# Presentation: 270358

## Office of Extramural Research, Education and Priority Populations  (OEREP)Grantsmanship 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: Steps to Success

- Debbie Rothstein, Ph.D.
- Senior Advisor, Extramural Research
- Office of Extramural Research,
- Education and Priority Populations
- Agency for Healthcare Research and Quality
- September 9, 2008

## Getting Started

- Internet is funding gateway
- AHRQ and NIH use essentially the same application processes and grant mechanisms
- Keep abreast of open solicitations and Agency research priorities

## AHRQ’s Website – www.ahrq.gov

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

**Notes:**
Research Findings --  Web  1” dwn
R. Activities...  past issues,
funded grants, other anouncmnts
key word search
	minority health
	patient safety
	long term care, 
	rural health, etc

## AHRQ and NIH: Grant Application Similarities

- Application forms:  SF 424(R&R), PHS 398
- Application submission dates
- Use of internet as the funding gateway to keep abreast of research priorities and open solicitations, staff can provide technical assistance
- Announcement publication:  *NIH* *Guide for Grants: *_[http://grants1.nih.gov/grants/guide/index.html](http://grants1.nih.gov/grants/guide/index.html)_* *and* *Grants.Gov:* *_[www.http://grants.gov](http://www.http://grants.gov)_

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

- Receipt and referral of grant applications
- Application review procedures
- Grant mechanisms – e.g., R01, R03, R13, R36, K01, K02, K08
- Transition to electronic submission of applications
- Some common Policy Notices and Funding Opportunity Announcements

## AHRQ and NIH: Grant Application Differences

- Detailed budget vs. modular budget
- Conference grants – AHRQ has small and large opportunities
- AHRQ doesn’t allow multiple PI’s
- Budget limitations
- Large grants (R01, R18) - $300K vs. $500K
- Small grants (R03) - $100K vs. $50K
- Fewer grant mechanisms used at AHRQ

## AHRQ Grant Opportunities 

- AHRQ announces availability of grants in a Funding Opportunity Announcement (FOA)
- FOA’s are published in the *NIH Guide for Grants* (_[http://](http://grants.nih.gov/grants/guide/index.html)__[grants.nih.gov/grants/guide/index.html](http://grants.nih.gov/grants/guide/index.html)_) and posted on Grants.gov (_[http://](http://www.grants.gov/)__[www.grants.gov](http://www.grants.gov/)__[/](http://www.grants.gov/)_
- Program Announcement (PA)
- Describes broad research interests
- Open over a period of time
- Request for Applications (RFA)
- More well defined area, specific program objectives
- Single application receipt date and amount of funds

## Common AHRQ Grant Opportunities

- R01: large research grants
- Feb 5, June 5, Oct 5 application receipt dates
- up to $300K/yr
- R18: research demonstration grants
- Jan 25, May 25, Sept 25 application receipt dates
- up to $300K/yr
- R03: small research projects
- Feb 16, June 16, Oct 16 application receipt dates
- up to $100K in total costs
- Large and small conference grants (R13)
- Large: Apr 12, Aug 12, Dec 12 receipt; up to $100K/yr in total costs
- Small: Feb 20, Apr 20, Jun 20, Aug 20, Oct 20, Dec 20 receipt; up to $50K

## AHRQ Grant Opportunities: Training/Career Development 

**Pre and Postdoctoral Training**
- Institutional Training Programs (T32)
- Individual Pre-doctoral Fellowships to Promote Diversity (F31)
- Individual Post-doctoral Fellowships (F32)
- Dissertation Grants (R36)
**Career Development Awards**
- Mentored  Scientist Awards (K01)
- Independent Scientist Awards (K02)
- Mentored Clinical Scientist Awards (K08)
- Detailed information at:
- 	 _[http://www.ahrq.gov/fund/training/trainix.htm](http://www.ahrq.gov/fund/training/trainix.htm)_
**Send questions to:  **_**[training@ahrq.hhs.gov](mailto:training@ahrq.hhs.gov)**_

## AHRQ Staff Involved in Grants Process

- Referral Officer
- Review Staff – Scientific Review Officer  and Grants Management Specialist
- Program Staff – Project Officer (PO)
- Grants Management Staff

## Electronic Application and Submission

**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?

- 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 Applications

- 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 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                         NEW

