University of Washington / Fred HutchCenter for AIDS Research (CFAR)

2020 Request for Applications (RFA)Mentored International Investigator Award

RFA Release Date February 10, 2020Pre-Application Consultation Deadlines:

Required Eligibility Check for Applicants March 2, 2020Required Budget ConsultationStrongly Encouraged Biostatistical and Qualitative ConsultationsOptional Consultations

March 2, 2020March 2, 2020

March 2, 2020Application Due Date March 24, 2020Estimated Review Date April 2020Earliest Award Date June 1, 2020

Mentored International Investigator Award (MIIA)

1) Overviewa) Purpose

The purpose of this award program is to encourage international junior investigators (at an advanced stage of training or recently independent) to conduct independent research with close mentorship from senior faculty. This research should ultimately lead to acquiring preliminary data to obtain funding to continue their HIV/AIDS research careers.

b) Eligibility Applicants must:i) Have the appropriate appointment, as follows:

(1) Junior faculty (including acting positions) or (2) a scientist completing a fellowships or (3) a senior post-doctoral fellow initiating a new area of HIV-related research that will form a basis

for their independent program, or (4) faculty-equivalent investigator at a community-based organization whose primary mission is

research, and ii) Have an MD or PhD or equivalent terminal degree (including an MBChB plus Master’s Degree)iii) Have not had an NIH R01 or equivalent grant in HIV/AIDS, andiv) From a low or middle income country and be stationed outside of the U.S. andv) Have a primary mentor at a U.S. based UW/Fred Hutch CFAR institution, andvi) Be a UW/Fred Hutch CFAR member.

Note that successful applicants usually have some preliminary data to support their application. Resubmission of revised projects from other CFAR award programs is allowed. Applicants are only allowed to submit one application to this program per cycle.

Contact cfarintl@uw.edu if you have questions about eligibility.

c) Types of Projects HIV-related research is defined broadly and includes basic science, clinical, epidemiological, behavioral, implementation science, and health services research.

We can only accept applications in the NIH’s HIV/AIDS research high or medium priority areas.

We cannot fund research with investigational drugs or clinical trials (see NIH’s definition of a Clinical Trial). If you are considering a study involving approved drugs and/or standard-of-care, please contact Ann Collier (acollier@uw.edu, cc: cfardev@uw.edu) to determine whether your proposed project would be eligible for funding through CFAR.

d) Funding Available One award of up to $20,000/year (direct costs). Applicants may apply for up to 2 years of funding.

Funding cannot be applied to alterations or renovations of any facilities.

Please note that for those requesting a two-year project, second year funding is contingent upon demonstration of satisfactory progress during year one.

Budget Development Guidelines and Restrictions1. Please note that the CFAR does not have funds to cover additional institutional indirect (F&A) costs.

The CFAR has negotiated indirect cost waivers from our partners Fred Hutch, Seattle Children’s and University of Hawaii. If the proposal requires a subcontract to an international institution, the maximum allowable indirect cost (F&A) rate is 8%. Indirect costs to international institutions must be budgeted as a direct cost. If you are including 8% F&A for a foreign institution, your direct costs should not exceed $18,518 to account for the F&A costs.

2. Requested support for project collaborators who are NOT at the same institution as the awardee should be listed as consultant costs. If the collaborator cannot accept consultancy fees, a

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subcontract must be issued to their institution. These costs must be listed in the detailed budget as consortium costs with applicable indirect costs included, which will count towards the direct costs limit. Please note that the UW has negotiated indirect cost waivers with several local partner institutions (See guideline 1 above.)

3. Requested support for equipment and technology, including computers, must be fully justified in the budget justification with a clear connection to the scientific aspects of the project and not for general office use. Be sure to read our Computer Policy if you would like to budget for a computer. General office supplies are not allowed.

4. All costs must conform to the NIH Grants Policy Statement (GPS) and applicable U.S. Office of Management and Budget OMB circulars for necessity and reasonability, allocability, conformance and consistency, as well as allowability. Please follow the link below to section 7.2 cost principles section of the NIH Grants Policy Statement.

2) Pre-Submission Processa) Required for All Applicants

Eligibility Checks: All applicants are required obtain approval that they are eligible to apply prior to development of their proposal. They should send a current NIH format biosketch or curriculum vitae for review to cfarintl@uw.edu) no later than March 2, 2020.

Budget Consultation: Applicants are required to consult with Linh Nguyen about their budgets to clarify budgetary issues. Please send a draft copy of your budget and budget justification to ltn128@uw.edu no later than March 2, 2020.

CFAR Membership: All applicants are required to be UW/Fred Hutch CFAR Members. Information about membership can be found at http://depts.washington.edu/cfar/get-involved/cfar-membership or by contacting cfarinfo@uw.edu.

Institutional Approval: Applicants should include a Letter of Intent from their institution with their application.

