NLM EARLY CAREER DEVELOPMENT AWARD FOR INFORMATICS (K22)

RELEASE DATE:  March 27, 2003

PA NUMBER:  PA-03-090 

May 11, 2010 - This PA has been reissued as (PAR-10-195).

(Notice of expiration, see NOT-LM-06-002)
                      (Peer Review change, see NOT-LM-05-007)
                      (see change NOT-LM-04-001)

EXPIRATION DATE:  March 20, 2006, unless reissued. 

National Library of Medicine (NLM)
 (http://www.nlm.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.879 NLM Medical 
Library Assistance

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
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  

This K22 award is intended to facilitate the transition of investigators 
from the mentored to the independent stage of their careers by providing  
"protected time" for newly independent investigators to develop and 
receive support for their initial research programs. The award applies 
to biomedical informaticians who are pursuing research in basic 
informatics, clinical informatics, or the informatics relevant to 
biomedical research.  

RESEARCH OBJECTIVES

The NLM Transition Career Development Award has been developed to 
provide support to promising informatics investigators while they are 
establishing their first independent research programs.  This award is 
available only to individuals with health professional degrees. 
 
To apply, a candidate must have completed TWO YEARS OR MORE of 
postdoctoral, mentored research or have been in an independent position 
for LESS THAN TWO YEARS at the time the application is submitted.  The 
unique feature of this award is that individuals may apply without a 
sponsoring institution while they are still in a "mentored" position.  
Successful postdoctoral applicants will be given up to 12 months to 
identify an independent, preferably tenure-track, position at a 
sponsoring institution before an award can be activated.  For 
postdoctoral applicants, the sponsoring institution for a K22 award can   
be their current institution or a new institution.   Candidates already 
in their first independent research position may apply for this award in 
the first or second year of this position.  

MECHANISM OF SUPPORT 

This PA will use the National Institutes of Health (NIH) K22 award 
mechanism.  The total project period for an application submitted in 
response to this PA may not exceed 3 years.  Planning, direction, and 
execution of the program will be the responsibility of the candidate.  
Awards are not renewable.

This PA uses just-in-time concepts.  It also uses the modular as well as 
the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).   
Specifically, if you are submitting an application with direct costs in 
each year   of $250,000 or less, use the modular format.  Otherwise 
follow the instructions for non-modular research grant applications.  
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 award provides support for three years to individuals who are 
currently postdoctoral trainees in INFORMATICS research or have just 
started in an independent position (See ELIGIBILITY REQUIREMENTS). 
Recipients of this award must devote a minimum of 75 percent effort to 
the proposed research program. The remaining 25 percent effort can be 
divided among other clinical and teaching activities only if they are 
consistent with the program goals, i.e. the candidate's development into 
an independent clinical investigator.

Under unusual and pressing circumstances, an awardee may submit a 
written request to the awarding component, requesting a reduction in 
professional effort below 75 percent. Such requests will be considered 
on a case-by-case basis during the award period. In no case, will it be 
permissible to work at a rate of less than 50 percent effort. The nature 
of the circumstances requiring reduced effort might include medical 
conditions, disability, or pressing personal or family situations such 
as child or elder care. Permission to reduce the level of effort will 
not be approved to accommodate other sources of funding, job 
opportunities, clinical practice, or clinical training. In each 
situation, the grantee institution must submit documentation supporting 
the need for reduced effort along with assurance of a continuing 
commitment to the scientific development of the awardee. Further, the 
awardee must submit assurance of his or her intention to return to full-
time professional effort (at least 75 percent) as soon as possible. 
During the period of reduced effort, the salary and other costs 
supported by the award will be reduced accordingly. 

The sponsoring institution must demonstrate a research environment 
conducive to the development of the investigator and the progress of his 
research.  

Allowable Costs
Salary: The Transition Career Development Award (K22) will provide 
salary up to $75,000 plus fringe benefits. The total salary requested 
must be based on a full-time, 12 month staff appointment requiring the 
candidate to devote a minimum of 75 percent effort to conducting 
informatics research with the remaining effort being devoted to 
activities related to relevant activities. The salary must be consistent 
both with the established salary structure at the institution and with 
salaries actually provided by the institution from its own funds to 
other staff members of equivalent qualifications, rank, and 
responsibilities in the department concerned. If full-time, 12-month 
salaries are not currently paid to comparable staff members, the salary 
proposed must be appropriately related to the existing salary structure. 

