Site Map
DOE Human Subjects Protection Program
Participating DOE Laboratories and Sites
- Ames Laboratory
- Argonne National Laboratory
- Bechtel Jacobs Company LLC
- Brookhaven National Laboratory
- Fermi National Accelerator Laboratory
- Idaho National Laboratory
- Lawrence Berkeley National Laboratory
- Lawrence Livermore National Laboratory
- Los Alamos National Laboratory
- Oak Ridge Institute for Science and Education
- Oak Ridge National Laboratory
- Pacific Northwest National Laboratory
- Sandia National Laboratories
- Savannah River Site
- Y-12 National Security Complex
Human Subjects Regulations, Orders, and Policies
- DOE O 443.1B, Protection of Human Research Subjects
- DOE Human Subjects Protection Resource Book
- DOE O 484.1, Reimbursable Work for the Department of Homeland Security
- DOE O 481.1C, Work For Others (Non-Department of Energy Funded Work)
- DOE O 412.1A, Work Authorization System
- DOE M 481.1-1A Chg 1, Reimbursable Work for Non-Federal Sponsors Process Manual
- DOE M 483.1-1, DOE Cooperative Research and Development Agreements Manual
- DOE O 241.1A Chg 1, Scientific and Technical Information Management
- National Nuclear Security Administration Act
- Code of Federal Regulations: access files on gpoaccess.gov site
- 10 CFR 1008, Records Maintained On Individuals
- 10 CFR 600, DOE Financial Assistance Rules
- 10 CFR 602, Epidemiology and Other Health Studies Financial Assistance
- 10 CFR 605, Office of Science Financial Assistance Program
- 10 CFR 745, Protection of Human Subjects
- 45 CFR 46, Protection of Human Subjects
- DOE Protecting Human Research Subjects Newsletter
- Quality Assurance and Quality Improvement – Is it Human Subjects Research?
- Human Subjects Working Group
- Review of HSWG Activities (pdf)
- Regular Members (pdf)
- Associate Members (pdf)
- DOE HSWG 2010 Fall Workshop (doc)
- DOE Information
- From Paper to People: After IRB Approval of Research Studies (pdf)
- Guidance for Informed Choice on Beryllium Testing (pdf)
- Worker Studies Guidelines: Creating an Ethical Framework for Studies That Involve the Worker Community
- Worker Studies Informational Brochure
- Human Subjects Protection Resource Book
- Human Subjects Informational Brochure
- Protecting Human Subjects Newsletter
- Protecting Human Subjects Poster
- DOE Assurances
- Self Assessment and Accreditation
- Analyzing Your Human Research Protection Program (pdf)
- Education and Training for Human Subjects Research
- Human Subjects Research Database
- Promotional Poster (pdf)
- Background information Brochure (pdf)
- Guidelines
- Human Subjects Protection Resource Book
- From Paper to People: After IRB Approval of Research Studies (pdf)
- Protecting Workers Who Are Human Research Subjects brochure
- Research on Human Specimens brochure
- IRB Guidebook, Department of Health and Human Services (HHS) Office for Human Research Protection (OHRP)
- Expedited Review
- Adverse Events and Unanticipated Problems
- Consent Form Information
- HHS OHRP Tips on Informed Consent
- HHS OHRP Informed Consent Checklist
- Glossary of Lay Terms for Use in Preparing Consent Forms for Human Subjects
- DOE Generic Sample Research Subject Informed Consent Form: Word | PDF
- Model Consent for Use of Tissue Samples for Human Genome Project Cell Lines
- Sample Consent Form for Use of Tissue for Research
- Food and Drug Administration's (FDA) Guide to Informed Consent
- FDA Guidance on Informed Consent for In Vitro Studies Using Leftover Human Specimens That Are Not Individually Identifiable (pdf)
- A Guide to Understanding Informed Consent
- DOE Requirements for Protecting Personally Identifiable Information (PII)
- Background on Protecting Personally Identifiable Information
- Checklist for Researchers Conducting Human Subjects Research with/at DOE Sites, with DOE Funding, or Using DOE Data
- Checklist for DOE Site IRBs and the Central DOE IRB
- DOE Memorandum to Former Worker Medical Screening Program Points of Contact (pdf)
- DOE Manual: Security Controls for Unclassified Information Systems Manual
- DOE Manual: Cyber Security Incident Management Manual
- DOE Order: Department of Energy Privacy Program
- DOE Manual: Manual for Identifying and Protecting Official Use Only Information
- Security Requirements for Cryptographic Modules
- Web Sites of Interest
- Advisory Committee on Human Radiation Experiments (ACHRE) (at the National Security Archive)
- American Society for Bioethics and Humanities
- Association of American Medical Colleges (AAMC)
- Bills introduced in the U.S. Senate and U.S. House
- Center for Bioethics, University of Pennsylvania
- Clinical Trials and Institutional Review Boards (FDA)
- Department of Energy's Human Radiation Experiments
- Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP)
- Department of Veterans Affairs, Office of Research Oversight (ORO)
- HealthPathfinder
- National Bioethics Advisory Commission Web Site
- National Human Research Protections Advisory Committee (NHRPAC) - Archive
- Secretary's Advisory Committee on Human Research Protections
- National Institutes of Health, Bioethics Resources on the Web
- National Institutes of Health, Office of Human Subjects Research (OHSR)
- National Institutes of Health Requirement for Education on the Protection of Human Subjects: FAQs
- Bioethics Research Library at Georgetown University
- Office of Inspector General/HHS Reports
- Public Responsibility in Medicine & Research (PRIM&R)
- Secretary's Advisory Committee on Human Research Protections
- University of Illinois at Chicago, Office for Protection of Research Subjects (OPRS)
- International Issues
- Genome Research Resources
- U.S. Department of Energy Human Genome Program
- National Institute of Environmental Health Sciences - Environmental Genome Project (EGP)
- National Institutes of Health, National Human Genome Research Institute (NHGRI)
- National Institutes of Health, NHGRI, Ethical, Legal and Social Implications Research Program
- Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS)
- Secretary's Advisory Committee on Genetics, Health, and Society
- Meetings and Conferences
- DOE Human Subjects Working Group (HSWG) 2010 Fall Workshop (doc)
- May 2009 DOE Human Subjects Working Group Spring Workshop
- Welcome and Introductions Expectations for Workshop (ppt)
- Protocol Compliance Monitoring (ppt)
- Succession Planning for the HRPP and IRB (ppt)
- DOE Human Subjects Website Report (pptx)
- Overview of Personally Identifiable Information (PII) Protection Requirements (ppt)
- Reporting Unanticipated Problems and Review/Approval of Projects that Use Personally Identifiable Information (ppt)
- Former Worker Medical Screening Program – Loss of PII (ppt)
- Plans for Central DOE IRB (CDOEIRB) (ppt)
- What New Policy/Guidance is Coming from OHRP? (ppt)
- November 2009 DOE Human Subjects Working Group Fall Workshop
- May 2008 DOE Human Subjects Working Group Spring Workshop
- DOE Workshop Expectations (ppt)
- Office of Human Research Protections (OHRP) Quality Improvement Program – Tutorial (ppt)
- Association for the Accreditation of Human Research Protection Programs (AAHRPP) Accreditation Tutorial (ppt)
- AAHRPP handout (pdf)
- Central IRBs (Oak Ridge Site-wide IRB, 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
- Dec. 2007 Human Subject Working Group Annual Meeting
- American Society for Bioethics and Humanities Meetings and Programs
- American Society of Law, Medicine & Ethics Conferences
- Global Bioethics Calendar
- Harvard School of Public Health
- Kennedy Institute of Ethics, Georgetown University, Events
- Secretary's Advisory Committee on Human Research Protections (SACHRP) Meetings
- National Human Subject Protections Educational Activities
- Office of Research Integrity (ORI) Conferences
- Public Responsibility in Medicine and Research (PRIM&R) Educational Activities
- CITI Web-based Training
- Researchers from DOE Laboratories
- Advance Notice of Proposed Rulemaking (ANPRM) for Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators
- Additional FAQs? Complaints? Compliments? Suggestions? Give us your feedback
DOE Worker Health-Related Studies and Programs
- Chronic Beryllium Disease
- DOE-Wide Central Institutional Review Board Review
- Authority and Procedures
- Guidance for Informed Choice on Beryllium Testing (pdf)
- Bridging DOE and Department of Labor (DOL) Medical Monitoring Programs for Chronic Beryllium Disease
- Prevention Program
- Sites with Prevention Programs
- Laws and Orders
- Beryllium Lymphocyte Proliferation Test (Be LPT)
- Beryllium Testing: National Supplemental Screening Program (NSSP) fact sheet and informed consent statement (pdf)
- Beryllium Testing for Former Beryllium Vendors fact sheet (pdf)
- Beryllium Testing for Former Beryllium Vendors: Informed Consent Form (pdf)
- Support Groups
- National Jewish Medical and Research Center
- Agency for Toxic Substances and Disease Registry ToxFAQs for Beryllium
- Beryllium-Related Industry Research
- Privacy
- DOE/HHS Memorandum of Understanding
- Access Handbook Conducting Health Studies at Department of Energy Sites (pdf)
- Communication Plan for Public Health Activities Conducted Under the
Memorandum of Understanding Between DOE and HHS (pdf) - Lost CD Information
- Instructions for Transmittal of Personal Identifiable Information for the Former Worker Programs (pdf)
- Transmittal of Personal Identifiable Information (pdf)
- Security Controls for Unclassified Information Systems Manual
- Cyber Security Incident Management Manual
- Department of Energy Privacy Program
- Manual for Identifying and Protecting Official Use Only Information (pdf)
- Security Requirement for Crytograpic Modules (pdf)
- Coalition for Patient Rights
- Health Privacy Project
- HHS Medical Privacy—National Standards to Protect the Privacy of Personal Health Information Web site
- Department of Health and Human Services, Office for Human Research Protections IRB Guidebook
- Privacy Act of 1974
- Legislative Survey of State Confidentiality Laws, with Specific Emphasis on HIV and Immunization
- Health Studies and Activities at DOE
- DOE Former Workers Medical Screening Program (FWP)
- Energy Employees Occupational Illness Compensation Program Act
- Comprehensive Epidemiologic Data Resource (CEDR)
- ORISE Center for Epidemiologic Research
- Worker and Public Health Studies
- Access Handbook—Conducting Health Studies at Department of Energy Sites (pdf)
- Worker Studies Guidelines: Creating an Ethical Framework for Studies That Involve the Worker Community
- Protecting Workers Who Are Human Research Subjects brochure
- Professional Codes for Conducting Worker Studies
- American College of Occupational and Environmental Medicine
- American Medical Association's Code of Medical Ethics
- Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects
- Hippocratic Oath
- Human Factors and Ergonomics Society Code of Ethics
- International Society for Environmental Epidemiology Code of Ethics
- National Association of Social Workers Code of Ethics
- Criteria Documents, Compliance, and Standards
- Other Web Sites of Interest
- U.S. Department of Health and Human Services Office for Human Research Protections (OHRP)
- HealthPathfinder
- Center for Bioethics, University of Pennsylvania
- Archive of the National Human Research Protections Advisory Committee (NHRPAC)
- Secretary's Advisory Committee on Human Research Protections
- Department of Veterans Affairs, Office of Research Oversight (ORO)
- Coalition for Patient Rights
- Statement of Administration Policy - Genetic Non-Discrimination Act of 2003
- Educational Information and Resources
- 45 CFR Part 46
- Bioethics Research Library at Georgetown University
- Responsible Conduct of Research Education Committee
- The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
- Executive Order 13145: To Prohibit Discrimination in Federal Employment Based on Genetic Information
- Policy Guidance on Executive Order 13145: To Prohibit Discrimination in Federal Employment Based on Genetic Information
- World Medical Association Declaration of Helsinki
- Meetings and Conferences
- Codes of Ethics
- American College of Occupational and Environmental Medicine/ Medical Review Officer Certification Council (MROCC)
- American Medical Association
- American Psychological Association
- Australia's National Health and Medical Research Council
- The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
- Canadian Medical Association (pdf)
- Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects
- Hippocratic Oath
- Human Factors and Ergonomics Society
- International Society for Environmental Epidemiology
- National Association of Social Workers
- Nuremberg Code
- World Medical Association
- Educational Information
- Meetings and Conferences
- Policy
- The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
- Executive Order 13145: To Prohibit Discrimination in Federal Employment Based on Genetic Information
- Policy Guidance on Executive Order 13145: To Prohibit Discrimination in Federal Employment Based on Genetic Information
- Federal Policy on Research Misconduct
- Web Sites of Interest
- American Society for Bioethics and Humanities
- Center for Bioethics, University of Pennsylvania
- DOE Human Genome Program, Ethical, Legal and Social Implications
- National Institutes of Health, NHGRI, Ethical, Legal and Social Implications Research Program
- Bioethics Research Library at Georgetown University
Content reviewed: August 27, 2012