Office of Extramural Research, Education and Priority Populations (OEREP)Office of Extramural Research, Education and Priority Populations (OEREP)

Grantsmanship SessionGrantsmanship Session

• Overview: Francis Chesley, MD – OEREP Director

• Prepare a Grant Application: Debbie Rothstein, PhD, Senior Advisor to the Director - OEREP

• AHRQ Peer Review Process: Kishena Wadhwani, PhD, MPH – Div. Scientific Review Director, OEREP

• Human Subjects Protections and Inclusions: Patrick McNeilly, PhD – AHRQ IRB Official, OEREP

Preparing a Grant Application: Preparing a Grant Application: Steps to SuccessSteps to Success

Debbie Rothstein, Ph.D.Senior Advisor, Extramural Research

Office of Extramural Research,Education and Priority Populations

Agency for Healthcare Research and QualitySeptember 9, 2008

Getting StartedGetting Started

Internet is funding gatewayInternet is funding gateway

AHRQ and NIH use essentially the same AHRQ and NIH use essentially the same application processes and grant mechanismsapplication processes and grant mechanisms

Keep abreast of open solicitations and Agency Keep abreast of open solicitations and Agency research priorities research priorities

AHRQ’s Website – AHRQ’s Website – www.ahrq.govwww.ahrq.gov

   AHRQ Research Agenda    Funding Announcements    Research Policies    Grants Process    Grant Application Basics    Training and Education    Contracts

AHRQ and NIH: Grant AHRQ and NIH: Grant Application SimilaritiesApplication Similarities

Application forms: SF 424(R&R), PHS 398Application forms: SF 424(R&R), PHS 398 Application submission dates Application submission dates Use of internet as the funding gateway to Use of internet as the funding gateway to

keep abreast of research priorities and open keep abreast of research priorities and open solicitations, staff can provide technical solicitations, staff can provide technical assistance assistance

Announcement publication: Announcement publication: NIHNIH Guide for Guide for Grants: Grants: http://grants1.nih.gov/grants/guide/index.htmlhttp://grants1.nih.gov/grants/guide/index.html andand Grants.Gov:Grants.Gov: www.http://grants.govwww.http://grants.gov

AHRQ and NIH: Grant AHRQ and NIH: Grant Application Similarities Application Similarities (cont’d)(cont’d)

Receipt and referral of grant applicationsReceipt and referral of grant applications Application review proceduresApplication review procedures Grant mechanisms – e.g., R01, R03, R13, Grant mechanisms – e.g., R01, R03, R13,

R36, K01, K02, K08R36, K01, K02, K08 Transition to electronic submission of Transition to electronic submission of

applicationsapplications Some common Policy Notices and Some common Policy Notices and

Funding Opportunity AnnouncementsFunding Opportunity Announcements

AHRQ and NIH: Grant AHRQ and NIH: Grant Application DifferencesApplication Differences

Detailed budget vs. modular budgetDetailed budget vs. modular budget

Conference grants – AHRQ has small and large Conference grants – AHRQ has small and large opportunitiesopportunities

AHRQ doesn’t allow multiple PI’sAHRQ doesn’t allow multiple PI’s

Budget limitations Budget limitations – Large grants (R01, R18) - $300K vs. $500KLarge grants (R01, R18) - $300K vs. $500K– Small grants (R03) - $100K vs. $50KSmall grants (R03) - $100K vs. $50K

Fewer grant mechanisms used at AHRQFewer grant mechanisms used at AHRQ

AHRQ Grant Opportunities AHRQ Grant Opportunities

AHRQ announces availability of grants in a Funding AHRQ announces availability of grants in a Funding Opportunity Announcement (FOA)Opportunity Announcement (FOA)

FOA’s are published in the FOA’s are published in the NIH Guide for GrantsNIH Guide for Grants ( (http://http://grants.nih.gov/grants/guide/index.htmlgrants.nih.gov/grants/guide/index.html) and posted on ) and posted on Grants.gov (Grants.gov (http://http://www.grants.govwww.grants.gov//

Program Announcement (PA)Program Announcement (PA)– Describes broad research interestsDescribes broad research interests– Open over a period of timeOpen over a period of time

