and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892
COLLABORATIVE CLINICAL TRIALS IN DRUG ABUSE
RELEASE DATE: March 9, 2004
PA NUMBER: PAR-04-073
EXPIRATION DATE: February 17, 2007, unless reissued.
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279
APPLICATION RECEIPT DATES:
June 16, 2004; October 13, 2004; February 16, 2005
June 16, 2005; October 13, 2005; February 16, 2006
June 16, 2006; October 13, 2006; February 16, 2007
THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION:
o Purpose of the PA
o Research Objectives
o Mechanism of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
This is a reissuance of PAR-01-039, Collaborative Clinical Studies in
Drug Abuse, published in the NIH Guide for Contracts and Grants,
January 2, 2001 at http://grants.nih.gov/grants/guide/pa-files/PAR-01-039.html.
This new announcement replaces PAR-01-039 in its entirety.
The National Institute on Drug Abuse (NIDA) seeks to increase the
collaboration of investigators at different sites in order to address
critical issues in the treatment of substance-related disorders that
require sample sizes greater than a single site can reasonably attain.
The expectation for the collaborative effort is that there will be
implementation of common clinical trials across different sites in
order to study patient outcomes, patient factors, provider factors,
setting characteristics, interactions of these, or other effects where
pooled samples are appropriate and necessary for the hypotheses under
consideration.
This announcement provides guidelines for the development, review, and
funding of Collaborative Clinical Trials in Drug Abuse (CCTDA)
projects.
RESEARCH OBJECTIVES
In order to draw valid conclusions from clinical trials of substance-
related disorders, in many cases a large sample size is needed, which
frequently can only be obtained through collaboration across multiple
study sites. For some research questions, such as clinical trials of
relatively infrequent behaviors, the required sample size effectively
prohibits a single site from being able to recruit sufficient numbers.
In other circumstances, even where the main hypotheses can be addressed
with the sample available, interesting hypotheses about subpopulations
(based on gender, ethnicity, drug use patterns, age, etc.), interaction
effects, or ancillary questions (e.g., such as about therapist
characteristics, patient matching to treatment, unexpected outcomes,
etc.) can only be examined by studying large samples of subjects.
Collaborative clinical trials allow multiple investigators to initiate
and submit separate applications, each with a separate PI and applicant
institution, that propose timely recruitment of an aggregate sample
sufficient to address clinical concerns. By allowing multiple sites to
recruit, a sample that otherwise could not be recruited, or could not
be recruited within a reasonable time frame, can be enrolled. CCTDA
seems ideally suited to foster the efficiency and creativity that can
be obtained through investigator initiated research and, at the same
time, allows multiple investigators to coordinate a focus on a
particular clinical issue relevant to drug abuse.
Examples of possible foci for a CCTDA are:
o Pharmacological treatments that may include new or already-marketed
medications.
o Large-scale clinical trials of psychopharmacological treatments,
alone or in combination with behavioral therapies.
o Clinical trials for relatively low prevalence conditions in drug
abusing populations or conditions for which it is difficult to recruit
subjects.
o Clinical trials involving neuroimaging studies of treatment effects
that require multiple sites in order to study sufficient numbers of
subjects of interest.
o Clinical trials powered to draw conclusions about the impact of
interventions associated with gender; racial, ethnic, or linguistic
group; sexual orientation; age; or other developmental variables.
o Clinical trials of other clinical issues in drug abuse (e.g.,
HIV/AIDS and other infectious diseases) that require multiple sites to
ensure a sufficiently large sample to answer the question posed.
MECHANISM OF SUPPORT
This PA will use the NIH R01 award mechanism; no other mechanisms may
be used. The applicant will be solely responsible for planning,
directing, and executing the proposed project. The total project period
for an application submitted in response to this PA may not exceed 5
years.
This PA uses just-in-time concepts. It also uses the modular budgeting
format (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. This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
ELIGIBILE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic and foreign institutions/organizations
The CCTDA requires more than one applicant organization, and each
applicant organization must meet the eligibility requirements above.
Multiple campuses of a single institution or university system are
considered separate organizations for the purposes of eligibility to
apply.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
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.
SPECIAL REQUIREMENTS
One of the sites should be the coordinating site for the trial. The
application for the coordinating site should explicitly state how it is
going to fulfill its function and its interaction with the other sites.
Similarly, the participating sites should describe their relationship
with the coordinating site. Although a foreign institution may be a
participating site, the coordinating site must be a domestic
institution.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA 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:
o Direct your questions about scientific/research issues to:
Ivan D. Montoya, M.D., M.P.H.
