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 (https://grants.nih.gov/grants/guide/
rfa-files/RFA-AA-03-008.html.)  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 
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
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. 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

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: https://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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-
02-001.html); a complete copy of the updated Guidelines is available at 
https://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 
https://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 
https://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 
https://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 
https://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  
https://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.

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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