Author

Laura Stark

  • Clinical Research

    NPRM Symposium: When will regs be revised again? & Marcia Angell in NYRB

    By Laura Stark There is plenty to say about the proposed changes to the Common Rule that the Office of Human Research Protections announced in September. But it’s striking to consider what is left unsaid—that…

    NPRM Symposium: When will regs be revised again? & Marcia Angell in NYRB

  • Health Law Policy

    Lesley Sharp’s Transplant Imaginary

    By Laura Stark The supply of donor organs is in constant peril. But researchers around the world are working to develop spare human parts out of both machines and animals. Professor Lesley Sharp’s new book,…

    Lesley Sharp’s Transplant Imaginary

  • Clinical Research

    Informed consent workshop today and tomorrow; papers available

    By Laura Stark The first session on “vulnerable populations” just wrapped up at the workshop on “Frontiers of Informed Consent” at Northeastern University in Boston—with great talks on migrant, refugee, and indigenous communities and conflicts…

    Informed consent workshop today and tomorrow; papers available

  • Bioethics

    Human Subjects Case Unfolds

    By Laura Stark Institutional Review Boards are in the top news at outlets such as the New York Times, as a research debacle unfolds. I looked through the documents that are publicly available to figure…

    Human Subjects Case Unfolds

  • Bioethics

    Common Rule Wrap-Up at National Academies

    By Laura Stark Working in private, the National Academy of Sciences’ panel on human-subjects regulations in social-behavioral sciences met this weekend to draft a final report.  On Friday, the panel had wrapped up its public…

    Common Rule Wrap-Up at National Academies

  • Bioethics

    Changing human-subjects regulations? Tune in now

    By Laura Stark Today and tomorrow, the National Academy of Sciences is hosting a workshop on revisions to the human-subjects regulations (the “Common Rule”), especially for rules on social and behavioral research. The workshop is…

    Changing human-subjects regulations? Tune in now

  • Bioethics

    New Data Reports on Learning “Research Integrity”

    By Laura Stark When it comes to research with human subjects, about 60 percent of faculty members and 50 percent of graduate students learned about ethics through online or print resources according to a recent…

    New Data Reports on Learning “Research Integrity”

  • Clinical Research

    FDA Drug Amendments: Still a good fit at fifty?

    By Laura Stark Fifty years ago on Wednesday, President Kennedy signed into law the US Food and Drug Amendments. The amendments radically overhauled the way in which manufacturers brought drugs to market. Most importantly, the…

    FDA Drug Amendments: Still a good fit at fifty?