SHORT-TERM COURSES IN RESEARCH ETHICS

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

PA NUMBER:  PAR-98-005

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 (NIH), Centers for Disease
Control (CDC), Health Resources and Services Administration (HRSA),
and the Agency for Health Care Policy and Research (AHCPR) invite
applications for grants to develop, conduct, and evaluate short-
term courses on ethical issues in research, particularly those
involving human participants. Courses should improve the skills of
biomedical, behavioral, social science, and public health
researchers in identifying and addressing the ethical, legal, and
social implications of their research, especially when human
subjects are involved.

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 fellowships - 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, Short-Term Courses in Research Ethics, is related
to all twenty-two priority areas.  Potential applicants may obtain
a copy of "Healthy People 2000" (Full Report:  Stock Number
017-001-00474-0 or Summary Report:  Stock Number 017-001-00474-1)
through the Superintendent of Documents, Government Printing
Office, Washington, DC 20402-9325 (Telephone 202-512-1800).

ELIGIBILITY

Applications may be submitted by domestic for-profit and non-
profit, public and private organizations, such as universities,
colleges, hospitals, laboratories, units of state and local
governments, and eligible agencies of the Federal government. 
Racial and ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as principal investigators.

MECHANISM OF SUPPORT

Support for this program will be provided through the Continuing
Education Training Grant (T15), which funds educational
institutions to establish or expand programs of continuing
professional education.  Grantees may develop, offer, and/or
evaluate research ethics courses ranging from three days to six
weeks in duration.  For organizations wanting to teach research
ethics courses, such courses should be offered at least once a
year.  Alternatively, courses could be developed that would be made
available to the student on the Internet, on video, or in another
distance-learning format.

Responsibility for the planning, direction, and execution of the
proposed research will be solely that of the applicant.

Applicants may request up to three years of support.  Allowable
costs include personnel, supplies, travel and per diem for faculty,
and other costs, such as printing, telephone, audio-visuals,
postage, recruitment materials, and computer software.  In
addition, travel and per diem funds for students attending courses
developed by grantees are appropriate when necessary.  However, it
is expected that courses will be partially supported through
registration fees paid for by the attendees.  Students may be
recruited locally (at the grantee institution), regionally, or
nationally.  The indirect cost rate for T15 awards is eight
percent.

RESEARCH OBJECTIVES

Background

Advances in preventing and controlling human diseases require
dedicated scientists and, frequently, altruistic volunteers who
participate in human experimentation.  Medical advances must be
made through a productive and respectful partnership between
researchers and participants.

The vast majority of collaborations between patients and scientists
in biomedical, behavioral, social science, and public health
research that have led to important advances in health care and an
improvement in the quality of life have occurred through such a
partnership.  At the same time, there have been some highly visible
cases of serious lapses in the ethical conduct of research
involving human participants.  Examples such as the Tuskegee
syphilis study, the Willowbrook State School experiments, and the
recently described Cold War radiation experiments remind the public
and researchers alike that protection of participants must be of
the highest priority.  Balancing the dual goals of scientific merit
and ethical acceptability is the responsibility of investigators
who design, conduct, review, fund, and disseminate the results of
research.

Though researchers must have an understanding of ethical issues,
most are presented with few opportunities to develop this
knowledge. Academic training through specialized curricula can
provide a key learning opportunity in this area; this program
announcement is one step in this important direction.

Research Objectives and Scope

The objective of this grant program is to support the development,
conduct, and evaluation of short-term courses on ethical issues in
research, particularly research involving human participants.  The
courses should improve the skills of active biomedical, behavioral,
social science, and public health researchers in identifying and
addressing the ethical, legal, and social implications of their
research, especially that involving human participants.  The long-
term objective is to increase the number of researchers who have
both awareness and skills in the ethical aspects of such research.

There are many topics in research ethics that can benefit from the
short course approach.  The following are examples of types of
courses that could be of value; they are not inclusive:

o  Courses that address practical problems arising in the design
and conduct of research; examples include the use of case studies
that illustrate problems faced by investigators.

o  Courses that address issues in handling the needs of specific
populations participating in research, for example, women or
minorities; populations with special needs, such as pregnant women,
children, prisoners, or persons who may be mentally or physically
challenged; or cases in which the subject's ability to make
decisions freely is not clear.

o  Courses that explore theoretical approaches to understanding
ethical, legal, and social issues in research involving human
participants, such as courses describing the principle-based
approach (e.g., respect for persons, beneficence, non-maleficence,
and justice) to resolve issues that arise in research; and courses
that explore ethics procedures used in research such as
risk/benefit assessments, informed consent, privacy and
confidentiality, and vulnerability.

o  Courses that address issues arising in the context of  initial
review board (IRB) review, for example, training for IRB members in
both standard areas of protocol review and new and emerging areas,
including genetic epidemiology, the use of stored tissue, or the
needs of special populations.

All courses should be developed to meet the needs of junior or
senior biomedical and behavioral researchers.  Courses need not be
comprehensive in the sense of covering a large number of issues in
research ethics; courses that address single issues or a small
number of issues in depth are also appropriate.  If an institution
wishes to offer a comprehensive course, each individual area should
be addressed in sufficient depth to show how it significantly
improves the participants' skills in addressing the ethical, legal,
and social implications of research.

In both developing and teaching courses, grantees are encouraged to
take an interdisciplinary approach and involve biomedical,
behavioral, social science, and public health investigators
experienced in addressing research ethics as well as scientists and
scholars in ethics, philosophy, law or other relevant fields in the
humanities.

Grantees should also address plans to include participants from
groups currently underrepresented in the field of research ethics.

Proposals for courses should also include clear plans for
evaluating the effectiveness of the course(s) in terms of students'
perceptions of the material and conduct of the course and,
importantly, the longer-term impact as measured by participants'
activities or responsibilities in their institutions in the areas
of research bioethics.  For example, assessments should address
whether course participants are assuming more leadership
responsibility in research bioethics as shown by membership on
ethics review committees, IRBs, and other such groups at their
institutions.

SPECIAL REQUIREMENTS

The participating agencies anticipate organizing an annual meeting
of course developers and course instructors to exchange information
about effective approaches to teaching research ethics, including
the sharing of course materials that may be widely useful. 
Requests for funds to support the travel of the principal
investigator and a small number of other participants to the
Washington, DC, area to attend this meeting should be included in
the application.

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 are provided that such inclusion is inappropriate
with respect to the health of the subjects of 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 the NIH Guide for Grants and Contracts, Vol. 23,
No. 11, March 18, 1994.

Investigators may obtain copies from these sources or from the
program staff listed under INQUIRIES.

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 the grant application 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, National
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD
20892-7910, telephone (301) 710-0267, email: asknih@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  20817-7710 (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 review criteria for the Short-term Courses in Research Ethics
will include:

o  Overall scientific and didactic merit.

o  Need for the course and its potential effectiveness in training
researchers in awareness of the ethical issues associated with
research.

o  Quality of the course content and adequacy of the syllabus.

o  Training, experience, and competence of the faculty in the
ethical issues applicable to this program.

o  Criteria for selecting participants and for awarding
scholarships, for publicizing the availability of the course to the
target audience of active researchers, and plans to outreach to
minority investigators.

o  Plans for evaluating the effectiveness of the course.

o  Adequacy and availability of any necessary institutional
facilities, such as the library.

o  Appropriateness of the requested budget for the proposed course.

AWARD CRITERIA

Funding decisions will be based on the recommendations of the
initial review group and the National Advisory Allergy and
Infectious Diseases Council regarding scientific and programmatic
merit as well as the availability of funds.

INQUIRIES

Written and telephone inquiries are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is
welcome.

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.  Awards are made under the
authority of Title III, Section 301 of the 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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