CAM PRACTITIONER RESEARCH EDUCATION PROJECT GRANT PARTNERSHIP

RELEASE DATE:  April 21, 2004

PA NUMBER:   PAR-04-097  (See Modified PAR PAR-08-095)

EXPIRATION DATE:  September 16, 2006

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION: 
National Center for Complementary and Alternative Medicine (NCCAM)
 (http://www.nccam.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.213

APPLICATION RECEIPT DATES:   September 15, 2004; September 15 2005; September 15, 
2006

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this PAR
o Research Objectives
o Mechanisms 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 PAR

The goal of this program announcement is to increase the quality and quantity of the 
research content in the curricula at complementary and alternative medicine (CAM) 
institutions in the United States where CAM practitioners are trained.  This 
initiative is not designed to directly train researchers, but rather to enhance CAM 
practitioners’ exposure to, understanding of, and appreciation of the evidenced-based 
biomedical research literature and approaches to advancing scientific knowledge.

CAM professional schools responding to this program announcement must partner in the 
development and implementation of their program with a research-intensive 
institution, such as a university, medical, dental or nursing school, or other type 
of health professional school.

For the purpose of this specific program announcement a CAM institution is defined as 
a U.S. domestic nationally or regionally fully accredited academic, health care or 
research institution with a primary goal of training students to be CAM 
practitioners. Only schools that offer a doctoral degree in a designated CAM practice 
that is licensed or certified at the state level will be eligible to submit an 
application in response to this announcement. Some examples of eligible institutions 
include but are not limited to colleges/schools of naturopathy, chiropractic, and 
traditional Chinese medicine.  NCCAM recognizes that a number of accredited CAM 
professional schools that train students in specific CAM therapies do not require a 
doctoral degree as the terminal degree to practice. While this program announcement 
is limited to schools offering doctoral degrees, it is anticipated that the 
experienced gained from this initiative will provide data that will inform the 
incorporation of research education at CAM institutions offering other types of 
terminal degrees and certificates. 

RESEARCH OBJECTIVES

Background

CAM practitioner training and curricula in naturopathic, chiropractic, Oriental 
medicine, and other CAM modalities are well established.  However, inclusion of 
biomedical research information, in terms of courses and short-term research 
experiences, varies considerably among CAM practitioner training curricula, and is 
often less common and less extensive compared to curricula in other types of health 
professional schools. Increasing the research content in CAM practitioner training 
curricula would enhance the ability of CAM practitioners to critically evaluate 
biomedical literature, have a more in depth knowledge of the therapies prescribed to 
their patient’s by allopathic physicians in integrative medical settings, become 
better able to participate in clinical research, and may stimulate some trainees to 
seek advanced training and career development in biomedical research.  

Research Scope

This initiative will support the development and enhancement of lecture and methods 
courses in biomedical research, support short-term faculty and student research 
projects (such as summer projects), strengthen the research skills of faculty, and 
promote the incorporation of research training components across the whole curricula 
in CAM practitioner training institutions.  All of this must be done in close 
partnership with a research-intensive institution (referred to as the partnering 
institution in this announcement) such as a conventional health professional school 
(medical school, dental school, nursing school) or university with a tradition of 
rigorous research.  

Since existing CAM practitioner curricula range widely in research content, 
initiatives that will lay new groundwork to introduce research-based information into 
a curriculum for the first time, as well as initiatives that will expand existing 
research training programs in CAM professional schools, will be accepted.  Where 
research programs are already underway, a significant expansion must be proposed.

Specific activities supported by this initiative may include, but are not limited to 
the following:

o Development of an overall research curriculum development plan;

o Assessment of students’ interests and needs as part of curriculum development; 

o Introduction and/or strengthening of research content in coursework across the 
entire CAM practitioner curricula;

o Support of faculty development in research methodology by supporting short-term 
faculty sabbaticals for research training, especially at the partnering research-
intensive institution; Funds may be used for such items as partial salary support, 
supplies, small equipment, and travel to scientific meetings;

o Development of mechanisms to facilitate and encourage longer term collaborations 
between faculty at the CAM practitioner institution and research faculty at the 
partnering institution;

o Support for short-term research projects for CAM practitioner students, such as 
summer projects, at the partnering research-intensive institution.  Funds may be used 
for supplies, small equipment, and travel to scientific meetings related to the R25 
educational program short term research projects.  Individuals already supported by 
NIH training and career development award mechanisms (K, T, and F grants) may not 
receive stipends or salary support from this program, however, limited support to 
defray participation costs may be provided.

o Strengthening of existing research-oriented courses and development of new courses 
in research methodology, such as biostatistics and clinical trial methodology, as 
well as courses related to preclinical/basic scientific studies;

o Support of adjunct faculty appointments for research scientists to teach or 
participate in research courses at CAM institutions;

o Development of a plan for program evaluation;

o Development of long range plans for sustainability of the successful curriculum 
changes after NCCAM support ends.

