and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organization
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Cancer Institute (NCI), (http://www.nci.nih.gov)
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov)
National Library of Medicine (NLM), (http://www.nlm.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov/)
Title: Continued Development and Maintenance of Software
Announcement Type
This is a reissue of PA-02-141.
Update: The following update relating to this announcement has been issued:
Program Announcement (PA) Number: PAR-05-057
Catalog of Federal Domestic Assistance Number(s)
93.389, 93.853, 93.396, 93.859, 93.242, 93.879, 93.279, 93.273
Key Dates
Release Date: February 25, 2005
Application Receipt Dates(s): May 17 and September 13 in 2005, 2006, and 2007
Peer Review Date(s): October and February annually
Council Review Date(s) : January and May annually
Earliest Anticipated Start Date: April and July annually
Expiration Date for R33 Applications: May 18, 2006
Expiration Date for R01 Applications: September 14, 2006
Expiration Date P01, P41, P50, P60 Applications: September 14, 2007
Additional Overview Content
Executive Summary
Biomedical research laboratories increasingly undertake a software development project to solve a problem of interest to that laboratory. These software packages sometimes become useful to a much broader community of users that can include translational and clinical researchers. The goal of this program announcement is to support the continued development, maintenance, testing and evaluation of existing software. The proposed work should apply best practices and proven methods for software design, construction, and implementation to extend the applicability of existing biomedical informatics/computational biology software to a broader biomedical research community. Because 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 number, quality, duration, and costs of the applications received. This program announcement uses the R01 mechanism as well as supplements to existing NIH awards. Eligible organizations include for-profit or non-profit organizations, public or private institutions, units of state and local governments, eligible agencies of the Federal government, and either domestic or foreign organizations. There is no limit on the number of applications that may be submitted. Applicants must use the most recent version of the PHS 398 form. That form is available at http://grants.nih.gov/grants/forms.htm. Telecommunications for the hearing impaired is available at: TTY 301-451-5936.
Table of ContentsPart II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement1. Research Objectives
This program announcement is aimed at satisfying one of the needs created by the parallel achievements and increased interdependence of the biological and computing sciences. This interdependence offers an unprecedented opportunity for sophisticated approaches to computer-enabled research in the biological, clinical, and behavioral sciences. The purpose of this program announcement is to assure the availability and continued usefulness of existing biomedical informatics/computational biology software.
This program announcement is meant for existing software that serves a biological, clinical, or behavioral community of users. Applicants who are interested in developing new software should consult the funding section of the BISTI web page http://www.bisti.nih.gov/bistic_funding.cfm for appropriate program announcements. Applications under this program announcement can seek support to improve the existing software in several different ways listed below. Any of these improvements should benefit the existing user community and/or have high potential for attracting significantly more users.
First, contemporary software must be easy to modify and extend, and must be fully documented. Users who experience problems with software should be able to correct the problem with limited effort and a mechanism must exist for incorporating these corrections into the software. As the needs of a community of users change, the software that supports their research efforts must be adaptable as well. The ability of software to be repaired and to evolve is particularly important because the scientific discovery process is open-ended and ever-changing. Applications to modernize existing software to meet these standards are welcome under this program announcement.
Second, interoperability among different software packages or among software and existing databases is a major concern. Applications with the goal of extending interoperability are welcome under this program announcement. Portability to different types of hardware is a related area of concern. Applications with the goal of improving software so that it operates on a variety of platforms employing different operating systems also are encouraged.
Finally, efforts to combine existing software with modern ontologies or libraries of controlled vocabularies also are well suited to the goals of this program announcement. Such applications might include (1) assessing data flow and use; (2) defining the terms used for data, fields, operations, etc.; (3) defining the relationships among terms and functions; (4) defining data models and schemas; and (5) other similar activities. It is important to emphasize that these activities are appropriate as they relate closely to the particular software itself, or to making the particular software interoperable with other specific software or databases. Thus the use of widely used ontologies, data models, etc. is encouraged.
