
Presides at review committee meetings
Prepares and releases summary statements
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Peer Reviewers
• Recruiting Criteria include:
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Expertise
Stature in field
Mature judgment
Impartiality
Ability to work well in a group
Managed conflicts of interest
• NIH attempts to ensure:
– Balanced representation
• Gender
• Geography
• Diversity
• Seniority
– Availability
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Types of Scientific Review Groups
(SRGs)
• “Chartered” SRGs
– Multi-year terms
– Formal appointment process
– May include temporary members for special
expertise
• Special Emphasis Panels (SEPs)
– Ad hoc membership
– Often meet only once
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Types of Reviewers
• Regular reviewers – permanent and
temporary
– Preliminary impact/priority scores, criterion scores,
written critiques
– Final impact/priority scores
• Other Contributing Reviewers (“mail”
reviewers)
– Written critiques, criterion scores, preliminary
impact/priority scores
– Cannot submit final impact/priority scores
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Reviewer Assignments
• For each application:
– ≥ Three qualified reviewers are assigned (“2 + 1”)
– Assignments are made by the SRO
• Based on the scientific content of application
• Expertise of the reviewer
• Suggestions from the PI on types of expertise –
– not names!
• Suggestions from Program staff
• Suggestions from SRG members
• Managing conflicts of interest
• Balancing workload
• Assignments are confidential
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Reviewer Conflicts of Interest (COI)
• Potential COIs between a reviewer and an
application:
– Financial
– Employment
– Personal
– Professional
– SRG membership
– Other interests
Two COI vouchers are submitted by each SRG
member.
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Scientific Review Groups (SRGs)
• Make recommendations on merit - not funding!
– Scientific and technical merit
– Budget and project duration
– Protection of human subjects, inclusion plans, vertebrate
animals, biohazards
– Resource Sharing Plans
– Other administrative factors
• Provide:
– Impact/priority scores
– Criterion scores
– Written critiques
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Confidentiality
• All confidential materials, discussions, documents
are deleted, retrieved, or destroyed
• Reviewers sent guidance with applications
• Application information provided on secure
websites or protected portable devices
• All questions must be referred to SRO
• SRG meetings are closed to the public
• Program staff may observe SRG meeting
Do not contact reviewers directly!
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Application Scoring
• Overall Impact:
– Likelihood for the project to exert a sustained,
powerful influence on the research field(s)
involved
• In consideration of:
– At least five scored criteria
• Receive individual, numerical scores
• Additional criteria in certain announcements
– Additional review criteria
• As applicable for the project proposed
• Do not receive individual, numerical scores
• Additional criteria in certain announcements
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Scored Review Criteria
• Applications for:
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Research Grants
Cooperative Agreements
Significance
Investigator(s)
Innovation
Approach
Environment
(FOA-specific criteria)
• Other review criteria apply to other mechanisms
• See “Review Criteria at a Glance”
(http://grants.nih.gov/grants/peer/reviewer_guidelines.
htm)
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Review Criterion: Significance
• Does the project address an important problem or
a critical barrier to progress in the field?
• If the aims of the project are achieved, how will
scientific knowledge, technical capability, and/or
clinical practice be improved?
• How will successful completion of the aims change
the concepts, methods, technologies, treatments,
services, or preventative interventions that drive
this field?
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Review Criterion: Investigator(s)
• Are the PD/PIs, collaborators, and other researchers well
suited to the project?
• If Early Stage Investigators or New Investigators, or in the
early stages of independent careers, do they have appropriate
experience and training?
• If established, have they demonstrated an ongoing record of
accomplishments that have advanced their field(s)?
• If the project is collaborative or multi-PD/PI, do the
investigators have complementary and integrated expertise;
are their leadership approach, governance and organizational
structure appropriate for the project?
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Review Criterion: Innovation
• Does the application challenge and seek to shift
current research or clinical practice paradigms by
utilizing novel theoretical concepts, approaches or
methodologies, instrumentation, or interventions?
• Are the concepts, approaches or methodologies,
instrumentation, or interventions novel to one field of
research or novel in a broad sense?
• Is a refinement, improvement, or new application of
theoretical concepts, approaches or methodologies,
instrumentation, or interventions proposed?
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Review Criterion: Approach
• Are the overall strategy, methodology, and
analyses well-reasoned and appropriate to
accomplish the specific aims of the project?
• Are potential problems, alternative strategies,
and benchmarks for success presented?
• If the project is in the early stages of
development, will the strategy establish
feasibility and will particularly risky aspects
be managed?
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Review Criterion: Approach (con’t.)
• If the project involves clinical research, are
the plans for 1) protection of human
subjects from research risks, and 2)
inclusion of minorities and members of
both sexes/genders, as well as the
inclusion of children, justified in terms of
the scientific goals and research strategy
proposed?
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Review Criterion: Environment
• Will the scientific environment in which the work
will be done contribute to the probability of
success?
• Are the institutional support, equipment and other
physical resources available to the investigators
adequate for the project proposed?
• Will the project benefit from unique features of the
scientific environment, subject populations, or
collaborative arrangements?
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Additional Review Criteria
• As applicable for the project proposed, reviewers:
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Consider in determining scientific and technical merit
Do not give separate scores for these items
FOA-specific criteria
Protections for Human Subjects
Inclusion of Women, Minorities, and Children
Vertebrate Animals
Resubmission Applications
Renewal Applications
Revision Applications
Biohazards
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Additional Review Considerations
• As applicable for the project proposed,
reviewers:
– Address each item
– Do not give scores for these items
– Should not consider them in providing an overall
impact/priority score
– FOA-specific considerations
– Select Agent Research
– Applications from Foreign Organizations
– Resource Sharing Plans
– Budget and Period Support
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NIH Scoring System
• Numerical scores
– 1.0 (exceptional) to 9.0 (poor)
– Final impact/priority score - average of individual
scores x 10
– Individual criterion scores
– Ranked by percentile for certain mechanisms
– Not Discussed (ND) – streamlining
– Other designations (DF = Deferred, AB =
Abstention, CF = Conflict, NP = Not Present)
– Final impact/priority scores range from 10 through
90.
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NIH Scoring System (con’t)
• Preliminary scores (before the SRG
meeting)
– Entered by assigned reviewers and discussants
in secure website
– Made available to other SRG members
• Final overall impact/priority scores (at the
SRG meeting)
– Voted by private ballot
– All eligible SRG members vote
• Reviewers are instructed to revise their
criterion scores after the meeting.
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Score Descriptors
Impact
High Impact
Moderate Impact
Low Impact
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Descriptor
1
Exceptional
2
Outstanding
3
Excellent
4
Very Good
5
Good
6
Satisfactory
7
Fair
8
Marginal
9
Poor
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Streamlining
• Allows discussion of more meritorious
applications
– Less meritorious applications tabled at the
SRG meeting, designated Not Discussed
(ND)
– Requires full concurrence of the entire SRG
– Summary statement:
• Reviewer critiques
• Individual criterion scores
• No numerical, overall impact/priority score
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Streamlining (con’t)
• Score order of review
– SRG discusses most meritorious applications first
– Entire SRG decides when to stop, which
applications will not be discussed in panel
• Other order of review (e.g., IC assignment,
mechanism)
– SRO prepares a list of average preliminary
scores
– Distributes to SRG
– Entire SRG decides which applications to discuss
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Pre-Meeting SRG Procedures
• SRO
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Performs administrative review of applications
Recruits reviewers, arranges for meeting date and site
Assigns 3 SRG members to each application
Makes applications available to reviewers
• Internet Assisted Review (IAR) site or on CDs
• Usually about six weeks before the SRG meeting
– Instructs reviewers in review procedures
– Monitors posting of initial scores and critiques in IAR
• Documents for Reviewers are available at:
http://grants.nih.gov/grants/peer/reviewer_guidelin
es.htm#general_guidelines
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Structured Critiques
• New summary statement format
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Bulleted comments from reviewers, less text
Criterion scores from assigned reviewers
Decreases variability
Increases quality of information in critiques
More succinct, better organized
Encourages evaluative statements
Ensures that reviewers address all review criteria and considerations
Reviewers also write a paragraph summarizing the factors that informed
their overall impact score to supplement the bulleted critiques.
• Critique templates are available at:
http://grants.nih.gov/grants/peer/reviewer_guidelines.htm#gene
ral_guidelines
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Templates for Reviewers
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Templates for Reviewers (con’t)
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Templates for Reviewers (con’t)
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Templates for Reviewers (con’t)
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Templates for Reviewers (con’t)
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Templates for Reviewers (con’t)
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Templates for Reviewers (con’t)
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Templates for Reviewers (con’t)
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Templates for Reviewers (con’t)
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Templates for Reviewers (con’t)
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Templates for Reviewers (con’t)
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Templates for Reviewers (con’t)
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Templates for Reviewers (con’t)
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Templates for Reviewers (con’t)
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Templates for Reviewers (con’t)
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Templates for Reviewers (con’t)
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Templates for Reviewers (con’t)
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Templates for Reviewers (con’t)
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Pre-Meeting SRG Procedures
• Reviewers
– Examine assignments
– Submit Conflict of Interest and Confidentiality
voucher
– Read applications, prepare written critiques in
templates
– Enter preliminary scores into IAR
– Read and consider other critiques and preliminary
scores
– Make travel and hotel arrangements
– Preliminary scores and critiques may be due
several days or a week in advance!
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Post-Submission Materials
• The NIH will only accept administrative materials resulting from
unanticipated events, such as:
• Revised budget page(s) (e.g., change in budget request due to new
funding or institutional acquisition of equipment);
• Biographical sketches (e.g., change in senior/key personnel due to
the hiring, replacement, or loss of an investigator);
• Letters of support or collaboration resulting from a change in
senior/key personnel due to the hiring, replacement, or loss of an
investigator;
• Adjustments resulting from natural disasters (e.g., loss of an animal
colony);
• Adjustments resulting from change of institution (e.g., PD/PI moves
to another university);
• News of an article accepted for publication (a copy of the article
should not be sent); and
• News of a professional promotion or positive tenure decision for any
Program Directors/Principal Investigators and Senior/Key
Personnel.
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SRG Meetings
• Agenda
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Call to Order – Chairperson
Policy and instructions – SRO
Discuss applications one at a time
Where feasible:
• In score order
• Cluster New Investigator (NI)/Early Stage Investigator (ESI)
applications
• Cluster clinical applications
– Score each application by private ballot after its discussion
– Discuss other considerations
• Budget
• Resource Sharing Plans
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Clustering NI/ESI Applications
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Applies to R01 applications only
New Investigator (NI)
– PD/PI who has not yet competed successfully for a substantial NIH
research grant
– If Multiple PD/PIs, all PD/PIs must meet requirements for NI status.
Early Stage Investigator (ESI)
– PD/PI who qualifies as a New Investigator AND is within 10 years of
completing the terminal research degree or is within 10 years of
completing medical residency (or equivalent)
NI and ESI R01 applications are clustered together in review.
– ESI applications are not separately clustered within the NI/ESI group.
– NI/ESI applications are identified for reviewers so there can be
appropriate review in context of career stage.
– Expectations of preliminary data and publication track record less than
for established investigators.
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Clustering Clinical Applications
• The goal of clustering clinical applications in
review is to increase fairness in the process
of reviewing clinical applications.
• A clinical application is defined as human
subjects research minus Exemption 4.
• The clustering of NI/ESI applications takes
precedence over the clustering of clinical
applications.
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SRG Meeting Procedures
• Discussion format
– Members with conflicts excused
– Initial levels of enthusiasm stated(assigned reviewers
and discussants)
– Primary reviewer - explains project, strengths,
weaknesses
– Other assigned reviewers and discussants follow
– Open discussion (full panel)
– Levels of enthusiasm (assigned reviewers) re-stated
– Individual SRG members vote
– Other review considerations discussed (budget)
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SRG Meeting Procedures (con’t)
• If 60 applications/SRG meeting
– ~ 50% streamlined, 30 applications to discuss
and score
• If 9 hour SRG meeting
– ~ ½ hour introduction, streamlining
– ~ 1 hour lunch, 2 x 15 minute breaks
• Which Leaves
– ~ 14 minutes on average/application
– ~ 3 - 4 minutes/reviewer
• Thus, clarity and brevity are essential!
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After the Review
• eRA Commons
(http://era.nih.gov/commons/index.cfm)
– Final Impact/Priority Score available three days after
the SRG meeting
– Summary statement available 4 – 8 weeks after
meeting
– Available also to Program Officers at that time
– Confidential document
– Available to:
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PD/PIs
NIH officials
Advisory Council members
No one else at LSUHSC-NO will see scores
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Summary Statement
• First page
– NIH Program Officer (upper left corner)
• Name
• Contact information
– Final Impact/Priority Score or other designation
– Percentile (if applicable)
– Codes
• Human subjects
• Vertebrate animals
• Inclusion plans
– Budget request
• A favorable score does not guarantee funding!
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Summary Statement (con’t)
• Subsequent Pages
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Description (provided by applicant)
Résumé and Summary of Discussion (if discussed)
Reviewer critiques – essentially unedited
Follow review criteria for mechanism
Protections for Human Subjects
Inclusion Plans
Vertebrate Animals
Biohazards
Budget
Administrative Notes
Meeting roster
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Summary Statement (con’t)
• Sample summary statements are available
here:
http://www.niaid.nih.gov/researchfunding/g
rant/pages/appsamples.aspx#rpindex.
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Appeals Process
• First, the investigator must contact the NIH
program officer (PO) to discuss the concerns
and outcomes.
• Second, if the investigator would still like to
proceed with an appeal, he or she should
contact The Office of Research Services,
since our authorized organization
representative (AOR), must concur with the
appeal in order for it to be accepted by NIH.
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Appeals Process (con’t)
• The appeal letter must meet these three criteria:
• Describe the flaws in the review process;
• Explain the reasons for the appeal; and
• Be based on one or more of the following issues:
• Evidence of bias on the part of one or more peer
reviewers;
• Conflict of interest, as specified in regulation at 42 CFR
52h.5. “Scientific Peer Review of Research Grant
Applications and Research and Development Contract
Projects”, on the part of one or more peer reviewers;
• Lack of appropriate expertise within the Scientific Review
Group (SRG); or
• Factual error(s) made by one or more reviewers that could
have altered the outcome of review substantially.
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Appeals Process (con’t)
• If the letter does not meet the criteria listed
above, then the concern is probably a
grievance and not an appeal.
• Also, if the appeal letter is based solely on
differences of scientific opinion, it will not be
accepted by NIH as an appeal.
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Appeals Process (con’t)
• If review staff and program staff support
the appeal, the original application will
be re-reviewed.
• If the review and program staff do not
support the appeal, then the PD/PI can
either:
• Withdraw the appeal, or;
• The appeal letter can be made available
to the IC’s council during the second
level of review.
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Appeals Process (con’t)
• Finally, if the appeal goes to council,
council can either recommend re-review or
deny the appeal. The PD/PI will be notified
of the decision within 30 days of the
council meeting.
• More details are provided in the complete
Guide Notice,
http://grants.nih.gov/grants/guide/noticefiles/NOT-OD-11-064.html.
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Advisory/Council Board
• Second level of review – recommendations on:
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Research priority areas
Policy
Appeals
Funding
Quality of SRG review
• Members
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Scientists from the extramural research community
Public representatives
Appointed to multi-year terms
Appointed as Special Government Employees
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Advisory/Council Board (con’t)
• Balanced representation
– Expertise
– Stature in field
– Mature judgment
– Impartiality
– Managed conflicts of interest
– Balanced representation
– Gender, Diversity
– Geography, Seniority
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Funding Considerations
• Authority of the IC Director
– Scientific and technical merit (initial peer
review)
– Council recommendations
– Relevance to program priorities in IC
– Compliance with policies
– Number of meritorious applications received
– Availability of funds
– Advice of IC Program Staff
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Timeline
Planning, Writing, and Submitting
Planning:
Applicant should
start early,
collect
preliminary
data, and
determine
internal
headlines
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Writing: Applicant
often begins writing
application several
months prior to
application due date.
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Submitting: Applicant
organization submits
most applications to NIH
through Grants.gov.
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Timeline
Receipt and Referral
Months 1-3
Applications
compliant with
NIH policies are
assigned for
review by the
Division of
Receipt and
Referral in the
Center for
Scientific Review
(CSR).
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CSR assigns application
to an NIH
Institute/Center (IC)
and a Scientific Review
Group (SRG).
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Scientific Review Officer
(SRO) assigns applications
to reviewers and readers.
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Timeline
Peer Review
Months 4 - 8
Initial Level of
Peer Review:
SRG members
review and
evaluate
applications for
scientific merit.
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Priority Scores:
Available to
Principal
Investigator on
eRA Commons.
Summary
Statement:
Available to
Principal
Investigator on eRA
Commons.
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Second Level of
Review: Advisory
council/board
reviews
applications.
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Timeline
Award
Months 9-10
Pre-Award
Process: IC
grants
management
staff conducts
final
administrative
review and
negotiates
award *
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Notification of Award :
Institute/Center (IC)
issues and sends Notice
of Award (NoA) to
applicant
institution/organization.
Congratulations!
Project period
officially begins!
* NIH requests additional information needed Just-in-Time
(“JIT”) for award.
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Video: NIH Peer Review Revealed
• This video provides a front-row seat to a
peer review meeting.
• http://www.youtube.com/watch?v=fBDxI6l4
dOA
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Additional Information and Resources
• Enhancing Peer Review Initiative
– http://enhancing-peer-review.nih.gov/
• Office of Extramural Research Peer Review Process
– http://grants.nih.gov/grants/peer_review_process.htm
• Peer Review Policies & Practices
– http://grants.nih.gov/grants/peer/peer.htm
• Center for Scientific Review
– http://cms.csr.nih.gov/AboutCSR/Welcome+to+CSR/
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Questions?
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Thank You!
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