Department of Health
and Human Services
National Institutes of Health (NIH), ( http://www.nih.gov)
Components of Participating Organizations
National Institute of Child Health and Human Development (NICHD), ( http://www.nichd.nih.gov/)
Title: Americas Fellowship in Reproductive Sciences (F05)
Update: The following update relating to this announcement has been issued:
Release Date: September 12, 2007
Letters of Intent Receipt Date(s): November 8, 2007, 2008, 2009
Application Receipt Date(s): December 8, 2007, 2008, 2009
Review Date(s): February/March, 2008, 2009, 2010
Council Review Date(s): May 2008, 2009, 2010
Earliest Anticipated Start Date(s): July 1, 2008, 2009, 2010
Expiration Date: New Date June 12, 2009 (See NOT-OD-09-106) Original Date: December 9, 2009
Due Dates for E.O.
Additional Overview Content
Table of Contents
1. Training and Research Objectives
Specific Research Interests:
Applicants can obtain information and research interests for the RSB at the web site (http://www.nichd.nih.gov/about/org/cpr/rs), or by contacting the NICHD program contact listed in this announcement (see Section VII. Agency Contacts).
VIII, Other Information - Required Federal Citations, for policies related
to this announcement.
Section II. Award Information
1. Mechanism(s) of
This funding opportunity will use the international research fellowship (F05) award mechanism.
The applicant and the North American sponsor are jointly responsible for planning, directing, and executing the proposed project.
This program is designed to provide training and research opportunities for qualified, non-immigrant Latin American scientists who are currently residing outside the U.S. and Canada. The applicant is required to have a doctoral degree (or its equivalent) in one of the biomedical sciences, or behavioral sciences. The proposed research training must be within the broad scope of biomedical research as it relates to reproductive sciences, and must offer an opportunity to enhance the fellow's understanding of the health-related sciences and to extend his or her potential for a productive independent research career.
This funding opportunity uses the non-modular budget format described in the PHS 416-1 application instructions (see http://grants.nih.gov/grants/funding/416/phs416.htm).
Duration of Support: Individuals may receive a minimum of one year and up to three years of support for research training at a basic or clinical research facility within the U.S. and Canada (referred to as the North American sponsoring institution).2. Funds Available
The number of awards that will be funded under this program announcement is contingent upon the quality of the applications received, the availability of funds.
Stipends: This fellowship award provides a stipend to the fellow to help defray living expenses during the research training experience at the North American sponsoring institution. The awards are not provided as a condition of employment with either the Federal government or the North American sponsoring institution.
Fellowship awardees are required to pursue their research training on a full-time basis, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies, to the training program. Research clinicians must also devote full-time to their proposed research training and must restrict clinical duties to activities that are directly related to their research training experience. This fellowship may not be used to support studies leading to a N.D., D.C., M.D., D.O., D.D.S., D.V.M., or other similar health-professional degrees, and it may not be used to support the clinical years of residency training.
The fellowship awardee's requested stipend must be in accordance with the salary structure of the North American sponsoring institution and consistent with the level of effort.
While the AFRS is not one of the Ruth L. Kirschstein National Research Service Award (NRSA) fellowships, the amount of the award will be determined by the NRSA postdoctoral stipend guidelines. The maximum NRSA stipend level is based on full years of relevant postdoctoral experience. Relevant experience may include research (including research in industry), teaching, internship, residency, clinical duties, or other time spent in full-time studies in a health-related field beyond that of the qualifying doctoral degree. The NRSA stipend schedule is updated nearly every year, and applicants are advised to check the current stipend schedule at http://grants.nih.gov/training/nrsa.htm. For fellows sponsored by domestic non-federal institutions, the stipend will be paid through the sponsoring institution. For fellows sponsored by Federal institutions, the monthly stipend payment will be deposited in the fellow’s U.S. bank account or paid directly to the fellow by a U.S. Department of Treasury check.
Tuition and Fees: The NICHD will reimburse the combined cost of tuition, fees and applicable health insurance according to the NRSA policies and rates at the time of award. The following rate is currently applied: an amount per postdoctoral trainee equal to 60% of the level requested by the applicant institution, up to $4,500 per year, will be provided. Costs associated with tuition and fees are allowable only if they are required for specific courses in support of the research training experience of the fellow at the North American sponsoring institution. A full description of the current tuition policy is can be obtained here: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html.
