Directory
Research
Ethics Human Subjects Research and IRBs
Policies and Regulations Guidance for Investigators IRB Resources Short Courses on Bioethical
Issues in Human Studies Research Resources Go to
Human Subjects Research Tutorials Go to Responsible
Conduct of Research Page Policies and Regulations
NIH Grants
Policy and Guidance
News Flashes from the
NIH Office of Extramural Research
Required
Education in the Protection of Human Research Participants
Procedures for
Registering Institutional Review Boards IRBs and Filing Federalwide
Assurances of Protection for Human Subjects (FWAs) - provided by the
Office for Human Research Protections (OHRP).
Approval
Process for the Use of Human Pluripotent Stem Cells in NIH-Supported
Research
DHHS Policy on Instruction in the Responsible Conduct of Research -- Suspended
Federal Regulations
for the Protection of Human Subjects - provided by the Office
for Human Research Protections (OHRP).
45-CFR-46
- Protection of Human Subjects - (Code of Federal Regulations effective
August 19, 1991) sometimes referred to as the "Common Rule".
International Ethical Guidelines,
Codes, and Declarations - as listed on this web site.
Canadian
Tri-council Policy Statement: Ethical Conduct for Research Involving Humans
- describes the policies of Canada's Medical Research Council
(MRC), the Natural Sciences and Engineering Research Council (NSERC),
and the Social Sciences and Humanities Research Council (SSHRC).
Guidance for Investigators
Office for Human Research Protections
- formerly the Office for Protections from Research Risks (OPRR). The
Office provides guidance and oversight for human subjects research conducted
with Public Health Service (PHS) funds. This site contains the IRB
Guidebook, federal
regulations, guidance
and educational materials, as well as sample informed
consent and assurance
documents.
Information Sheets
for the Guidance of IRBs and Clinical Investigators - provided by
The Food and Drug Administration (FDA). Topics include, among
others: answers to FAQs, informed consent guidance, list of various
regulations and their differences, and information on continuing review.
Information
for Clinical Investigators - provided by the Center for Drug
Evaluation and Research of the FDA.
Interpreting the
Common Rule for the Protection of Human Subjects for Behavioral and
Social Science Research - provided by the National Science
Foundation.
The
Department of Energy (DOE) Protecting Human Subjects - page has
links to human subjects policies and regulations, educational information
and resources, genome research resources, a national conference calendar,
computer-based training for human subjects researchers, as well as links
to the DOE Human Subjects Working Group, Research Projects Data Base,
Worker Health Related Studies, the Human Radiation Experiments, and
soon, a site for Scientific Integrity.
Centers for Disease Control and Prevention Human Subjects Research
Page - provides human subjects regulating documents, ethical guidelines
for the protection of human subjects, and IRB checklists and forms.
Human Research Report
- a monthly newsletter on research ethics and compliance published by
the Deem Corporation.
Investigator Manual
for the Protection of Human Subjects - published by University
of California, Los Angeles
Institutional Review Board (IRB) Resources
The IRB Forum - a
forum sponsored by the Medical College of Wisconsin that promotes
the exchange of ethical, regulatory, and policy concerns of human subjects
research
The
IRB Guidebook
- provided by the Office for Human Research Protections
Public Responsibility in Medicine and
Research (PRIM&R;) - a national organization dedicated to providing
a multidisciplinary forum for addressing biomedical and bioethical issues.
University of California
San Francisco (UCSF) Committee on Human Research - contains policies
and procedures, national and international guidelines, and links to
other IRB web sites
The Medical School IRB of
the University of Michigan - this site contains links to human subjects
research pages, federal regulatory policies, and key ethics source documents
Stanford University
Research Policy Handbook - on the use of human subjects.
University of California Los Angeles
(UCLA) Office for the Protection of Research Subjects - includes
their comprehensive Investigator
Manual for the Protection of Human Subjects
Office of Research Integrity at the University of Kentucky - site provides links to regulations
and research integrity information
Human Research Report
- a monthly newsletter on research ethics and compliance published by
the Deem Corporation.
Fred Hutchinson Cancer
Research Center Institutional Review Office- site provides extensive
information about the purpose and necessity of IRB review.
University of Minnesota
(IRB/IACUC)- access to a "Human Subjects Guide" as well as
consent and application forms.
University
of Miami IRB Home Page- site contains information on the protection
of human subjects in research, as well as necessary forms and guidelines
for conducting such research.
University
of California, San Francisco Committee on Human Research- links to
information on the consent process, federal regulations, training,
outside resources and more.
Short Courses on Ethical Issues in Human Studies
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, assessing student learning, and model curricula
in research ethics.
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 (T15 Grants):
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.
Research Resources
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.
Resources
on Nonconsensual Human Experimentation - page contains links to
resources on human experimentation including the Tuskegee Experiment,
Experiments by Nazi doctors, Atomic Energy Commission experiments, and
general human experimentation resources. Page is maintained by Steven
Hale at DeKalb College.
DOE
Office of Human Radiation Experiments - established in March 1994,
leads the Department of Energy's efforts to tell the agency's Cold War
story of radiation research using human subjects. The web site provides
historical information, multimedia clips, a searchable database, and
related links.
Responsible Research:
A Systems Approach to Protecting Research Participants - a report from the Institute of Medicine's Committee
on Assessing the System for Protecting Human Research Participants, published by the National Academies Press in 2002.
Last updated: 12/06/02 2:45 PM