Because of the complexities of modifying existing professional school curriculum in 
collaboration with another institution, an advisory committee is required to help 
chart the progress of the proposed plan and help resolve issues that may arise.  This 
committee should be chaired by the principal investigator and should include senior 
staff at the CAM Institution who are in charge of curriculum development and senior 
staff at the research-intensive partnering institution who have agreed to participate 
in this Education Project Grant. The frequency of meetings should be decided by the 
principal investigator, but should not be less than twice a year. A roster of the 
advisory committee must be provided in the application along with letters from the 
nominated members indicating their willingness to serve.  For successful applicants, 
an additional two advisory members from outside the two participating institutions 
will be selected at the time of award, but should not be named in the application. 

MECHANISM OF SUPPORT

This PAR will use the NIH Education Project Grant mechanism (R25).  
As an applicant you will be solely responsible for planning, directing, and executing 
the proposed project.

This PAR uses just-in-time concepts.  It also uses the modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm). This program does not 
require cost sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.

The maximum duration for support that can be requested is 4 years.  It is expected 
that the majority of time during the first year of funding will be devoted to the 
development of plans for implementation in the following years of support.  Planning 
during the first year could include but is not limited to any of the following:

o Developing the content of new research training courses or planning how existing 
courses could be modified to include research training elements in collaboration with 
faculty from the partnering institution.  This could include determining the number 
of hours and content of new courses; what the prerequisites would be, where they 
would fit in the curriculum; whether they would be required or elective, who would 
teach the courses or course modules, etc.

o Reaching consensus among course directors and others in authority at the CAM 
Institution on plans to modify the curriculum;

o Developing plans with faculty from the partnering institution on how short term 
research experiences for students and faculty will be structured, selected, and 
evaluated;

o Determining how specific faculty from the partnering institution will contribute to 
teaching and mentoring of students at the CAM institution who are interested in 
research training; 

o Developing  guidance to encourage and implement collaborations between faculties at 
the CAM institution who are interested in research with faculty at the partnering 
institution;

o Developing strategies to advertise changes in curriculum to attract interested 
students and faculty who are interested in research to this new program;

o Developing an evaluation plan for the whole education project;

o Finalizing the advisory committee roster and setting up a schedule of meetings.

Because it is expected that the first year will be devoted mostly to planning, the 
maximum total direct cost that may be requested for the first year is $100,000.  The 
maximum annual direct cost that may be requested for the subsequent years of the 
grant, when implementation of the plans are expected to take place, is $200,000 per 
year.  Facilities and administrative costs for this Education Project Grant will be 
limited to 8 percent modified total direct costs for both the applicant organization 
and for subcontracts.  The total subcontract costs to the research intensive 
institution should not be more than one third of the total requested budget.  As part 
of the direct cost for years after the first year, the principal investigator should 
budget travel expenses for the principal investigator and one senior member of the 
team from the partnering institution to attend an annual CAM R25 awardees meeting in 
Bethesda, Maryland.

After the first 12 months of support, a programmatic review will be conducted to 
assess progress.  The review criteria will be based on the suggested planning 
activities for the first year described above.  The main goal of this review will be 
to discuss progress and future plans with the principal investigator and his/her team 
and to provide advice to help ensure the success of the project. Subsequent to this 
review, funds for the remaining years of the project will be approved and released. 
We anticipate approval of continuing support after the first year for all funded 
grants.  However, if progress is judged to be inadequate then a grant may be phased 
out at or before the end of the second year of support.

Grantees who successfully transition through the first year of their initial award 
period have the option of submitting one 4-year competitive renewal on the same 
receipt date as new applications (September 15 of the appropriate year).  It is 
expected that competitive renewal applications will focus on further implementation 
and refinements of their programs and implementation of strategies that will provide 
sustainability of the programs once NCCAM support has ended.  Maximum direct costs of 
each year of the competitive renewal will be $200,000 with a limit of 8 percent of 
modified total direct cost for facilities and administrative costs for both the 
applicant organization and for subcontracts.

