and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
Title: Field-Deployable Tools for Quantifying Exposures to Psychosocial Stress and to Addictive Substances for Studies of Health and Disease (U01)
Announcement Type
New
Request For Applications (RFA) Number: RFA-DA-07-005
Catalog of Federal Domestic Assistance Number(s)
93.279
Key Dates
Release Date: October 2, 2006
Letters of Intent Receipt Date(s): November 22, 2006
Application Receipt Date(s): December 22, 2006
Peer Review Date(s): March-April 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date(s): July 2007
Additional Information To Be Available Date (Activation Date): N/A
Expiration Date: December 23, 2006
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism 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. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically 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
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 Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Nature of the Research Opportunity
The NIH invites applications to support the development of new technologies to measure psychosocial stress and/or addictive substances (licit and illicit), for the NIH-wide Genes and Environment Initiative (GEI).
The GEI is a four-year, NIH-wide program proposed in the President’s 2007 budget and currently awaiting Congressional approval. If approved, the program will support efforts to identify major genetic susceptibility factors for diseases of public health significance and to develop technologies for reliable and reproducible measurement of potentially causative environmental exposures. The GEI is being developed and implemented by an NIH-wide Coordinating Committee, and administered via two complementary programs, the Exposure Biology Program led by the National Institute of Environmental Health Sciences (NIEHS) and the Genetics Program led by the National Human Genome Research Institute (NHGRI).
The Exposure Biology Program of the GEI is intended to be a multi-component program involving several solicitations. A major component will support the development of technology to make precise, quantitative measurements of personal exposure to environmental chemical/biological agents, diet, physical activity, and psychosocial stress. The other exposure biology component includes development of biological response indicators for a variety of environmental stressors. These activities will generate new exposure assessment tools that can be applied in future population-based and whole genome association studies supported by the GEI to better inform about the role of gene-environment interactions in human disease.
The GEI will also consider pathways to disparities in health outcomes, including but not limited to environmental exposures, genetic variations and/or other underlying biological, race/ethnic, social, and familial factors. Health disparities research provides an important opportunity to integrate biological with social/behavioral knowledge in better identification and understanding of the determinants of disease, reducing disease risks, and providing better treatment. How genetic variation contributes to health disparities remains largely unclear since most genetic studies do not have adequate measures of behavioral, physical, social, and environmental factors. The GEI will provide a valuable scientific contribution to health disparities research by its collection and analyses of genotype, phenotype, and exposure data, while simultaneously measuring other factors within disease subgroups (e.g., race, ethnicity, behaviors, geography, genetic backgrounds, exposures and social environments) that may lead to differential health outcomes.
There are 5 RFAs being announced concurrently that define the scope of the Exposure Biology Program. The RFA numbers and titles are as follows: RFA-ES-06-011 Environmental Sensors for Personal Exposure Assessment (U01); RFA-CA-07-032 Improved Measures of Diet and Physical Activity for the Genes and Environment Initiative (GEI) (U01); RFA-DA-07-005 Field-deployable Tools for Quantifying Exposures to Psychosocial Stress and to Addictive Substances for Studies of Health and Disease (U01); RFA-ES-06-012 Biological Response Indicators to Environmental Stressors Centers (U54); and RFA-ES-06-013 Biological Response Indicators to Environmental Stressors (U01).
The objective of this funding opportunity is to support research to develop new technologies to measure psychosocial stress and/or addictive substances (licit and Illicit) for use within large-scale studies of diverse populations. Diverse populations include subgroups based on gender, culture, and socio-economic status, ethnicity, geography, race, and age, from infants to adults. This FOA encourages the development, improvement and/or adaptation of measurement technologies which, by the end of the funding period, will be verified field-deployable tools that can detect and quantify personal exposure to psychosocial stress and/or addictive substances with maximum precision and reliability. Ideally, the technology could feasibly be applied in large-scale population genomics-by-environment studies to comprehensively measure multiple addictive substances and psychosocial stress events, either singly or jointly, as risk factors for a wide range of diseases and disorders. Comprehensive assessment includes measuring acute/chronic/cumulative exposures to psychosocial stress and/or addictive substances with a high degree of temporal and spatial resolution (i.e., as a person moves through environments), and with a high degree of accuracy and sensitivity to detect meaningful variations in extent of and response to exposure across developmental periods (ranging from prenatal to senescence) and among various population groups. Given the recent advances in environmental and biological sensor technology in the medical diagnostic and military arenas, the creation of product-oriented tools for comprehensive assessment of exposure to psychosocial stress and addictive substances is a reachable goal that will greatly improve the study of gene-environment interaction in human disease. In view of the technical complexity of the science called for in this announcement, transdisciplinary alliances between academic researchers, technology experts, and analytical laboratory scientists are strongly encouraged.
