Blog Justice Postings on Bioethics Regulations and Governing Documents 21 CFR Part 56 - Institutional Review Boards 21 CFR Part 50 : Protection of Human Subjects Hippocratic Oath Nuremberg Code Declaration of Helsinki IRB Guidebook The Belmont Report Human Subjects Policy Paper DOE P.443 :Protection of Human Subjects Title 45: Protection of Human Subjects IRB Information Sheets Page 1 Updated 9/98 United States v. Stanley, 483 U.S. 669 (1987)

Bioethic Chronology by Alan Milstein

• Bioethic Chronology: A History of Broken Rules

The Claim for Human Dignity

• The Claim for Human Dignity

Documents On Human Experimentation

Tuskeegee Study

• Twenty Years of Followup Experience In a Long-Range Medical Study
• The Tuskegee Syphilis Study Legacy Committee Report

Nazi Experiments

• Miscellaneous Nazi Documents

CIA MKULTRA Experiments

• MKULTRA Documents

Government Radiation Experiments

• Selected Descriptions of AEC Experiments involving Human Subjects
• ACHRE Report
• Declassified Documents

Milgram Experiment

• Milgram Reenactment || Links to sites related to milgram, conformity and obedie
• Resources on the Milgram Experiment

Government Drug and Mind Control Experiments

• Resources on Drug Experiments Performed by the U. S. Government

Project Paperclip

• Project Paperclip

Willowbrook

• NSC830

Fernald Experiments

• The Studies at the Fernald School

Death of Ellen Roche

• FDA Warning Letter to Hopkins
• Hopkins Letter to OHRP
• OHRP Letter to Hopkins on decision to suspend funding
• OHRP Letter to Hopkins

Death of Jesse Gelsinger

• A Family's Quest For Answers
• Human guinea pigs on the frontiers of medicine
• Feburary 8, 2002 FDA Letter to James Wilson
• Jessie's Intent
• Danforth Report
• Penn vows to redouble efforts to meet highest safety standards
• President Judith Rodin's Letter to U.S. Senate on Gene Therapy
• IHGT - Statement on the Death of Jesse Gelsinger
• IHGT - Preliminary Findings on the death of Jesse Gelsinger

Death of Nicole Wan

• Case Report On Death of Nicole Wan
• Dedication to Nicole Wan
• Rochester Death Halts MIT-Funded Study
• Student dies at Rochester in MIT-based study

Death of Elaine Holden-Able

• A Death During Research (washingtonpost.com)

Death of Gage Stevens

• Propulsid Withdrawn from the Market
• Salon.com health | Kids as guinea pigs
• propulsid1
• Propulsid Linked to Children's Death

Fred Hutchinson Cancer Research Center Protocol 126

• Various Documents

Anthrax Vaccine

• FDA Reports and Warning Letters

University of Oklahoma Melanoma Study

• FDA Warning Letter to McGee
• Latest FDA Letter to McGee

The Artificial Heart

• Life, But At What Cost?
• Informed Consent Document
• Abiomed Press Release on Death of James Quinn
• Hahnemann Press Release on Death of James Quinn
• Hahnemann Briefings on Mr. Quinn's Progress
• Abiomed Webcasts
• Abiomed Investor Information
• On Medicine's Frontier: The Last Journey of James Quinn
• Mechanical-heart patient comes to regret his life-saving choice
• Barney Clark Press Conference

Stanford Prison Experiment

• Informed Consent Document
• Zimbardo's Slide Show
• The Stanford Prison Experiment: Still powerful after all these years
• Thirty years later, Stanford Prison Experiment lives on

 

ADHD/SSRI Issues

• Overview of SSRIs and Case Evaluation Form
• Media Coverage of the Backlash
• Documents, Articles & News Items
• ADHD/SSRI Litigation

 

Organizations

• CIRCARE
• Alliance for Human Research Protection
• WMA World Medical Association, Inc.
• Responsible Conduct of Research: Online resource for instruction and training
• OHRP Assurance Staff
• OHRP Policy and Assurances
• ORI - Office of Research Integrity
• U. S. Department of Education Protection of Human Subjects
• AAHRPP Interim Accreditation Standards & Procedures
• ARENA's Mission
• IRB Forum - The Institutional Review Board Discussion and News Forum
• WMA World Medical Association, Inc.
• Responsible Conduct of Research: Online resource for instruction and training
• Center for the Study of Bioethics
• National Institutes of Health
• DOE : Human Radiation Experiments
• Global Health: How to Interpret the Common Rule
• Centerwatch Clinical Trials Listing Service!
• ClinicalTrials.gov
• Stanford University Center for Biomedical Ethics
• The Institute for Jewish Medical Ethics
• The Hastings Center For Bioethics
• Biomedical Ethics Unit of McGill University
• Encyclopedia of Ethical, Legal and Policy Issues in Bio
• Public Responsibility in Medicine and Research
• MCW IRB Homepage
• NHRPAC Main Page
• Office for Human Research Protections (OHRP)
• Public Responsibility in Medicine and Research
• DOE Protecting Human Subjects Home Page
• Office for Human Research Protections (OHRP)
• The American Society of Bioethics and Humanities Home Page
• National Bioethics Advisory Commission
• National Human Genome Institute
• Center for Clinical Bioethics, Georgetown University Medical Center
• Eubios Ethics Institute
• Clinical Trials Research Group

