and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892
RAPID RESPONSE TO COLLEGE DRINKING PROBLEMS
RELEASE DATE: June 3, 2003
PA NUMBER: PAR-03-133
EXPIRATION DATE: December 15, 2004, unless reissued.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS(S): 93.273
THIS PA CONTAINS THE FOLLOWING INFORMATION:
o Purpose of the Program Announcement
o Research Objectives
o Mechanism(s) 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
The purpose of this Program Announcement (PA) is to provide a rapid funding
mechanism for timely research on interventions to prevent or reduce alcohol-
related problems among college students. This kind of research most often
has a serious urgency with regard to availability or access to data,
facilities, or research subjects. The regular grant submission, review, and
funding process is lengthy, such that it requires investigators who would
conduct such studies to wait a minimum of 9 months after the submission of
the application to obtain research support, during which time important data
may be lost, appropriate subjects may no longer be available, and the optimal
opportunity to directly address a particularly urgent issue or problem may no
longer exist.
Applications in response to this Program Announcement can be sent within 6
weeks of the identified event, thus allowing for a much more immediate
response on the part of the NIH.
The Federal responsibility for addressing issues related to the excessive use
of alcohol and its consequences in these special residential environments
rests with several agencies. Therefore, the National Institute on Alcohol
Abuse and Alcoholism joins with the Substance Abuse and Mental Health
Services Administration, and the National Highway Traffic Safety
Administration, Department of Transportation, in support for this Program
Announcement. Under this Program Announcement, rapidly developed high
quality studies of services or interventions that can capitalize on natural
experiments (e.g., unanticipated adverse events, policy changes, new media
campaigns) will be supported. Applications may propose to study the
consequences of a change in policies and practices or new prevention
approaches that impact drinking in order to inform policy makers about their
options to address a problem. Studies to determine and test approaches that
might be used to address special serious consequences may also be supported.
There continues to be a need to work closely with college administrators to
provide a rapid response to the need for studies that might inform the
development of effective policies and actions. It is envisioned that college
administrators, recognizing an urgent need to quickly address an alcohol
related problem on their campuses, would apply for a grant under this
announcement. For applications funded under this announcement, experienced
research scientists would be partnered with the applicant institution to
assist in the design and evaluation of the proposed intervention. The NIAAA
will be involved in identifying appropriate scientists, given the topic to be
studied.
The Rapid Response to College Drinking Problems grants described in this
Program Announcement are designed to provide a limited amount of support for
the immediate implementation of research protocols for rapid intervention,
working concurrently with one or more awardees under the Research Partnership
Awards for Rapid Response to College Drinking Problems, as described in
detail in RFA AA-03-008. Each awardee under this PA is required to partner
with an awardee under RFA AA-03-008. Together, these pairs will work with
the NIAAA Staff Collaborator to form individual Steering Committees.
RESEARCH OBJECTIVES
Excessive drinking among college students is associated with a variety of
negative consequences including fatal and nonfatal injuries; alcohol
poisoning; blackouts; academic failure; violence, including rape and assault;
unintended pregnancy; sexually transmitted diseases, including HIV/AIDS;
property damage; and emotional, vocational, and criminal consequences that
could jeopardize future job prospects.
The consequences of excessive and underage drinking affect virtually all
college campuses, college communication, and college students, whether they
choose to drink or not. It is estimated that 1,400 college students die each
year from alcohol-related unintentional injuries, including motor vehicle
crashes. The estimates include a half million students injured and more than
600,000 alcohol related assaults. Other problems include sexual abuse, unsafe
sex, academic problems, suicide attempts, vandalism, property damage, drunk
driving and police involvement. These potential fatal and devastating
problems do not address the needs of non-alcohol consuming students who must
suffer the consequences (interrupted sleep, assaults, riding in automobiles
with intoxicated drivers, etc.) related to the behavior of their peers.
In recognition of the need to address the serious consequences of alcohol
abuse among college students, the National Advisory Council to the National
Institute on Alcohol Abuse and Alcoholism (NIAAA) established a Task Force on
College Drinking in 1998. The Task Force was composed of college Presidents
and administrators as well as selected experts in alcohol research. In April,
2002 a report entitled, "A Call to Action: Changing the Culture of Drinking
at US Colleges", was released and is available on the NIAAA webpage:
http://www.collegedrinkingprevention.gov. The report supported the use of
comprehensive integrated programs with multiple complementary components that
target: (1) individuals, including at-risk or problem drinkers; (2) the
student population as a whole; and (3) the college and the surrounding
community.
It is understood that each college environment and student community is
different. Differences in ethnic mix, rural vs. urban, private vs. public,
etc. can result in different approaches to appropriate interventions. This
Program Announcement is intended to provide an opportunity for college
administrators to assess the issues and problems that have lead or might lead
to emergency and devastating alcohol related problems, to identify an
approach that might be appropriate given the unique environment and
circumstances, and to design and perform a study of the intervention or
prevention service in partnership with research scientists.
