Source: https://science.osti.gov/ber/human-subjects/About
Timestamp: 2020-07-06 16:50:29
Document Index: 534158014

Matched Legal Cases: ['art 745', 'art 46', 'art 745', 'art 46', 'art 46', 'art 46']

﻿ HUMAN SUBJECTS About | U.S. DOE Office of Science (SC)
The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies, including DOE, have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). A final rule was published in the Federal Register (FR) on January 19, 2017, and was amended to delay the effective and compliance dates on January 22, 2018 and June 19, 2018.
The revised Common Rule was effective July 19, 2018; note that from July 19, 2018 through January 20, 2019 institutions were not permitted to implement the entirety of the revised Common Rule. This is explained in the transition provision (45 CFR 46.101(l), as amended June 19, 2018). All projects initiated on or after January 20, 2019 must fully comply with the 2018 Requirements. Studies that were ongoing as of that date may remain under the original (referred to as the Pre-2018 Requirements) Common Rule requirements or may be transitioned to the revised Common Rule.
All research involving human subjects conducted at DOE institutions, supported with DOE funds, or performed by DOE employees, including research that is classified and proprietary, whether done domestically or in an international environment, must comply with all federal regulations and DOE requirements that address the protection of human subjects, including:
10 CFR Part 745, Protection of Human Subjects (DOE’s implementation of the Common Rule, Subpart A of 45 CFR Part 46), Pre-2018 Requirements
10 CFRPart 745, Protection of Human Subjects (DOE’s implementation of the revised Common Rule, Subpart A of 45 CFR Part 46), 2018 Requirements
45 CFR Part 46, Department of Health and Human Services (HHS), Protection of Human Subjects (all other Subparts); Note: This is a link to both the Pre-2018 and the 2018 requirements, as well as all other subparts of 45 CFR Part 46. DOE requires compliance with all subparts.
DOE-specific Requirements:
DOE O 443.1C, Protection of Human Research Subjects
Note: No human subjects research may be initiated without both a Federalwide Assurance (FWA) and approval by the cognizant Institutional Review Board (IRB) in accordance with 10 CFR 745.103 and DOE Order 443.1C, Section 4a(1).
The departments and agencies following the Common Rule identified a need to update the rule to reflect the changes in how research is conducted. It will better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The revision is also an effort to modernize, simplify, and enhance the current system of oversight. The revised Common Rule is designed to more thoroughly address the broader types of research conducted or otherwise supported by all of the Common Rule departments and agencies such as behavioral and social science research. It also benefits from continuing efforts to harmonize human subjects policies across federal departments and agencies.
humans in the testing of transformative energy technologies, devices, products, or materials developed through research; human-machine interfaces; or environmental alterations to a human environment;
bodily materials such as DNA, cells, blood, tissues, or urine that are identifiable with individuals even if the materials were not collected for the study in question;
identifiable data, including surveys, collected through direct intervention or interaction with individuals;
studies focused on Internet Research, Artificial Intelligence, Machine Learning and Big Data; and
epidemiologic and other studies conducted to gain generalizable knowledge about categories or classes of subjects (e.g., worker populations or subgroups).