Background
The NIH Gene and Environment Initiative (GEI) seeks to investigate the interactions between genetic and environmental factors that underlie complex human diseases. A critical objective of the GEI is to accurately identify, quantify, and verify personal exposure to environmental factors associated with a range of diseases. Ultimately, the successful identification of specific genes and related mechanisms, physiologic systems, and other etiological processes of complex diseases depend on precise measurement of environmental exposures to evaluate their impact on disease risk.
Exposure to psychosocial stress and addictive substances can contribute to repetitive maladaptive patterns of behavior that result in adverse lifestyle consequences and negative effects on physiological function leading to disease. Repeated exposures to psychosocial stress and addictive substances are associated with myriad human diseases (e.g., cancer, drug addiction, heart disease, depression) of tremendous public health burden. The ability to precisely measure exposure to psychosocial stress and addictive substances, a major research priority within the GEI, will advance our understanding of how these exposures interact with genetic factors in the etiology of prevalent human diseases.
Psychosocial stress refers to acute or chronic events of psychological or social origin which challenge the homeostatic state of biological systems, including the neuroendocrine and sympathoadrenal stress response systems, via corticolimbic pathways. Psychosocial stressors include, but are not limited to, exposure to adverse environments and life experiences such as natural disasters (e.g., earthquakes and hurricanes), crowding or isolation, relative position in a social hierarchy, stigma and discrimination, catastrophic/traumatic events (e.g., war, terrorism), loss of job, disease, family violence, deprivation, child abuse, adverse social environments or situations (e.g., being a chronic caregiver to an ailing family member), and detrimental parental behaviors. Psychosocial stress stands in contrast to systemic stress which results from physical challenges to the body, such as exercise or injury/inflammation that input into the stress response system. Some stressors can be both psychosocial and systemic.
The term "addictive substances" as used in this FOA refers to nicotine, alcohol, cannabis, stimulants, and opiates, but also includes the range of substances of potential addiction and their component mood-altering chemicals. Exposure includes active/voluntary as well as inactive/passive contact between an individual and one or more substances either acutely or chronically. Measurement spans the entire range of exposure to substances from initial contact, experimentation or use, to frequent contact or chronic contact and/or use.
Psychosocial stress and addiction can be linked at multiple levels. They have been associated with similar genes (e.g., COMT, SERT, OPRM1, DRD2), neurochemicals (e.g., corticotropin-releasing hormone, serotonin, MAOA, endogenous opioids, dopamine), brain regions (e.g., amygdala, hippocampus, hypothalamic-pituitary-adrenal axis), and environmental exposures (e.g., life events, trauma, child abuse). Psychosocial stress and substance use influence each other in a bidirectional and cascading manner. Psychosocial stress can trigger consumption and increase the rewarding properties of addictive substances. Exposure to addictive substances can induce and modify the psychosocial stress response. Repetitive and cyclical patterns of psychosocial stress and substance use can influence common chronic and relapsing diseases (e.g., depression, anxiety, heart disease, cancer). Interactive effects between specific genetic variants and exposure to psychosocial stress have been shown to alter gene expression, physiology, and the development of psychiatric disorders in humans.
To date, measurement of exposure to psychosocial stress relies on self-report or multi-informant data (from respondent, family members, and public records) via inventories (e.g., paper and pencil, web-based checklists) of daily hassles, occurrence and impact of stressful life events and their impact on functioning (e.g., coping, and sleep and mood disturbances). Other measures of psychosocial stress involve laboratory-based assays (e.g., cortisol, adrenocorticotropic hormone, C-reactive protein), and behavioral indicators (e.g., blink rate, memory impairment, cardiac activity). Measurement may employ technological devices (e.g., electronic diaries, real-time heart rate). Similarly, traditional means to measure human exposure to addictive substances relies heavily on self-report and/or biochemical analyses of urine, blood, or other biological specimens. Some measures of exposure have involved the use of daily diaries and handheld devices to record frequency and amounts of substance use.
For substance users with erratic patterns of use or who perceive negative consequences for reporting use, self-report proves to suffer from biases yielding unreliable and inaccurate data. For analysis of biological specimens, sporadic assessments do not accurately portray patterns of use or timing/duration/frequency/intensity of exposure.
While informative, extant measures of exposure to psychosocial stress and addictive substances can represent barriers to application in large scale population studies detecting gene-by-environment interactive effects. First, they generally detect static single agent exposures, thereby offering minimal information about changes in exposure and responses over time (i.e., temporal resolution), intensity (e.g., dosage or concentration), and across locations (i.e., spatial resolution). Second, self-report is prone to recall and social desirability biases that can yield inaccurate data (e.g., substance users who perceive negative consequences for use may misreport). Third, for passive/involuntary exposure (e.g., inhalation of second-hand tobacco smoke, neighborhood crime), measurement is typically at the greater environmental level rather than at the individual (acute and/or cumulative) personal-exposures level. Fourth, the analytical methods require laboratory-based processing as opposed to in-field analysis. Fifth, many of the biological and behavioral indicators are non-specific (e.g., sleep disturbance may be due to substance use or psychosocial stress, changes in hormone concentrations may be due to psychosocial stress or physical exertion). Sixth, while previous research has demonstrated associations between exposure to stressors and substances, the lack of temporal sequencing of behavioral, cognitive, and physiological mechanisms of these associations remain unclear. Thus, for research that investigates the contribution of multiple environmental exposures impacting health and disease in conjunction with genetic and biologic factors, more precise and quantifiable measurement of individualized exposures is paramount.
Scientific Knowledge to be Achieved
The goal of the trans-NIH Genes and Environment Initiative is to determine the etiology of common diseases by focusing on the interaction of genetic and environmental factors that increase the risk of these diseases. The Exposure Biology component of the GEI will develop new methods to assess personal exposure to stressors in the environment and the response to these stressors in key biological pathways involved the pathogenesis of common diseases. Projects developed under this FOA should focus on support the development of new technologies to measure psychosocial stress and/or addictive substances (licit and illicit), for the Exposure Biology Program.
Objectives
This initiative addresses barriers to personal exposure assessment by fostering the development, improvement and/or adaptation, and validation of measurement technologies which, by the end of the funding period, will be field-deployable tools (rather than laboratory-based prototypes) that detect personal exposure to psychosocial stress and/or addictive substances (licit and illicit). This initiative will promote the measurement of exposure with maximal precision, quantification, and reliability with a high degree of temporal (acute or chronic) and spatial resolution for application in large-scale studies of human health and disease. The technologies and devices developed through this FOA must be ready for application to population studies at the end of the funding period. The Network on Exposure to Psychosocial Stress and Addictive Substances (NEPSAS) is defined as the final group of Awardees funded through this FOA.
Three specific categories of research activities are targeted by this initiative. In their applications, investigators must indicate to which of the following Categories they are responding.
Programmatic priority will be given to the development of devices that detect multiple addictive substances, multiple stress events, or a panel that combines psychosocial stress and substance exposures measurement. Whenever possible, the activities will detect meaningful variations in extent of and response to exposure across age, developmental periods, sex, and population groups.
