Introduction
Clinical Trials Overview
Institutional Review Boards & Informed Consent
Frequently Asked Questions (FAQs)
Links to Useful Information for Anyone Interested in Clinical Trials
Concerns About Research
Links to useful information for anyone interested in clinical research:
OHRP - the HHS Office for Human Research Protections - offers a free pamphlet called,
"Becoming a Research Volunteer: It's Your Decision"
. A copy of the pamphlet, along with related information, is available at
www.hhs.gov/ohrp/outreach
. The pamphlet is also available in Spanish at
http://www.hhs.gov/ohrp/espanol/OHRP3PanelSpanish.pdf
.
The NIH Office of Biotechnology Activities offers an
Informational Brochure Available for Potential Participants in Gene Transfer Research
-- Potential research participants, as well as those who enroll participants in trials - such as investigators and trial coordinators - may be interested in a new brochure that OBA has developed to assist in decisions regarding participation in human gene transfer research. The brochure titled "Deciding whether to participate in human gene transfer research?" helps potential participants understand fundamental concepts in gene transfer research and suggests questions they should pose to their physicians and to research staff in order to make a fully informed decision about participation. The brochure is available at
http://www4.od.nih.gov/oba/brochure/decide_gene_transfer.pdf
FDA (Food and Drug Administration) website - Basic questions and answers about clinical trials:
http://www.fda.gov/oashi/clinicaltrials/clintrialdoc.html
www.clinicaltrials.gov
The Belmont Report -
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm
www.Centerwatch.com
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