Institutional Allowance at the North American Sponsoring Institution: The NICHD will provide an institutional allowance of up to $7,850 per 12-month period to nonprofit nonfederal North American sponsoring institutions or up to $6,750 per 12 month period to for-profit or U.S. Federal laboratories to help defray such awardee's expenses as research supplies, equipment, health insurance (see below), books, travel to scientific meetings and/or to the fellow’s home institution. This allowance is intended to cover the research training-related expenses for the individual awardee. The allowance for traveling back to the Latin American institution may include a single economy or coach round-trip travel fare. No travel allowance is provided for the awardee’s dependents. U.S. flag air carriers must be used to the maximum extent possible when commercial air transportation is available for travel between the U.S. or Canada and the Latin American country. For fellows at for-profit institutions, the institutional allowance will be paid to the institution for disbursement to the fellow. For fellows at U.S. Federal laboratories, the allowance will be disbursed from the NICHD. The allowance is not available until the fellow officially activates the award. See: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html.
Health Insurance: Self-only health insurance (available to fellows without families) or family health insurance (available to fellows with families) is an allowable cost for fellows at the North American sponsoring institution only if such self or family health insurance is required of all persons in a similar training status regardless of the source of support. Health insurance for fellows who are eligible for this coverage is included in the allowable amount for the Institutional Allowance. See: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html.
Other Training Costs: Additional funds may be requested by the North American sponsoring institution for accommodations for fellows who are disabled, as defined by the Americans with Disabilities Act. The funds requested for costs of this nature must be reasonable in relationship to the total dollars awarded under the fellowship and must be directly related to the approved research training experience. Such additional funds shall be provided only for circumstances that are fully justified and explained by the North American sponsoring institution in the application.
Facilities and Administrative (F&A) Costs: F&A costs are not allowed for the NIH fellowship programs.
Supplementation of Stipends, Compensation, and Other Income
The North American sponsoring institution is allowed to provide funds to the fellow in addition to the stipend and institutional allowance paid by the NIH awarding institute while the fellow is training at the North American institution. Such additional amounts may be in the form of an augmented stipend (supplementation) or in the form of compensation, provided the conditions described below are met. Under no circumstances may the conditions of stipend supplementation interfere with, detract from, or prolong the fellow’s approved AFRS research training program.
Stipend Supplementation: Supplementation, or additional support to offset the cost of living, may be provided by the North American sponsoring institution. Supplementation does not require additional effort from the fellow. DHHS funds may not be used for supplementation under any circumstances. Additionally, no funds from other Federal agencies may be used for supplementation unless specifically authorized by both the NIH and the other Federal agency.
Compensation: The North American sponsoring institution may not provide funds in addition to the stipend in the form of compensation, such as salary or tuition remission, for services provided, such as teaching. The fellow should spend 100 percent effort on activities related to this research training award and must not be required to perform additional paid services while at the North American sponsoring institution.
The complete policy for stipend supplementation and compensation is located in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm.
1. Eligible Applicants
1.A. Eligible Institutions
You (as the sponsoring institution) may submit (an) application(s) if your organization has any of the following characteristics:
Please note that National Institutes of Health intramural laboratories are not included as eligible agencies of the Federal Government. The sponsoring institution must be a basic or clinical research facility in the U. S. or Canada.
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research training is invited to work with his or her North American sponsor and sponsoring institution to develop an application for support. Women, individuals from underrepresented racial and ethnic groups as well as individuals with disabilities and individuals from disadvantaged backgrounds are always encouraged to apply for NIH support.
Degree Requirements: Applicants to the AFRS must have earned a doctoral degree (M.D., Ph.D., D.V.M., D.D.S., D.O., O.D., D.P.M., Sc.D., Eng.D., D.N.S., Pharm.D., D.S.W., or equivalent) from an accredited U.S. or foreign institution at the time their application is submitted in response to this program announcement. The applicant must provide a photocopy of his or her diploma, and a certified English translation if the original document is not in English.
Citizenship: Non-immigrant foreign scientists who are not currently residing in the U.S. or Canada are eligible for this award. U.S. citizens, non-citizen nationals, or persons with U.S. permanent resident status are not eligible for this award. Individuals in the latter three categories should consult the NIH website for descriptions of other fellowship and career development awards for which they may be eligible (http://www.training.nih.gov/).
VISA Requirements: Foreign nationals who apply for this fellowship must have a visa that permits training or employment in the U.S. or Canada at the time that an award is made.
It will be the responsibility of the candidate’s North American sponsoring institution to determine and document that the candidate’s visa will allow him or her to remain in the North American country long enough to complete the proposed research training program.
Language Requirement: The applicant must be proficient in English.