Category 1 includes the development, improvement and/or adaptation, and validation of measurement technologies which, by the end of the funding period, will be field-deployable tools that detect personal exposure to psychosocial stress. Possible topics include but are not limited to:
Category 2 includes the development, improvement and/or adaptation, and validation of measurement technologies which, by the end of the funding period, will be field-deployable tools that detect personal exposure to addictive substances (e.g., nicotine, alcohol, cannabis, stimulants opiates, and other mood altering chemicals) at the point of contact with or entry to the body via routes of administration including dermal absorption, inhalation, ingestion, and injection. Possible topics include but are not limited to:
Category 3 includes the development, improvement and/or adaptation, and validation of measurement technologies which, by the end of the funding period, become field-deployable tools that detect personal exposure to psychosocial stress AND addictive substances at the point of contact with or entry to the body via routes of administration including dermal absorption, inhalation, ingestion, and injection. Deployment of tools that measure the bidirectional influence between these exposures is warranted because it is known that psychosocial stress triggers consumption of addictive substance, and that exposure to addictive substances induces and/or modifies psychosocial stress. Thus, tools that jointly measure exposure to psychosocial stress and addictive substances hold promise of revealing contingent temporal and interactive response variations that represent episodes of increased vulnerability to disease outcomes through similar biological pathways. Possible topics include but are not limited to those presented for Category 1 or 2, jointly coordinated, detected, or deployed.
Application Information Meeting
NIH staff will conduct an Application Information Meeting and videoconference in Research Triangle Park, NC, on October 20, 2006. This meeting will allow potential applicants to discuss and clarify any issues related to this FOA with NIH staff. Detailed information about the meeting (e.g., time, location, videoconference information, etc.) will be available on the Exposure Biology website (http://www.gei.nih.gov/index.asp). Whether you plan to attend or videoconference into the meeting, please register online at this website. Potential applicants are encouraged to submit their questions via email to Dr. Kay L. Wanke (wankek@nida.nih.gov) in advance of the meeting.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information
1. Mechanism(s) of Support
This funding opportunity will use the U01 Research Project Cooperative Agreement award mechanism.
As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.
The NIH U01 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".
2. Funds Available
The total amount of funding committed to this program is $8 million (total costs) over a 4-year period. NIH, intends to commit approximately $2 million in FY2007 to fund 3-5 new grants in response to this FOA. An applicant may request a project period of up to 4 years and a budget for direct costs up to $325,000 dollars per year.
The anticipated start date is July 2007 and the program period will be from July 1, 2007 to June 30, 2011.
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 NOT-OD-05-004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
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 support.
2. Cost Sharing or Matching
No cost sharing is 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
Milestones
All applications must include a specific section labeled Milestones for each year. Milestones should be annual, well-described, quantitative, and scientifically justified and not simply a restatement of the specific aims. Rather, the milestones should offer a timeline and a pathway for the development of the proposed technology. These milestones will be used to judge the success of the proposed research on an individual-project basis. It is expected that the milestones will be adjusted annually at the award anniversary dates to incorporate the group's scientific accomplishments and progress and to reflect any recommendations of the Steering and Advisory Committees.
Meetings
The Exposure Biology Program investigators will be expected to attend Steering Committee meetings two times per year and participate in monthly conference calls to discuss their research progress. Funds to support travel of the key investigators to attend these meetings should be included in the application budget.
Applicants may submit more than one application, provided each application is scientifically distinct
Section IV. Application and Submission Information
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 must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
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.
Foreign Organizations
Several special provisions apply to applications submitted by foreign organizations:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
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 22, 2006
Application Receipt Date(s): December 22, 2006
Peer Review Date(s): March-April 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date(s): July 2007
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, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed in Section IV.3.A.
The letter of intent should be sent to:
DA-07-005.
Director, Office of Extramural Affairs
National Institute on Drug Abuse
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Telephone: (301) 443-2755
Fax: (301) 443-0538
Email: tlevitin@mail.nih.gov
3.B. Sending an Application to the NIH
Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three 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)
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:
Teri Levitin, Ph.D.
Director, Office of Extramural Affairs
National Institute on Drug Abuse
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Telephone: (301) 443-2755
Fax: (301) 443-0538
Email: tlevitin@mail.nih.gov
Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
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 the CSR and responsiveness by NIH. Incomplete and non-responsive applications will not be reviewed. If the application is not responsive to the FOA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle.
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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a new application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
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 review.
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.
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 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 award.
The incurrence of pre-award costs in anticipation of a 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
Plan for Sharing Research Data
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 must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.
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 presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.
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.
The NIH will support the research and technology needed to accelerate the development and commercialization of exposure assessment devices and technologies that support them in order to characterize the response to environmental stressors.
Applicants are expected to include a plan addressing how they will exercise their intellectual property rights, while making such research resources available within and across the NIH Gene Environment Initiative (GEI) programs, and to the broader scientific community for research purposes consistent with the goals of the GEI. A reasonable time frame for release of materials should be specified in the data sharing plan and will be considered by program staff. Furthermore, transfers of research resources must be made consistent with the NIH Research Tools Policy (http://www.ott.nih.gov/policy/rt_guide_final.html) and other NIH sharing policies. In the development of any sharing and intellectual property plans, applicants should confer with their own institution's office(s) responsible for handling technology transfer related matters and/or their sponsored research office. If applicants or their representatives require additional guidance in preparing these plans, they are encouraged to make further inquiries to the appropriate contacts listed below for such matters.
Program staff, in determining whether the application shall be awarded, will consider the adequacy of the proposed plans. The plans as approved after negotiation with the applicant when necessary will be part of the terms and conditions of the award. Evaluation of progress reports (PHS 2590) will include assessment of the awardee's adherence to the proposed plans, and will be a criterion for continued funding of the award.
Applicants also are reminded that the grantee institution is required to disclose each subject invention within 2 months after the inventor discloses it in writing to grantee institutional personnel responsible for patent matters. The lead institute reserves the right to monitor awardee activity in this area to ascertain if patents or patent applications are adversely affecting the goals of this FOA.
Public Domain of Data
All awards made under this FOA are subject to the Final NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html) and the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (http://www.ott.nih.gov/policy/rt_guide_final.html). This document also defines terms, parties, responsibilities, prescribes the order of disposition of rights, prescribes a chronology of reporting requirements, and delineates the basis for and extent of government actions to retain rights. Patent rights clauses may be found at 37 CFR Part 401.14 and are accessible from the Interagency Edison web page, http://www.iedison.gov. It is expected that research resources generated through the award will be shared by awardees according to these guidelines. The plans for the development of resources for use by the biomedical community will have the appropriate timelines and milestones. Program staff will evaluate the compliance with the sharing plan and scientific progress in the non-competing progress report (Form 2590); such compliance will be a criterion for continued funding of the award.
All extramural scientists will meet two times a year in order to share information. Key co-investigators and pre- and postdoctoral trainees, in addition to the PIs are eligible to attend these meetings. The costs of attending these meetings should be included in the proposed research budget.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
The following will be considered in making funding decisions:
2. Review and Selection Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
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 exposure measurement problem that, if addressed, will further the assessment of individual exposure to environmental stressors that have significant public health burden? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the approach employ a product-development framework? Has the applicant adequately described the measurement problem being addressed by the proposed technology and articulated appropriate and sufficient milestones and timelines?
Innovation: Does the project employ new, existing, or emerging concepts, approaches, methods, or technologies in a novel way? Is the proposed technology likely to either be an improvement over existing methods or provide unique information?
Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment 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).
Inclusion 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 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
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
The reasonableness of the data sharing plan or the rationale for not sharing research data will 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 presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.
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.
Program staff will be responsible for the administrative review of the plan for sharing research resources.
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.
Section VI. Award Administration Information
1. Award Notices
After the peer review of 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 business official.
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 Policy Requirements
All NIH grant and 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).
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.
2.A. Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the U01 Cooperative Agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The Network on Exposure to Psychosocial Stress and Addictive Substances (NEPSAS) is defined as the final group of Awardees (Principal Investigators) funded through RFA-DA-07-005. This may include one or more Research Projects in their entirety as originally submitted and/or may include individual Research Project components chosen to add value to the overall effort. NEPSAS members will be expected to work in collaboration with each other, the NEPSAS Steering Committee, and the NIH Project Scientist(s) to achieve the goals of the initiative. This network is part of the NIH Exposure Biology Program of the NIH Genes and Environment Initiative (GEI).