Mentoring and Mentoring Plan: All applicants must identify a mentor and include a mentoring plan in their proposal. A statement from the applicant’s primary mentor that they have read and discussed the application with the applicant must also accompany the application (should be included in the letter of support from the mentor). The mentoring plan should include specific competencies the mentee will develop through the mentoring relationship, frequency/type of communication, outputs and objectives for the mentoring relationship, and how this mentoring plan supports a pathway to independence for the investigator. Please note that a Mentoring Committee will be formed for the successful applicant to provide career development guidance and assess progress. A separate agreement with the committee will be required for the successful applicant after the award is made.

Human Subjects and Animal Care Approvals (if applicable): Animal Care and Institutional Review Board approvals, if applicable, must be obtained prior to receipt of award funding , but are not required to submit an application.

b) Strongly Encouraged ConsultationsWe encourage all applicants to use or contact CFAR Cores or link to Scientific Working Groups (see Consultation Information below). Information about other CFAR Cores and services can be found at http://depts.washington.edu/cfar/find-a-service.

Biostatistical Consultation: All applicants are strongly encouraged to discuss their proposal with a CFAR biostatistician prior to/during the preparation of their application, with limited exceptions for those with prior biostatistical involvement or project review. This consultation is best done early in the preparation process but must occur before March 2, 2020. In order to receive this consultation, applicants must send a copy of your draft methods to cfarintl@uw.edu in order to arrange a consultation.

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Qualitative Methods Consultation: Applicants whose projects include behavioral research are strongly encouraged to obtain a consultation from the Behavioral Science Core consult with them regarding methods and study design. In order to receive this consultation, applicants must send a copy of your draft methods to cfarintl@uw.edu by March 2, 2020 in order to arrange a consultation.

c) Consultation InformationWe encourage you to utilize services from the CFAR Cores and/or Scientific Working Groups early in the preparation of your application. The Cores and Scientific Working Groups have explicitly offered their consultations services (see list below). More information about CFAR Cores and services can be found at http://depts.washington.edu/cfar/discover-cfar/cores. These consultations are best done early in the preparation process and should be requested no later than March 2, 2020. Contact cfarintl@uw.edu to access these consultations.

HIV-Associated Malignancies Core: Provides assays and data instruments to enable studies of HIV-associated malignancies.

Immunology Core: Provides advanced tools and training for evaluating humoral and cellular responses to HIV infection.

Implementation Science Core: Provides resources to help investigators form interdisciplinary teams; translate their research into public health or clinical practice; and provide technical support in implementation science measures, research design, economic modeling, and disease transmission modeling.

Retrovirology and Molecular Data Science Core: Assists researchers perform optimized viral analysis experiments and analyze data from state-of-the-art genomics and database technologies, in support of HIV and related research.

Adolescent Health Consultation : Applicants proposing a study involving adolescent health should have an expert from the Adolescent Health SWG consult with them regarding their study.

Cure Consultation: Applicants proposing a study in HIV cure should have an expert from the Curative Therapies for HIV SWG consult with them regarding their study.

eHealth Consultation: Applicants proposing a study involving eHealth, mHealth, and related technologies should have an expert from the eHealth SWG consult with them regarding their study.

3) Post-Award Requirements

Human Subjects and Animal Care Approvals: If applicable, prior to funding, a copy of all Institutional Biohazard, Animal Care and IRB approvals must be forwarded to cfarintl@uw.edu.

NIH International and Clinical Clearances: If the project involves human subjects and the institutional IRB has deemed the study “greater than minimal risk”, the awardee must submit a Clinical Research Checklist to the CFAR Program Manager before funding is released. Proposals involving either international sites or clinical research above minimal risk will require additional clearance from NIH prior to receipt of an award, which requires documenting IRB approval from all participating sites, human subjects training certification for all key personnel, and providing the approved consent form(s). Please note that international projects, especially those involving human subjects, can take several months to obtain all required approvals and therefore applicants should incorporate this into their study timeline.

Mentoring Committee and Agreement: The Awardee will work with his or her mentor(s) to develop a brief written agreement identifying members of the mentoring committee and setting terms and expectations for the mentoring process.

Reporting and Presentation Requirements: The awardee will be required to submit yearly progress reports to the CFAR. The chair of the mentoring committee will also be required to submit a brief

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progress report annually before Year 2 funding can be received. Additionally, we expect awardees to disseminate the results from NIA projects to the communities relevant to the research, ideally both through scientific and community forums, and where appropriate, shared with public health decision makers.

CFAR Support: The UW/Fred Hutch CFAR grant number (P30 AI027757) must be cited in all publications and presentations derived from CFAR funding (see: http://depts.washington.edu/cfar/discover-cfar/acknowledge-cfar).

Other Support: In the event that pending other support is funded which overlaps with or reduces your effort on this CFAR project, you must notify cfarintl@uw.edu. Your application aims and budget will be reviewed and if it is determined that you are unable to meet the specific aims of your CFAR proposal, the CFAR award will be revoked.

4) Review Process and CriteriaThe evaluation criteria for proposals include:

Scientific Merit of the proposal and the likelihood of the project to exert a sustained powerful influence on the field. Will this proposal be likely to provide information that can significantly advance our understanding of HIV and/or provide preliminary data that is likely to lead towards independent research grant funding?

Significance – Does the study address an important problem consistent with the objective to advance our understanding of HIV? If the aims are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive the field of HIV and AIDS?

Investigator – Are the PI, mentor(s), collaborators, and other researchers well suited to the project? Does this person have appropriate experience and training? If the project is collaborative, do the investigators/mentors have complementary expertise?

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 alternatives?

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?

Mentorship Plan and Impact of Project on Pathway to Independence – Will the project help prepare the applicant for a career as an independent HIV/AIDS researcher? Will the proposed mentorship aid in the investigator’s career development?

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UW/Fred Hutch Center for AIDS Research2020 Mentored International Investigator Award

Application

1. Title of Project      City and Country of Project:       Field Site:      

2. Principal Investigator          Name and Title:      Organization:      Address:      City:       State:       Zip:      Phone:       Fax:       Email:        

3. Mentor    Name and Title:      Organization:      Address:      City:       Country:      Phone:       Fax:       Email:        

4. Research Plan (Maximum 5 pages for a-e below):a.  Specific Aims (suggested length ½ page)

b. Significance (suggested length 1 page)

c. Innovation (suggested length ½ page)

d. Approach (suggested length 2 pages)

e. Mentoring Plan (suggested length 1 page)—include specific competencies the mentoring relationship will develop, frequency/type of communication, outputs and objectives for the mentoring relationship, and how this mentoring plan supports a pathway to independence for the investigator.

       

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12. Co-Investigators              Name Affiliation     Email                                                                                         

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2020 CFAR Mentored International Investigator Award RFA

DETAILED BUDGET FOR INITIAL BUDGET PERIOD

DIRECT COSTS ONLY

FROM THROUGH

           

List PERSONNEL (Applicant organization only), Use Cal, Acad, or Summer to Enter Months Devoted to Project Enter Dollar Amounts Requested (omit cents) for Salary Requested and Fringe Benefits

NAMEROLE ONPROJECT

Cal.Mnths

Acad.Mnths

SummerMnths

INST.BASESALARY

SALARYREQUESTED

FRINGEBENEFITS TOTAL

      PD/PI                                          

                                                     

                                                     

                                                     

                                                     

                                                     

                                                     

SUBTOTALS                 

CONSULTANT COSTS     

     EQUIPMENT (Itemize)     

     SUPPLIES (Itemize by category)     

     TRAVEL     

     

INPATIENT CARE COSTS            

OUTPATIENT CARE COSTS            ALTERATIONS AND RENOVATIONS (Itemize by category)     

     OTHER EXPENSES (Itemize by category)     

     

CONSORTIUM/CONTRACTUAL COSTS DIRECT COSTS      

SUBTOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD (Item 7a, Face Page) $      

CONSORTIUM/CONTRACTUAL COSTS FACILITIES AND ADMINISTRATIVE COSTS      

TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD $      

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2020 CFAR Mentored International Investigator Award RFA

BUDGET FOR ENTIRE PROPOSED PROJECT PERIODDIRECT COSTS ONLY

BUDGET CATEGORYTOTALS

INITIAL BUDGETPERIOD

(from Form Page 4)

2nd ADDITIONAL YEAR OF SUPPORT

REQUESTEDPERSONNEL: Salary and fringe benefits. Applicant organization only.            CONSULTANT COSTS            EQUIPMENT            

SUPPLIES            

TRAVEL            

INPATIENT CARECOSTS            

OUTPATIENT CARE COSTS            

ALTERATIONS ANDRENOVATIONS            

OTHER EXPENSES            DIRECT CONSORTIUM/CONTRACTUALCOSTS            

SUBTOTAL DIRECT COSTS(Sum = Item 8a, Face Page)            

F&A CONSORTIUM/CONTRACTUALCOSTS            

TOTAL DIRECT COSTS            

TOTAL DIRECT COSTS FOR ENTIRE PROPOSED PROJECT PERIOD $      

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2020 CFAR Mentored International Investigator Award RFA

JUSTIFICATION. Follow the budget justification instructions exactly. Use continuation pages as needed.     

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2020 CFAR Mentored International Investigator Award RFA

Attach: 1. Biosketches of PI and Mentor(s)2. Mentor’s Letter of Support (should include the statement “I have read and discussed

this application with ________ and am supportive of its submission)3. Letters of support (Only include letters from collaborators essential to the proposed

project. Biosketches are not required from collaborators) 4. Institutional Letter of Support

Please note: If your application is selected, all investigators will need to complete Human Subjects Training.

Email completed application to cfarintl@uw.edu by March 24, 2020.

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