External Links
Below are links to external sites that contain information on IRB processes,
guidelines, and news. These sites are not affiliated with the University
of Indianapolis.
- Advertising for and Recruiting Study Subjects
- Belmont Report
On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed
into law, there-by creating the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research. One of the charges
to the Commission was to identify the basic ethical principles that should
underlie the conduct of biomedical and behavioral research involving human
subjects and to develop guidelines which should be followed to assure that
such research is conducted in accordance with those principles.
- Belmont Report Historical Archive
The Belmont Archive includes the following:
- Belmont Report Oral History Interviews: transcripts of interviews with
members, staff and consultants of the National Commission for the Protection
of Human Subjects of Biomedical and Behavioral Research (1974-78); OHRP
will soon add the video versions of these interviews
- Training Video: a 9-minute educational/training video with highlights
from the Oral History interviews
- Commemorative Program Video: a one-hour edited version of the November
16, 2004 Department of Health and Human Services (HHS) ceremony honoring
the members, staff and consultants of the National Commission
- History of the Belmont Report: a short history of the Belmont Report
and the current human subject protection regulations
- Categories of Research Federally Classified as Exempt
Research which may be classified as “exempt” from IRB review is
described in 45 CFR 46.101B (Common Rule). The University of Indianapolis
IRB will “in most instances” review research in these categories
using an “expedited” process. Consistent with Federal Regulations,
it is the responsibility of the IRB to make the final determination regarding
the review “status” of research protocols.
- Categories of Research that may be Reviewed by the IRB through
an Expedited Review Procedure
Research activities that (1) present no more than minimal risk to human
subjects, and (2) involve only procedures listed in one or more of the following
categories, may be reviewed by the IRB through the expedited review procedure
authorized by 45 CFR 46.110 and 21 CFR 56.110.
- Definition of Research: Federal Policy for the Protection of Human Subjects
Research means a systematic investigation, including research development,
testing and evaluation, designed to develop or contribute to generalizable
knowledge. Activities which meet this definition constitute research for
purposes of this policy, whether or not they are conducted or supported
under a program which is considered research for other purposes. For example,
some demonstration and service programs may include research activities.
- FDA Guidance for Institutional Review Boards and Clinical Investigators:
1998 Update
These information sheets from the Federal Drug Administration (FDA) provide
guidance in the following areas: Charging Participants for Investigational
Products; Recruitment of Study Subjects; Payment to Research Subjects; and
Screening Tests Prior to Study Enrollment
- Guidance for Institutional Review Boards and Clinical Investigators
The U.S. Food and Drug Administration Guidance Update for IRB Boards and Investigators.
- IRB Guidebook Online
The impetus for developing this Guidebook for Institutional Review Boards
(IRBs) was a finding of need by the President's Commission for the Study
of Ethical Problems in Medicine and Biomedical and Behavioral Research.
In its 1981 report, Protecting Human Subjects: The Adequacy and Uniformity
of Federal Rules and their Implementation, the Commission stated that it
“is clear that researchers and IRB members desire help both in understanding
the policies and principles that underlie the regulations governing research
with human subjects, and in identifying the issues to which one should be
sensitive in designing or reviewing research proposals”.
A first edition of the Guidebook was produced in the early 1980s under
contract for the President's Commission by Public Responsibility in Medicine
and Research (PRIM&R). PRIM&R is a Boston-based, nonprofit organization
that sponsors annual conferences on topics related to the protection of
human subjects.
The present Guidebook is a revised, updated, and expanded second edition,
prepared under contract by Robin Levin Penslar, Research Associate at the
Poynter Center for the Study of Ethics and American Institutions, in consultation
with the Office for Protection from Research Risks and its numerous advisors.
The Poynter Center is an independent ethics center housed at Indiana University.
- Office for Human Research Protections
The Office for Human Research Protections (OHRP) is a division of the US
Department of Health and Human Services (DHHS). From the OHRP web site,
educational materials, policy statements and contact information is available.
- Office of Human Subjects Research: Regulations and Ethical Guidelines
Important foundational documents regarding legal and ethical aspects of
human subjects research found on this site include the Belmont Report, Nuremberg
Code, World Medical Association Declaration of Helsinki & Guidelines
for the Conduct of Research Involving Human Subjects (45 CFR 46)
- Prisoners Involved in Research (45 CFR part 46, subpart C)
- Federal Register Notice for waiver of certain provisions of 45 CFR part
46, subpart C, for HHS-conducted or supported epidemiologic research involving
prisoners as subjects
- OHRP Guidance on the Involvement of Prisoners in Research
- Recent News In Research With Human Subjects
This site includes links to articles about recent news in research with
human subjects. These articles are from newspapers across the country.
- Subtitle A—Department of Health and Human Services Part 46--Protection
of Human Subjects
This is the federal document that includes information about IRB functions
and operating procedures.