This award is made in response to RFA-DA-07-005 Field-Deployable Tools for Quanitfying Exposures to Psychosocial Stress and to Addictive Substances for Studies of Health and Disease (U01), which is one of the five RFAs that define the scope of the Exposure Biology Program of the NIH-wide Genes and Environment Initiative (GEI); the Exposure Biology Program is lead by the National Institute of Environmental Health Sciences (NIEHS).
2.A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies. The Principal Investigator will agree to accept close coordination, cooperation and management of the project as described under NIH Responsibilities. Specifically, the Principal Investigator will:
The Principal Investigator will retain custody of, and have primary rights to information developed under the cooperative agreement, subject to Government rights of access consistent with the current HHS, PHS, and NIH policies. Publication and copyright agreements and the requirements for financial status reports, retention of records, and terminal progress reports will be as stated in the NIH Grants Policy Statement.
2.A.2. NIH Responsibilities
An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
A NIH Project Scientist will be assigned to each of the awarded U01 projects. This staff member is a scientist from the staff of any of the participating NIH institutes who is selected because of relevant scientific content-area expertise and experience with regard to the scientific goals and objectives of a given U01 award. These staff members will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice and coordination. However, the role of the NIH staff will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus of the GEI-NEPSAS Steering Committee and that NIH will be given the opportunity to offer input into this process. There will be no more than 2 NIH Project Scientists participating as members of the Steering Committee; however, there will be only one NIH vote, reached by consensus. The Project Scientists will have the following substantial involvement:
Additionally, a Program Director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the Notice of Grant Award. The Program Director will closely monitor progress of assigned grants and recommend the withholding or reduction of support from any project that fails to achieve its goals or comply with the Terms and Conditions of award. The Program Director will not serve as the Project Scientist.
2.A.3. Collaborative Responsibilities
All involved investigators will meet two times a year in order to share information. Key co-investigators and pre- and post-doctoral trainees, in addition to the Principal Investigators, are eligible to attend these meetings. Close interaction among the participating investigators will be required, as well as significant involvement from the NIH to develop and monitor program milestones and timelines for research and product development, small-scale field testing, and functional validation, in order to meet the overall goals of the NIH Genes and Environment Initiative.
The GEI-NEPSAS Steering Committee will serve as the governing board for the Cooperative Agreements made in response to RFA-DA 07-005. Membership will consist of the Principal Investigator of each U01 award and NIH Project Scientist(s). The chair of the Steering Committee will be selected by vote. Principal Investigators are eligible to become the chair of the Steering Committee. It is anticipated that there will be no more than 2 NIH Project Scientists on the Steering Committee. If more are assigned to the awards, then membership will be rotated. There will be only one NIH vote, reached by consensus.
The GEI-NEPSAS Steering Committee will meet face to face two times a year and monthly on conference calls. The roles and responsibilities of the Steering Committee include:
2.A.4. Arbitration Process
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
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 Contacts
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:
Kay L. Wanke, PhD, MPH
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5153
Bethesda, MD 20892-9589
Telephone: (301) 451-8663
Fax: (301) 443-2636
Email: wankek@nida.nih.gov
2. Peer Review Contacts:
Teri Levitin, Ph.D.
Director, Office of Extramural Affairs
National Institute on Drug Abuse
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Telephone: (301) 443-2755
Fax: (301) 443-0538
Email: tlevitin@mail.nih.gov
3. Financial or Grants Management Contacts:
Daisey Parker
Grants Management Branch
National Institute on Drug Abuse/NIH/DHSS
6001 Executive Blvd., MSC 9541
Rockville, MD 20892-9541
Telephone: 301-443-6710
Fax: 301-594-6849
E-mail: dparker1@nida.nih.gov
Section VIII. Other Information
Required Federal Citations
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 submitting an NIH application in response to this FOA regardless of cost, 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.
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 at 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 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.
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.
HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: Researchers funded by NIH who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing service for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.
National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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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