***Paper No More, Use 424 ******(R&R)**** ***OLD                         NEW**

**Notes:**
Process Description
Applicant assembles application with authoring tools
Word Processor for documents
Custom presentation for structured data entry
Each Service provider has a separate interface
Grants.gov has PureEdge forms
Word processing file transformed into PDF
Systems assembles a transaction of
XML structured data
PDF attachments
Package is transmitted to NIH and verified
NIH rebuilds the image
Format the XML data into either 398 or 424
Concatenates PDF without changing their content
Adds header, footer page, numbers, table of contents, bookmarks
Generates one single PDF “image” for both structured data and documents

## What Determines Which        Awards Are Made?

- Scientific merit
- Significance and originality
- Methods
- Program / Agency considerations
- What is uniquely AHRQ
- Existing research portfolio balance
- Anticipated IMPACT of research
- Availability of funds

## Ingredients of a Successful Grant Application

- Good Idea
- Good Science
- Good Application
- Fits Agency Research Priorities

**Notes:**
If U respnd clrly & well to th seqnc of ?s in th aplct’n U will be on th way towrds dvlpng a well crafted applct’n.		PRACTICE:
statng spcfc obj in 1-2 sentences &
how hypth (small in #) link to OBJ
decrb how analys pln is designed to ans hypoth			    
Hndout--cmprhnsve “schlrly _/ lst + rvwrs -- SEE ROSTER (+ HRDI)

## AHRQ PEER REVIEW PROCESS 

**	****	****	****Kishena C. Wadhwani, Ph.D., M.P.H.**
** ****	****	****	****Director, Division of Scientific Review (DSR)**
***	******	******	******Kishena.wadhwani@ahrq.hhs.gov*****	****	****	****Phone:  *****(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 CHART

**Office 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 Decision Sciences (HCTDS)**

**Health Care Research Training (HCRT)**

**Study Section Clusters**

**SRO: Dr. Carl Ohata**
**GMS:  Maureen Gallagher**

**DSR**
**Director: Dr. Kishena Wadhwani**

**OEREP**
**Director: Dr. Francis Chesley**

**SRO: TBD**
**GMS: Ms. Carmen Colston**

**SRO:  Dr. Boris Aponte**
**GMS: Ms. Rebecca Trocki**

**Committee Management**

**SRO: Ali Azadegan**
**GMS: Ms. Diane Manuel**

**Receipts  &  Referrals **

**Health Care**** ****System Research (HSR)**

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

| Health Care Systems Research (HSR) | Health Care Technology and Decision Sciences (HCTDS)  | Health Care Quality & Effectiveness Research (HCQER) | Health Care Research Training
 (HCRT) |
| --- | --- | --- | --- |
| Translational Research | Translational Research | Translational Research | Translational Research |
| Implementation Research | Implementation Research | Implementation Research | Implementation Research |
| Access and Utilization | Technology/HIT Assessment | Healthcare Quality & Effectiveness | Training & Career Development |
| Cost/Finance/Markets | Information Sciences; Dissemination | Cost-effectiveness Research | Training-related Conferences/Workshops |
| Qualitative & Quantitative Methods | Qualitative & Quantitative Methods | Qualitative & Quantitative Methods | Qualitative & Quantitative Methods |
| Delivery Systems | Clinical/Translational Decision-making | Evidence-based Medicine | Institutional Training & Career Development |
| Organizational Studies | Patient Utilities, Morbidity &Function | Quality of Care Research | Demonstrations & Evaluations |
| Infrastructure Building Research | Outcome Research
 | Access to & Utilization of  Care
 | Outcome Research
 |
| Provider Workforce | Healthcare Quality & Cost Improvement | Clinical Outcome Research | Healthcare-related   IT Training |

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

| Study Section
( Meeting Dates) | October 2008 Meeting  | March 2009 Meeting | June 2009 Meeting  |
| --- | --- | --- | --- |
| HSR
Ohata/Gallagher | October 24, 2008 | March 5-6, 2009 | 

June 24-25, 2009
 |
| HCQER
TBD/Colston | October 30, 2008 | February 23-24, 2009 | 

June 18-19, 2009
 |
| HCTDS
Aponte/Trocki | October 29, 2008 | February 24, 2009 | 

June 18-19, 2009
 |
| HCRT
Azadegan/Manuel | October 23-24, 2008 | March 5-6, 2009 | 

June 24-25, 2009
 |

**SCHEDULE OF STUDY SECTION MEETINGS, FY08-FY09 (TENTATIVE)**
**(Updated:  09/01/2008)**

## Process of Review for New Individual Research Project 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: 

**Types of Committees (Study 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 Review

**To evaluate the ****scientific and technical **
**merit**** of grant applications, ****providing **
**information**** ****(Recommendations)**** used by the Agencies/Institutes and Centers to make funding decisions.**

