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/archive/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.


H H S Department of Health
and Human Services

 
  N I H National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892