Request for Applications (RFA)Request for Applications (RFA)– More well defined area, specific program objectivesMore well defined area, specific program objectives– Single application receipt date and amount of fundsSingle application receipt date and amount of funds

Common AHRQ Grant Common AHRQ Grant OpportunitiesOpportunities

R01: large research grantsR01: large research grants– Feb 5, June 5, Oct 5 application receipt datesFeb 5, June 5, Oct 5 application receipt dates– up to $300K/yr up to $300K/yr

R18: research demonstration grantsR18: research demonstration grants– Jan 25, May 25, Sept 25 application receipt datesJan 25, May 25, Sept 25 application receipt dates– up to $300K/yrup to $300K/yr

R03: small research projectsR03: small research projects– Feb 16, June 16, Oct 16 application receipt datesFeb 16, June 16, Oct 16 application receipt dates– up to $100K in total costsup to $100K in total costs

Large and small conference grants (R13)Large and small conference grants (R13)– Large: Apr 12, Aug 12, Dec 12 receipt; up to Large: Apr 12, Aug 12, Dec 12 receipt; up to

$100K/yr in total costs$100K/yr in total costs– Small: Feb 20, Apr 20, Jun 20, Aug 20, Oct 20, Small: Feb 20, Apr 20, Jun 20, Aug 20, Oct 20,

Dec 20 receipt; up to $50KDec 20 receipt; up to $50K

AHRQ Grant Opportunities: AHRQ Grant Opportunities: Training/Career Development Training/Career Development

Pre and Postdoctoral TrainingPre and Postdoctoral Training– Institutional Training Programs (T32)Institutional Training Programs (T32)– Individual Pre-doctoral Fellowships to Promote Diversity (F31)Individual Pre-doctoral Fellowships to Promote Diversity (F31)– Individual Post-doctoral Fellowships (F32)Individual Post-doctoral Fellowships (F32)– Dissertation Grants (R36)Dissertation Grants (R36)

Career Development AwardsCareer Development Awards

– Mentored Scientist Awards (K01)Mentored Scientist Awards (K01)– Independent Scientist Awards (K02)Independent Scientist Awards (K02)– Mentored Clinical Scientist Awards (K08)Mentored Clinical Scientist Awards (K08)

Detailed information at:Detailed information at: http://www.ahrq.gov/fund/training/trainix.htmhttp://www.ahrq.gov/fund/training/trainix.htm

Send questions to: Send questions to: training@ahrq.hhs.govtraining@ahrq.hhs.gov

AHRQ Staff Involved in AHRQ Staff Involved in Grants ProcessGrants Process

Referral OfficerReferral Officer Review Staff – Scientific Review Officer Review Staff – Scientific Review Officer

and Grants Management Specialist and Grants Management Specialist Program Staff – Project Officer (PO)Program Staff – Project Officer (PO) Grants Management StaffGrants Management Staff

Electronic Application and Electronic Application and SubmissionSubmission

Transition to Electronic Receipt began Dec, 2005

Vast majority of all competing applications to AHRQ are now submitted electronically using SF 424 (R&R) application

All major mechanisms used by AHRQ have transitioned except for the training grants

What is Grants.gov?What is Grants.gov?

Federal government’s single, online portal to electronically:

– Find Grant Opportunities– Apply for Grants

A cross-agency initiative spanning 900 grant programs from the 26 grant-making agencies, and over $350 billion in annual awards.

Electronic Submission of Grant Electronic Submission of Grant ApplicationsApplications

With this new process, it’s critical to read and follow all instructions in the announcement and application guide

Applicant must prepare for e-submission by completing mandatory registrations– Grants.gov: registration for organization– ERA Commons: registration for

organization and the PI

SF424 (R&R) Application FormSF424 (R&R) Application Form

Provides a consistent electronic submission process through Grants.gov

Consists of common data elements, arranged in components– Not all components will be used for every Funding

Opportunity Announcement (FOA)

Each FOA will have the appropriate application package attached

From data files, application image is generated– Applicant should view and verify the application image

Electronic Application and Submission - General Information and Help Links

SF424 (R&R) Application and Electronic Submission Information:

http://grants.nih.gov/grants/funding/424/index.htm

General information on Electronic Submission of Grant Applications:

http://era.nih.gov/ElectronicReceipt/

Finding Help: http://era.nih.gov/ElectronicReceipt/support.htm

Paper No More, Use 424 (R&R)

OLD NEWOLD NEW

What Determines Which What Determines Which Awards Are Made? Awards Are Made?

