DOE Human Subjects Resources

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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. Previous issues are available.

Issue 18, Spring 2009
In this issue:

This edition of Protecting Human Subjects focuses on issues related to the evolving understanding of regulations designed both to protect human subjects and encourage research. Articles consider the issue of whether IRBs need more or less rigid oversight and whether flexibility is a virtue or a vice. Other articles raise questions about whether some assumptions about human subjects protection should be reconsidered and whether there are better ways to protect the vulnerable

  • Ivor Pritchard, director, Office of Human Research Protections, on flexibility in applying regulations
  • Rethinking exploitation of vulnerable populations
  • NIH says informed consent must be a “robust” process in stem cell research
  • What IRBs need to know about data bank specimens and the uncertainty of confidentiality
  • Research is shifting from academic institutions to commercial industries
  • DOE’s Central Beryllium IRB adds the Former Worker Medical Screening Program
  • Pittsburgh is trying to change African American mistrust of the research community
  • What do social scientists want in their relationships with IRBs?
  • Ethical standards should not change for research in the developing world
  • The danger of exploitation in globalizing clinical trials
  • When researchers attend IRB meetings, things work more smoothly
  • Ways to avoid conflict between IRBs and investigators

Quality Assurance and Quality Improvement – Is it Human Subjects Research?
Explores the relationship between quality assurance and quality improvement activities and human subjects research.

Human Subjects Working Group
Offers a historical overview of this group and links to membership lists.

DOE Information
Includes links to several useful documents and brochures as well as newsletters, all developed in support of DOE's Human Subjects Protection Program.

DOE Assurances
Includes a listing of DOE sites with human subjects activities, their assurances to perform such work, their Institutional Review Board (IRB) chairpersons or non-DOE institution, and their IRB administrator or contact.

Self Assessment and Accreditation
Describes methods and objective standards to evaluate the quality and level of protection that an organization provides to research participants to allow an organization to demonstrate the overall excellence of its program for the protection of human subjects in research.

Analyzing Your Human Research Protection Program (pdf)
An older resource is provided for information about modeling a systematic approach to create an effective structure for protecting human subjects. It is based on prior experiences at the Veterans Administration. Some of the elements presented may have been superseded by later information contained in other self-assessment and accreditation programs.

Education and Training for Human Subjects Research  
Includes a link to the DOE Protecting Human Subjects newsletter and training sites.

Human Subjects Research Database
Contains information relating to research projects involving human subjects (projects reviewed by an IRB and not given "exempt" status) that are currently funded by the Department of Energy, or are performed at DOE facilities with support from other sponsors, or performed by DOE personnel or DOE contractor personnel. This database consists of a searchable interface, detailed descriptions of each research project and a section that summarizes the information for quick referencing. Currently the database is administered by ORISE. Promotional poster and background information brochure.

Guidelines
Links to several guideline documents.

Consent Form Information
Links to sample forms and other resources related to consent forms.

Content reviewed: October 30, 2009