Research on the Health of LGBTI Populations (R01 Clinical Trial Required)

Research on the Health of LGBTI Populations (R01 Clinical Trial Required) is sponsored by National Institute of Mental Health (NIMH). Funds research projects focusing on the health of LGBTI populations, including mental health, requiring clinical trials.

Expired PA-06-218: Health Research with Diverse Populations (R01) This notice has expired. Check the NIH Guide for active opportunities and notices. Part I Overview Information Department of Health and Human Services Institute of Mental Health (NIMH), ( http://www.

nimh. nih. gov ) Participating Organizations Institutes of Health (NIH), ( http://www.

nih. gov ) Components of Participating Organizations Institute of Mental Health (NIMH), ( http://www. nimh.

nih. gov ) National Institute on Drug Abuse (NIDA), ( http://www. nida.

nih. gov ) National Institute on Alcohol Abuse and Alcoholism (NIAAA), ( http://www. niaaa.

nih. gov ) National Institute of Child Health and Human Development (NICHD), ( http://www. nichd.

nih. gov ) Office of Behavioral and Social Sciences Research (OBSSR), ( http://obssr. od.

nih. gov ) Office of Research on Women’s Health (ORWH), ( http://orwh. od.

nih. gov ) with Diverse Populations (R01) with modifications of PA-01-096 , which was previously released May 21, 2001. Update: The following update relating to this announcement has been issued: July 19, 2007 - This PA has been reissued as (PA-07-409).

January 3, 2007 - Effective with the February 5, 2007 submission date, all R01 applications must be submitted through Grants. gov using the electronic SF424 (R&R) application. Accordingly, this funding opportunity expires on January 3, 2007.

Unsolicited or investigator-initiated R01 electronic SF424 (R&R) applications may be submitted through the Research Project Grant (Parent R01) announcement. ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants. gov and the use of the SF 424 Research and Related (R&R) forms.

Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants. gov.. For more information and an initial timeline, see http://era.

nih. gov/ElectronicReceipt/ . NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts ( http://grants.

nih. gov/grants/guide/index. html ).

Specific funding opportunity announcements will also clearly indicate if Grants. gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site ( http://grants.

nih. gov/grants/forms. htm ) for the most current information when preparing a grant application.

Program Announcement (PA) Domestic Assistance Number(s) 93. 242, 93. 279, 93.

273, 93. 865 Release Date: March 07, 2006 Application Submission Dates: Standard dates apply, please see http://grants. nih.

gov/grants/funding/submissionschedule. htm for details. dates apply, please see http://grants.

nih. gov/grants/funding/submissionschedule. htm#reviewandaward for details.

Council Review Date(s): Standard dates apply, please see http://grants. nih. gov/grants/funding/submissionschedule.

htm#reviewandaward for details. Earliest Anticipated Start Date: Standard dates apply, please see http://grants. nih.

gov/grants/funding/submissionschedule. htm#reviewandaward for details.

Additional Information To Be Available Date (Url Expiration Date for R01 Non-AIDS Applications : November 2, 2006 Expiration Date for R01 AIDS and AIDS-Related Applications : January 3, 2007 purpose of this Program Announcement is to invite grant applications for biological, behavioral, social, mental health, and drug and alcohol abuse research bearing on the health of lesbian, gay, bisexual, transgender, intersex, and related populations.

Proposed research should be appropriate for the missions of one or more of the participating Institutes. the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications National Institutes of Health (NIH) Research Project (R01) award mechanism.

may be submitted by for-profit and non-profit organizations; public and private institutions, such as universities, colleges, hospitals, and laboratories; units of State, Tribal, and local governments; eligible agencies of the Federal government; foreign and domestic institutions; and faith-based or community-based organizations.

with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are encouraged to apply. may submit more than one application, provided they are scientifically IV.

1 for application materials. for the hearing impaired is available at: TTY 301-451-5936 II Full Text of Announcement I. Funding Opportunity Description 1.

Mechanism(s) of Support III. Eligibility Information 2. Cost Sharing or Matching 3.

Other - Special Eligibility Criteria IV. Application and Submission Information 1. Address to Request Application Information 2.

Content and Form of Application 3. Submission Dates and Times A. Submission, Review and B.

Sending an Application to C. Application Processing 4. Intergovernmental Review 6.

Other Submission Requirements V. Application Review Information 2. Review and Selection Process A.

Additional Review Criteria D. Sharing Research Resources 3. Anticipated Announcement and Award VI.

Award Administration Information 2. Administrative and National Policy A. Cooperative Agreement Terms 1.

Scientific/Research Contact(s) 2. Peer Review Contact(s) 3. Financial/ Grants Management Contact(s) VIII.