2. Cost Sharing or Matching
Cost sharing is not
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
Sponsor: Before submitting a fellowship application, the applicant must identify a North American sponsoring institution and an individual who will serve as the sponsor (also called mentor or supervisor). The sponsor must be affiliated with the North American sponsoring institution and be funded to conduct independent research (e.g., Principal Investigator on an NIH R01 grant) in an area that is appropriate for the proposed research training. The sponsor must be committed to the training and must directly supervise the fellow's research during the entire period of the fellowship. The sponsor must document the availability of sufficient current research support and facilities for high-quality research training at the North American sponsoring institution.
Sponsoring Institution: The sponsoring institution must have staff and facilities available on site to provide a suitable environment for performing high-quality research training in the proposed research area.
Requirements for the Latin American Institution: The fellowship will be awarded to the North American sponsoring institution only. However, no application will be accepted without an accompanying endorsement letter from the Latin American Institution to which the applicant plans to return. In this letter, the Latin American Institution must assure that the applicant has a guaranteed appointment at the institution upon his or her return. The letter should contain the following information: 1) the title and description of the applicant’s appointment at this institution; 2) the guaranteed duration of the appointment; and 3) a description of the research facility and environment at this institution, including facilities and equipment available to the applicant. This letter must be signed by the appropriate institutional business and academic officials (such as a university dean who is responsible for the applicant's appointment) and included in the same package with the copies of the completed application.
1. Address to Request
The PHS 416-1 (rev. 10/05) fellowship application instructions are available at http://grants.nih.gov/grants/funding/416/phs416.htm#forms in an interactive format. Applicants must use the currently approved version of the PHS 416-1. Please note the PHS 416-1 form is used for several different types of fellowship applications. Therefore, not all statements in the form may be applicable to the INF. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of
Applications must be prepared using the most current PHS 416-1 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 13b of the face page of the PHS 416-1 form.
The title and number of this program announcement must be typed on line 3 of the face page of the application form and the YES box must be checked.
Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
3. Submission Dates and Times
See Section IV.3.A for details.
3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): November 8, 2007, 2008, 2009
Application Receipt Date(s): December 8, 2007, 2008, 2009
Review Date(s): February/March, 2008, 2009, 2010
Council Review Date(s): May 2008, 2009, 2010
Earliest Anticipated Start Date: July 1, 2008, 2009, 2010
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although a letter of intent
is not required and is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows NIH staff to
estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning of this document.
The letter of intent should be sent to:
Koji Yoshinaga, Ph.D.
Reproductive Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard
Bethesda, MD 20892-7510
Telephone: (301) 435-6992
FAX: (301) 480-2389
3.B. Sending an Application to the NIH
Applications must be prepared using the training grant application forms found in the PHS 416-1 instructions for preparing a fellowship application. Submit a signed, typewritten original of the application, including the checklist, sealed reference letters, and all other required materials) and two exact, clear, single-sided photocopies of the signed application, in one package to:
Center for Scientific
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Applications responding to this program announcement must include at least three sealed letter of reference following the instructions and using the CDA Reference Guidelines Format Page found in Section III of the PHS 398 application attached to the face page of the original application. Applications submitted without the required number of reference letters will be considered incomplete and will be returned without review.
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
Applications must be received on or before the application receipt/submission date(s) described above (Section
IV.3.A.). If an application is received after that date, it will be
returned to the applicant without review.
Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.
The NIH will not accept 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.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
5. Funding Restrictions
All NIH awards are 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.
Concurrent Awards: TheAFRS may not be held concurrently with another U.S. federally sponsored fellowship or similar Federal award that provides a stipend/salary or otherwise duplicates provisions of this award.
6. Other Submission Requirements
Applicants are advised to pay special attention to the following items in the PHS 416-1:
Section I - Applicant Information:
Section II – Sponsor Information:
Instruction in the Responsible Conduct of Research Applications must include the candidate's plans for obtaining instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency and duration of instruction. Although the NIH has not established specific curriculum or format requirements for this training, it is suggested that the following topics be covered: conflict of interest, data sharing, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Applications without plans for training in responsible conduct of research will be considered incomplete and may be returned without review. No award will be made if an application lacks this component.
Human Subjects Research If the proposed research involves human subjects, the applicant must be responsive to the instructions in the current version of the PHS 416-1. The adequacy of plans to include appropriate human subjects is included in the fellowship evaluation (see Additional Review Criteria below). Note that NIH defines children as individuals under 21 years of age. Consult the decision tree for the exemptions that apply: http://grants.nih.gov/grants/funding/children/pol_children_decision_tree.htm
Care and Use of Vertebrate Animals in Research If vertebrate animals are to be used in the project, the applicant must be responsive to the instructions in the current version of the PHS 416-1. The adequacy of plans for the care and use of vertebrate animals is assessed as part of the fellowship evaluation.
Biohazards The investigator and the sponsoring institution are responsible for protecting the environment and research personnel from hazardous conditions. If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, please describe the procedures to be taken in order to ensure adequate protection.
