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Information Resources for Human Research Protections

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.

Basic Information

new icon 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

Phase I Research Clinics

Focused Information / Publications

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 Books, Bibliography, and Search Resources (Institute of Medicine National Academies of Science publications)

Bioethics and Human Research Protections Reports

U.S. Government Information Resources and Regulations

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.

U.S. Food and Drug Administration

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.

Office For Human Research Protections

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.

National Institutes of Health

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Consumer Information

Clinical Trial Registries

National Institutes of Health ClinicalTrials.gov

Study Results Databases / Tips for Use

PhARMA's Clinical Study Results Database

Drug Information Resources   Including U.S. and international information resources, FDA databases, and selected professional, nonprofit, and commercial information resources.

Drugs@FDA (FDA Drug Database)

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.

Devices@FDA (FDA Medical Device Database)

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.

State Medical Board Cases: Physician Conduct in Research and Related Cases Physician Last Names A – G

State Medical Board Cases: Physician Conduct in Research and Related Cases Physician Last Names H – Z

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Special Topics

Burzynski Research Institute Document Index

Dan Markingson and the CAFE Trial at the University of Minnesota

Criminal Case: Synthes, Inc., Norian Corporation, Michael D. Huggins, Thomas B. Higgins, Richard E. Bohner, and John J. Walsh

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

Stem Cell Research Index Page

Ketek™ / Clinical Trials and FDA Approval

In re Cardiac Devices Qui Tam Litigation

SFBC International Inc.

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.

If you're still unsure where to find information on the CIRCARE website, try the Site Map or use the search form on the upper right side of this page. If all else fails, Contact CIRCARE and we'll try to help you find the information you're looking for.


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Last Updated: 2012-03-20

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