Other Information - Required Federal Citations - Full Text of Announcement Section I. Funding Opportunity The National Institutes of Health (NIH) is committed to supporting research that will increase scientific understanding of the health status of various population groups and lead to more effective health interventions and services for individuals within those groups.

High priority is placed on research with groups that appear to have distinctive health risk profiles but thus far have received insufficient attention from investigators. This Program Announcement (PA) highlights a particular set of such groups: lesbian, gay, bisexual, transgender, intersex, and related populations (designated here as LGBTI populations).

The National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), and National Institute of Child Health and Human Development (NICHD) invite submission of grant applications for biological, behavioral, social, mental health, and drug and alcohol abuse research with LGBTI populations.

The Office of Behavioral and Social Sciences Research (OBSSR) joins this PA as part of its effort to promote research on the behavioral and social aspects of health and illness, and the Office of Research on Women's Health (ORWH) joins this PA as part of its effort to promote research that will lead to improved health for women. However, only NIMH, NIDA, NIAAA, and NICHD will provide direct grant support under this PA.

Basic, clinical, and services research that is relevant to the missions of the four sponsoring Institutes may be proposed. Prospective applicants are encouraged to consult with Institute program officials early in the development of their research ideas. The focus of this program announcement is research bearing on the health of lesbian, gay, bisexual, transgender, intersex, and related populations.

These populations may be characterized as encompassing several broad, partially overlapping clusters: People whose sexual orientation--as manifested in behaviors, attractions, cognitions, or identity--is directed towards the same gender or both genders. This cluster includes, but is not limited to, individuals who describe themselves by terms such as lesbian, gay, and bisexual.

People whose gender-related identity, roles, expression, or behavior are atypical or nonconforming to conventional standards. This cluster includes people who are often labeled as transgender or transsexual. People whose reproductive system structure or function is atypical in ways that may affect gender-related identity or behavior, including people who are labeled as intersex.

Following recent usage, the term LGBTI is adopted here as a general designation for these diverse populations as well as for individuals within these populations. However, grant applicants may adopt other classification frameworks and terminologies as appropriate for Current scientific evidence clearly indicates that the majority of LGBTI people do not suffer from clinical disorders.

However, recent data from both national health surveys and targeted studies suggest that prevalence rates of affective disorders, eating disorders, tobacco addiction, alcohol abuse, certain forms of drug abuse, and possibly other conditions are higher for LGBTI populations (or particular segments of those populations) than for the general population.

Some of this evidence indicates that stress related to stigmatization and discrimination contributes to higher rates of disorder and symptoms. Data also suggest that LGBTIs are more likely than the general population to seek mental health and substance abuse services.

But LGBTI clients may often fail to receive appropriate and effective services, because many service providers have limited knowledge of or experience in working with LGBTIs. In addition, factors tied to household and family structure and access to economic and social resources may have distinctive influences on the health of LGBTI people.

Further research is required to clarify the nature, extent, and determinants of mental disorder, drug and alcohol abuse, and related aspects of individual and household well-being among LGBTIs. Also needed is research that will lead to improved forms of prevention, treatment, counseling, and service delivery for LGBTIs.

More broadly, work on these topics can be expected to enrich the general scientific understanding of the linkages between gender and health and to suggest new directions for studies of both LGBTI and non-LGBTI populations.

Priority is given to research that aims to characterize the biological, behavioral, and social processes that determine health within LGBTI populations and on the development of effective preventive, treatment, and counseling interventions and service delivery methods for those populations. The focus of such work should be on specific and measurable health outcomes.

Basic research that can lead to new or enhanced forms of health research is also invited. In all research areas, innovative work that addresses questions that have not been previously explored or that incorporates new methodologies is especially encouraged. Research should be designed so that the generalizability of its findings beyond the particular sample investigated can be readily assessed.

Applicants should provide a precise description of the target population and of the sampling methods to be employed, paying attention not only to sexual orientation and gender-related characteristics but also to other variables such as age, generational cohort, race/ethnicity, culture, geography, socioeconomic status, and physical and psychological qualities.

Given the diversity of LGBTI populations, it is expected that most projects will focus on one or a few well-defined segments of those Proposed research may draw from the full range of approaches within contemporary biological, behavioral, and social science (including both quantitative and qualitative approaches).

Design and selection of instruments and procedures should be undertaken rigorously and with sensitivity to the experiences and concerns of the research participants. Community-based research, with a fully trained scientist serving as principal investigator, is encouraged.

