and Human Services (HHS)
EXPIRED
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/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) 710-0267, 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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