Scientific meritScientific merit– Significance and originalitySignificance and originality

– Methods Methods

Program / Agency considerationsProgram / Agency considerations– What is uniquely AHRQWhat is uniquely AHRQ

– Existing research portfolio balanceExisting research portfolio balance

– Anticipated IMPACT of researchAnticipated IMPACT of research

Availability of fundsAvailability of funds

Ingredients of a Successful Ingredients of a Successful Grant ApplicationGrant Application

Good IdeaGood Idea

Good ScienceGood Science

Good ApplicationGood Application

Fits Agency Research PrioritiesFits Agency Research Priorities

AHRQ PEER REVIEW PROCESS

Kishena C. Wadhwani, Ph.D., M.P.H. Director, Division of Scientific Review (DSR)

Kishena.wadhwani@ahrq.hhs.govPhone: (301) 427-1556

Office of Extramural Research, Education and Priority Population (OEREP) Agency for HealthCare Research and Quality (AHRQ)

Department of Health and Human Services (DHHS)

10/09/2008

ORGANIZATIONAL CHARTOffice of Extramural Research, Education and Priority Populations (OEREP)Division of Scientific Review (DSR)Current Study Review Group (SRG) Clusters and the Corresponding SRO/GMS

Health Care Quality & Effectiveness Research (HCQER)

Health Care Technology and Health Care Technology and Decision Sciences (HCTDS)Decision Sciences (HCTDS)

Health Care Research Health Care Research Training (HCRT)Training (HCRT)

Study Section ClustersStudy Section Clusters

SRO: Dr. Carl OhataGMS: Maureen Gallagher

DSR

Director: Dr. Kishena Wadhwani

OEREPDirector: Dr. Francis Chesley

SRO: TBDSRO: TBDGMS: Ms. Carmen ColstonGMS: Ms. Carmen Colston

SRO: Dr. Boris AponteSRO: Dr. Boris AponteGMS: Ms. Rebecca TrockiGMS: Ms. Rebecca Trocki

Committee ManagementCommittee Management

SRO: Ali AzadeganSRO: Ali AzadeganGMS: Ms. Diane ManuelGMS: Ms. Diane Manuel

Receipts & Referrals Receipts & Referrals

Health Care System Research (HSR)

AHRQ HEALTH SERVICES RESEARCH SRG AND ITS AHRQ HEALTH SERVICES RESEARCH SRG AND ITS PRIMARY RESEARCH FOCIPRIMARY RESEARCH FOCI

Health Care Systems Health Care Systems Research (HSR)Research (HSR)

Health Care Technology Health Care Technology and Decision Sciences and Decision Sciences

(HCTDS)(HCTDS)

Health Care Quality & Health Care Quality & Effectiveness Research Effectiveness Research

(HCQER)(HCQER)

Health Care Research Health Care Research TrainingTraining

(HCRT)(HCRT)

Translational ResearchTranslational Research Translational ResearchTranslational Research Translational ResearchTranslational Research Translational ResearchTranslational Research

Implementation ResearchImplementation Research Implementation ResearchImplementation Research Implementation ResearchImplementation Research Implementation ResearchImplementation Research

Access and UtilizationAccess and Utilization Technology/HIT Technology/HIT AssessmentAssessment

Healthcare Quality & Healthcare Quality & EffectivenessEffectiveness

Training & Career Training & Career DevelopmentDevelopment

Cost/Finance/MarketsCost/Finance/Markets Information Sciences; Information Sciences; DisseminationDissemination

Cost-effectiveness Cost-effectiveness ResearchResearch

Training-related Training-related Conferences/WorkshopsConferences/Workshops

Qualitative & Quantitative Qualitative & Quantitative MethodsMethods

Qualitative & Quantitative Qualitative & Quantitative MethodsMethods

Qualitative & Quantitative Qualitative & Quantitative MethodsMethods

Qualitative & Quantitative Qualitative & Quantitative MethodsMethods

Delivery SystemsDelivery Systems Clinical/Translational Clinical/Translational Decision-makingDecision-making