Articles and News Items

• Eight Years after Jesse’s Death, Are Human Research Subjects Any Safer?
• When Drug Trials Go Wrong, Patients Have Little Recourse
• Guinea-Pigging - Healthy human subjects for drug-safety trials are in demand. But is it a living?
• Widows' VA suit thrown out
• Participants Left Uninformed in Some Halted Medical Trials
• The Legal and Ethical Issues Surrounding Financial Conflict of Interest in Orthopaedic Research
  Widow wins settlement in corrupt cancer study, but 6 others kept waiting
• Family to be awarded $500,000 in VA case
  Widow wins settlement in corrupt cancer study, but 6 others kept waiting
• Parexel Misled Subjects Sickened in London Study, Ethicists Say
• Lawsuits demand answers by VA Widows of veterans who died in drug study say men were guinea pigs
• Drug Tests Require More FDA Scrutiny, Grassley Says
• Clinical Trial Lawsuits Are On The Rise
• Patient Choice in Clinical Trials
• Drug trials on trial
• Firms aim to educate patients on test risks
• Effort grows to teach risks, benefits of clinical trials
• Parkinson's Patients Suing Amgen Over Drug
• Abuses Endangered Veterans in Cancer Drug Experiments
• FDA Considers Drugging Healty Kids for Science
• A Godsend, Till a Life Unravels
• Study Devalues a Popular Idea on Evaluating Medical Trials
• Drugs of 4 Patients Subbed without OK
• Four years later, Gelsinger case still has lasting implications
• Suffer the little children in the search for cures
• Practice Standards for Patient Advocates Defined in Memo to Back Malpractice Suit
• HHS draft guidance on Conflicts of Interest in clinical research
• Drug trials under scrutiny
• Transcript of BBC documentary on the death of Jesse Gelsinger
• Researcher fights for her notes
• Does Litigation Raise Standards of Care in Clinical Research?
• Researcher Hired Despite Revoked License; Feds Launch Probe of VA Hiring Practices
• Death Prompts Scrutiny of Research Risks
• Researchers Under Criminal Investigation For VA Drug Study Deaths in New York
• Human Guinea Pigs
• Clinical Trial Conduct
• Medisch-ethische commissies als doelwit van schadeclaims?
• The patient or the portfolio?
• Halt invasive research on kids
• IOM Report Responsible Research: A Systems Approach to Protecting Research Participants (2002)
• On Medicine's Frontier: The Last Journey of James Quinn
• Lawsuits target medical research Patient safeguards, oversight key issues
• A Hospital's Conflict Of Interest - Patients Weren't Told Of Stake in Cancer Drug
• Mechanical-heart patient comes to regret his life-saving choice
• Stop drug research on Oregon kids
• OHSU, school districts named in drug lawsuit
• Lawsuit Claims Investigator, IRB Liability In Study of Fecal Incontinence Control Device
• Lawyer sees his role as warning to clinical researchers
• Human guinea pigs on the frontiers of medicine
• Mutiny of the Guinea Pigs
• Crusader for the Rights of Research Volunteers
• Lawsuits Attack Medical Trials
• Informed Consent
• Researcher Wilson to step down as IHGT head
  The Institute for Human Gene Therapy came under fire after the death of an 18-year-old test participant.
• TIME Magazine: At Your Own Risk
• Safety among medical testing under scrutiny
• Lucrative licensing deals with drug, biotech firms are raising ethics issues for hospitals
• MY KIDS WERE USED AS GUINEA PIGS
• Is It Ethical to Do Research on Healthy People?
• Md. Court of Appeals decision in Grimes v Kennedy Kreiger Institute
• Md. Appeals Court Slams Researchers
• Lawsuits Attack Medical Trial As claims arise, some fear tests will lose public support
• Medical experiment disclosure hinges on a flawed honor system, Hopkins worker death raises wider questions.
• I Was in a Scientific Study? No One Told Me
• Hopkins study was exempt from FDA
• Uninformed consent. What's missing from the fine print when students sign up as guinea pigs?
• Clinical Trials: Are They Safe? Look for the Stamp Feds Want a 'Seal of Approval' to Help Guarantee Patient Safety, Trust
• Columbia study on children criticized
• Yale study on 12 year olds criticized. (pdf 578k)
• USA TodayFederal rules for research on people often fail
• Washingtonpost.com: Science on the Ethical Frontier
• National Reference Center for BioEthics Literature
• Health Law resources-American Society of Law, Medicine and Ethics
• Bioethics Resources on the Web - National Institutes of Health
• Concentration Camps
• Unit 731 - A Half Century of Denial
• Kids as guinea pigs