DOE Human Subjects Resources

DOE Protecting Human Research Subjects Newsletter

The newsletter addresses current issues and concerns about human research supported by DOE. It focuses on DOE laboratories and specific issues DOE laboratories face while conducting human subject research at their facilities. The newsletter often refers the reader to materials or informational contacts that may provide further guidance on human subjects research. The newsletter also announces upcoming meetings and other events that cover human research topics.

The following documents are available as PDF files. To view them, you will need the Adobe Acrobat Reader, which can be downloaded free from the Adobe Support Site.

Fall 2013 Newsletter - Highlights from the October 2013 DOE Human Subjects Working Group (HSWG) Meeting

In this issue:

  • Big Data and Social Media
  • Update of Federal Requirements
  • Modification of the Human Environment
  • DOE Updates

Issue 22, Summer 2011

In this issue:

    Front page of newsletter
  • Is anonymization of data really possible?
  • Arguments for and against abolishing consent forms.
  • Community member workshop ideas; i.e., how to engage community members in the IRB’s work and how to enhance their contribution.
  • What attributes to look for when selecting a community member.
  • Ezekiel Emanuel outlines both criticisms and inconsistencies of regulations and asks where we go from here.
  • U.S. Department of Health and Human Services is considering ways of enhancing regulations overseeing research on human subjects.
  • Eva Mozes Kor recounts her participation in Auschwitz death camp experiments.
  • Ethical issues in new technologies; i.e., problems with sharing genomic information, confidentiality, conflicts of interest, genetic nondiscrimination, etc.
  • Concern about the quality of information about alternatives to research that is found in consent forms.
  • Research with cognitively impaired subjects—why IRB review matters.
  • Research during humanitarian emergencies—data should produce some benefit to population from which the data is coming.
  • Conducting ethical research during disasters, war, and other complex emergencies.
  • International Research Panel of the Presidential Commission for the Study of Bioethical Issues releases its report.

Issue 21, Winter 2011

In this issue:

    Front page of newsletter
  • The U.S. Food and Drug Administration describes its wide-ranging effort to improve quality and trust in human subjects research.
  • Should research results be shared with donors of biological samples? Bioethicist says Yes. Accuracy of information says No. More participants if Yes.
  • The contributions of community IRB members were the focus of discussions in San Diego.
  • DOE’s Elizabeth White says regular self-assessments and external reviews are critical to the continuous improvement of human research protection programs.
  • Brookhaven National Lab receives full accreditation from the Association for the Accreditation of Human Research Protection Programs.
  • Lawrence Livermore National Laboratory chooses OHRP’s QA consultation rather than accreditation.
  • Human subject volunteers don’t care whether the consent form is long or short; clarity is what counts.
  • Emory University had 22 conflict of interest policies, but the gaps caused headaches.
  • Effects of conflicts of interest on research. On participants.
  • Federal funding for human subjects research is at an historic high.

Issue 20, Fall 2010

In this issue:

    Front page of newsletter
  • Ellen Clayton, Director of Vanderbilt's Center for Biomedical Ethics and Society discusses data sharing and human subjects
  • The Central DOE IRB is up and running. Elizabeth White, DOE's Program Manager for Protection of Human Research Subjects, Describes its task
  • The Belmont Report may not adequately address some current research issues
  • How can community members be most useful to communities and to research?
  • The Former Worker Medical Screening Program has provided about 70,000 evaluations
  • People can't be counted on to make rational choices, which should be understood by those designing research protocols.
  • The case for centralized IRB review is made by Dan Nelson of the University of North Carolina, Chapel Hill.
  • The case for local IRB review is made by David Forster of Western IRB


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Content reviewed: February 6, 2014