The institution may supplement the NIH salary contribution up to a level 
that is consistent with the institution's salary scale; however, 
supplementation may not be from Federal funds unless specifically 
authorized by the Federal program from which such funds are derived. 
Because the salary amount provided by this award is based on the full-
time institutional salary, no other PHS funds may be used for salary 
supplementation. Institutional supplementation of salary must not 
require extra duties or responsibilities that would interfere with the 
purpose of the K22. Under expanded authorities, however, institutions 
may rebudget funds within the total costs awarded to cover salaries 
consistent with the institution's salary scale. 

Research Development Support: Up to $50,000 per year will be provided 
for the following types of expenses: (a) research expenses, such as 
supplies, equipment, and technical personnel; (b) statistical services 
including personnel and computer time; (c) tuition, fees, and books 
related to career development; and (d) travel to research meetings or 
for training. The level of research development support may be 
negotiated downward with the acquisition of any independent grant 
support from any source. Ancillary Personnel Support: Salary for 
mentors, secretarial and administrative assistance, etc. is NOT allowed.

Facilities and Administrative Costs: These costs, which were formerly 
called indirect costs, will be reimbursed at 8 percent of modified total 
direct costs. 

Evaluation 
In carrying out its stewardship of human resource related programs, the 
NIH may begin requesting information essential to an assessment of the 
effectiveness of this program. Accordingly, recipients are hereby 
notified that they may be contacted after the completion of this award 
for periodic updates on various aspects of their employment history, 
publications, support from research grants or contracts, honors and 
awards, professional activities, and other information helpful in 
evaluating the impact of the program. 

Other Income 
Fees resulting from clinical practice, professional consultation, or 
other comparable activities required by the research and research-
related activities of this award may not be retained by the career award 
recipient. Such fees must be assigned to the grantee institution for 
disposition by any of the following methods: 

o The funds may be expended by the grantee institution in accordance 
with the NIH policy on supplementation of career award salaries and to 
provide fringe benefits in proportion to such supplementation. Such 
salary supplementation and fringe benefit payments must be within the 
established policies of the grantee institution 

o The funds may be used for health-related research purposes 

o The funds may be paid to miscellaneous receipts of the U.S. Treasury. 
Checks should be made payable to the Department of Health and Human 
Services, NIH and forwarded to the Director, Division of Financial 
Management, NIH, Bethesda, Maryland 20892. Checks must identify the 
relevant award account and reason for the payment

o Awardees may retain royalties and fees for activities such as 
scholarly writing, service on advisory groups, or honoraria from other 
institutions for lectures or seminars, and fees resulting from clinical 
practice, professional consultation or other comparable activities, 
provided these activities remain incidental, are not required by the 
research and research-related activities of this award, and provided 
that the retention of such pay is consistent with the policies and 
practices of the grantee institution 

Usually, funds budgeted in an NIH supported research or research 
training grant for the salaries or fringe benefits of individuals, but 
freed as a result of a career award, may not be rebudgeted. The awarding 
component will give consideration to approval for the use of released 
funds only under unusual circumstances. Any proposed retention of funds 
released as a result of a career award must receive prior written 
approval of the NIH awarding component. 

Special Leave 
Leave to another institution, including a foreign laboratory, with award 
support may be permitted if the proposed experience is directly related 
to the purpose of the award. Only local, institutional approval is 
required if such leave does not exceed 3 months. For longer periods, 
prior written approval of the NIH funding component is required. To 
obtain prior approval, the award recipient must submit a letter to the 
NIH funding component describing the plan, countersigned by his or her 
department head and the appropriate institutional official. A copy of a 
letter or other evidence from the institution where the leave is to be 
taken must be submitted to assure that satisfactory arrangements have 
been made. Support from the career award will continue during such 
leave. Leave without award support may not exceed 12 months. Such leave 
requires the prior written approval of the NIH funding component and 
will be granted only in unusual situations. Support from other sources 
is permissible during the period of leave. Such leave does not reduce 
the total number of months of program support for which an individual is 
eligible. Parental leave will be granted consistent with the policies of 
the grantee institution. 