Awards made under this program announcement will support the continued development, evaluation, and testing of pre-existing bioinformatics/computational biology software. Support will be provided to improve software in any of the areas mentioned above or in closely related areas. The National Institute of Mental Health (NIMH) is interested in efforts to enhance software that can be used to advance the understanding of basic brain and behavioral sciences relevant to NIMH or designed to better understand etiology, treatment, and prevention of mental disorders. If you have questions concerning whether your proposal is suitable for this program announcement, please contact one of the Scientific/Research contacts listed in Section VII.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information1. Mechanism of Support
This funding opportunity will use the R01 award mechanism as well as competitive supplements to existing R01, R33, P01, P41, P50 and P60 grants that have already been awarded by one of the participating Institutes or Centers. Applications for competitive supplements cannot begin in the final year of the parent award. The principal investigator of a competitive supplement must be the same as the parent award. The budget format (modular or non-modular) for competitive supplements should be the same as the parent grant. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
This funding 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.
2. Funds Available
Because 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. 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.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.
Section III. Eligibility Information1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
Foreign institutions are allowed to apply, but such applications should address the additional review criteria concerning applications from foreign institutions that can be found in http://www.csr.nih.gov/guidelines/proc.pdf.
1.B. Eligible Individuals
Any individual 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 always encouraged to apply for NIH programs.
2. Cost Sharing or Matching
Cost sharing is not required.
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
Not Applicable.
1. Address to Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants should use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be 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 form.
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 must be checked.
3. Submission Dates and Times
Applications must be submitted on or before the receipt date described below (Section IV.3.A). Submission times NA.
3.A. Receipt, Review and Anticipated Start Dates
Application Receipt Date(s): May 17 and September 13 in 2005, 2006, and 2007
Peer Review Date(s): October and February annually
Council Review Date(s) : January and May annually
Earliest Anticipated Start Date: April and July annually
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Sending an Application to the NIH
Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:
Center for Scientific Review
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)
3.C. Application Processing
Applications must be received on or before the application receipt 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 and responsiveness by the ICs.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial 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.
Although there is no 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
This initiative is not subject to intergovernmental review.
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 (see also Section VI.3. Reporting).
Pre-Award Costs are 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
Specific 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.
Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.
Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;
2) 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 application.
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.
Specific Instructions for Competitive Supplements
Applications for competitive supplements cannot begin in the final year of the parent award. The principal investigator of a competitive supplement must be the same as the parent award. The budget format (modular or non-modular) for competitive supplements should be the same as the parent grant.
Specific Instructions for Demonstration Software.
Applicants who would like to submit a CD containing a demonstration version of their software should consult with the Peer Review Contact listed in Section VII after the application has been assigned to a special emphasis panel.
Plan for Sharing Research Data
It is not expected that applications under this program announcement will propose data collection. However, it is possible that in some cases, data collection might be required for software testing. If such data collection is proposed, the following data sharing guidelines apply.
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
Applicants requesting 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.
Sharing Research Resources
NIH policy requires that 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). See Section VI.3. Reporting.
Applicants are strongly encouraged to make their software easily available to the academic community. To preserve utility to the community, the software should be transferable to another individual or team in the event that the original investigators are unwilling or unable to continue development.
Section V. Application Review Information1. Criteria
Not applicable
2. Review and Selection Process
Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.
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 will:
The following will be considered in making funding decisions:
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.
1. 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? Does the software serve a biomedical/behavioral community of researchers? Will the proposed software modifications create improvements that represent a significant advance over the existing software package or over other competing software packages? Will the plans to improve the software meet the needs of the community of users? Will the potential scientific impact of the software be limited by lack of availability?
2. 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? Is the approach to software design appropriate? Is the proposed software development process appropriate and likely to succeed? Are plans to document the software appropriate? Have scalability, extensibility, interoperability, testing and evaluation been addressed adequately? Are plans to make the software available to the scientific community appropriate? Will the software be readily available to interested users? Will other users be able to modify the software and/or reuse components of it without being subject to prohibitive restrictions? If the application involves ontologies or controlled vocabularies, have the appropriate ontologies/vocabularies been chosen?