Additional Documents required for the Program
• Letters of Reference (three required) and statements related to the potential of the applicant for a leadership position in research, academia or public health in his or her home country
• Endorsement letter from the Latin American institution indicating a guaranteed appointment following completion of the F05 program
Plan for Sharing
NIH policy expects that grant 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 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). See Section VI.3. Reporting.
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be considered in the review process.
2. Review and Selection
Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by CSR in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
The following will be considered in making funding decisions:
The goal of the AFRS Program is to strengthen the human resource capital of reproduction research in international institutions. Through this program announcement, investigators are expected to pursue independent and productive careers which stimulate research in the reproductive sciences on a global scale, and continue collaborative research with investigators in Latin American and North American countries. The scientific review group will be asked to address each of the following criteria when assigning the overall score, weighting them as appropriate for each application.
Sponsor and Training Environment at the North American Sponsoring Institution
Research and Training Proposal
2.A. Additional Review Criteria:
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
Protection 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 398).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from 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 the PHS Form 398).
Care and 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.
2.B. Additional Review Considerations
Responsible Conduct of Research. Every AFRS fellow must receive instruction in the responsible conduct of research ( http://grants.nih.gov/grants/guide/notice-files/not92-236.html). Applications must include the candidate's plans for obtaining instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency and duration of instruction. The plan will be discussed after the overall determination of merit, so that the review panel's evaluation of the plan will not be a factor in the determination of the priority score. The plan will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note of the summary statement.
Endorsement letter – is the required endorsement letter from the Latin American institution to which the fellow is to return following the fellowship adequate? Does is guarantee a position appropriate for the postdoctoral research experience?
2.C. Sharing Research
2.D. Sharing Research Resources
NIH policy expects that grant 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.
The adequacy of the resources sharing plan will be considered by Program staff of the NICHD when making recommendations about funding applications. Program staff may negotiate modifications of the resource sharing plan with the principal investigator before recommending funding of an application. The final version of the resource sharing plan 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 VI.3. Reporting.
1. Award Notices
After the peer review of the application is completed, the applicant will be able to access his or her Summary Statement (written critique) via the eRA Commons.
A formal notification in the form of a Notice of Research Fellowship Award will be provided to the applicant organization. This notice signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, this notice will be sent electronically to the designated North American Sponsoring institution ’s business official listed on the face page of the application or may be retrieved by the institution through its NIH eRA Commons account.
Selection of an application
for award is not an authorization to begin performance. No funds may be
disbursed until the fellow has started training under the award and an
Activation Notice (PHS 416-5) has been submitted to the NIH. The fellow
has up to six months from the fellowship award issue date to activate the
2. Administrative and National Policy Requirements
Fellowships must be administered in accordance with the current fellowship section of the Grants Policy Statement ( http://grants.nih.gov/grants/policy/policy.htm), and any terms and conditions specified on the Notice of Grant Award.
Leave Policies: In general, during the years of support at the North American sponsoring institution, fellows may receive a stipend during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Fellows may receive stipend for up to 15 calendar days of sick leave per year.
A period of terminal leave is not permitted and payment may not be made from fellowship funds for leave not taken. Fellows requiring periods of time away from their research training experience longer than specified here must seek approval from the NIH awarding institute for an unpaid leave of absence.3. Reporting
Application for Continued Support and Progress Report: For two or three year awards, the awardees are required to submit the form PHS 416-9, Continuation of AFRS Award, annually (http://grants.nih.gov/grants/forms.htm) as required in the NIH Grants Policy Statement. The report is due two months before the beginning date of the next budget period and must include information related to the current year's progress as well as the plans for the coming year.
Termination Notice and Final Report: When support ends, the awardee must submit a Termination Notice (PHS 416-7) to the NIH within 30 days following termination. Forms may be found at http://grants.nih.gov/grants/funding/416/phs416-7.doc. The fellow and the North American sponsor are responsible for providing a final report, detailing the following information:
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 or grants management issues:
1. Scientific/Research Contacts:
Koji Yoshinaga, Ph.D.
Reproductive Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Blvd.
Bethesda, MD 20892-7510
2. Peer Review
3. Financial or Grants
Grants Management Specialist
National Institute of Child Health and Human Development
Room 8A 17L
6001 Executive Blvd
Bethesda, MD 20892-7510
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals ( http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained ( http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators should seek guidance from their institutions on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of scientific merit or the priority score.
Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R); and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system ( http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://PublicAccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR Website ( http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Section 307 of the Public Health Service Act (42 USC 242l) and under Federal Regulations 42 CFR 63a and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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