Bioethics
and the NIH
This page
is an effort to bring together all web-based resources at the NIH having
to do with bioethics.
Offices and Programs - NIH organizations
that deal directly bioethical issues
Research
Resources - starting points for bioethics research provided by NIH
Bioethics
Documents - guidelines, FAQs, fact sheets, position statements,
and reports
Educational
Opportunities - tutorials, training courses, and intramural events
Funding
for Bioethics Research
- grants for bioethics projects
Funded Training Courses and Publications
- short courses in research ethics funded by NIH
Named Populations
in Genetic Studies
Protection of Third Party
Information in Research
Trans-NIH
Bioethics Committee (T-NBC) - contributes directly to the agency's
policy development and decision-making processes by provided an ongoing,
coordinated approach to the consideration of ethical, legal, and social
implications of NIH-funded research. T-NBC is coordinated by the Office
of Science Policy.
NIH
Inter-Institute Bioethics Interest Group -
a discussion group of scientists, ethicists, IRB members, policy makers,
and others interested in bioethics. Established in 1997, the group has
monthly meetings for the discussion of a wide range of topics in bioethics,
especially in research ethics. Although primarily intended for the NIH
community, the Interest Group has a large public membership.
Office of the Director (OD) - the administrative locus of the
NIH. The OD coordinates the activities of the 25 national institutes
and centers in both the intramural (on site) and extramural (off site)
research programs. The following offices are located within the OD:
Office
of Science Policy and Planning (OSPP) - as the principal site
for science policy and planning for the NIH, OSPP coordinates
the Trans-NIH
Bioethics Committee (T-NBC) as well as activities in science
policy, planning, biomarkers, and economic studies.
Office
of Biotechnology Activities (OBA) - monitors scientific progress
in human genetics research in order to anticipate future developments,
including ethical, legal, and social concerns, in basic and clinical
research involving Recombinant DNA, Genetic Testing, and Xenotransplantation.
It also manages the operation of the NIH Recombinant DNA Advisory
Committee (RAC), the DHHS Secretary's Advisory Committee on Genetic
Testing (SACGT), and the DHHS Secretary's Advisory Committee on
Xenotransplantation (SACX).
Office
of Extramural Research (OER) - NIH devotes 80-85 percent of its
total budget ($17
billion FY '00) to extramural research. The grants support biomedical
and behavioral research and research training by more than 50,000 scientists
located at more than 1,700 universities, research institutions, and
medical centers across the United States and abroad. OER's site provides
resources on human subjects protections and grant policy and guidance.
Office
of Laboratory Animal Welfare (OLAW) - is responsible for all of
the animal-related functions of the former OPRR, including implementing
and interpreting the Public Health Service Policy on Humane Care and
Use of Laboratory Animals, administering an educational program for
PHS-supported institutions and investigators, negotiating Animal Welfare
Assurances, and evaluating compliance with the PHS Policy. The web site
provides guidance, news flashes, policies and laws, and useful links.
Office
of Legislative Policy and Analysis (OLPA) - serves as the principal
office within the Office of the Director (OD) for providing legislative
analysis, policy development, and liaison with the Congress. Webpage
provides reports, a listing of legislation in which the NIH is involved,
and information on NIH participation in congressional hearings.
Ethical, Legal, and Social
Implications (ELSI) Program of the National Human Genome Research
Institute (NHGRI) - established in 1990 to to identify, analyze, and
address the ethical, legal, and social implications of the Human Genome
Project (HGP) at the same time the basic science issues are being studied.
The web site provides background information, press releases, links
to genome ethics policy and legislation and off-site funding for genome
ethics research.
Department of Clinical Bioethics (DCB)
of the Walter Grant Magnuson Clinical Center. The Department has 3 sections: ethics of human
subjects research; ethics of health policy; and ethical issues in
genetics. The Department conducts research in each of these
areas. It provides ethics consultation services for the Clinical
Center, as well as a variety of educational courses and seminars.
The Office of Genome Ethics in the Division of Intramural Research at NHGRI -
seeks to assist intramural researchers at the NHGRI to identify and to address ethical issues arising from genome research.
National Institute of Environmental
Health Sciences (NIEHS) Research Ethics Web Site - provides a colloquium
on research ethics, a directory of resources in genetics and
ethics, and contains the NIEHS IRB web page.
Bioethics
Consult Service - made up of members of the Department of Clinical
Bioethics and the Clinical Center Ethics Committee who listen and
provide advice regarding the ethical concerns of patients, their families,
and health care providers in the Clinical
Center.
Office of Human Subjects Research
(OHSR) - was established to help intramural investigators understand
and comply with the ethical guidelines and regulatory requirements for
research involving human subjects. The site provides the federal regulations
for the protection of human subjects, the text of the Belmont Report,
and a computer-based training program: Protecting Human Subjects in
the IRP (Intramural Research Program), NIH.
John
E. Fogarty International Center (FIC)
- serves as the organizational locus for NIH international activities.
The Center fosters research partnerships between American scientists
and foreign counterparts and explores the ethical issues of international
clinical trials through its International
Research Bioethics Initiatives.
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Ethical Issues
in Research Involving Human Participants - A comprehensive bibliography
with over 4,650 citations; also includes other issues in bioethics.
The site is maintained by the National Library of Medicine.
ClinicalTrials.gov - recently
released (March 2000), this web site by the National Library of Medicine
and the NIH allows the public to search for clinical trials by title
and funding organization.
NIH
Health Information - NIH provided information on clinical trials
and a variety of different health information.
The National Library of Medicine
- provides several search engines including PubMed, MEDLINE, and Grateful
Med.
Library Literature
and Resources (for NIH use only) - contains electronic resources
and databases
NIH
Draft Statement on Sharing Research Data
NHLBI Data
Sharing Policies and Resources
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General
NIH
Press Releases - current
and past
NIH Stem Cell Information
- draft guidelines for research, primers, testimony, and press releases
National Standards to Protect the
Privacy of Personal Health Information - from
the Department of Health and Human Services
Protection of Participants in Behavioral and Social Sciences
Research - from the NIH Office of Behavioral and Social Sciences Research
Reports
by the Office of Legislative Policy and Analysis
Centerwatch Clinical Trials
Listing Service- provides
information related to clinical trials and is designed to be a resource
both for patients interested in participating in clinical trials and for
research professionals.
Clinical
Research
Information
Sheets, Forms, and Checklists - provided
by the Intramural Office of Human Subjects Research at the NIH
Guidelines
for the Conduct of Research Involving Human Subjects at the National
Institutes of Health
- provided by the Intramural Office of Human Subjects Research
New
Federalwide Assurance and IRB Registration Web site
Human
Subjects Research Enhancement Awards - from the Office of Extramural Research at the NIH, a website providing information on this program
that provides short-term support for institutional activities that will strengthen oversight of human subjects research.
Research
Involving Individuals with Questionable Capacity to Consent: Points
to Consider - a report (interim) by the Office of Extramural Research
(November, 1998)
Question
and Answers about the NIH Policy and Guidelines on the Inclusion of
Children in as Participants in Studies Involving Human Subjects
Research on Human
Specimens: are you conducting research using human subjects? - provided
by the National Cancer Institute (NCI) of the NIH.
Belmont
Report - Ethical Principles and Guidelines for the Protection of
Human Subjects of Research (April 18, 1979)
45-CFR-46
- Protection of Human Subjects (The Common Rule) - (Code of Federal
Regulations effective August 19, 1991)
Genetics
Ethical, Legal, and Social Implications Program of the National Human
Genome Research Institute: 1)
Public Affairs News, Information, and Events, 2)
Press Release Archive, 3)
Task Force and Workshop Reports, and
Grant Products and Publications
Executive
Order "To Prohibit Discrimination in Federal Employment Based on
Genetic Information - NHGRI (February
8, 2000)
Grants
and Funding
New
Federalwide Assurance and IRB Registration Web site
To
NIH Grantees and Applicants: Notice of Amendment to A-110 - the
Office of Management and Budget (OMB) Circular A-110 has been revised
to provide public access under some circumstances to research data through
the Freedom of Information Act (FOIA).
NIH
Initiative to Reduce Regulatory Burden
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Educational
and Training Opportunities in Bioethics at the NIH
Online tutorial for intramural
researchers on the protection of human research subjects provided
by NIH's Office of Human Subjects Research.
A continuing education program on the protection of
human participants in research is available online at
http://cme.nci.nih.gov. This program is
developed by the National Cancer Institute in collaboration with several
other NIH Institutes and offices.
cancerTrials - a clinical
trials information resource from the National Cancer Institute (NCI).
The web page provides a guideline to understanding informed consent,
templates for informed consent documents, related links, and tools for
performing clinical trials.
Division
of AIDS Ethics page - of NIAID provides links to several online
articles on the ethics of HIV/AIDS clinical trials.
NIH Office of Science Education
- sponsors presentations and educational activities involving bioethics.
The Office of Science Education
at NHGRI Division of Intramural Research was
established to increase the working knowledge of human genetics and
genetic technologies among the general public, health care professionals,
media, educators and students.
Current
and upcoming Ethics Grand Rounds at
the Warren Grant Magnuson Clinical Center. Click here
for past rounds.