Evidence-based MedicineEvidence-based Medicine Institutional Training & Institutional Training & Career DevelopmentCareer Development

Organizational StudiesOrganizational Studies Patient Utilities, Morbidity Patient Utilities, Morbidity &Function&Function

Quality of Care ResearchQuality of Care Research Demonstrations & Demonstrations & EvaluationsEvaluations

Infrastructure Building Infrastructure Building ResearchResearch

Outcome ResearchOutcome Research Access to & Utilization of Access to & Utilization of CareCare

Outcome ResearchOutcome Research

Provider WorkforceProvider Workforce Healthcare Quality & Cost Healthcare Quality & Cost ImprovementImprovement

Clinical Outcome Clinical Outcome ResearchResearch

Healthcare-related IT Healthcare-related IT TrainingTraining

Study Section( Meeting Dates)

October 2008 Meeting March 2009 Meeting June 2009 Meeting

HSROhata/Gallagher

October 24, 2008 March 5-6, 2009June 24-25, 2009

HCQERTBD/Colston

October 30, 2008 February 23-24, 2009June 18-19, 2009

HCTDSAponte/Trocki

October 29, 2008 February 24, 2009June 18-19, 2009

HCRTAzadegan/Manuel

October 23-24, 2008 March 5-6, 2009June 24-25, 2009

SCHEDULE OF STUDY SECTION MEETINGS, FY08-FY09 (TENTATIVE)

(Updated: 09/01/2008)

Process of Review for New Individual Research Process of Review for New Individual Research Project Grant ApplicationsProject Grant Applications

Three overlapping cycles per year:

- Submit in February (June, October)

- Review in June – July (Oct - Nov, February - March)

- SLT in July - August (December, May - June)

- Earliest award in December (April, August - September)

Peer Review at NIH/AHRQ: Peer Review at NIH/AHRQ:

Types of Committees (Study Types of Committees (Study Sections):Sections):• Standing Committees

- Chartered; multi-year commitment

- Temporary members added as needed

- Roster posted on NIH/AHRQ websites

• Special Emphasis Panels (SEPs)

- All Temporary (Ad-hoc) members

Purpose of Peer ReviewPurpose of Peer Review

To evaluate the To evaluate the scientific and technical scientific and technical

meritmerit of grant applications, of grant applications, providing providing

informationinformation (Recommendations)(Recommendations) used by the used by the

Agencies/Institutes and Centers to make Agencies/Institutes and Centers to make

funding decisions.funding decisions.

Reviewers considerReviewers consider

Scientific and technical merit of proposed Scientific and technical merit of proposed research/trainingresearch/training

Qualifications of Principal Investigator(s) and Qualifications of Principal Investigator(s) and research teamresearch team

Availability of resources (Labs, Institutions)Availability of resources (Labs, Institutions)

Reviewers also consider (Cont.)Reviewers also consider (Cont.)

Reasonableness of requested budget for work Reasonableness of requested budget for work proposedproposed

Other factors (e.g., human subjects, animal welfare, Other factors (e.g., human subjects, animal welfare, inclusion policies/plans)inclusion policies/plans)

Reviewers Reviewers do notdo not consider consider

Program relevance (Except if stated in FOA)Program relevance (Except if stated in FOA)

Policy issuesPolicy issues

Funding levelsFunding levels

Anticipated budget reductionsAnticipated budget reductions

Comparisons with other applicationsComparisons with other applications

Review CriteriaReview Criteria

For all R01, R03, R15, R21, and P01 For all R01, R03, R15, R21, and P01 subprojects:subprojects:

Significance and OriginalitySignificance and Originality Approach – Methods and DataApproach – Methods and Data InnovationInnovation Organization of the ProjectOrganization of the Project InvestigatorsInvestigators Environment – Facilities and ResourcesEnvironment – Facilities and Resources

Sole Basis of Review: Review Sole Basis of Review: Review

CriteriaCriteria Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field?

Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers (if any)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of the unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?

(The NIH 5 – as an example)(The NIH 5 – as an example)

Also...Also...

