This Program Announcement expires on March 13, 2004, unless reissued.

MENTORED SCIENTIST DEVELOPMENT AWARD IN RESEARCH ETHICS

Release Date:  September 27, 2001

PA NUMBER:  PAR-01-144

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

Application Receipt Dates:  March 12, 2002, March 12, 2003, March 12, 2004

PURPOSE

The National Institutes of Health invites biomedical, behavioral, and public 
health researchers to apply for the Mentored Scientist Development Award 
(MSDA).  The MSDA will support training in research ethics for health 
professionals working at academic and other health-related institutions in 
biomedical, behavioral, or public health research, particularly research 
involving human participants.

The goals of the MSDA are two fold.  First, the award should enhance the 
career of the candidate such that he or she would become an independent 
investigator in applied research ethics.  Second, the candidate would become a 
resource in the area of research ethics for the sponsoring institution and its 
scientific community.  As such, applications for the MSDA should include a 
mentored research experience that will measurably enhance the candidate"s 
scientific career as a research ethicist.

This MSDA program is intended to support two kinds of individuals:  (1) those 
who have an established career in another field, and now want to move into 
research ethics, and (2) those who are already in the field of research ethics 
but, because of their junior status, require a period of mentored career 
development in order to become independent scientists in the field of research 
ethics.

This initiative together with a parallel Program Announcement, Short-Term 
Courses in Research Ethics (T15), is part of NIH’s efforts to develop a 
comprehensive program in research ethics.  As used in this program 
announcement, research ethics refers to ethical, legal, and social principles 
guiding the responsible conduct of research, particularly focusing on 
scientific integrity and protection of the interests of research participants.

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 Program Announcement (PA), Mentored 
Scientist Development Award in Research Ethics, 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/.

ELIGIBILITY REQUIREMENTS

The candidate must have a doctorate or its equivalent and should have 
demonstrated the capacity or have shown the potential for highly productive, 
independent postdoctoral research.  The applicant must be willing to commit a 
minimum of 75 percent of his or her full-time professional effort to 
conducting research and pursuing research career development activities for 
the period of the award.

The candidate must identify a mentor with extensive research and academic 
experience in ethical issues related to biomedical research.  It is important 
that the mentor be an individual with established credentials in the field of 
research ethics or a closely related field.

The sponsoring institution should submit the application on behalf of the 
candidate.  Candidates may be members of domestic public or private 
organizations, such as medical, dental, public health, or nursing schools or 
other institutions of higher education.  Minorities, women, and individuals 
with disabilities are encouraged to apply.  Candidates must be U.S. citizens 
or non-citizen nationals or must have been lawfully admitted for permanent 
residence.  Individuals on temporary or student visas are not eligible.

MECHANISM OF SUPPORT

This PA will use the K01 mechanism, which provides an additional period of 
support to a doctoral-level candidate in a new research area or in an area 
that would enhance the candidate"s career in research ethics.  The candidate 
and mentor are responsible for the planning, direction, and execution of the 
program on behalf of the sponsoring institution. Candidates must show the 
potential for highly productive, independent careers in the field of research 
ethics.

The project period is for three, four, or five years depending upon prior 
experience and the need for additional research experience.  Awards are not 
renewable.

RESEARCH OBJECTIVES

Advances in biomedical and behavioral research and their application to human 
research have highlighted the importance of ethical issues in these areas.  
The advent of gene transfer research, xenotransplantation, HIV vaccine trials, 
the testing of therapies in settings which preclude informed consent (e.g., 
coma and severe trauma), as well as ongoing attention to past abuses such as 
the Tuskegee Syphilis Study have catalyzed a realization that greater emphasis 
on research ethics is needed.

As part of the plan to address this issue, the NIH has chosen to increase the 
cadre of researchers trained in the social, legal, and ethical issues arising 
from biomedical, behavioral, and public health research. The areas described 
below, although not exhaustive, represent scientific areas where research can 
substantially inform public policy in this field.  Researchers proposing 
training in other areas must show the relevance of such training to social, 
legal, and ethical issues in biomedical, behavioral, nursing, social science, 
or public health research.

o Ethical and legal guidance for protection of human participants in 
research.
o Scientific integrity and responsibility.
o Interplay of medical and research ethics in clinical research.
o Privacy and confidentiality protections for research participants.
o Implications of innovations in biotechnology and biomedical research, risks 
to participants from developing laboratory and information technology.
o Ethics review processes in research organizations and institutions.
o Cultural issues in ethical principles and standards.
o Ethical issues related to health services research.