## Reviewers consider

- Scientific and technical merit of proposed research/training
- Qualifications of Principal Investigator(s) and research team
- Availability of resources (Labs, Institutions)

## Reviewers also consider (Cont.)

- Reasonableness of requested budget for work proposed
- Other factors (e.g., human subjects,  animal welfare, inclusion policies/plans)

## Reviewers do not consider

- Program relevance (Except if stated in FOA)
- Policy issues
- Funding levels
- Anticipated budget reductions
- Comparisons with other applications

## Review Criteria

- For all R01, R03, R15, R21, and P01 subprojects:
- Significance and Originality
- Approach – Methods and Data
- Innovation
- Organization of the Project
- Investigators
- Environment – Facilities and Resources

## Sole Basis of Review: Review Criteria   

_**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)**

## Also...

- Reviewers evaluate
- Protection of human subjects, the environment, and animal welfare

-  Inclusion of women, minorities, and children

-  Budget

-  Inclusion of AHRQ Priority Populations

## Research Involving Human Subjects

**Important Considerations that must be addressed in the application because they impact on priority score - considered to be part of the Approach**
**Are there any risks* to the human subjects?**
**Are the protections adequate?**
**Are there potential benefits to the subjects and to others?**
**What is the importance of the knowledge to be gained?**
**Are the plans for inclusion of minorities, both genders and children adequately addressed?**
**Is the proposed study exempt from human subject review?**
_**No page limits**_

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

## AHRQ Requirement:Inclusion of Priority Populations

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

## Review Criteria (Cont.)

- For FOAs (RFAs or PAs) , modified or additional criteria may be specified
- For other mechanisms, specific criteria apply

## Peer Review Process

**Each application assigned to 3 reviewers for written comments**
**Streamlined Review may be used**
**Group discussion of each application, including budget recommendation**
**Recommended score range**
**Reviewers privately assign priority score**

## Peer Review Group Actions

- Unscored (Streamlined Review)
_**Scientific Merit Rating (Priority Score)**_

## Priority Scores/ Percentiles

-  **Priority scores range from:**
**                            ****100 (Best)  to  500 (Worst)                                                              **
**                             ****[100 x (1.0 – 5.0)]**
**In Streamlined Review, those in lower    half are eliminated (unscored)**
** ****Percentiles calculated to normalize scoring behavior across review groups**

## Priority Scores Assigned by Reviewers

**SCORED  (stronger)****            ****1.0 ******** 1.4    (Outstanding)**
**        **
**                                               **_**1.5 **__****__** 2.0   (Excellent)**__**            (25%)**__** **_
**	**** ****	****	****	****	****                                  **
**                                               **_**2.0 **__****__** 3.0                      **__**           (25%)**_
**UNSCORED  (weaker )        3.0 ******** 4.0**
**                                              **_**4.0 **__****__** 5.0               **__**                   (50%)**_

## HINTS:  PREPARING AN APPLICATION

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

## PREPARING AN APPLICATION (cont.)

**Explicitly state the purpose of the proposed work**
**Refer to the literature thoroughly but thoughtfully**
**Present an organized, lucid write-up**
**Be mindful of the review criteria to be used**
**Get advice from colleagues**

##   Art of Persuasion: Assumptions

-   **Art of Persuasion: Assumptions**

** ****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**

## Strategies to Strengthen Applications: The Short List

**Ask scientist with AHRQ support to critically review your application prior to submission – **_**more than once **_
**Talk with an Agency (AHRQ, etc.) program officer(s)**

## Strengthening Applications - 

**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 Merits

**Think like a reviewer – **
**Learn as much as possible about The System (e.g., figure out the likely review group)**
**Preempt criticism**
**Include collaborators who can compensate for your deficiencies**
**Learn as much as possible about what research projects in your area that have been funded  by the NIH/AHRQ/HRSA/CDC/etc.**
**                            ****CRISP Database:  **_***(http://crisp.oit.nih.gov)***_

## http://crisp.oit.nih.gov

**http://crisp.oit.nih.gov**

## Slide 47

| 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 EDUCATION

**AND PROFESSIONAL ENDEAVORS!**
**ANY QUESTIONS?**

## Human Subjects Protections 

- Overview for Applicants
- Patrick McNeilly, Ph.D.
- September 2008

## Background

- Belmont Report
- 	- Respect for Persons
- 	- Beneficence
- 	- Justice
- Common Rule (45 CFR 46)
- _[http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm)__ _