Although this Program Announcement is designed to support research on
unanticipated opportunities, the following are some of the areas in which
research plans might be developed (see Tier 2 and Tier 3 of the Task Force on
College Drinking Report, which can be found at the following website:
http://www.collegedrinkingprevention.gov .) These are in no way meant to be
exhaustive or limiting but are examples of topics that might be studied.
Such topics might include:
o The implementation and evaluation of a program of alcohol screening and
brief interventions;
o Changes in campus or community policies and practices to directly address
factors contributing to abusive drinking, or they may involve changes in
campus systems or structures to promote non-drinking norms;
o Policies and practices of campus health-care systems and providers with
regard to alcohol abuse;
o Policies directed toward high-risk groups, such as athletes or students in
the Greek system;
o Emergency action plans by campus administrators in response to adverse
alcohol-related injuries and deaths;
o The academic environment, including class and examination schedules and
academic standards;
o Campus policies, such as rules and administrative proclamations regarding
alcohol use on campus, in dormitories, and at campus events;
o Disciplinary procedures, such as parental notification, mandatory
counseling, and other sanctions for rule violations;
o Planning and conducting marketing campaigns aimed at correcting student
misperceptions about alcohol use;
o The formation of a campus and community coalition consisting of community
leaders and law enforcement to directly address the problem of student
drinking.
The regular peer review process for grant applications does not facilitate
the ability to quickly respond to crises related to drinking on college
campuses. There is a significant delay between the conceptualization of the
grant, submission, review, and final funding. Unless there is a special
mechanism to investigate these naturally-occurring situations, the
opportunity to address them in a systematic manner will be missed.
Therefore, in response to applications submitted under this Program
Announcement and judged to be responsive, a special review group will be
convened as rapidly as possible after submission to provide a scientific
review. The nine-month and semester academic calendar and the urgency of
addressing the campus and individual student needs following an alcohol
related emergency are factors that were considered in the development of this
Program Announcement.
MECHANISM(S) OF SUPPORT
A. This PA will use the NIH U18 award mechanism, which provides for up to
$200,000 in direct costs per year. The total project period for an
application submitted in response to this PA may not exceed 3 years. As an
applicant, you will be solely responsible for planning, directing, and
executing the proposed project. Awardees are strongly encouraged to seek
outside support to continue these activities after the three year period has
ended.
B. This PA uses just-in-time concepts.
C. The NIH U18 is a cooperative agreement award mechanism in which 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 "Cooperative Agreement Terms and Conditions of
Award".
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics (small colleges are particularly encouraged to
apply):
o Public or private universities, and colleges
o Faith-based or community-based organizations
Foreign institutions are not eligible 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.
For this program, the Principal Investigator must be authorized to speak on
behalf of administrative policymakers and/or implementers in the college or
university (e.g., College President, Dean of Student Affairs, Academic Dean,
etc.) Evidence of this authority must be provided through a letter of
support if the principal investigator does not directly hold this position of
authority.
SPECIAL REQUIREMENTS
The applications should include budgetary allowance for attendance at two
mandatory meetings per year with NIAAA and other participating Federal
agencies. These meetings of all awardees under this PA and those under the
RFA AA-03-008 will be held at approximately 6-month intervals in the
Washington, D.C. area.
COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD
The following Terms and Conditions will be incorporated into the new award
statements and will be provided to the principal investigators and to the
appropriate institutional officials at the time 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
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIAAA programmatic involvement
with the awardees is anticipated during performance of the activities. Under
the cooperative agreement, the NIAAA supports and stimulates the recipients'
activities by involvement in and otherwise working jointly with the award
recipients in a partnership role. The NIAAA 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.
o The Primary Rights and Responsibilities of the Principal Investigator (PI)
The PI Awardee has primary authority and responsibility to define objectives
and approaches, and to plan, conduct, analyze, and publish results,
interpretations, and conclusions of their research, career development, and
other activities. The PI will:
- Create a Program Advisory Committee (PAC) in consultation with the NIAAA
and other participating Federal agencies, and the Staff Scientific
Collaborator.
- Coordinate a regular schedule of PAC meetings for review and consultation.
- Implement the approved three-year plan for the planning effort, with
periodic updates as needed.
- Coordinate project activities within their institution, with outside
collaborators, and with the NIAAA Staff Scientific Collaborator.
- Maintain collaboration and partnership with an established NIAAA
investigator and collaborating alcohol research program.
- Accept assistance from the NIAAA Staff Scientific Collaborator in pursuing
project goals.
- Awardees will retain custody of and have primary rights to the data
developed under these awards, subject to Government rights of access
consistent with current HHS, PHS, and NIH policies.
o NIAAA Staff Rights and Responsibilities
As per the terms of the cooperative agreement arrangement, the NIAAA will
appoint a Program Official and a Staff Scientific Collaborator to participate
in the conduct of each U18 Cooperative Agreement Program.