Division of Treatment Research and Development
National Institute on Drug Abuse
National Institutes of Health/DHHS
6001 Executive Boulevard, Room 4123, MSC 9551
Bethesda, MD 20892-9551
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-8639
Email: imontoya@mail.nih.gov
o Direct your questions about peer review to:
Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse
National Institutes of Health/DHHS
6101 Executive Boulevard, Room 220, MSC 8401
Bethesda, MD 20892-9547
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
Email: tl25u@nih.gov
o Direct your questions about financial or grants management matters
to:
Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
National Institutes of Health/DHHS
6101 Executive Boulevard, Room 242, MSC 8403
Bethesda, MD 20892-9541
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-6710
Email: gf6s@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). Applications must
have a Dun and Bradstreet (D&B;) Data Universal Numbering System (DUNS)
number as the Universal Identifier when applying for Federal grants or
cooperative agreements. The DUNS number can be obtained by calling
(866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on
line 11 of the face page of the PHS 398 form. The PHS 398 is available
at http://grants.nih.gov/grants/funding/phs398/phs398.html in an
interactive format. For further assistance contact GrantsInfo,
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
The title and number of this program announcement must be typed on line
2 of the face page of the application form and the YES box must be
checked.
APPLICATION RECEIPT DATES: All applications (Type 1 and Type 2 or
amended) submitted in response to this program announcement will be
accepted at: June 16, 2004; October 13, 2004; February 16, 2005; June
16, 2005; October 13, 2005; February 16, 2006; June 16, 2006; October
13, 2006 and February 16, 2007. AIDS applications must comply with the
standard AIDS receipt dates; the last AIDS receipt date for this PA
will May 1, 2007.
Separate applications must be prepared by each applicant institution.
Because the CCTDA is expected to address questions that are not
addressable in single site clinical trials, competing continuation of
single site clinical trials would not be appropriate.
SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS:
Applications requesting up to $250,000 per year in direct costs must be
submitted in a modular budget grant format. The modular budget grant
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 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants. Additional information
on modular grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER
YEAR: Applications requesting $500,000 or more in direct costs for any
year must include a cover letter identifying the NIH staff member
within one of NIH institutes or centers who has agreed to accept
assignment of the application.
Applicants requesting more than $500,000 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) Identify, in a cover letter sent with the application, the staff
member at the 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.
SENDING AN APPLICATION TO THE NIH: 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
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: All applications (Type 1 and Type 2, or
amended) must be bundled together and mailed on or before the receipt
dates of June 16, 2004; October 13, 2004; February 16, 2005; June 16,
2005; October 13, 2005; February 16, 2006; June 16, 2006; October 13,
2006 and February 16, 2007. AIDS applications must comply with the
standard AIDS receipt dates; the last AIDS receipt date for this PA
will be May 1, 2007. CSR will not accept any application in response
to this PA that is essentially the same as one currently pending
initial review unless the applicant withdraws the pending application.
The CSR 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 unfunded version 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 8 weeks.
The application must be organized in accordance with standard PHS Form
398 instructions, with the following modifications:
Each application in a CCTDA group should be essentially identical to
the others, with the exception of expected differences in elements such
as numbers of available subjects, resources and environment, budgetary
requirements, and staff.
Each application must include an overview section that is no longer
than 2 pages and constitutes the first pages of the RESEARCH PLAN
section (i.e., immediately precedes the Specific Aims). This overview
should list the individual applicant organizations participating in the
CCTDA and the Principal Investigator for each. It should establish the
need for applying as a CCTDA and justify the role for each applicant
organization in the CCTDA. The investigators may also wish to identify
one individual as the contact person for the group for the purposes of
facilitating communication. If so, that should be noted in the
overview.
Sections A-D of the research plan should describe those aspects of the
project that are common to all sites. The research procedures and
protocol should be presented in detail, along with description of the
study population from which samples are drawn, the anticipated samples
themselves, resources, plans for data analysis, and characteristics
that support each site’s (i.e., not simply the applicant’s site) role
in the project. Where there are minor variations in plans, these
should be noted in the text and then summarized in a separate
subheading in Section D (which counts toward the 25 page limit) titled
“ELEMENTS UNIQUE TO THIS SITE.”
