№ lp_1_2_38386
Regulatory guidance document establishing mandatory requirements and oversight procedures for protecting human participants in Department of Energy–conducted or supported research, including classified studies and the handling of personally identifiable information.
Purpose: Guidance on additional obligations for investigators conducting research supported or conducted by the Department of Energy
Subject: Human participant protections in research
Applicable organization: U.S. Department of Energy
Scope of application: Research conducted at DOE institutions or by DOE employees and contractors
Regulatory basis: 10 CFR Part 745.103
Research types covered: Domestic and international research, including classified, proprietary, and Human Terrain Mapping research
Oversight body: Institutional Review Board
Reporting requirements: Adverse events, unanticipated problems, complaints, and loss of personally identifiable information
Data protection requirements: Protection and handling of personally identifiable information and protected health information
Security standards referenced: Federal Information Processing Standards 140-2
Consent requirements: Additional disclosure elements for classified research
Prohibited practices in classified research: Exemptions, expedited review, waiver of consent, waiver of consent documentation
Responsible officials: DOE Institutional Official; DOE Human Subjects Protection Program Manager
References: 10 CFR 745; DOE Order 443.1.B; Checklist for IRBs to Use in Verifying That HS Research Protocols Are in Compliance with DOE Requirements
Price: 8 / 10 USD
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