MENTORED SCIENTIST DEVELOPMENT AWARD IN RESEARCH ETHICS

Release Date:  January 22, 1999

PA NUMBER:  PA-99-050

P.T.

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

Application receipt date: March 6

PURPOSE

The National Institutes of Health, Centers for Disease Control, Health Resources
and Services Administration, Substance Abuse and Mental Health 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 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 (such as clinical medicine, nursing,
biomedical or behavioral research, or have a background in the humanities), 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.

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 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 responsible conduct of research, 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 þ for post-graduate training in research ethics 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.  Individuals with doctorates in the
humanities are also eligible to apply.

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.  It is important that the mentor be an individual with
established credentials in the field of research ethics.

Applications should be submitted by the candidate directly and should include a
letter of commitment from 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 career in research ethics.  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 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

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, 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; new
risks to participants from developing 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.  Facilities and Administrative Costs:  These costs will be reimbursed at eight
percent of modified total direct costs or at the actual 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 the career award recipient may not
retain research-related activities of this award.  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 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 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. 4/98).  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. 4/98). 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

*  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.
*  Identify all consultants by name and organizational affiliation and describe
the services to be performed.
*  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.
*  Facilities and Administrative 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 cost exclusions prior to award.
*  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.

*  Complete the education block at the top of the form page.
*  List current position(s) and those previous positions directly relevant to the
application.
*  List selected peer-reviewed publications directly relevant to the proposed
project, with full citation.
*  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 of the PHS 398.  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

*  Establish the candidate's commitment to a career in research ethics.
*  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.
*  Summarize the candidate's immediate and long-term career objectives,
explaining how the award will contribute to their attainment.
*  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

*  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

*  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

*  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

*  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.

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 which is available at the following URL
address:  http://www.nih.gov/grants/guide/notice-files/not98-024.html

Investigators may obtain copies from these sources or from program staff listed
in INQUIRIES below who may also provide additional relevant information
concerning the policy.

APPLICATION PROCEDURES

Applications are to be submitted on form PHS 398 (rev. 4/98).  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: GrantsInfo@nih.gov.   Applications are
also available on the World Wide Web at http://www.nih.gov/grants/forms.htm.

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
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 of March 6.

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

*  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

*  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.

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  alternative tactics?

Mentor

*  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

*  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?
*  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:

*  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 human participants will also be
evaluated.
*  The reasonableness of the proposed budget and duration in relation to the
proposed activities.
*  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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