Environment

The sponsoring institution must have a well-established academic program in 
research ethics or a related field.  It must have suitable library facilities 
and make a commitment to assist the trainee with access to institutional 
resources (such as a hospital or research environment) suitable for the 
proposed field of study.  It must provide a qualified person to serve as a 
mentor.  The institution must demonstrate a commitment to the development of 
the candidate as a productive, independent investigator.  The candidate, 
mentor, and institution must be able to describe a career development program 
that will maximize the use of relevant research and educational resources.

Program

The award provides three to five years of funding.  At least 75 percent of the 
candidate"s full-time professional effort must be devoted to the program, and 
the remainder devoted to other research-related and/or teaching pursuits 
consistent with the objectives of the award.  For example, if the applicant 
has proposed a research plan involving ethical issues in clinical research, 
continuation of his or her current activities in that area could be considered 
"other research-related pursuits."  The candidate may find it appropriate to 
include relevant didactic and laboratory or field research experiences.

Mentor

The candidate must receive appropriate mentoring throughout the three- to 
five-year program.  The mentor should be a senior individual who is well known 
in the field of research ethics or a closely related field.  Because suitable 
mentors may not be available at the sponsoring institution, applicants may 
choose a reasonable and workable mentorship from another institution.

Allowable Costs

1. Salary:  This award will provide salary and fringe benefits for the 
candidate up to $75,000 per year.  In addition, the institution may supplement 
this 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 program from which such funds are derived.  
Institutional supplementation of salary must not require extra duties or 
responsibilities that would interfere with the purpose of the MSDA.  
Continuation of clinical or research activities that relate to the proposed 
area of concentration in research ethics is acceptable.

The total salary requested must be based on a full-time, 12-month staff 
appointment.  It 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.

2. Research Development Support: This award will provide up to $20,000 per 
year for the following expenses: (a) tuition, fees, and books related to 
career development, (b) research expenses, such as supplies, equipment, and 
technical personnel, (c) travel to research meetings or training, including at 
least one meeting convened by the NIH for awardees to discuss research 
progress, (d) statistical services, including personnel and computer time.

3. Ancillary Personnel Support:  Salary for mentors, secretarial or 
administrative assistance is not allowed.

4. Facilities and Administrative Costs:  These costs will be reimbursed at 
eight percent of the total direct costs excluding equipment.

Evaluation

In carrying out its stewardship of human resource-related programs, the HHS 
may request information essential to an assessment of the effectiveness of 
this program. Accordingly, candidates 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 sponsoring institution in accordance with 
the HHS/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 sponsoring 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 must 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.

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, provided these activities remain incidental and provided 
that the retention of such pay is consistent with the policies and practices 
of the sponsoring institution.

Usually, funds budgeted in an HHS/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 re-budgeted.  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 an MRSDA career award must receive prior written approval of the program 
administrator.

Special Leave

Leave to another institution, including a foreign laboratory, may be permitted 
if directly related to the purpose of the award. Only local, institutional 
approval is required if such leave does not exceed three months.  For longer 
periods, prior written approval of the awarding organization is required.  To 
obtain prior approval, the award candidate must submit a letter to the 
institute describing the plan, countersigned by his or her department head and 
the appropriate local 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 awarding institute 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 NIH and the sponsoring 
institution.

Termination or Change of Institution

When a grantee institution plans to terminate an award, the awarding institute 
must be notified in writing at the earliest possible time so that appropriate 
instructions can be given for termination.  If the individual is moving to 
another eligible institution, career award support will be considered at the 
new institution, provided a new career award application is submitted by the 
new institution, the period of support requested is no more than the time 
remaining within the existing award period, and the new application is 
submitted far enough in advance of the requested effective date to allow the 
necessary time for review.  The awarding institute may require a review by an 
initial review group and/or the appropriate national advisory council or 
board.  Alternatively, staff of the awarding institute may carry out the 
review, depending upon the circumstances.

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 sponsoring institution 
and career award candidate in writing of this determination, the reasons for 
the discontinuation, the effective date, and the right to appeal the decision.

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.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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 biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are 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 research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000  
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html).

A complete copy of the up-dated Guidelines is available at  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to 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) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH 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 was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html.  
Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES. Program staff may also provide additional relevant 
information concerning the policy.

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.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following website: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

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.

APPLICATION PROCEDURES

The career award section of PHS 398 research grant application instructions 
and forms (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in 
applying for these grants.  This version of the PHS 398 is available in an 
interactive, searchable PDF format.  For further assistance contact 
GrantsInfo, Telephone 301/435-0714, Email: GrantsInfo@nih.gov.

For purposes of identification and processing, the PA title and number must be 
typed in item 2 on the face page of the application and the "YES" box must be 
marked.

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)

Applications must be received by the application receipt date listed in the 
heading of this RFA.  If an application is received after that date, it will 
be returned to the applicant without review.   

Only domestic institutions are eligible to apply for support under this 
program announcement.  Potential applicants are encouraged to discuss their 
plans and objectives of their proposed courses with the NIH staff listed under 
INQUIRIES before submitting an application.