Termination of Award 
When a grantee institution plans to terminate an award, the NIH funding 
component must be notified in writing at the earliest possible time so 
that appropriate instructions can be given for termination. The Director 
of the NIH may discontinue an award upon determination that the purpose 
or terms of the award are not being fulfilled. In the event an award is 
terminated, the Director of the NIH shall notify the grantee institution 
and career award recipient in writing of this determination, the reasons 
therefore, the effective date, and the right to appeal the decision. 

Change of Institution
Individuals planning a change of institution AFTER AN AWARD HAS BEEN 
INITIATED (see Award Criteria and Procedures below) must submit to the 
NLM in advance of the change a written request for transfer, 
countersigned by the appropriate institutional business official, 
describing the reasons for the change. The awardee must establish in 
this request that the specific aims of the research program to be 
conducted at the new institution are within the scope of the original 
peer reviewed research program. Staff within the NLM will review this 
request. Upon approval of this request the new institution must follow 
all of the procedures outlined in the section on AWARD CRITERIA AND 
PROCEDURES for submission and NLM approval of a "Statement of 
Environment and Institutional Commitment." Upon approval of the 
"Statement" a new career award application must be submitted by the new 
institution far enough in advance of the requested effective date to 
permit review. The period of support requested in the new application 
must be no more than the time remaining within the existing award 
period. A final progress report, invention statement, and Financial 
Status Report are required upon either termination of an award or 
relinquishment of an award in a change of institution situation. 

ELIGIBLE INSTITUTIONS  

Only domestic non-Federal organizations, public or private, such as 
medical, dental or nursing schools or other institutions of higher 
education, may accept an award on behalf of an applicant.  

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

To be eligible a candidate must have a doctoral degree (e.g. M.D., 
Ph.D.) and training in biomedical informatics. 

Candidates must currently be in a "mentored" informatics research 
postdoctoral   position and have completed TWO YEARS OR MORE of research 
in this capacity at   the time of the application, or be in a suitable 
independent position for LESS THAN TWO YEARS with continuous previous 
postdoctoral informatics research training at the time of the 
application.  Postdoctoral informaticians working in informatics 
research as Federal employees are not eligible for this award.   

A candidate for a K22 may not simultaneously submit or have pending an 
application for any other PHS award that duplicates any of the 
provisions of this award.  Former or current principal investigators on 
any NIH research   grants or non-PHS peer reviewed grants that are over 
$100,000 direct costs   per year or project leaders on sub-projects of 
program project (P01) or   center grants (P50) are NOT eligible to apply.

Candidates must be U.S. citizens or non-citizen nationals, or must have 
been lawfully   admitted for permanent residence and possess an Alien 
Registration Receipt Card (I-151 or I-551) or some other verification of 
legal admission as a permanent resident.  Non-citizen nationals, 
although not U.S. citizens, owe permanent allegiance to the U.S.  They 
are usually born in lands that are not states, but are under U.S. 
sovereignty, jurisdiction, or administration.  Individuals on temporary 
or student visas are not eligible. Individuals from underrepresented 
racial and ethnic groups as well as individuals with disabilities are 
always encouraged to apply for NIH programs.   

SPECIAL REQUIREMENTS

The information summarized below must be provided in the application: 

Candidate

o (Only for applicants already in an independent position) Describe the 
current position in terms of its ability to enable the candidate to 
pursue an INDEPENDENT career in informatics research;

o Describe all activities during the "mentored" period of informatics 
research training. Include all research experiences and mentors, any 
pertinent didactic experiences and any other experiences designed to 
acquire critical skills, techniques and scientific perspectives for 
pursuing an independent career in the chosen area of BIOMEDICAL 
INFORMATICS RESEARCH.

o Describe scientific productivity during the mentored period of career 
development

o Describe factors that support potential to manage an independent 
research program

o Describe opportunities to interact and collaborate with other 
scientists

o Establish the ability to make a commitment of at least 75 percent 
effort 
to the career objectives of this award
 
o Three letters of recommendation from established scientists familiar 
with   the candidate's potential and capability to become a successful 
independent investigator. These letters should be provided in sealed 
envelopes attached to the front page of the application.