ELIGIBLE INSTITUTIONS 

You may submit an application if your institution is a CAM institution as defined 
below, and has any of the following characteristics: 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
  and laboratories 
o Domestic institutions/organizations 
o Faith-based or community-based organizations
o Foreign institutions and foreign collaborations are not eligible for this award. 

For the purposes of this Program Announcement, the CAM and research-intensive 
partnering institutions are defined in the following manner:

o A CAM institution is defined as a U.S. domestic nationally or regionally fully 
accredited academic, health care or research institution with a primary goal of 
training students to be CAM practitioners. Only schools that offer a doctoral degree 
in a designated CAM practice that are licensed or certified at the state level will 
be eligible to submit an application in response to this announcement. 

o For the purposes of this initiative, U.S. domestic osteopathic medical institutions   
that teach manual manipulation as part of the core curriculum required for all 
students for a doctoral degree may be considered a CAM institution and may 
collaborate with another conventional institution as the research-intensive partner 
institution. If the osteopathic medical institution is part of a conventional 
research intensive health professional school or university, then the partnering 
institution may be within the same health professional school or university.  

o A research-intensive partnering institution is defined as a U.S. domestic academic, 
health care and/or research institution with a tradition of rigorous research and a 
record of substantive NIH research funding that does not have as a primary goal of 
training CAM practitioners. Examples are conventional healthcare professional schools 
such as medical schools, dental schools, or nursing schools or research-intensive 
universities. 

For this program announcement, the applicant institution must be a CAM institution.

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 his/her institution to develop an 
application for support.  Individuals from underrepresented racial and ethnic groups 
as well as individuals with disabilities are always encouraged to apply for NIH 
programs.  

SPECIAL REQUIREMENTS:  

The following supplemental information must be provided in the Resources Section 
(Section 7) of the application, not in the appendix.

o A document or documents verifying current national and/or regional accreditation of 
the CAM institution;

o A document outlining the present curriculum required for doctoral students at the 
CAM Institution;

o A roster of the proposed advisory committee and a letter from each nominated member 
indicating his/her willingness to serve; 

o A letter of support from the appropriate official at the CAM Institution in charge 
of curriculum development, such as the President or appropriate Dean, describing how 
the institution will provide support for the proposed plan outlined in this 
application;

o A letter of support from the appropriate official in the unit (department, branch, 
school, etc.) at the research-intensive institution, describing how the unit will 
support the proposed plan outlined in the application.

NCCAM Policies

In addition to applicable NIH policies, applicants should follow these NCCAM 
policies.

o Applications that plan to include research on natural products should follow 
NCCAM’s policy on Quality of Natural Products: 
http://www.nccam.nih.gov/research/policies/naturalproducts.htm

o Applications that plan to include clinical research should follow NCCAM’s policy on 
Terms of Awards for Clinical Trials: 
http://www.nccam.nih.gov/research/policies/terms-of-awards.htm 

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:  

Nancy J. Pearson, Ph.D.
Program Officer
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD  20892- 5475
Bethesda, MD 20817 (for express mail/courier service)
Telephone: (301) 594 0519
FAX: (301) 480 3621
Email: pearsonn@mail.nih.gov

o Direct your questions about peer review issues to:

Martin Goldrosen, Ph.D.
Chief, Office of Scientific Review
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892 (for express/courier service use 20817)
Telephone: (301) 594 2014
Fax: (301) 480 2419
Email: goldrosm@nccam.nih.gov
 
o Direct your questions about financial or grants management matters to:  

Brian Campbell
Grants Management Specialist
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
Bethesda, MD 20817 (for express mail/courier service)
Telephone: (301) 594 8738
Fax: (301) 480 3631
Email: campbeb@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 
is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an 
interactive format.  For further assistance contact GrantsInfo, Telephone 
(301) 435-0714, Email: GrantsInfo@nih.gov.

The title and number of this program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be checked.

APPLICATION RECEIPT DATES:  

Receipt dates:  September 15, 2004, 2005, 2006
Peer Review: February/ March
Council Date: May/June
Earliest Possible Start Date:  July

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes 
step-by-step guidance for preparing modular grants.  Additional information 
on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including the checklist, and four 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)

Also send one copy of the application to:

Martin Goldrosen, Ph.D.
Director, Office of Scientific Review
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD  20892-5475
Bethesda, MD 20817 (for express mail/courier service)

APPLICATION PROCESSING: Applications must be mailed on or before the receipt 
dates described at described above.

