DOE Human Subjects Protection Program

DOE Laboratory/Sites Human Subjects Programs

Human Subjects Regulations, Orders,
and Policies

DOE Human Subjects Resources

DOE Human Subjects Research Database

Other Resources

Central DOE IRB

Community IRB Members

Frequently Asked Questions

DOE Worker
Health-Related Studies and Programs

Scientific Integrity

DOE Newsletter

HSWG Members

Contract Acknowledgement

Other Resources

Meetings and Conferences

CDOEIRB Meetings and Events

DOE MEETINGS AND EVENTS

CALLS

Archived Meetings and Conferences

DOE Human Subjects Working Group (HSWG) 2011 Fall Workshop
December 1, 2011
National Harbor, Maryland

• Agenda for DOE Human Subjects Working Group (HSWG) 2011 Fall Workshop

DOE Human Subjects Working Group (HSWG) 2010 Fall Workshop.
December 5, 2010
San Diego, California

• Agenda for DOE Human Subjects Working Group (HSWG) Workshop, Fall 2010

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DOE Human Subjects Working Group (HSWG) 2009 Fall Workshop.  The workshop will focus on Community Members, with open discussion on challenging case studies.  A highlight of the meeting will be roundtable discussion with Community Members and IRB Administrators on What works? and What doesn’t? One of the latest issues is understanding what is Human Terrain Mapping or Human Social & Cultural Behavior research.

• Agenda for DOE Human Subjects Working Group (HSWG) Workshop

DOE Human Subjects Working Group (HSWG) Spring Workshop. At the workshop held on May 6-7, 2009 in Georgetown, Maryland, awards were presented to Terry Reser, Administrator, Human Studies Board, Sandia National Laboratory, and Peter Kirchner, MD, Senior Scientist Advisor, DOE, for exemplary service to the DOE human subjects protection program.

• Agenda for DOE Human Subjects Working Group (HSWG) Workshop
• Welcome and Introductions Expectations for Workshop
  Sharlene Weatherwax, PhD
  Director, Biological Systems Sciences Division
• Protocol Compliance Monitoring
  Darcy Mallon
  Brookhaven National Laboratory
• Succession Planning for the HRPP and IRB
  Kathy Ertell, MS, CIH
• DOE Human Subjects Website Report
  Charles Pietri
  HITECH Consultant
• Overview of Personally Identifiable Information (PII) Protection Requirements
  Ray Holmer, Director
  Office of Information Management
  Office of Resource Management
  Office of Health, Safety, and Security
  U.S. Department of Energy
• Reporting Unanticipated Problems and Review/Approval of Projects that Use Personally Identifiable Information
  Libby White, SC
• Former Worker Medical Screening Program – Loss of PII
  Mary Fields, Program Manager Office of Health, Safety and Security Department of Energy
• Plans for Central DOE IRB (CDOEIRB)
  Mary Fields and Isaf Al-Nabulsi, HSSLibby White, SC
• What New Policy/Guidance is Coming from OHRP?
  Julie Kaneshiro
  HHS Office for Human Research Protections

DOE Human Subjects Working Group (HSWG) Fall Workshop
November 16, 2008
Orlando, Florida

The DOE HSWG meets bi-annually to learn about the latest policies and practices related to human subjects protection from notable authorities in the field. The working group also discusses issues and concerns within DOE and elsewhere that affect, or could affect, the human subjects activities at their sites. At times, representatives from other organizations and federal agencies are invited to attend or make presentations. It is an educational and networking event for the group. The 2008 HSWG workshop was held in conjunction with the PRIM&R Professional Conference that was held, November 17-19, 2008.

• Agenda for DOE Human Subjects Working Group (HSWG) Workshop

DOE Human Subjects Working Group (HSWG) Spring Workshop
May 6-7, 2008
Rockville, Maryland

The DOE HSWG members met for a day and a half workshop to learn how to assess their human subjects program processes through self-assessment. Speakers from the Office of Human Subject Protections provided training on how the self-assessment process works. The training was followed-up by presentations from two authorities on full accreditation. One was from a DOE laboratory and the other from the University of Southern California. Below are the materials from the, May 6-7, 2008 workshop.

• Agenda for DOE Human Subjects Working Group (HSWG) Workshop
• DOE Workshop Expectations
  Libby White, Program Manager, DOE, Office of Science, Human Subjects Protection Program
  Peter Kirchner, Senior Scientist Advisor, DOE, Office of Science, Human Subjects Protection Program
  This session set the stage for the workshop to provide participants with two approaches to self-assessment and quality improvement.
• Office of Human Research Protections (OHRP) Quality Improvement Program - Tutorial
  Lynda Lahl and Michelle Feige, Department of Health and Human Services (HHS), OHRP, Division of Education and Development
  This training session gave participants an opportunity to see what ORHP expects during the on-site review of DOE laboratory self-assessment plans. The session include overviews on OHRP's Quality Improvement Program, Assurance of Compliance, IRB Membership, and Investigator Responsibilities.
• Association for the Accreditation of Human Research Protection Programs (AAHRPP) Accreditation Tutorial
  Sherry Davis, Battelle-Pacific Northwest National Laboratory
  Susan Rose, University of Southern California (AAHRPP handout)
  This tutorial gave a step-by-step look at how the AAHRPP process was completed at a DOE laboratory and a University.
• Central IRBs (Oak Ridge Site-wide IRB, Central Beryllium IRB)
  Betsy Ellis and Becky Hawkins, Oak Ridge Institute for Science and Education
  This presentation provided an overview of ORAU's management, history and operation of the Oak Ridge Site-Wide IRB and the DOE Central Beryllium IRB.
• Sherry Davis Honored by the Human Subjects Working Group Members
• Susan Rose Honored by the Human Subjects Working Group Members
• Michael Viola Honored by the Human Subjects Working Group Members

DOE Human Subjects Working Group (HSWG) Annual Meeting
By invitation only. The DOE HSWG meets annually to learn about the latest policies and practices related to human subjects protection from notable authorities in the field. The working group also discusses issues and concerns within DOE and elsewhere that affect, or could affect, the human subjects activities at their sites. At times, representatives from other organizations and federal agencies are invited to attend or make presentations. It is an educational and networking event for the group. The annual meeting is usually held in conjunction with a major professional meeting such as PRIM&R.

• Agenda and Presentations for Dec. 1, 2007, HSWG meeting in Boston, Mass.

American Society for Bioethics and Humanities Meetings and Programs
This organization promotes the exchange of ideas and fosters multidisciplinary, interdisciplinary, and inter-professional scholarship, research, teaching, policy development, professional development, and collegiality among people engaged in clinical and academic bioethics and the medical humanities.

American Society of Law, Medicine & Ethics Conferences
The mission of the American Society of Law, Medicine & Ethics is to provide high-quality scholarship, debate, and critical thought to the community of professionals at the nexus of law, medicine, and ethics.

Global Bioethics Calendar
Comprehensive listing of events such as conferences, graduate school workshops, symposiums or meetings of membership associations from all regions in the world.

Harvard School of Public Health
The Program on Ethical Issues in International Health Research at Harvard serves as the umbrella under which a number of ethics-related educational initiatives are developed and implemented. These include the annual summer workshop at Harvard on "Ethical Issues in International Health Research" as well as international short courses.

Kennedy Institute of Ethics, Georgetown University, Events
Founded in 1971, this institute is the world's oldest and most comprehensive academic bioethics center. The Institute and its library serve as an unequalled resource for those who research and study ethics, as well as those who debate and make public policy.

Secretary's Advisory Committee on Human Research Protections (SACHRP) Meetings
SCHRP provides expert advice and recommendations to the Secretary of Health and Human Services and the Assistant Secretary for Health on issues and topics pertaining to or associated with the protection of human research subjects.

National Human Subject Protections Educational Activities
Sponsored by HHS (OHRP) and FDA, these activities include conferences, workshops, and research community forums.

Office of Research Integrity (ORI) Conferences
ORI oversees and directs Public Health Service research integrity activities on behalf of the Secretary of Health and Human Services with the exception of the regulatory research integrity activities of the Food and Drug Administration.

Public Responsibility in Medicine and Research (PRIM&R) Educational Activities
PRIM&R offers learning opportunities in the fields of biomedical and social/behavioral/educational research. PRIM&R provides current information on the ethics and legal issues related to human and animal subjects protections, and offers best practices and strategies for implementing successful research protection programs.

Content reviewed: January 7, 2013