The research plan should describe a feasible strategy for integration
of research procedures, managerial and administrative responsibilities,
and training across sites to ensure the integrity of the research
effort. The Principal Investigators may wish to designate a Steering
Committee or other decision-making body. If so, the biosketches of
these individuals should be included. If not, a feasible strategy for
decision-making must be detailed.
Plans for ensuring access to data by all sites, analytic resources,
publication and authorship procedures, public use of data,
dissemination of results, and means of arbitrating disagreements should
be addressed.
Any site that contracts out elements of the research should note this
as an element unique to the site, both in the main body of the research
plan and in the separate section on unique elements. The nature,
purpose, and oversight of the contractual arrangement should be fully
described.
Revised submissions of CSDAs must include an introduction to the
revision that highlights changes in the research plan and how delays in
initiating the project will affect the work. This is particularly
important in cases where some but not all of the CCTDA sites have
already begun work on a project.
All applications submitted as part of the CCTDA should be mailed
together in one package, in order to assure that they are processed as
CCTDA submissions. All of the applications constituting the proposed
CCTDA group must be submitted in a single package, whether or not the
applications are from the same institution. A cover letter must list
the total number of applications submitted for the CCTDA group, clearly
identifying each application and the principal investigator of each.
For each component application in the CCTDA group, the original, five
copies, and the appendix material must be bundled together and clearly
identified
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. Appropriate scientific review
groups convened by NIDA 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:
o Undergo a selection process in which only those applications deemed
to have the highest scientific merit, generally the top half of
applications under review, will be discussed and assigned a priority
score
o Receive a written critique
o Receive a second level review by the National Advisory Council on
Drug Abuse
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments reviewers will be asked to discuss the
following aspects of the application 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.
o Significance
o Approach
o Innovation
o Investigator
o Environment
Note that the application does not need to be strong in all categories
to be judged likely to have major scientific impact and thus deserve a
high priority score. For example, an investigator may propose to carry
out important work that by its nature is not innovative but is
essential to move a field forward.
SIGNIFICANCE: Does this study address an important problem? If the
aims of the application are achieved, how will scientific knowledge be
advanced? What will be the effect of these studies on the concepts or
methods 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 applicant acknowledge potential problem areas
and consider alternative tactics?
INNOVATION: Does the project employ novel concepts, approaches, or
method? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
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
(if any)?
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?
RATIONALE AND FEASIBILITY OF THE COLLABORATION: How well is the use of
collaborating sites justified? How necessary is collaboration to
address the scientific issues? How well does this application
establish, through preliminary data or other means that other sites
will be able to contribute to the study?
MANAGEMENT PLANS: How well developed and reasonable are the plans for
coordination, decision-making, quality control, and arbitration? In
particular, how well have other administrative and managerial issues
been addressed with respect to:
o the reliability and accuracy of the main administrative site's past
performance and the potential of the main administrative site's future
performance in clinical trials;
o the experience of the Principal Investigator and other key personnel
in conducting clinical trials;
o the ability of the main administrative site to manage and analyze
data for the clinical trial; and,
o the appropriateness of the proposed procedures for data management,
data storage, and analytical activities.
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the
following items will 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 criteria
included in the section on Federal Citations, below).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.
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 Inclusion Criteria
in the sections on Federal Citations, below).
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 398 research grant application instructions (rev. 5/2001)
will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
Sharing Research Data: Applicants requesting more than $500,000 in
direct costs in any year of the proposed research are expected to
include a data sharing plan in their application. 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 priority score.
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available
funds with all other recommended applications. The following will be
considered in making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
Funding decisions will also consider whether there are sufficient high
quality collaborating sites for the CCTDA project.
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 types of clinical trials,
including physiologic, toxicity, and dose-finding studies (phase I);
efficacy studies (phase II), efficacy, effectiveness and comparative
trials (phase III). The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risk to the participants. (NIH
Policy for Data Safety and Monitoring, NIH Guide for Grants and
Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
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, 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 - Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the NIH, unless there are scientific and
ethical reasons not to include them. This policy applies to all initial
(Type 1) applications submitted for receipt dates after October 1, 1998.
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 that is available at
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 proposals for
research involving human subjects. You will find this policy
announcement in the NIH Guide for Grants and Contracts Announcement,
dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON
DRUG ABUSE: Researchers funded by NIDA 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
http://www.nida.nih.gov under the Funding, or may be obtained by
calling (301) 443-2755.
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 (see 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).
Those who must comply with the Privacy Rule (classified under the Rule
as “covered entities”) must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
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.healthypeople.gov/.
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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Department of Health and Human Services |
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National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |