Alphabet Soup (U.S. Federal Agencies): CDER: Center For Drug Evaluation and Research; CBER: Center For Biologics Evaluation and Research; CDRH: Center For Devices and Radiological Health; FDA: Food and Drug Administration (part of DHHS); DHHS: Department of Health and Human Services; OHRP: Office For Human Research Protections (part of DHHS); ORI: Office of Research Integrity (part of DHHS); OIG: Office of the Inspector General.
Books We're Reading New and interesting books on human research protection and bioethics
Introduction and Overview Including introductory and basic articles on the protection of human subjects in research, and glossaries of terms used in biomedical research
Ethical Codes and Guidelines for the Protection of Human Subjects Including national and international guidelines for the protection of human research subjects, and codes, e.g., The Belmont Report, The Nuremberg Code, and the Common Rule, and guidelines, statements, and codes promulgated by professional organizations
Commissions and Committees on Human Subject Protections Including the Secretary's Advisory Committee on Human Research Protections (SACHRP), the National Human Research Protections Advisory Committee (NHRPAC), and the National Bioethics Commission (NBAC)
Research and Bioethics Organizations Including academic departments and university bioethics programs, organizations offering human subject protection training and education programs
Commercial Institutional Review Boards (IRBs) Including IRB accreditation
Articles on Human Research Protections and Related Topics Authors A — K
Articles on Human Research Protections and Related Topics Authors L — Z
Bioethics and Medical Journals
Bioethics and Human Research Protections Reports
U.S. Food and Drug Administration (FDA) Research Regulations and Information Including FDA regulations governing human subject protections, institutional review boards, informed consent, research subject to FDA regulations, drug, device, dietary supplement, and cosmetic regulations, medical device information, warning letters and compliance actions, IND and clinical investigator inspection list databases, and how to complain to FDA.
Office For Human Research Protections (OHRP) Including OHRP/DHHS regulations (The Common Rule
), determination letters, searchable database of IRBs, institutions and entities with Federal Wide Assurances, OHRP guidance's, reports, and education resources, Office of Research Integrity (ORI), and HIPAA.
National Institutes of Health (NIH) Including general information on NIH research, research funded by NIH, NIH grant award information by state, foreign site and year, NIH peer review, and NIH policies.
Study Results Databases / Tips for Use
Drug Information Resources Including U.S. and international information resources, FDA databases, and selected professional, nonprofit, and commercial information resources.
FDA Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies
Vioxx Documents, a searchable database of documents from Vioxx litigation [Non-FDA]
Drug Industry Document Archive, a searchable database of documents from Neurontin litigation [Non-FDA]
Medical Device Regulations and Information Resources for finding information about FDA-regulated medical devices including approvals, indicated uses, and medical device adverse events.
How To Complain About Research
Children in Federally Regulated Research
Index of Resources for Consumers and Research Subjects
How To Complain About FDA-Regulated Drugs, Medical Devices, and Dietary Supplements
Medicare Coverage of Clinical Trials
Medicare's New Policy on Coverage with Evidence Development and Implantable Cardioverter Defibrillators Including draft guidance documents, policies, information, and CIRCARE's concerns about Medicare's new policy that requires research participation in return for coverage under certain conditions.
Treatment & Medical Care Information When making a decision about research participation, it's often helpful to have treatment information. Included here are clinical practice guidelines (many of which approximate standard treatment), providers of reliable health & disease information, medical dictionaries, Merck Manuals, hospital, clinic, provider quality, accreditation, and program exclusion information.
State Medical and Osteopathic Licensing Boards Locate disciplinary actions against physicians and osteopaths, file complaints, or look up medical practice acts.
Dr. Paolo Macchiarini, Trachea Transplants
Burzynski Research Institute Document Index
Dan Markingson and the CAFE Trial at the University of Minnesota
Coast Institutional Review Board
Trial to Assess Chelation Therapy (TACT) Information and Document Index
Andrew J. Wakefield and Research with Autistic Children
TGN1412 Tegenero AG Clinical Trial
Tanezumab Clinical Trials Sponsored by Pfizer
Ketek™ / Clinical Trials and FDA Approval
In re Cardiac Devices Qui Tam Litigation
Howlers in Human Research Protections
Research on Induced Malaria for HIV Henry Heimlich M.D. and The Heimlich Institute Foundation.
Pediatric Medical Device Research at A. I. Dupont Hospital for Children William I. Norwood M.D. and colleagues and the Cheatham Covered Platinum Stent.
External Website Troubling Research: PermaDerm ™ Sandy Frost Newsvine Site
Research on Induced Malaria for Lyme Disease Henry Heimlich M.D. and The Heimlich Institute Foundation.
Great Lakes College of Clinical Medicine Institutional Review Board
EmpowerPlus Research University of Calgary, University of Utah, The Synergy Group of Canada Inc., and Truehope Nutritional Support Ltd.
Pesticide Research in Human Subjects
(In)Famous Research and High-Profile Cases
Genetic Research Stop worrying about rubbish like the Rhaelians or reports of human-llama hybrids. Find out the real risks so you can make intelligent choices about research and protect yourself from misuse of specimens or fly-by-night web sites hawking dubious genetic tests. Included are U.S. Federal (DHHS/NIH) information resources, databases, and oversight committees, legislation, genetic information resources and glossaries of terms.
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Last Updated: 2016-03-10
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