4
Mar2016

This week’s Research Ethics Roundup examines the National Institutes of Health’s (NIH) decision to host a workshop on using monkeys in research, a new BMJ study on academic institutions that are not reporting to ClinicalTrials.gov, and two editorials on government initiatives in the United States and the United Kingdom.

Safety First: In this editorial, Nature states their concern that some federal departments have still not complied with a Presidential Commission for the Study of Bioethical Issues’ request that basic data about departmental work with human subjects be publicly available. Nature argues, “Such data should be publicly available to ensure volunteers’ safety.”

daydreaming-chimpanzee-1553285-638x477NIH to Review its Policies on All Nonhuman Primate Research: In this piece for Science, David Grimm reports on the NIH’s announcement that they will host a workshop this summer on the ethical procedures needed when monkeys are involved in research. NIH made the announcement as the result of a Congressional mandate that NIH “conduct a review of its ethical policies and processes with respect to nonhuman primate research subjects.”

clinicalTrialsAcademics Fall Short in Reporting Results of Clinical Trials: Daniel Cressey of Nature highlights the findings of a new BMJ study that show leading American academic institutions are not complying with federal law and reporting to ClinicalTrials.gov. The study’s lead author, Harlan Krumholz, said “The lack of timely reporting and publication fundamentally impairs the research enterprise, violates the commitment made by investigators to patients and funders, squanders precious time and resources, and threatens to compromise evidence based clinical decision making.”

UK Guidance on Human-Animal Hybrid Research: In this editorial, The Lancet reviews new guidance from the British government on research that “involves the introduction of human DNA sequences, cells, or tissues into animals to create animal models of human diseases.” The British government decided they needed to establish a national expert body to monitor new forms of human-animal hybrid research.

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3 thoughts on “Research Ethics Roundup: Editorials on Human-Animal Hybrid Research and Transparency in Federal Human Subjects Research, and More

  1. Pingback: Research Ethics Roundup: Editorials on Human-Animal Hybrid Research and Transparency in Federal Human Subjects Research, and More - Bioethics Research Library

  2. John H Noble Jr

    David Cressey’s Nature report, “Academics fall short in reporting results of clinical trials,” has a companion report by Peter Doshi in the British Medical Journal, “Data too important to share: do those who control the data control the message? BMJ 2016; 352 doi: http://dx.doi.org/10.1136/bmj.i1027 (Published 02 March 2016)
    Cite this as: BMJ 2016;352:i1027.

    If this state of affairs is not a breach of basic research ethics, what else can be considered so? The essential compact between human research subjects and researchers is their contribution of knowledge for the future good of society. Despite yards of human research protection regulations, how can it be that the field has lost its way? What responsibility does PRIM&R have for this state of affairs? What responsibility does PRIM&R have for taking remedial action?

    Reply
    1. Elisa Hurley

      Thank you for your comments, John.

      I think it’s important to note that PRIM&R concurs that data sharing and transparency are ethical imperatives, and that failures to properly share clinical trial data and outcomes amount to failures to both respect current research subjects and to protect potential subjects from harm. Indeed, I’ve just written another blog post to this effect, and PRIM&R will likely take up the issue of data sharing and transparency in some future public policy work. In so doing, and as we do in much of our policy work, we will surface the very real challenges and tradeoffs that mandatory data sharing presents for IRBs, investigators, research subjects, and institutions. Making progress toward a sustainable culture of data sharing demands we address these challenges.

      Reply