**Notes:**
Three Guiding Principles:
1. Respect for persons = Requirement for Informed Consent
2. Beneficence = Weighing Risk/Benefit
3. Justice = Adequate subject selection; adequate distribution of burdens

Belmont Report principles codified in regulation at 45 CFR 46

Called Common Rule – adopted by 17 D/A

## Common Rule Requires

- IRB Review
- Informed Consent
- Evaluations of all applications and proposals involving human subjects (45 CFR 46.120)

**Notes:**
Common Rule requires that each application be reviewed 

Criteria:
1. Risks to the subjects, likelihood & seriousness
2. Adequate protection from risks
3. Potential benefits to subjects and others
4. Importance of the knowledge to be gained

## Peer Review vs IRB

- Peer review
- 	- 	Evaluate the application
- 	- 	Identify human subjects concerns in any                                         	portion of the application
- 	- 	Justification of exemption
- IRB
- 	- 	Initial and continuing review of research
- 	-	Approve modifications to research

**Notes:**
Not expecting them to be an IRB or as knowledgeable as an IRB.

First protection of human subjects is good science.

Acceptable for study section to comment on human subjects protections just as it is appropriate for IRB to question the science involved.

IRB reviews from the perspective of the subject

## Human Subjects Concern

- Any actual or potential unacceptable risk, or inadequate protection against risk, to human subjects as described in any portion of the application.
- 	- Captured in Summary Statement
- 	- Administratively coded

**Notes:**
Study section are experts in the field of study and know what is acceptable within the field.

You know where the risks lie

SRO will capture the discussion and write summary statement

SRO will determine the coding

## Common Peer Review Issues

- No human subject protection plan
- Unidentified subjects
- Unidentified risks
- Informed consent issues

**Notes:**
Some typical issues that might be raised during peer review would include:

The applicant failed to include any plan for the protection of human subjects, even though it was requested in the application.

The peer reviewers may identify human subjects which were not considered by the applicant. (e.g., surveying providers, but not having and informed consent process for them)

The reviewers may also identify risks to the subjects which the applicant had not mentioned.

There is also the possibility of the peer reviewers identifying specific issues related to the informed consent document or process.

## Resolution of Issues

- Written response from Principal Investigator to all human subjects concerns
- AHRQ Program Official will consult with human protections administrator on adequacy of response

**Notes:**
For those applications which will be funded, the PO is responsible for ensuring that issues related to human subjects are addressed before the application is funded.  The PO should be in contact with the applicant and make sure that a written response is provided which addresses the peer-reviewer’s comments.

The PO should consult with the Human Protections Administrator (HPA) regarding the adequacy of the applicant’s response to the human subjects issues.  The HPA is the only the person who can change the human subjects code to allow the funding of the application.

It is important that the PO request a change of the HS code.  If you don’t request the change, it may not occur and funding could be delayed.

## Exemption from HHS Regulations

- Six categories of exemption
- Not all health services research is exempt
- Is there an appropriate justification of exemption?

**Notes:**
Most likely to be exempt under 1, 2, or 4.

Just because it was exempt before doen’t mean it will still be if something changes.

Providing list if exemptions and a decision tree for exemptions

## Inclusion of Women & Minorities

- Women and members of minority groups must be included
- Unless a clear and compelling rationale to exclude
- _[http://grants.nih.gov/grants/funding/women_min/women_min.htm](http://grants.nih.gov/grants/funding/women_min/women_min.htm)__ _

## Priority Populations

- Inner-city; rural; low income; minority; women; children; elderly; special health care needs
- Studies should consider including one or more AHRQ priority populations
- AHRQ specific requirement
- _[http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html](http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html)_

**Notes:**
Special health care needs include those with disabilities, need chronic care, or need end-of-life health care.

## Example 1

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

**Notes:**
Study involves human subjects & study identifies risks to physicians and children in the study

Physician participation is voluntary and informed consent requested.

Parental permission was requested to be waived by the IRB

Identified abuse will be reported as required by law

Subject data will be de-identified for the analysis

Reviews questioned:
It was not clear why physicians were being asked for consent if unit of study was the patient.
Concerned that the risks may change with the study – subjects at increased risk of falsely identified as having non-accidental trauma

## Example 1 (cont’d)

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

## Example 2

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

## Example 2 (cont’d)

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

## 

				Questions?

- 				Questions?