The resources on this page can provide you with a great deal of information and guidance regarding clinical research. We have organized these resources in one convenient page for easy access.
- Schulman Associates Institutional Review Board, Inc.: www.sairb.com. The website for SAIRB provides investigators with all forms and information needed for new trials that use SAIRB as a central IRB.
- Federal Regulations and Clinical Research Resources.
- FDA Guidance for Institutional Review Boards and Clinical Investigators, 1998 Update. Go to www.fda.gov/oc/ohrt/irbs/default.htm.
- FDA Guide to Informed Consent, 1998 Update. Go to www.fda.gov/oc/ohrt/irbs/informedconsent.html.
- FDA Regulation concerning the Sponsor-Investigator-IRB Interrelationship. Go to www.fda.gov/oc/ohrt/irbs/toc4.html.
- FDA regulations concerning Emergency Use of an Investigational Drug or Biologic. Go to www.fda.gov/oc/ohrt/irbs/drugsbiologics.html#emergency.
- FDA Inspection Information. Go to www.fda.gov/oc/ohrt/irbs/operations.html#inspections.
- A List of Selected FDA Regulations Relating to the Protection of Human Subjects. Go to www.fda.gov/oc/ohrt/irbs/applist.html.
- 21 CFR (Code of Federal Regulations) Part 50 — Protection of Human Subjects. Go to www.fda.gov/oc/ohrt/irbs/appendixb.html.
- Significant Differences in FDA and HHS Regulations for Protection of Human Subjects. Go to www.fda.gov/oc/ohrt/irbs/appendixe.html.
- Web Sites of Interest for Good Clinical Practice and Clinical Trials Information. Go to www.fda.gov/oc/ohrt/irbs/websites.html.
- Office for Human Research Protections. Go to ohrp.osophs.dhhs.gov.
- The National Bioethics Advisory Committee. Please note that the charter of the NBAC expired on October 3, 2001. Nevertheless, their site is at www.georgetown.edu/research/nrcbl/nbac.
- US Department of Health and Human Services (HHS). Go to www.hhs.gov.
- HHS, Agency for Healthcare Research and Quality. Go to www.ahrq.gov.
- National Institutes of Health www.nih.gov
- National Cancer Institute www.cancer.gov
- HIPAA (Health Insurance Portability and Accountability Act of 1996).
- Medical Privacy — National Standards to Protect the Privacy of Personal Health Information as presented by the HHS, Office for Civil Rights — HIPAA www.hhs.gov/ocr/hipaa
- Public Law 104-191, August 21, 1996: HIPAA
- HIPAA Privacy Rule Booklet for Research privacyruleandresearch.nih.gov/pr_02.asp
- The Clinical Trials Registry www.clinicaltrials.gov
- National Center for Research Resources, National Institutes of Health.
"The NCRR plays a key role in addressing pressing trans-NIH research issues, such as access to state-of-the-art instrumentation and biomedical technologies; containment of the escalating costs of highly sophisticated clinical research; development of appropriate, specialized research models both animal and nonanimal; and remedying the shortage of independent clinical investigators and the underrepresentation of minority investigators. Present and future program directions emphasize "smart," network-connected technologies, computer-aided drug design, development and testing of gene and molecular therapies, bioengineering approaches to decrease health care costs, and enhanced training and career development for patient-oriented research." www.ncrr.nih.gov/clinical_rsrch.asp
- Centerwatch.com www.centerwatch.com
- Here you will find their monthly newsletter www.centerwatch.com/bookstore/pubs_profs_cwnews.html, which alerts investigators of new trials.
- Their industry provider profiles www.centerwatch.com/professional/provtlst.html, which list various services related to research. The list is at www.centerwatch.com/professional/provtcat3.html.
- Finally, review their "Trialwatch" service at www.centerwatch.com/professional/trialwatch.html.
Please note that this site is not an end in itself, though, and is merely a place to begin. Centerwatch only learns that new trials exist some weeks after the Contract Research Organizations (CROs) are aware of them. Therefore, it is best to ally yourself with several CROs, so you can learn of new trials quicker.