Reviewers evaluateReviewers evaluate

Protection of human subjects, the Protection of human subjects, the environment, and animal welfareenvironment, and animal welfare

Inclusion of women, minorities, and children

Budget

Inclusion of AHRQ Priority Populations

Research Involving Human SubjectsResearch Involving Human SubjectsImportant Considerations that must be addressed in the application Important Considerations that must be addressed in the application

because they impact on priority score - considered to be part of the because they impact on priority score - considered to be part of the ApproachApproach

Are there any risks* to the human subjects?Are there any risks* to the human subjects? Are the protections adequate?Are the protections adequate? Are there potential benefits to the subjects and to others?Are there potential benefits to the subjects and to others? What is the importance of the knowledge to be gained?What is the importance of the knowledge to be gained? Are the plans for inclusion of minorities, both genders and Are the plans for inclusion of minorities, both genders and

children adequately addressed?children adequately addressed? Is the proposed study exempt from human subject review?Is the proposed study exempt from human subject review? No page limitsNo page limits

* “Risks” include the possibility of physical, psychological, social injury or safety resulting from research.

AHRQ Requirement:AHRQ Requirement:Inclusion of Priority PopulationsInclusion of Priority Populations

Inclusion of Children? Inclusion of Children? -- Rationale?Rationale? Inclusion of Elderly? Inclusion of Elderly? -- Rationale?Rationale? Inclusion of Rural? Inclusion of Rural? -- Rationale?Rationale? Inclusion of Inner City? Inclusion of Inner City? -- Rationale?Rationale? Inclusion of Low Income? Inclusion of Low Income? -- Rationale?Rationale? Inclusion of Disabled? Inclusion of Disabled? -- Rationale?Rationale? Inclusion of Chronic Care? - Inclusion of Chronic Care? - Rationale?Rationale? Inclusion of End of Life? - Inclusion of End of Life? - Rationale?Rationale?

Review Criteria (Cont.)Review Criteria (Cont.)

For FOAs (RFAs or PAs) , modified or For FOAs (RFAs or PAs) , modified or additional criteria may be specifiedadditional criteria may be specified

For other mechanisms, specific criteria For other mechanisms, specific criteria applyapply

Peer Review ProcessPeer Review Process

Each application assigned to 3 reviewers for written Each application assigned to 3 reviewers for written commentscomments

Streamlined Review may be usedStreamlined Review may be used

Group discussion of each application, including budget Group discussion of each application, including budget recommendationrecommendation

Recommended score rangeRecommended score range

Reviewers privately assign priority scoreReviewers privately assign priority score

Peer Review Group ActionsPeer Review Group Actions

Unscored (Streamlined Review)Unscored (Streamlined Review)

Scientific Merit Rating (Priority Score)Scientific Merit Rating (Priority Score)

Priority Scores/ PercentilesPriority Scores/ Percentiles

Priority scores range from:Priority scores range from:

100 (Best) to 500 (Worst) 100 (Best) to 500 (Worst)

[100 x (1.0 – 5.0)][100 x (1.0 – 5.0)]

In Streamlined Review, those in lower half In Streamlined Review, those in lower half are eliminated (unscored)are eliminated (unscored)

Percentiles calculated to normalize scoring Percentiles calculated to normalize scoring behavior across review groupsbehavior across review groups

Priority Scores Assigned by ReviewersPriority Scores Assigned by Reviewers

SCORED (stronger)SCORED (stronger) 1.0 1.0 1.4 (Outstanding) 1.4 (Outstanding)

1.5 1.5 2.0 (Excellent) 2.0 (Excellent) (25%)(25%)

2.0 2.0 3.0 3.0 (25%)(25%)

UNSCORED (weaker ) 3.0 UNSCORED (weaker ) 3.0 4.0 4.0

4.0 4.0 5.0 5.0 (50%)(50%)

HINTS: PREPARING AN APPLICATIONHINTS: PREPARING AN APPLICATION

Start earlyStart early Read and follow instructionsRead and follow instructions Clarify any confusing instructions earlyClarify any confusing instructions early Do not assume staff or reviewers “will know what you mean”Do not assume staff or reviewers “will know what you mean” Include well designed tables and figuresInclude well designed tables and figures Format - consider the reviewersFormat - consider the reviewers Proofread and check Proofread and check beforebefore sending sending

PREPARING AN APPLICATION (cont.)PREPARING AN APPLICATION (cont.)