- Program Official
The NIAAA Program Official provides normal program stewardship and reviews
the scientific progress of individual research project components, and the
use of the core resource facilities among the research projects within each
Cooperative Agreement. The Program Official also monitors compliance by the
Cooperative Agreement with the operating policies of this PA. The NIAAA
Program Official may recommend withholding of support, suspension, or
termination of an award for lack of scientific progress or failure to adhere
to policies established by the PA or the Award Statement.
- NIAAA Staff Scientific Collaborator
The NIAAA Staff Scientific Collaborator will have substantial scientific-
programmatic involvement with the awardees through providing technical
assistance, advice, and coordination above and beyond normal program
stewardship of research grants. The NIAAA Staff Scientific Collaborator will:
a) facilitate the coordination necessary to manage this complex project;
b) participate as a non-voting member of the PAC;
c) participate in monitoring progress of ongoing studies;
d) participate in planning and implementing efforts to disseminate information;
e) provide instruction in faculty development activities;
f) participate in data interpretation and, when appropriate, in the
preparation of publications and presentations.
The NIAAA Staff Scientific Collaborator is subject to the same
publication/authorship policies governing all participants in the study, as
well as to the official NIH Publication Policy governing extramural
employees.
o Arbitration Process
Any disagreement that may arise on scientific or programmatic matters between
U18 awardees and the NIAAA may be brought to arbitration before an
arbitration panel. The arbitration panel will be composed of three members.
One member will be chosen by the awardee. A second member will be selected by
the NIAAA. The third member, having expertise in the relevant scientific
area, will be chosen by the two selected members. This special arbitration
procedure in no way affects the awardee's right to appeal an adverse action
that is otherwise appealable in accordance with the PHS regulations at 42 CFR
Part 50, Subpart D and HHS regulation at 45 CFR Part 16.
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:
Peggy Murray
Director, International and Health Education Programs Branch
Office of Collaborative Research
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 302
6000 Executive Boulevard, MSC 7003
Bethesda, MD 20892-7003
Telephone: (301) 443-2594
FAX: (301) 480-2358
Email: pmurray@mail.nih.gov
o Direct your inquiries about peer review issues to:
Eugene G. Hayunga, Ph.D.
Chief, Extramural Project Review Branch
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 409
6000 Executive Boulevard, MSC 7003
Bethesda, MD 20892-7003
Telephone: (301) 443-4375
FAX: (301) 443-6077
Email: hayungae@mail.nih.gov
o Direct your questions about financial or grants management matters to:
Judy Fox
Chief, Grants Management Branch
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 504
6000 Executive Boulevard, MSC 7003
Bethesda, MD 20892-7003
(301) 443-4704 (telephone)
(301) 443-3891 (fax)
Email: jsimons@willco.niaaa.nih.gov
SUBMITTING AN APPLICATION
RAPID applications involve expedited peer review and funding consideration
processes. Potential applicants are strongly encouraged to contact the
Program Officer, at the address listed under WHERE TO SEND INQUIRIES, before
submitting a RAPID application to determine whether the proposed work meets
the guidelines of this program, whether requested RAPID funding is likely to
be available, and whether the idea should be considered for initial
submission as a fully developed application. Inquiries not meeting the RAPID
guidelines may be guided to other grant mechanisms and to program contacts to
discuss alternatives.
To meet the goals of the RAPID program, applications should be submitted
within approximately 6 weeks of the identified event that prompted a rapid
response and/or intervention. RAPID applications will be handled on an
expedited external peer review and award basis to meet the goals of this
program.
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). 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.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at any time during the year.
SENDING AN APPLICATION TO THE NIH: 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
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application must be
sent to:
Eugene Hayunga, Ph.D.
Extramural Project Review Branch
Attn: PA No. PAR-03-133
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Room 409, MSC 7003
Bethesda, MD 20892-7003
Rockville, MD 20852 (for express/courier service)
APPLICATION PROCESSING: The 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 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.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. An appropriate scientific review group
convened in accordance with the standard NIH peer review procedures
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific
and technical merit.
As part of the initial merit review, all applications will:
o Receive a written critique
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 second level review by the National Advisory Council on Alcohol
Abuse and Alcoholism.
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:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning your application's overall score, weighting them as appropriate
for each application. Your 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 methods?
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?
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:
o Suitability of the project to the RAPID award criteria, as described in
this Announcement.
o Evidence of commitment from service providers, communities, or others and
the extent to which the project director will be working with members of the
university community.
o Extent to which the applicant demonstrates an adequate participatory
planning process which involves individuals reflective of the target
population in the preparation of the application, planned implementation of
the project, and data interpretations.
o Demonstrated commitment to work with designated alcohol researchers in
refining a research protocol to address the defined problem.
o Authority of the project director and qualifications of the study
coordinator and other key personnel, including any proposed consultants and
subcontractors.
o Adequacy and availability of core resources to support the proposed
project.
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 in the sections on
Federal Citations, below).
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 CONSIDERATIONS
DATA SHARING: The adequacy of the proposed plan to share data.
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
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.
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (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).
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 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 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.
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.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 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 42 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.
|
|
Department of Health and Human Services |
|
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |