DOE Human Subjects Resources

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.

DOE Human Subjects Research Database Poster and Flyer presented at the PRIM&R 2012 Advancing Ethical Research Conference, December 4-6, 2012 in San Diego, CA

DOE Protecting Human Research Subjects Newsletter
The newsletter addresses current issues and concerns about human research supported by DOE.

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.

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 Human Subject Protection Program Poster presented at the PRIM&R 2011 Advancing Ethical Research Conference, December 2-4 in National Harbor, Maryland. See the poster's fact sheet.

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: September 23, 2013