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

SHORT-TERM COURSES IN RESEARCH ETHICS

Release Date:  September 27, 2001

PA NUMBER:  PAR-01-143

National Institutes of Health
 (http://www.nih.gov/)
Centers for Disease Control and Prevention
 (http://www.cdc.gov/)
Agency for Healthcare Research and Quality
 (http://www.ahrq.gov/)

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

PURPOSE

The National Institutes of Health (NIH), the Centers for Disease Control and 
Prevention (CDC), and the Agency for Health and Research Quality (AHRQ) invite 
applications for grants to develop, conduct, evaluate, and disseminate short-
term courses on ethical issues in research, particularly those involving human 
participants. Courses should improve the skills of biomedical, behavioral, 
nursing, social science, and public health researchers in identifying and 
addressing the ethical, legal, and social implications of their research, 
especially when human participants are involved.

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), Short-
Term Courses in Research Ethics, is related to all priority areas.  Potential 
applicants may obtain a copy of  Healthy People 2010" at 
http://www.health.gov/healthypeople/.

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

This PA will use the NIH Continuing Education Training Grant (T15) award 
mechanism, which funds institutions to establish or expand programs of 
continuing professional education.  Research ethics courses may be of any 
duration as long as they are consistent with the goals of the proposed 
program.  For organizations wanting to teach research ethics courses, such 
courses should be offered at least once a year.  Courses can be developed for 
the Internet, video, or other formats.

Responsibility for the planning, direction, and execution of the proposed 
curriculum 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 those 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.  Attendees may be recruited locally (at the grantee 
institution), regionally, or nationally.  The facilities and administration 
rate for T15 awards is eight percent.

RESEARCH OBJECTIVES

Background

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

The vast majority of collaborations between research participants and 
scientists in biomedical, behavioral, nursing, social science, and public 
health research that have led to important advances in health care and life 
expectancy, 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 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 advances and ethical 
acceptability is the responsibility of investigators who design, conduct, 
analyze, and disseminate the results of research.

Although researchers must have an understanding of ethical issues that pertain 
to research, most are presented with few opportunities to obtain and develop 
this knowledge. Academic training through specialized curricula related to 
research ethics can provide a key learning opportunity in this area, this 
program announcement is one step in this 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 biomedical, behavioral, nursing, social science, and 
public health researchers in identifying and addressing the ethical, legal, 
and social implications of their research, especially research 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.  Further, applicants are encouraged to propose innovative programs 
with new approaches to the teaching and learning of research ethics.

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

o  Practical problems arising in the design and conduct of research, using 
case studies that illustrate problems faced by investigators.

o  Issues in handling the needs of specific populations participating in 
research, including women or minorities, populations with special needs, such 
as pregnant women, children, prisoners, or persons who may be mentally or 
physically challenged, or those whose capacity to make decisions freely is not 
clear.  Applicants should discuss their expertise and competency to study 
racial and ethnic minority groups.  Curricula must reflect understanding of 
cultural values, beliefs, and practices.

o  International issues in research ethics, including those arising in the 
conduct of clinical trials in the developing world.

o  Theoretical approaches to understanding ethical, legal, and social issues. 
 These might include the principle-based approach, risk/benefit assessments, 
informed consent process, privacy and confidentiality, and methods to 
recognize and respond to vulnerability of human participants.

o  Issues arising in the context of institutional review board (IRB) review, 
for example, training for IRB members in both traditional areas of protocol 
review and areas such as genetic epidemiology, the use of stored tissue, and 
the needs of special populations.

All courses should be developed to meet the needs of junior or senior 
biomedical and behavioral researchers.  Each individual area of the 
application should be addressed in sufficient depth to show how it 
significantly improves the attendees" 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, nursing, 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.  It is important for one or more of the scientists involved 
in the proposed program to actually have recognized expertise in the field of 
research ethics.

Applicants to this program will be required to disseminate their educational 
materials widely. Applicants should describe what specific mechanisms they 
will employ for dissemination.  In the case of internet-based materials, 
applicants are encouraged to submit plans on how these materials will be 
advertised and made available to the appropriate communities and evaluated for 
effectiveness.

Applications from institutions seeking to implement a program with a large 
target population of researchers are encouraged to apply.  Although others are 
eligible to apply, priority will be given to those applications reaching a 
broad audience.

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

Proposals for courses should include clear plans for evaluating the 
effectiveness of the course(s) in terms of attendees" perceptions of the 
material and conduct of the course.  Importantly, there must be plans for 
assessing the longer-term impact, as measured by attendees" subsequent 
activities or responsibilities in their institutions in the areas of research 
bioethics.  For example, assessments might 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.

SPECIAL REQUIREMENTS

The participating agencies will organize a bi-annual meeting of course 
developers and course instructors to exchange information about effective 
approaches to teaching research ethics and sharing course materials.  The 
applicant should include a request for funds to support the travel of the 
principal investigator and a small number of other course participants to the 
Washington, DC, area to attend this meeting.

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 updated Guidelines are 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.

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 RFA 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 PHS 398 research grant application instructions and forms (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html are to 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 301/710-0267, Email: [email protected].

Applicants planning to submit an investigator-initiated new (type 1), 
competing continuation (type 2), competing supplement, or any amended/revised 
version of the preceding grant application types requesting $500,000 or more 
in direct costs for any year are advised that he or she must contact the 
Institute or Center (IC) program staff before submitting the application, i.e, 
as plans for the study are being developed.  Furthermore, the application must 
obtain agreement from the IC staff that the IC will accept the application for 
consideration for award.  Finally, the applicant must identify, in a cover 
letter sent with the application, the staff member and Institute or Center who 
agreed to accept assignment of the application.  This policy requires an 
applicant to obtain agreement for acceptance of both any such application and 
any such subsequent amendment.  Refer to the NIH Guide for Grants and 
Contracts, March 20, 1998 at 
http://grants.nih.gov/grants/guide/notice-files/not98-030.html

Applicants should employ the forms and format for Institutional National 
Research Service Award, described in section V of Form PHS 398.  However, 
because section V provides instructions for submitting a traditional training 
grant (T32) and the present T15 mechanism is considerably different, 
applicants are encouraged to modify the format appropriately.  In addition, 
applicants should use the budget format for research grants (section I, pages 
DD and EE), for the present T15 application.

The title and number of the program announcement must be typed on line 2 of 
the face page of the application form 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)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral 
guidelines.  Applications will be evaluated for scientific and technical merit 
by an appropriate scientific review group convened in accordance with the 
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 applications under review, will be discussed, assigned a 
priority score, and receive a second level review by the appropriate national 
advisory council or board.

Review Criteria

The review criteria for the Short-term Courses in Research Ethics will 
include:

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 trainees and for awarding scholarships, for 
publicizing the availability of the course to the target audience of active 
researchers, and plans to reach out to underrepresented investigators.
o  Plans for evaluating the effectiveness and the extent of dissemination of 
the course.
o  Plans for disseminating curricula to a broad audience.
o  Adequacy and availability of any necessary institutional facilities, such 
as the library and computer resources.

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

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

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

Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.

Inquiries regarding programmatic issues may be directed to:

Lawrence Friedman, M.D.
National Heart, Lung, and Blood Institute 
Building 31, Room 5A03
Bethesda, MD  20892-2482
Telephone:  (301) 496-9899
FAX:  (301) 402-1056
Email: [email protected]

Direct inquiries regarding fiscal matters to:

Suzanne White
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7154
Bethesda, MD  20817-7926
Telephone:  (301) 435-0171
FAX:  (301) 480-3310
Email:  [email protected]

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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