3. 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)?
4. 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?
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:
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).
2.B. Additional Review Considerations
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 budget.
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.
2.D. Sharing Research Resources
NIH policy requires that 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.
The adequacy of the 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 VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Not applicable
1. Award Notices
After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.
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 Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document. Notification of award via NGA will be sent to the Signing Official/Business Official either electronically, if the grantee is an email-enabled institution, or via US Mail.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA 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 Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. 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).
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
Awardees will be 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.
Section VII. Agency ContactsWe 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:
Gregory K. Farber, Ph.D.
Division of Biomedical Technology Research and Research Resources
National Center for Research Resources
6701 Democracy Boulevard
Room 960, MSC 4874
Bethesda, MD 20892
Telephone (301) 435-0778
Email: [email protected]
Jennifer A. Couch, Ph.D.
Structural Biology and Molecular Applications Branch
Division of Cancer Biology
National Cancer Institute
Executive Plaza North, Room 5004
6130 Executive Boulevard
Rockville, MD 20892
Telephone: (301) 435-5226
E-mail: [email protected]
Charles P. Friedman, Ph.D.
Division of Extramural Programs
National Library of Medicine
6705 Rockledge Drive, Suite 301
Bethesda, MD 20892-7968
Telephone: (301) 594-4927
E-mail: [email protected]
Michael F. Huerta, Ph.D.
Director, Office of Interdisciplinary Research and Scientific Technology
National Institute of Mental Health
Neuroscience Center, Room 7202
6001 Executive Boulevard
Rockville, MD 20852
Telephone: (301) 443-3563
E-mail: [email protected]
Eric Jakobsson, Ph.D.
Director, Center for Bioinformatics and Computational Biology
Natcher Building, Room 2AS55
45 Center Drive
Bethesda, MD 20892-6200
Telephone: (301) 594-5236
E-mail: [email protected]
Yuan Liu, Ph.D.
Chief, Office of International Activities
Program Director, Computational Neuroscience and Neuroinformatics
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 2187
6001 Executive Boulevard, MSC 9523
Rockville, MD 20892-9523
Telephone: (301) 496-1917
E-mail: [email protected]
Peter Lyster, Ph.D.
Center for Bioinformatics and Computational Biology
Natcher Building, Room 2AS55K
45 Center Drive
Bethesda, MD 20892-6200
Telephone: (301) 594-3928
E-mail: [email protected]
Karen Skinner, Ph.D.
Division of Basic Neurosciences and Behavior Research
National Institute on Drug Abuse
Neuroscience Center, Room 4255
6001 Executive Boulevard, MSC 9555
Rockville, MD 20892-9555
Telephone: (301) 443-1887
E-mail: [email protected]
John Whitmarsh, Ph.D.
Assistant Director, Center for Bioinformatics and Computational Biology
Natcher Building, Room 2AS55F
45 Center Drive
Bethesda, MD 20892-6200
Telephone: (301) 451-6446
E-mail: [email protected]
2. Peer Review Contacts:
Sally A. Amero, Ph.D.
Chief, BST IRG
Center for Scientific Review
2 Rockledge Center, Room 4190
6701 Rockledge Drive
Bethesda , MD 20892
Telephone: (301) 435-1159
FAX: (301) 480-4042
Email: [email protected]
3. Financial or Grants Management Contacts:
Sheryl Lane
Division of Grants Management
National Center for Research Resources
6701 Democracy Boulevard
Room 1044, MSC 4874
Bethesda, MD 20892
Telephone: (301) 435-0846
Email: [email protected]
Required Federal Citations
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 submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
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 the scientific merit or the priority score.
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 new PHS Form 398; 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.
Public 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 public 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 PA 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.
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 Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 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.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.
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NIH Funding Opportunities and Notices
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