July 15, 2002 Short Drug Tests, Fatal Flaws. Thomas J. Moore. Op Ed. Boston Globe. FYI “We need new laws, a national scientific program, and money to assure that every important drug intended for long-term use receives the same long-term testing as was provided for hormone replacement therapy.” An Op-ed…
Dissenting Opinion (NHRPAC Children Workgroup) re: Proposed Reinterpretation of Fed. Regs Protecting Children (45 CFR 46, sections 404 and 406) May 14, 2002 To: Alan Fleischman, MD, Chair, Children’s Workgroup of NARPAC Mary Faith Marshall, Ph.D., Chair, NARPAC From: Vera Hassner Sharav Re: Dissenting Opinion re: Report to NHRPAC, proposing…
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.
Text of AHRP Amicus Brief filed with the Maryland Court of Appeals in support of the Court’s ruling against Kennedy Krieger Institute for exposing children to lead poison in an experiment. The Court of Appeals Decision Validates AHRP’s Stand Against Using Children in Harmful Research Experiments.
