MENTORED SCIENTIST DEVELOPMENT AWARD IN RESEARCH ETHICS

NIH GUIDE, Volume 26, Number 37, November 7, 1997

PA NUMBER:  PAR-98-006

P.T.

National Institutes of Health
Centers for Disease Control
Health Resources and Services Administration
Agency for Health Care Policy and Research

Letter of Intent Receipt Dates:  February 6 and May 22, 1998
Application receipt Dates:  March 6 and June 24, 1998

PURPOSE

The National Institutes of Health, Centers for Disease Control,
Health Resources and Services Administration, and the Agency for
Health Care Policy and Research invite 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, and
second, the candidate would become a resource on research ethics
for the sponsoring institution and its scientific community.  As
such, applications for the MSDA should include a mentored research
experience that will demonstrably enhance the candidate's
scientific career as a research ethicist.  The award is designed
for investigators who would refocus their research careers to the
field of applied research ethics.

Although this Program Announcement applies to several agencies, it
will be administered according to NIH policies.  This initiative
together with a parallel Program Announcement, Short-Term Courses
in Research Ethics (T15), are first steps towards developing a
comprehensive program in research ethics.  As used in this program
announcement, research ethics refers to ethical, legal, and social
principles guiding the proper conduct of research programs,
particularly focusing on scientific integrity and protection of the
interests of research participants.

This initiative follows a directive from the Secretary of Health
and Human Services in response to President Clinton's apology to
the survivors and relatives of the men who participated in the
Tuskegee Syphilis Study. The directive requires DHHS agencies to
offer training - with special outreach to minority scientists - for
post-graduate training in bioethics and for the development of
short courses in research ethics.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the
health promotion and disease prevention objectives of "Healthy
People 2000," a PHS-led national activity for setting priority
areas. This PA, Mentored Scientist Development Award in Research
Ethics, is related to the priority area of human resource
development. Potential applicants may obtain a copy of "Healthy
People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary
Report: Stock No. 017-001-00473-1) from the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202-512-1800).

ELIGIBILITY

The candidate must have a research or a health-professional
doctorate or its equivalent and should have demonstrated the
capacity or have shown the potential for highly productive,
independent postdoctoral research in her or his chosen field prior
to applying for this award.

The candidate must identify a mentor with extensive research and
academic experience in ethical issues related to biomedical
research and 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.

Applications should be submitted by the candidate directly and
should include a letter of commitment of the proposed institution. 
Applicants may be members of domestic, non-federal, 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 noncitizen nationals
or must have been lawfully admitted for permanent residence. 
Individuals on temporary or student visas are not eligible. 
Current principal investigators of research grants from NIH or any
of the other sponsoring agencies are not eligible.

MECHANISM OF SUPPORT

Awards from 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
scientific career.  The candidate and mentor are responsible for
the planning, direction, and execution of the program on behalf of
the applicant institution. Candidates must show the capacity or
potential for highly productive, independent research.

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

Recent 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 genetic therapies,
xenotransplantation, HIV vaccine trials, the testing of therapies
which preclude informed consent (e.g., coma and severe trauma), as
well as recent 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 sponsoring agencies
have 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 critical 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, 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 protection for human research subjects.
o  Implications of innovations in biotechnology and biomedical
research; new risks to participants from changing laboratory and
information technology. o  Ethics review processes in research
organizations and institutions - value and benefits.
o  Cultural issues in ethical principles and standards.
o  Ethical issues related to health services research.

Environment

The 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 qualified faculty to serve as mentors. The institution must
be able to 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 recipient'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 recipient 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. 
Because suitable mentors may not be available at the applicant
institution, applicants may chose a reasonable and workable
mentorship from another institution.

Allowable Costs

1.  Salary:  This award will provide salary and fringe benefits for
the recipient up to $50,000 per year (plus fringe benefits).  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 or secretarial
or administrative assistance is not allowed.

4.  Indirect Costs:  Indirect costs will be reimbursed at eight
percent of modified total direct costs or at the actual indirect
cost rate, whichever is less.

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, 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 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:

The funds may be expended by the grantee 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 grantee
institution.

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

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
grantee 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
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 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 recipient 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 grantee
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 may be continued 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, review may be carried out by staff within the
awarding institute, 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 grantee institution and career award recipient in
writing of this determination, the reasons therefor, 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.

Budget

Detailed budget for Initial Budget Period - do not complete form
page 4 of the PHS 398 (rev. 5/95).  It is not required nor will it
be accepted at the time of application.  In some cases, it may be
requested prior to award.

Budget for Entire Proposed Period of Support - Do not complete the
categorical budget table on form page 5 in the PHS 398 (rev. 5/95).
Only the requested total direct costs for each year and total
direct costs for the entire proposed period of support should be
shown.  Begin the budget justification in the space provided, using
continuation pages as needed.