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 eight weeks.

PEER REVIEW PROCESS

Applications submitted for this PAR 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 Committee on Complementary 
and Alternative Medicine

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 the application's overall score, weighting them as appropriate 
for each application.  The application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, an investigator may propose to 
carry out important work that by its nature is not innovative but is essential 

SIGNIFICANCE:  Does this study address an important problem?  If the aims of 
the application are achieved, how will they enhance CAM practitioners’ exposure to 
and understanding of evidence-based biomedical research literature and approaches to 
advancing knowledge through research in CAM? What will be the effect of the education 
project 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 this CAM 
Education Project? Does the applicant acknowledge potential problem areas and 
consider alternative tactics?  Is an adequate program evaluation plan proposed? Have 
the investigators considered how the program will be sustained?

INNOVATION:  Does the CAM Education Project employ novel educational and scientific 
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 CAM Education Project proposed appropriate to the 
experience level of the Principal Investigator and other researchers and educators?

ENVIRONMENT:  Does the educational and scientific research environment in which the 
work will be done at the CAM institution and partnering institution
contribute to the probability of success?  Does the proposed CAM Education Project  
take advantage of unique features of the educational and scientific research 
environment and employ useful collaborative arrangements with the partnering 
institution?  Is there evidence of institutional support at both the CAM institution 
and the partnering institution based on the letters of support from appropriate 
officials at each institution and the description of interactions between the two 
institutions in the text of the proposal?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK:  The involvement of human 
subjects and protections from research risk relating to their participation in 
the proposed research will be assessed.  (See criteria included in the section 
on Federal Citations, below.)

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.

SHARING RESEARCH DATA:  Applicants requesting more than $500,000 in direct 
costs in any year of the proposed research are expected to include a data 
sharing plan in their application. The reasonableness of the data sharing plan 
or the rationale for not sharing research data will be assessed by the 
reviewers. However, reviewers will not factor the proposed data sharing plan 
into the determination of scientific merit or priority score.

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

AWARD CRITERIA

Applications submitted in response to a PAR 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

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities involving live, 
vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory 
Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as 
mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal 
Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as 
applicable.

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained. 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

DATA AND SAFETY MONITORING PLAN:  Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the participants    
(NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and 
Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA:  Investigators submitting an NIH application seeking $500,000 
or more in direct costs in any single year are expected to include a plan for data 
sharing or state why this is not possible 
(http://grants.nih.gov/grants/policy/data_sharing).  Investigators should seek 
guidance from their institutions on issues related to institutional policies, 
local IRB rules, as well as local, state and Federal laws and regulations, 
including the Privacy Rule. Reviewers will consider the data sharing plan but 
will not factor the plan into the determination of the scientific merit or the 
priority score.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines 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.  

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.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs 
can be found at http://stemcells.nih.gov/index.asp and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only research 
using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry 
will be eligible for Federal funding (see http://escr.nih.gov).  It is the 
responsibility of the applicant to provide, in the project description and elsewhere 
in the application as appropriate, the official NIH identifier(s)for the hESC 
line(s)to be used in the proposed research.  Applications that do not provide this 
information will be returned without review.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:  The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) cited 
publicly and officially by a Federal agency in support of an action that has 
the force and effect of law (i.e., a regulation) may be accessed through FOIA.  
It is important for applicants to understand the basic scope of this 
amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public archive, 
which can provide protections for the data and manage the distribution for an 
indefinite period of time.  If so, the application should include a 
description of the archiving plan in the study design and include information 
about this in the budget justification section of the application.  In 
addition, applicants should think about how to structure informed consent 
statements and other human subjects procedures given the potential for wider 
use of data collected under this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the “Standards for Privacy of Individually Identifiable Health Information”, 
the “Privacy Rule,” on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR).  

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 the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, Public 
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain 
facilities (or in some cases, any portion of a facility) in which regular or 
routine education, library, day care, health care, or early childhood 
development services are provided to children.  This is consistent with the 
PHS mission to protect and advance the physical and mental health of the 
American people.


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NIH Funding Opportunities and Notices


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Research (OER)
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Bethesda, Maryland 20892
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and Human Services (HHS)
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