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Go Behind the AHRQ/NIH Study Section Door
A Mock Review
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The Panel Linda Greenberg, PhD Willard Manning, PhD
Ming Tai-Seale, PhD
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The Agenda Relevant funding mechanisms: Rs, Ks Life of a proposal
Scientific review: who, where, how Critical areas for improvement Mock review Summary statement How to work with federal officials Questions and answers If they can be a speck on the paper of the proposal, we will take them through the process
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Funding Mechanisms Linda
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Rxx GRANTS FOR HEALTH SERVICES DISSERTATION RESEARCH (R36) R01, R03, …
Support students seeking a doctorate after successful dissertation defense in areas relevant to health services research Total direct costs <$30,000 R01, R03, … Barbara?
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Relevant Funding Mechanisms: K01, K02, K08, …
Mentored Clinical Scientist Development Award (K08) Development of outstanding research scientists. Specialized study support for trained professionals who are committed to a career in research and have the potential to develop into independent investigators Focuses on progression to independence Study and development consistent with his/her needs, and previous research or clinical experience. The proposed length of the award must be well explained and justified Support will only be provided for the period deemed necessary to achieve independence
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The Life of a Proposal Ming
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Who Serve on Study Sections?
Disciplines Anthropology Biostatistics Economics Epidemiology Health services research Medicine Nursing Organizational Theory Sociology Methodological Orientations Quantitative Qualitative Mixed Stages in Their Own Careers Senior Scholars Emergent scientists Everyone has equal weight in scoring, you have to communicate clearly, especially to those who don’t share your disciplinary training, You have to convince them why your proposal is good.
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Where is the Review Done
NIH AHRQ Let’s go there …
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The Physical Setting
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Protection of Human Subjects
Applicant must address: Risks to human subjects Adequacy Summary reviewer choices: Human subjects NOT involved Human subjects involved, ACCEPTABLE Human subjects involved, UNACCEPTABLE Human subjects involved, exemption claimed
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Inclusion of Women and Minorities
Gender Code: First Character = G 1= Both Gender 2= Only Women 3= Only Men 4= Gender Unknown Third Character: A= Scientifically acceptable U= Scientifically unacceptable Minority Code: First character = M Second character: 1=Minority and Nonminority 2= Only Minority 3= Only Nonminority 4= Minority unknown Third Character: A= Scientifically acceptable U= Scientifically unacceptable
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Inclusion of AHRQ Priority Populations Checklist
Included Excluded Not addressed Children Elderly Rural Inner city Low income Disabled Chronically ill End of life This is only for portfolio purpose, we are not suppose to ding them on this. Adequate numbers for sub-group analysis? For excluded, including rationale?
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Inclusion of Women and Minorities
Gender Code: First Character = G 1= Both Gender 2= Only Women 3= Only Men 4= Gender Unknown Third Character: A= Scientifically acceptable U= Scientifically unacceptable Minority Code: First character = M Second character: 1=Minority and Nonminority 2= Only Minority 3= Only Nonminority 4= Minority unknown Third Character: A= Scientifically acceptable U= Scientifically unacceptable
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Adjectives Used in Review
Outstanding Excellent Very Good Good Acceptable
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Priority Score How is the summary priority score calculated?
Group average Equal weight What is the fundable range? Study sections can have different norms When in doubt, ask the project officer
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Critical Areas for Improvement for K0x
Will
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Critical Areas for Improvement for K0x
It Is Not About 5 years of support 75 percent buyout $$$
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It Is About Mentored Clinical Scientist Development
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It Is About (cont’d) It does require mentoring
It is about career development for researchers Not just about more education Not just about doing preliminary studies Don’t confuse K with series of R03’s
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Disconnected Mentor Mentor’s letter not closely tied to content of proposal. Mentor’s letter written by proposer and it looks like it. Mentor approached with proposal with only week left before due date. Little impact on proposal. Worse if proposal is naïve.
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Distant Mentor Always very hard to sell.
Study section distrusts supposed level of commitment by mentor. Plans for linkage, visiting vague.
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Who is in charge? Too many mentors No strong primary
Nobody with oversight responsibility
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Career Development Plan
R-Avoidance Its thinly disguised research support for 5 years. Little or no education component. A La Carte Education: Lacks coherent rationale for what’s proposed. Need to lay out individual strengths and weaknesses. It’s OK to say you’re imperfect!!!
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Career Development Plan
Educational elements too vague Visiting Prof. Jones T times per year. T small. Lack of specificity Not clear depth of training Formal course work preferred if a good match for needs. if level appropriate Avoid lower level MPH courses.
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Critical Areas for Improvement in Rs
Design problem Measurement Choice of variables Intervention/comparison Analysis problem Choice of approach Technique Test
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Critical Areas for Improvement in Rs
Weak justification for study Background and significance unconvincing Literature review incomplete Investigator expertise deficient Needs consultants or collaborators Theoretical or conceptual model or framework Missing, deficient, or erroneous
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Mock Review Chair: Willard Manning, PhD Primary: Ming Tai-Seale, PhD
Secondary: Willard Manning, PhD Usually there is a tertiary reviewer K08 – Mentored Clinical Scientist Development Award
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Review Guideline Candidate Career development plan Research plan
Mentor/co-mentor Environment and institutional commitment Budget Human subjects Women/minorities/children SUMMARY major strengths and weaknesses Recommendation for or against funding
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Summary Statement Ask Will about the story of the Pink Sheet Ming
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How to Read the Pink Sheet
Expect the language to be Frank, and Not overly enthusiastic Be emotionally detached, after the initial… Talk to an experienced grant-maker Resubmit unless you see “fatally flawed” Do NOT resubmit right away Recruit a “cold reviewer”
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Take a Vacation …
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Role of Federal Officials
Linda
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What Can You Expect From
Project officers Read your concept paper and draft Send it in EARLY! Interpret the fundability of your priority score Scientific review administrators Assign reviewers who may have expertise to review your proposal Francis
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Questions & Answers Panel
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Resources Video on Peer Review for Clinical Research
Instructions on how to prepare your application Our contact information Linda: Will: Ming: Can’t comment on any current proposal in the review process
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