Explicitly state the purpose of the proposed Explicitly state the purpose of the proposed workwork

Refer to the literature thoroughly but Refer to the literature thoroughly but thoughtfullythoughtfully

Present an organized, lucid write-upPresent an organized, lucid write-up Be mindful of the review criteria to be usedBe mindful of the review criteria to be used Get advice from colleaguesGet advice from colleagues

Art of Persuasion: Art of Persuasion: AssumptionsAssumptions that the reviewers are knowledgeable and

committed to doing a thorough job of evaluating each application

that the reviewers have less time to complete the task than desirable

that good formatting will assist reviewers to remember your organization and the thrust of your arguments

43

Strategies to Strengthen Applications: Strategies to Strengthen Applications: The Short ListThe Short List

- Ask scientist with AHRQ support to critically review Ask scientist with AHRQ support to critically review your application prior to submission – your application prior to submission – more than once more than once

- Talk with an Agency (AHRQ, etc.) program officer(s)Talk with an Agency (AHRQ, etc.) program officer(s)

Strengthening Applications Strengthening Applications - -

The Long List:The Long List: Significance of problem: Best if transparent yet not insultingly obvious

Scientific Rationale: New &/or original ideas clearly identified

Include a plan for acquiring needed expertise, if needed

Discuss the limitations of the chosen approach

Include abundant detail about the methodology

Scope of work midway on the trivial – grandiose continuum

Describe the participants & their involvement in the study in detail

Include pilot or preliminary data

Describe future research directions

Help Reviewers See the MeritsHelp Reviewers See the Merits Think like a reviewer – Think like a reviewer –

Learn as much as possible about The System (e.g., figure out the Learn as much as possible about The System (e.g., figure out the

likely review group)likely review group)

Preempt criticismPreempt criticism

Include collaborators who can compensate for your deficienciesInclude collaborators who can compensate for your deficiencies

Learn as much as possible about what research projects in your Learn as much as possible about what research projects in your

area that have been funded by the NIH/AHRQ/HRSA/CDC/etc.area that have been funded by the NIH/AHRQ/HRSA/CDC/etc.

CRISP Database: CRISP Database: (http://crisp.oit.nih.gov)(http://crisp.oit.nih.gov)

http://crisp.oit.nih.gov

Grant Applications Reviewed and Funded (HCRT) FY08

0

10

20

30

40

50

60

70

80

F32 K02 K08 R36 R01 R13 Total

Application Types

Ap

plic

ati

on

Nu

mb

ers

Reviewed

Funded

HCRT Grant Applications Reviewed and Funded in FY08

Types Reviewed Funded % Sucessful

F31 2 0 0%

F32 8 2 25%

K02 5 3 60%

K08 12 6 50%

R36 39 11 28%

R01 1 1 100%

R13 1 0 0%

Total 68 23 34%

“In God We Trust….

All Others Must Bring Data.”

Olivia Bartlett, Ph.D.Chief, Research Programs Review Branch

Division of Extramural Activities, NCI

BEST WISHES TO YOUR EDUCATIONBEST WISHES TO YOUR EDUCATION

AND PROFESSIONAL ENDEAVORS!AND PROFESSIONAL ENDEAVORS!

ANY QUESTIONS?ANY QUESTIONS?

Human Subjects Human Subjects Protections Protections

Overview for ApplicantsOverview for Applicants

Patrick McNeilly, Ph.D.Patrick McNeilly, Ph.D.