Research Plan

Describe an original research plan in basic or applied informatics 
research The research plan must be described as outlined in form PHS 398 
including sections on the Specific Aims, Background and Significance, 
Progress Report/Preliminary Studies, Research Design and Methods;

o Describe how the proposed research extends the mentored research 
training that has been completed into new concepts and ideas

o Describe the equipment, specialized facilities and personnel resources 
that will be needed to conduct the proposed research

o Describe the plans for inclusion of women, minorities and children in 
any clinical or population research activities

Budget

o Within the limitation of $50,000 direct costs for research development 
support, provide a description, with justification, for all equipment, 
supplies and personnel that will be used.

Non-Competing renewals

o In addition to the information requested in the Application for 
Continuation Grant form PHS 2590 (Rev. 5/2001), documentation must be 
provided with the Progress Report for the second year of the award 
showing that the awardee has submitted an R01-type research grant 
application to NIH for funding.  This documentation should minimally be 
a copy of the face page of the application with all required 
institutional signatures.

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:

Dr. Carol Bean
Extramural Programs
National Library of Medicine
6705 Rockledge Drive, Suite 301
Bethesda, MD 20892
Tel: (301) 594 4882
FAX: (301) 402-2952
Email: beanc@mail.nlm.nih.gov  

o Direct your questions about peer review issues to: (Contact changed, see NOT-LM-05-007)

Dr. Arthur Petrosian
Scientific Review Administrator
6705 Rockledge Drive, Suite 301, MSC 7968
Bethesda, MD 20892-7968
Bethesda, MD 20817 (for courier/express service)
Telephone: (301) 594-4933
FAX: (301) 402-2952
Email: petrosia@mail.nih.gov

o Direct your questions about financial or grants management matters to:

Mr. Christopher Robey
Grants Management Specialist
National Library of Medicine
6705 Rockledge Drive,  Suite 300
Bethesda, MD 20892
Tel: (301) 496-4221
FAX: (301) 402-0421
Email: robeyc@mail.nlm.nih.gov

SUBMITTING AN APPLICATION

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 the standard application 
deadlines, which are available at http://grants.nih.gov/grants/dates.htm.
Application deadlines are also indicated in the PHS 398 application kit.  

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original 
of the application, including the checklist, and five signed photocopies 
in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application must 
be sent to:

Dr. Merlyn Rodrigues
Scientific Review Administrator
Division of Extramural Programs
National Library of Medicine
6705 Rockledge Drive Suite 300
Bethesda, MD 20892

APPLICATION RECEIPT DATES: Applications must be mailed on or before the 
receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm. 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 to the National 
Library of Medicine.  Applications that are complete and responsive to 
the program announcement will be evaluated for scientific and technical 
merit by a peer review group convened by the Division of Extramural 
Activities of the NLM. Review will be conducted in accordance with 
standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm). 

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 Board of Regents of the National 
Library of 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 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: 

Candidate

o (Only for candidates already in an independent position) Suitability 
of the position for the candidate to pursue an independent research 
career;

o Quality of the mentored period of Informatics research training in 
terms of research experience(s), didactic experiences and other 
experiences (e.g., special skills, perspectives, techniques) that will 
enhance the candidate's ability to pursue an independent informatics 
research career in the chosen area of informatics research;

o Scientific productivity during the mentored period of career development;

o Potential ability to manage an independent research project;

o Ability to interact and collaborate with other scientists;

o The potential to become a successful independent investigator;

o Letters of reference on behalf of the candidate. 

Research Plan

o The originality, innovativeness and scientific merit of the proposed 
Research Plan relative to the experience level of the applicant;

o Extent to which the research plan goes beyond the mentored environment 
and will test new concepts and ideas

o The medical and/or health significance of the Research Plan to 
informatics;

o The adequacy of plans to include women, children and minorities in any 
clinical or population research activities;

o The adequacy of the proposed protection of humans, animals or the 
environment to the extent they may be adversely affected by activities 
proposed in the application.

Non-Competing Renewals

o Adequacy of the progress towards achieving the research and career 
development objectives of the program

o Adequacy of the efforts to obtain R01-type research grant support for 
the research program.

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.

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

The NLM will notify candidates who have competed successfully for 
funding with a "Letter of Intent to Commit Funds." Candidates in a 
postdoctoral position will then have one year from the date of the 
letter to find an institution that offers a position, preferably tenure-
track, suitable for enhancing a research career. For a candidate who 
already has a position in a sponsoring institution, negotiations with 
the institution will begin without delay. Negotiations will be initiated 
by asking the candidate's institution to submit a "Statement of 
Environment and Institutional Commitment" to the NLM. NLM staff using 
the following criteria will evaluate this statement: 

o Documentation of a strong, well-established research program related 
to the candidate's area of interest, including a high-quality research 
environment with staff capable of productive collaboration with the 
candidate; 

o Agreement of the institution's statement of commitment of equipment, 
physical and personnel resources with the peer-reviewed recommendation 
of needs;

o Adequacy of the institutional commitment to the required 75 percent 
effort requirement of this award for the development of an independently 
funded research program; 

o Adequacy of the arrangements with the candidate to provide a 
permanent, preferably tenure-track, position; adequate facilities for 
conducting a research program, and additional resources conducive to the 
development of a research project and establishment of a successful 
research career. 

For postdoctoral candidates, if the NLM approves the "Statement of 
Environment and Institutional Commitment" offered by the institution, 
the institution will be asked to submit a completed PHS Form 398 
application. For candidates who already have a position in a sponsoring 
institution, the NLM only needs to approve the Statement. After NLM 
approval and subject to the availability of funds, the institution will 
receive an award. At the time of the award to the grantee institution in 
support of the K22, any current award held or other support provided for 
the mentored training of the candidate will be terminated. An award can 
be terminated prior to the end of the third year by the NLM if the 
candidate does not submit an R01 type grant application or equivalent 
for peer review before the end of the second year (See SPECIAL REQUIREMENTS). 

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 AND SAFETY 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 and Safety 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 are available at http://
grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new 
OMB standards; clarification of language governing NIH-defined Phase III 
clinical trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: 
a) all applications or proposals and/or protocols must provide a description 
of plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS: The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them. This policy applies to all initial 
(Type 1) applications submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines" on the inclusion of children as 
participants in research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for 
research involving human subjects.  You will find this policy 
announcement in the NIH Guide for Grants and Contracts Announcement, 
dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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

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

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  
The Department of Health and Human Services (DHHS) issued final 
modification to the "Standards for Privacy of Individually Identifiable 
Health Information", the "Privacy Rule," on August 14, 2002.  The 
Privacy Rule is a federal regulation under the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996 that governs the 
protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR). 
Those who must comply with the Privacy Rule (classified under the Rule 
as "covered entities") must do so by April 14, 2003  (with the exception 
of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule 
reside with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, 
including a complete Regulation Text and a set of decision tools on "Am 
I a covered entity?"  Information on the impact of the HIPAA Privacy 
Rule on NIH processes involving the review, funding, and progress monitoring 
of grants, cooperative agreements, and research contracts can be found 
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and 
proposals for NIH funding must be self-contained within specified page 
limitations. Unless otherwise specified in an NIH solicitation, 
Internet addresses (URLs) should not be used to provide information 
necessary to the review because reviewers are under no obligation to 
view the Internet sites.   Furthermore, we caution reviewers that their 
anonymity may be compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas. This PA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance, Medical Library Assistance, 93.879. Awards 
are made under the authority of the Public Health Service Act, Section 
472 (42 USC 286b-3) and administered under PHS grants policies and 
Federal Regulations, most specifically at 42 CFR Part 61 and 45 CFR Part 
74.  This program is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems Agency review.  
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


H H S Department of Health
and Human Services

 
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