The application must address the following issues:

Candidate

o Establish the candidate"s commitment to a career in research ethics.
o Establish the candidate"s potential to develop into a successful 
independent investigator or (for more senior candidates) establish that the 
candidate has achieved a successful independent career in biomedical, 
behavioral, or public health research.
o Summarize the candidate"s immediate and long-term career objectives, 
explaining how the award will contribute to their attainment.
o Letters of recommendation. Three sealed letters of recommendation 
addressing the candidate"s potential for a career in research ethics must be 
included as part of the application.

Career Development Plan

o Describe the career development plan, incorporating consideration of the 
candidate"s goals and prior experience. It should describe a systematic plan 
to obtain the necessary background and research experience to launch a career 
in research ethics.

Research Plan

o The candidate and mentor together must describe the research plan as 
outlined in form PHS 398 including sections on the Specific Aims, Background 
and Significance, Progress Report/Preliminary Studies, Research Design, and 
Methods.

Mentor

o The application must include information on the mentor(s), including 
research qualifications and previous experience as a research supervisor.  The 
application must also include information that describes the nature and extent 
of supervision that will occur during the proposed award period.  A letter 
from the proposed mentor indicating his or her commitment to the candidate"s 
training must be included in the application.

Environment and Institutional Commitment

o The sponsoring institution must document a strong, well-established 
research program related to social, ethical, and legal issues stemming from 
biomedical and behavioral research, including a high-quality research 
environment with staff capable of productive collaboration with the candidate. 
The sponsoring institution also must provide a statement of commitment to the 
candidate"s development into a productive, independent investigator.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the NIH Center 
for Scientific Review (CSR).  Incomplete applications will be returned to the 
applicant without further consideration.

Applications received in response to this program announcement will be 
reviewed for scientific and technical merit by an initial review group in the 
CSR, in accordance with standard NIH peer review procedures.  As part of the 
initial merit review, all applications will receive a written critique and 
undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under review, 
will be discussed and assigned a priority score and receive a second level of 
review by the National Heart, Lung, and Blood Advisory Council.

Review Criteria

The following review criteria will be applied:

Candidate

o Is the candidate appropriately trained and suited to the proposed career 
development activities, i.e., well trained and productive in his or her 
current field and prepared for the proposed career development activities?

Career Development Plan

o Is the career development plan proposed one which will give the candidate 
sufficient grounding in principles, content, and methods of ethics related to 
biomedical research such that the candidate can establish an independent 
research career in the field?

Research Plan

All candidates for this award will have had previous research experience and 
in some cases will have been principal investigators in other scientific 
fields.  A sound research plan that is consistent with the career development 
plan and the candidate"s level of research development must be provided.

Significance:  Does this project address an important problem?  How well does 
the proposed research experience complement the proposed career development 
activities?

Approach:  Are the methods adequately developed, well integrated, and 
appropriate to the research plan and career development goals of the 
candidate?  Does the candidate acknowledge potential problem areas and 
consider other approaches?

Mentor

o Is the mentor sufficiently qualified, experienced, and available to 
assist the candidate sufficiently in the proposed career development and 
research activities?

Institutional Environment and Commitment

o Is the institution"s (or institutions" - if the candidate and mentor are 
located at different institutions) commitment sufficient to increase the 
probability of success?  Is there appropriate collaboration among departments 
and units within the institution?  Are there special features in the 
institutional environment that can increase the chances of success?  Are the 
resources adequate?

o Is the sponsoring institution willing to develop an appropriate mix of 
research, teaching, and administrative responsibilities for the candidate?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following criteria 
where they are applicable:

o The adequacy of plans to include both genders, minorities, and their 
subgroups as appropriate for the scientific goals of any research activities. 

o The reasonableness of the proposed budget and duration in relation to the 
proposed activities.

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

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o scientific merit (as determined by peer review)
o availability of funds
o programmatic priorities.

INQUIRIES

Written and telephone inquiries concerning this PA are encouraged, especially 
during the planning phase of the application.

Inquiries regarding programmatic issues may be directed to:

Lawrence Friedman, M.D.
National Heart, Lung and Blood Institute
Building 31, Room 5A03
Telephone:  (301) 496-9899
FAX:  (301) 402-1056
Email:  lawrence_friedman@nih.gov

Direct inquiries regarding fiscal matters to:

Suzanne White
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7154
Bethesda, MD  20892-7926
Telephone:  (301) 435-0171
FAX:  (301) 480-3310
Email:  whitesa@nhlbi.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.837.  Awards are made under authorization of sections 301 and 405 of the 
Public Health Service Act as amended (42 USC 241 and 284) and administered 
under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 
74 and 92.  This program is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-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, and 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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