September 2008September 2008

BackgroundBackground

Belmont ReportBelmont Report

- Respect for Persons- Respect for Persons

- Beneficence- Beneficence

- Justice- Justice Common Rule (45 CFR 46)Common Rule (45 CFR 46)

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.hhttp://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htmtm

Common Rule RequiresCommon Rule Requires

IRB ReviewIRB Review Informed ConsentInformed Consent Evaluations of all applications and Evaluations of all applications and

proposals involving human subjects (45 proposals involving human subjects (45 CFR 46.120) CFR 46.120)

Peer Review vs IRBPeer Review vs IRB Peer reviewPeer review

- - Evaluate the applicationEvaluate the application

- - Identify human subjects concerns in any Identify human subjects concerns in any portion of the portion of the applicationapplication

- - Justification of exemptionJustification of exemption IRBIRB

- - Initial and continuing review of researchInitial and continuing review of research

-- Approve modifications to researchApprove modifications to research

Human Subjects ConcernHuman Subjects Concern

Any actual or potential unacceptable Any actual or potential unacceptable risk, or inadequate protection against risk, or inadequate protection against risk, to human subjects as described in risk, to human subjects as described in any portion of the application.any portion of the application.

- Captured in Summary Statement- Captured in Summary Statement

- Administratively coded - Administratively coded

Common Peer Review Common Peer Review IssuesIssues

No human subject protection planNo human subject protection plan Unidentified subjectsUnidentified subjects Unidentified risksUnidentified risks Informed consent issuesInformed consent issues

Resolution of IssuesResolution of Issues

Written response from Principal Investigator Written response from Principal Investigator to all human subjects concernsto all human subjects concerns

AHRQ Program Official will consult with AHRQ Program Official will consult with human protections administrator on human protections administrator on adequacy of responseadequacy of response

Exemption from HHS Exemption from HHS RegulationsRegulations

Six categories of exemptionSix categories of exemption Not all health services research is Not all health services research is

exemptexempt Is there an appropriate justification of Is there an appropriate justification of

exemption?exemption?

Inclusion of Women & Inclusion of Women & MinoritiesMinorities

Women and members of minority groups must Women and members of minority groups must be includedbe included

Unless a clear and compelling rationale to Unless a clear and compelling rationale to excludeexclude

http://grants.nih.gov/grants/funding/women_min/women_min.htmhttp://grants.nih.gov/grants/funding/women_min/women_min.htm

Priority PopulationsPriority Populations

Inner-city; rural; low income; minority; Inner-city; rural; low income; minority; women; children; elderly; special health women; children; elderly; special health care needscare needs

Studies should consider including one or Studies should consider including one or more AHRQ priority populationsmore AHRQ priority populations

AHRQ specific requirementAHRQ specific requirement

http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.htmlhttp://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html

Example 1Example 1

The proposed study will provide a screening The proposed study will provide a screening tool in the form of a Bruising Clinical Decision tool in the form of a Bruising Clinical Decision Rule (BCDR) for discriminating bruises caused Rule (BCDR) for discriminating bruises caused by physical child abuse vs. accidental trauma. by physical child abuse vs. accidental trauma. Success will result in a BCDR to function as a Success will result in a BCDR to function as a screening tool to identify children and infants screening tool to identify children and infants with bruising who are at high risk for physical with bruising who are at high risk for physical abuse and require further evaluation.abuse and require further evaluation.

Example 1 (cont’d)Example 1 (cont’d)

The proposed study is a prospective The proposed study is a prospective observational study of bruising characteristics observational study of bruising characteristics in children over 4 years of age. Data on in children over 4 years of age. Data on bruising characteristics will be collected by bruising characteristics will be collected by pediatric emergency medicine physicians and pediatric emergency medicine physicians and child abuse experts on 1,000 children with child abuse experts on 1,000 children with bruising.bruising.

Example 2Example 2

In an application focusing on the In an application focusing on the differences in treatment of prostate differences in treatment of prostate cancer for whites compared to non-cancer for whites compared to non-whites. whites.

Example 2 (cont’d)Example 2 (cont’d)

Reviewers Commented:Reviewers Commented:

““Given the application’s focus, prostate Given the application’s focus, prostate cancer, the exclusion of women is cancer, the exclusion of women is appropriate. However, the low minority appropriate. However, the low minority representation and poor recruitment representation and poor recruitment strategies for minorities (85% White, 7% strategies for minorities (85% White, 7% Hispanic, 8% African American) would Hispanic, 8% African American) would make it difficult for comparisons of make it difficult for comparisons of treatment methods by racial and ethnic treatment methods by racial and ethnic categories to be madecategories to be made .” .”

Questions?Questions?