Useful
research publications/links:
The
National Bioethics Advisory Commission (NBAC) was
commissioned in 1995 to examine the adequacy of the
current system for the protection of human participants
in research.
National Bioethics Advisory Commission (NBAC), August
2001
Ethical
and Policy Issues in Research Involving Human Participants
In October 2000, the DHHS asked the Institute of Medicine
(IOM) to conduct a two-phase study to address the
concerns about protecting the rights and interests
of research participants. Two publications that resulted from this study
include:
Preserving
Public Trust: Accreditation and Human Research Participant
Protection Programs (Executive Summary) http://books.nap.edu/html/public_trust/summary.pdf
Responsible Research: A Systems Approach to Protecting Research Participants
(2002) http://books.nap.edu/books/0309084881/html/31.html#pagetop
Research Practitioner-Published by the Center for
Clinical Research Practice http://www.researchpractice.com/rp_cumulative.shtml
CenterWatch Article Reprint-Inside the Informed Consent
Process http://www.centerwatch.com/careers/CW0905_InformedConsent.pdf
Federal
Agency Research Links
NIH
Homepage http://www.nih.gov/
National
Institutes of Health: Bioethics Resources on the Web http://www.nih.gov/sigs/bioethics/
PubMed-free
access to medline for literature searches http://www.ncbi.nlm.nih.gov/PubMed/
FDA
Homepage http://www.fda.gov/
U.S.
Food and Drug Administration Information Sheets
Guidance
for Institutional Review Boards and Clinical Investigators:
1998 Updates http://www.fda.gov/oc/ohrt/irbs/default.htm
Food
and Drug Administration (FDA)
Good Clinical Practice in FDA-Regulated Clinical Trials
http://www.fda.gov/oc/gcp/default.htm
OHRP-Office
of Human Research Protection http://www.hhs.gov/ohrp/
Clinical
Research Links
ACRP-Association
of Clinical Research Professionals http://www.acrpnet.org/
Association
of American Medical Colleges (AAMC)
Research Compliance Resources
http://www.aamc.org/research/dbr/compliance/startcom.htm
Association
for the Accreditation of Human Research Protection
Programs, Inc. http://www.aahrpp.org/index.html
Clinical
Research Compliance Links http://www.mcg.edu/Research/octc/clinreslink.htm
National
Association of IRB Managers http://www.naim.org/
ORCA-Office
or Research Compliance and Assurance http://www.va.gov/oro/
Public
Responsibility in Medicine and Research http://www.primr.org/
U.S.
Department of Veterans Affairs (VA)
Human Research Protection Accreditation Program
developed by National Committee for Quality Assurance
(NCQA) http://www.ncqa.org/Programs/QSG/VAHRPAP/vahrpap.htm
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