Training
in the Responsible Conduct of Research - provided by the OER
- includes research policies and training opportunities. Links to fellowships,
training grants, NRSA policy issues, programs for special populations,
and educational programs for the responsible conduct of research are
provided.
Research and Training Opportunities
at the NIH - extramural and intramural student, postdoctoral, clinical, and tenure-track
opportunities.
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Funding
for Research and Training in Bioethics Provided by the NIH
Research
on Ethical Issues in Human Studies (R01) -
Program Announcement (PA) sponsored by 21 Institutes, Agencies, and
offices inviting research grant applications (R01) for support to conduct
research on ethical issues that arise with research involving human
participants.
The
International Bioethics Education and Career Development Award (R25)
- Program Announcement (PA) sponsored by the NIH Fogarty International
Center to develop or expand on current graduate curricula in international
bioethics related to performing research in in low- and middle-income
nations.
Short
Term Courses in Research Ethics (T15) - supported by the NIH,
CDC, AHQR, and HRSA to 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.
Predoctoral and Postdoctoral Fellowships
are offered by the Department of Clinical Bioethics
of the Walter Grant Magnuson Clinical Center.
ELSI
Program Announcement Ethical, Legal and Social Implications of Human
Genetics Research Program sponsored by NHGRI, NIMH, and
NINR.
Studies of the Ethical,
Legal, and Social Implications (ELSI) of Human Genetic Variation Research for Individuals and Diverse
Racial and Ethnic Groups
A comprehensive updated
and annotated list of currently available announcements (Use search
phrase "ethics" or "bioethics")
Computer Retrieval
of Information on Scientific Projects(CRISP) - a database of available
and historical award information funded by NIH, SAMHSA, HRSA, FDA,
CDCP, AHQR, and OASH. (Use search phrase "ethics" or "bioethics").
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Funded Training
Courses and Publications
Teaching
Research Ethics - a three-day workshop at Indiana Univeristy-Bloomington.
Topics include ethical theory, human subjects, animal subjects, responsible
data management, misconduct in science, using case studies, using short
writing assignments, assesing student learning, and model curricula
in research ethics.
Examples of short courses in research ethics funded under an initiative mandated
by President Bill Clinton at his apology
to the victims of the Tuskegee Syphilis Study on May 16, 1997 (additional examples
can be found on the T15 Grant website):
Scientists
and Subjects: A Web-based Seminar on the Ethics of Research with Human
Subjects - The Poynter Center for the Study of Ethics and American
Institutions, Indiana University. A three-day retreat at Indiana University-Bloomington
followed by a 3-4 month seminar delivered via the World Wide Web.
Ethics in
Research Focussing on Behavioral Health Services
- University of South Florida. A
four-day, intensive training course focusing on ethical and legal issues
that arise when vulnerable populations, particularly people with severe
mental illness, are research participants.
Ethics
of Research with Humans: Past, Present, & Future - University of
Washington. This one-week course is an intensive introduction to ethical
issues in research with humans. It is directed to, and registration
is limited to, members and managers of IRB committees, active researchers
from any discipline who currently conduct research with human participants,
and other research professionals who are significantly involved in designing
and executing human research protocols.
Program on Ethical
Issues in International Health Research - Harvard School of Public
Health. This program is directed to any individual or organization who
will fund, approve, conduct, or collaborate in health research, providing
an opportunity to explore ethical issues in international health care
through lectures, discussions, and case analysis.
Short
Course on Racial and Ethnic Minorities as Research Subjects: Challenges
for Research Ethics - American Association for the Advancement of
Science, University of Wisconsin, and Tuskegee University. The course,
to be held in the Washington D.C. area and at the Tuskegee Institute,
will help researchers identify barriers, such as varying communication
patterns and expectations that may impede minority participation in
research, provide examples of strategies for overcoming those barriers,
examine successful and unsuccessful attempts at building relations of
trust, and identify resources where researchers can obtain additional
information.
Research Ethics
in the Clinical, Biomedical, and Public Health Sciences - University
of Illinois at Chicago, College of Medicine. Program provides a lecture
series, workshops, short courses, semester courses, bibliographies,
videocassette materials, and anthologies.
Funded
ELSI Grants (1990 to present)
- a list of abstracts of funded ELSI grants (over 175 since 1990) and
accompanying list of grant products and publications that have come
from these grants.
Computer Retrieval
of Information on Scientific Projects(CRISP) - a database of available
and historical award information funded by NIH, SAMHSA, HRSA, FDA,
CDCP, AHQR, and OASH. (Use search phrase "ethics" or "bioethics").
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Last
updated: 04/30/03
10:35 AM