Budget Justification

o  List the name, role on project and percent effort for all
project personnel (salaried or unsalaried) and provide a narrative
justification for each person based on his or her role on the
project and proposed level of effort.

o  Identify all consultants by name and organizational affiliation
and describe the services to be performed.

o  Provide a narrative justification for any major budget items,
other than personnel, that are requested for the conduct of the
project that would be considered unusual for the scope of 
research.  No specific costs for items or categories should be
shown.

o  Indirect costs will be calculated at the time of the award at an
eight percent rate or at the institution's actual rate, whichever
is lower.  Applicants will be asked to identify the indirect cost
exclusions prior to award.

o  If consortium/contractual costs are requested, provide the
percentage of the subcontract total costs (direct and indirect)
relative to the total direct costs of the overall project. The
subcontract budget justification should be prepared following the
instructions provided above.

Biographical Sketch

A biographical sketch is required for all key personnel, following
the modified instructions below.  Do not exceed the two-page limit
for each person.

o  Complete the education block at the top of the form page.

o  List current position(s) and those previous positions directly
relevant to the application.

o  List selected peer-reviewed publications directly relevant to
the proposed project, with full citation.

o  Provide information on research projects completed and/or
research grants participated in during the last five years that are
relevant to the proposed project.  Title, principal investigator,
funding source, and role on project must be provided.

Other Support

Do not complete the other support page (form page 7 of the PHS 398,
rev. 5/95).  Instead include information on relevant grant support
within the biosketch for each of the key personnel.  Information on
active support for key personnel will be requested prior to award. 
It is still necessary, however, to provide information about the
research activity of the sponsor and co-sponsor on mentored career
awards.  Information about the level and nature of the sponsor(s)
research support will continue to be used by review committees to
judge the strength of the research environment available to the
candidate during the award period.

Applicants are to provide information on the sponsor's and
cosponsor's current and pending research support relevant to the
candidate's research plan in a table within the section titled
Statement by the Sponsor(s), Consultant(s), and Collaborator(s) in
Section II, Part 2 of the application.  Within this table, the
following information on all related research projects must be
provided: the funding source, the title of the project, the name of
the principal investigator, the dates of the approved or proposed
project, the annual direct costs, and a brief description of the
major goals.

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's Statement

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.

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.

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 subpopulations must be included in all NIH
supported biomedical and behavioral research projects involving
human subjects, unless a clear and compelling rationale and
justification is provided 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 "NIH Guidelines For Inclusion of Women and
Minorities as Subjects in Clinical Research," which have been
published in the Federal Register of March 28, 1994 (FR 59
14508-14513), and in the NIH GUIDE FOR GRANTS AND CONTRACTS of
March 18, 1994, Volume 23, Number 11.

Investigators may obtain copies from these sources or from the
program staff or contact person listed under INQUIRIES.  Program
staff may also provide additional relevant information concerning
the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by February 6, 1998 or
May 22, 1998, a letter of intent that includes a descriptive title
of the proposed research; the name, address and telephone number of
the Principal Investigator; the identities of other key personnel
and participating institutions; and the number and title of the RFA
in response to which the application may be submitted.  Although a
letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information
that it contains allows institute staff to estimate the potential
review workload and avoid conflict of interest in the review.

The letter of intent is to be sent to:

Milton J. Hernandez, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 3C21
Bethesda, MD  20892-7640
Telephone:  (301) 496-3775
FAX:  (301) 402-0369
Email:  mh35c@nih.gov

APPLICATION PROCEDURES

Applications are to be submitted on form PHS 398 (rev. 5/95). 
Application kits are available at most institutional offices of
sponsored research and may be obtained from the Division of
Extramural Outreach and Information Resources, National Institutes
of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910,
telephone 301/435-0714, email: ASKNIH@od.od.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.

The completed, signed original and five legible, single-sided
copies of the application and five copies of the appendices must be
sent or delivered to:

CENTER FOR SCIENTIFIC REVIEW (formerly Division of Research Grants)
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 dates of
March 6, 1998 or June 24, 1998.

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.

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 Advisory Allergy and Infectious Diseases
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 research ethics 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.

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

o  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 alternative tactics?

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 trainee 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 unique features in the institutional environment that can
increase the chances of success?  Are the resources adequate?

o  Is the applicant 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.  Plans for the recruitment and retention of
subjects will also be evaluated.

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

Funding decisions will be made based on the recommendations of the
initial review group and the appropriate national advisory council
and the availability of funds.

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:

Milton J. Hernandez, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 3C21
Bethesda, MD  20892-7640
Telephone:  (301) 496-3775
FAX:  (301) 402-0369
Email:  mh35c@nih.gov

Direct inquiries regarding fiscal matters to:

Barbara Huffman
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 3C25
Bethesda, MD  20892-7640
Telephone:  (301) 496-3821
FAX:      (301) 402-0369
Email:  bh23q@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance Nos. 93.855 and 93.856.  The MRSDA awards are made under
the authority of Title III, Section 301 of the Public Health
Service (PHS) Act as amended.  The Code of Federal Regulations,
Title 42 Part 52, and Title 45 part 74, are applicable to this
program.  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, 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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