While the primary domain of interest is LGBTI populations within the United States, research with non-U.S. populations is acceptable if the work can substantively contribute to scientific understanding In pursuing research on the topics described here, it may be useful to consider approaches and findings from work on other types of health disparities involving LGBTI groups that have been established (e.g., HIV/AIDS) or are suspected (e.g., obesity, cardiovascular disease, certain cancers).

Investigators may also benefit from making linkages with other research areas that address the influences of sex and gender on biological and behavioral function. Examples of Research Areas All prospective applicants are encouraged to discuss their research ideas with program staff before submitting an application.

Potential research areas include (but are not limited to): Basic research on the nature and development of sexual orientation and of gender-related identity, roles, expression, and behavior. Health-relevant studies of the interactions of sexual orientation and gender-related characteristics with affective, cognitive, personality, and identity processes.

Health-relevant studies of the interpersonal relationships, social networks, families, and households of LGBTI persons. Studies of health-relevant demographic and socioeconomic characteristics of LGBTI populations. Epidemiological studies of mental health status, drug and alcohol use, and health services utilization in LGBTI populations.

Studies of the characteristics and underlying processes of mental disorder and drug and alcohol abuse in LGBTI populations. Studies of protective and resiliency factors and of coping processes within LGBTI populations. Studies of suicidality in LGBTI populations, including prevalence, risk and protective factors, and preventive interventions.

Studies of the mechanisms by which experiences of stigmatization, discrimination, and violence affect health in LGBTI Studies of current and emerging patterns of drug and alcohol use and abuse in LGBTI communities (including such topics as contexts of substance use, social diffusion of particular forms of substance use, and Studies of patterns and determinants of comorbidity among mental disorders, drug and alcohol abuse, and physical disorders (e.g., HIV/AIDS, cancer, cardiovascular disease) in LGBTI populations.

Studies of the interactions of health disparities associated with sexual orientation and gender-related characteristics with other forms of health disparities (associated with race/ethnicity, socioeconomic status, Development and evaluation of preventive, treatment, counseling and rehabilitative interventions for mental disorders and drug and alcohol abuse that are sensitive to the particular characteristics and needs of LGBTI people (i.e., culturally competent).

Biological and behavioral research with transgender people, including longitudinal studies of transsexual people who seek or have received hormonal or surgical interventions; development and evaluation of approaches to psychosocial assessment and counseling for transgender people and their family Developmental and longitudinal studies of gender-related and other biological and behavioral characteristics of intersex people, including long-term follow-up studies of persons who have received hormonal or surgical interventions and studies of effects of early gender assignment; development and evaluation of approaches to psychosocial assessment and counseling for intersex people and their families.

Studies of the factors determining accessibility, quality, and outcomes of mental health and substance abuse services for LGBTI people. Studies of service providers competence in working with LGBTI people; development and evaluation of training and knowledge dissemination programs for service providers on LGBTI topics.

Studies of LGBTI people’s beliefs, expectations and attitudes concerning mental health and substance abuse services and how these are related to service utilization and effectiveness. VIII, Other Information - Required Federal Citations , for policies related 1. Mechanism(s) of Support This funding opportunity will use the NIH Research Project Grant (R01) award mechanism .

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.

nih. gov/grants/funding/modular/modular. htm ).

Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

Applicants may also seek support for research in the areas described in this funding opportunity through other award mechanisms, including: the NIH Small Research Grant (R03) (see http://grants. nih. gov/grants/guide/pa-files/PA-03-108.

html ), the NIH Academic Research Enhancement Award (R15) (see http://grants. nih. gov/grants/guide/pa-files/PA-06-042.

html ) , and the NIH Exploratory/Developmental Research Grant (R21) (see http://grants. nih. gov/grants/guide/pa-files/PA-03-107.

html ). scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004 . III. Eligibility Information 1.

A. Eligible Institutions application(s) if your organization has any of the following characteristics: or private institutions, such as universities, colleges, hospitals, and agencies of the Federal government or community-based organizations 1. B.

Eligible Individuals skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. 2.

Cost Sharing or Matching The most current Grants Policy Statement can be found at: http://grants. nih. gov/grants/policy/nihgps_2003/nihgps_Part2.

htm#matching_or_cost_sharing 3. Other-Special Eligibility Criteria IV. Application and Submission Information 1.

Address to Request Application Information instructions are available at http://grants. nih. gov/grants/funding/phs398/phs398.

html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected] .

the hearing impaired: TTY 301-451-5936. 2. Content and Form of Application Submission prepared using the most current PHS 398 research grant application instructions and forms.

Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www. dnb.

com/us/ . The D&B number should be entered on line 11 of the face page of the PHS 398 The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box Several special provisions apply to applications submitted by foreign organizations: back of customs and import fees is not allowed.

every effort should be made to comply with the format specifications, which are based upon a standard US paper size of 8. 5" x 11." for up to 8% administrative costs (excluding equipment) can now be requested ( http://grants.

nih. gov/grants/guide/notice-files/NOT-OD-01-028. html ) must comply with federal/NIH policies on human subjects, animals, and must comply with federal/NIH biosafety and biosecurity regulations.

See Section VI. 2 . Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

Proposed research should provide a unique research opportunity not available in the U.S. 3. Submission Dates and Times Submission, Review and Anticipated Start Dates Application Submission Dates: Standard dates apply, please see http://grants. nih.

gov/grants/funding/submissionschedule. htm for details. Peer Review Date(s): Standard dates apply, please see http://grants.

nih. gov/grants/funding/submissionschedule. htm#reviewandaward for details.

Council Review Date(s): Standard dates apply, please see http://grants. nih. gov/grants/funding/submissionschedule.

htm#reviewandaward for details. Earliest Anticipated Start Date: Standard dates apply, please see http://grants. nih.

gov/grants/funding/submissionschedule. htm#reviewandaward for details. not required for the funding opportunity.

prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application.

Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 (U.S. Postal Service Express Bethesda, MD 20817 (for express/courier service; applications are no longer permitted (see http://grants. nih. gov/grants/guide/notice-files/NOT-OD-03-040.

html ). Applications must be submitted on or before the application receipt/submission dates described above ( Section IV. 3.

A. ) and at http://grants. nih.

gov/grants/dates. htm . applications will be evaluated for completeness by CSR.

Incomplete applications any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed.

This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks. 4.

Intergovernmental Review subject to intergovernmental subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants. nih.

gov/grants/policy/policy. htm . allowable.

A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval.

If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred.

NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants. nih.

gov/grants/policy/nihgps_2003/NIHGPS_Part6. htm . 6.

Other Submission Requirements Instructions for Modular Grant applications Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules.

Section C of the research grant application instructions for the PHS 398 at http://grants. nih. gov/grants/funding/phs398/phs398.

html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.

nih. gov/grants/funding/modular/modular. htm .

Instructions for Applications Requesting $500,000 (direct costs) or More per $500,000 or more in direct costs for any year must carry out the following program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types.

Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants. nih. gov/grants/guide/notice-files/NOT-OD-02-004.

html . Plan for Sharing Research more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy ( http://grants.

nih. gov/grants/policy/data_sharing ). The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers.

However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

sensitivity of information related to gender and sexuality, any data sharing plan must include strong measures to protect the privacy of all research Sharing Research Resources grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants. nih. gov/grants/policy/nihgps_2003/index.

htm and http://grants. nih. gov/grants/policy/nihgps_2003/NIHGPS_Part7.

htm#_Toc54600131 ). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible. The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications.

The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants. nih. gov/grants/funding/2590/2590.

htm ). V. Application Review Information Only the review criteria described below will be considered in the review process.

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures ( http://www. csr. nih.

gov/refrev. htm ) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.

Receive a written critique Receive a second level of review by an appropriate national advisory council or board. following will be considered in making funding decisions: Scientific merit of the proposed project as determined by peer Relevance of program priorities The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health.

In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Significance: Does this study address an important problem?

If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Innovation: Is the project original and innovative?

For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Investigators: Are the investigators 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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Environment: Does the scientific environment in which the work will be done contribute to the probability of success?

Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

criteria, the following items will continue to be considered in the determination of scientific merit and the priority score: of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed.

Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate. Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the 2.

C. Sharing Research Data Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

The funding organization will be responsible for monitoring the data sharing policy. http://grants. nih.

gov/grants/policy/data_sharing . grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants. nih.

gov/grants/policy/nihgps/part_ii_5. htm#availofrr and http://www. ott.

nih. gov/policy/rt_guide_final. html ).

Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible. responsible for the administrative review of the plan for sharing research resources. resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications.

Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590).

See Section 3. Anticipated Announcement and Award Dates VI. Award Administration Information the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons .

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General ( http://grants. nih.

gov/grants/policy/nihgps_2003/NIHGPS_part4. htm ). A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization.

The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page).

If a grantee is not email enabled, a hard copy of the NoA will be mailed to the Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

See Also Section IV. 5. Funding Restrictions .

2. Administrative and National cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General ( http://grants.

nih. gov/grants/policy/nihgps_2003/NIHGPS_Part4. htm ) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities ( http://grants.

nih. gov/grants/policy/nihgps_2003/NIHGPS_part9. htm ).

required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually ( http://grants. nih. gov/grants/funding/2590/2590.

htm ) and financial statements as required in the NIH Grants Policy Statement. We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial