InfoMail for April 29, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav April 29, 2002 China Daily: Harvard Project ViolatesFarmers’ Rights FYI American experiments on impoverished populations inunderdeveloped countries needs much more oversight than seems to have beenprovided. XIONG…

Protecting Human Subjects in Research: Are Current Safeguards Adequate?

Current federal regulations set no limits on the level of risk that a competent adult may voluntarily choose to undertake for the sake of science. The regulations require prior approval by a review board (IRB) to ensure the research meets scientific and ethical justification, to ensure that the risks and benefits (if any) are fully disclosed to the subject, and that the subject can exercise the right to give or withhold informed consent.

InfoMail for April 15, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav April 15, 2002 Bill Would Enable Californians to Earn Easy Money by Consigning Relatives toMedical Experimentation FYI A bill has been introduced in the California StateAssembly, AB…

InfoMail for April 13, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav April 14, 2002Clinical Trials Given "At Your Own Risk" FYI TIME Magazine’s cover story, "At Your Own Risk,"(excerpts below) focuses on several high profile research scandals that…

InfoMail for April 1, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav April 1, 2002 Three CardiologistsSuspended from Baylor Clinical Research up to 5 years FYI The Baylor College of Medicine Institutional Review Board(IRB) has suspended research privileges from…

InfoMail for March 31, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav March 31, 2002 Harvard research jeopardizedthe welfare of disadvantaged Chinese people while violating federal regulations. FYI Sadly, Harvard joins the list of prestigious academicresearch institutions that have…

InfoMail for March 15, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav March 15, 2002  Seattle Times Reports 6 More FamiliesSue Fred Hutchinson Cancer Center FYI The Seattle Times reports that 6 additional families havefiled lawsuits against The Fred…

Who is a Human Subject? Who has the Right to Informed Consent?

"The voluntary consent of the human subject is absolutely essential."
[Nuremberg Code, 1947]

"Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. [ Code of Federal Regulations 45 CFR 46.102 (f)]

On October 30, 2001, the National Human Research Protection Advisory Committee (NHRPAC) signed off on recommendations redefining the term "human subject" in an effort to accommodate research that invades people’s privacy by declaring that "human subjects" are only those "who interact personally with research investigators."

InfoMail for March 5, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav March 5, 2002  Placebo Trials and Tribulations FYI An interesting article by Dr. Charles Weijer addresses thedebate about the ethics of conducting placebo controlled clinical trials inpatients,…

InfoMail for February 22, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav February 22, 2002  Alzheimer’s Drug Tests Halted When 12Volunteers Contract Encephalitis FYI The culture that led to the death of 19-year old, NicoleWan, a University of Rochester…

InfoMail for February 18, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav February 18, 2002  FYI The Fred Hutchison Center in Seattle WA has failedthree FDA inspections The Seattle Times reported on Sunday that aleukemia study at the Fred…