Common Rule Departments and Agencies

CFR Citation (2018): 22 CFR Part 225
Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b), unless otherwise noted.
Status under Pre-2018 Requirements: Common Rule Signatory
Status under 2018 Requirements: Common Rule Signatory
Applies Subparts? No Subparts in CFR.

CFR Citation (2018): 7 CFR Part 1c
Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).
Status under Pre-2018 Requirements: Common Rule Signatory
Status under 2018 Requirements: Common Rule Signatory
Applies Subparts? No Subparts in CFR.

Relevant Website: https://www.bop.gov/resources/research_and_reports.jsp
CFR Citation (2018): 28 CFR Part 46
Authority: Department of Justice
Status under Pre-2018 Requirements: Common Rule Signatory
Status under 2018 Requirements: Intends to become an official signatory.
Applies Subparts? No Subparts in CFR.

CFR Citation (2018): None
Authority: EO 12333 (1981), amended by EO 13284 (2003), EO 13355 (2004), and EO 13470 (2008).
Status under Pre-2018 Requirements: Follows Common Rule because of EO 12333, as amended.
Status under 2018 Requirements: Follows Common Rule because of EO 12333, as amended.
Applies Subparts? Complies with all Subparts per EO 12333, as amended.

Relevant Website: [None currently]
CFR Citation: 45 CFR 2584
Authority: 42 U.S.C. 12651c(c)
Status under Pre-2018 Requirements: Not a Common Rule Signatory
Status under 2018 Requirements: Common Rule Signatory
Applies Subparts [B through E]? No Subparts in CFR.

Relevant Website: https://www.nist.gov/associate-director-laboratory-programs/research-protections-office/human-subjects-protection-program
CFR Citation (2018): 15 CFR Part 27
Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).
Status under Pre-2018 Requirements: Common Rule Signatory
Status under 2018 Requirements: Common Rule Signatory
Applies Subparts? No Subparts in CFR.

CFR Citation (2018): 16 CFR Part 1028
Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b)
Status under Pre-2018 Requirements: Common Rule Signatory
Status under 2018 Requirements: Common Rule Signatory
Applies Subparts? No Subparts in CFR.

Relevant Website: https://rt.cto.mil/ddre-rt/dd-rtl/hsd/hrp/
CFR Citation (2018): 32 CFR Part 219
Authority: 5 U.S.C. 301.
Status under Pre-2018 Requirements: Common Rule Signatory
Status under 2018 Requirements: Common Rule Signatory
Applies Subparts? Applies Subparts B, C, D, and E of 45 CFR 46, with caveats for Subparts B, C, and D. See page 19 of DoD Instruction
3216.02: https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/321602p.pdf
Additional Information: For additional information see DoD Instruction
3216.02: https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/321602p.pdf

Relevant Website: http://www.ed.gov/about/offices/list/ocfo/humansub.html
CFR Citation (2018): 34 CFR Part 97
Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474.
Status under Pre-2018 Requirements: Common Rule Signatory
Status under 2018 Requirements: Common Rule Signatory
Applies Subparts? Has adopted Subpart D only.

Relevant Website: https://science.osti.gov/ber/human-subjects
CFR Citation (2018): 10 CFR Part 745
Authority: 5 U.S.C. 301; 42 U.S.C. 7254; 42 U.S.C. 300v-1(b).
Status under Pre-2018 Requirements: Common Rule Signatory
Status under 2018 Requirements: Common Rule Signatory
Applies Subparts? No Subparts in CFR, but Subparts B, C, and D are applied if applicable to the research.
Additional Information: DOE-Specific Requirements: https://science.osti.gov/ber/human-subjects/Regulations-and-Requirements/DOE-Specific-Requirements
IRB Membership and Quorum: https://www.directives.doe.gov/directives-documents/400-series/0443.1-BOrder-c/@@images/file

Relevant Website: https://www.epa.gov/osa/basic-information-about-human-subjects-research-0
CFR Citation (2018): 40 CFR Part 26
Authority: 5 U.S.C. 301; 7 U.S.C. 136a(a) and 136w(a)(1); 21 U.S.C. 346a(e)(1)(C); sec. 201, Pub. L. 109-54, 119 Stat. 531; and 42 U.S.C. 300v-1(b).
Status under Pre-2018 Requirements: Common Rule Signatory
Status under 2018 Requirements: Common Rule Signatory
Applies Subparts? EPA has three Subparts for the protection of children, pregnant women, and nursing women in research (Subparts B-D). Subparts K-Q are special regulations related to the review of pesticide research involving human participants. 
Additional Information:
Pregnant and Nursing Individuals and Children: The EPA prohibits research involving the intentional exposure of pregnant participants, nursing participants, or children to any substance (40 CFR 26 Subpart B).

Protection for Subjects in Human Research with Pesticides: https://www.epa.gov/pesticide-advisory-committees-and-regulatory-partners/protections-subjects-human-research

EPA Order 1000.17 on Policy and Procedures of Protection of Human Research Subjects in EPA Conducted or Supported Research: https://www.epa.gov/osa/epa-order-100017-policy-and-procedures-protection-human-research-subjects-epa-conducted-or

Relevant Website: https://nij.ojp.gov/funding/human-subjects-protection
CFR Citation (2018): 28 CFR Part 46; CPD 0737D
Authority: Department of Justice
Status under Pre-2018 Requirements: Common Rule Signatory
Status under 2018 Requirements: Collaborating with NIJ to assist DOJ to become 2018 signatory.
Applies Subparts? No Subparts in CFR.

Relevant Website: http://www.hhs.gov/ohrp
CFR Citation (2018): 45 CFR Part 46
Authority: 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b)
Status under Pre-2018 Requirements: Common Rule Signatory
Status under 2018 Requirements: Common Rule Signatory
Applies Subparts? Applies all Subparts.

CFR Citation (2018): 6 CFR Part 46
Authority: P.L. 108-458, sec. 8306.
Status under Pre-2018 Requirements: Follows Common Rule and all Subparts per statute (Pub. L. 108-458, title VIII, section 8306)
Status under 2018 Requirements: Common Rule Signatory
Applies Subparts? Follows all Subparts per statute and Departmental policy.
Additional Information:
DHS Management Directive 026-04: https://www.dhs.gov/sites/default/files/publications/mgmt/general-science-and-innovation/mgmt-dir_026-04-protection-of-human-subjects_revision-01.pdf

CFR Citation (2018): 24 CFR Part 60
Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b) and 3535(d). 
Status under Pre-2018 Requirements: Common Rule Signatory
Status under 2018 Requirements: Common Rule Signatory
Applies Subparts? No Subparts in CFR.

Relevant Website: https://nij.ojp.gov/funding/human-subjects-protection
CFR Citation (2018): 28 CFR Part 46
Authority: Department of Justice
Status under Pre-2018 Requirements: Common Rule Signatory
Status under 2018 Requirements: Intends to become an official signatory.
Applies Subparts? No Subparts in CFR.

CFR Citation (2018): 29 CFR Part 21
Authority: 5 U.S.C. 301; 29 U.S.C. 551.
Status under Pre-2018 Requirements: Not a Common Rule Signatory
Status under 2018 Requirements: Common Rule Signatory
Applies Subparts? TBD
Additional Information: TBD

Relevant Website: https://www.nasa.gov/hrp
CFR Citation (2018): 14 CFR Part 1230
Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).
Status under Pre-2018 Requirements: Common Rule Signatory
Status under 2018 Requirements: Common Rule Signatory
Applies Subparts? No Subparts in CFR.

Relevant Website: https://new.nsf.gov/funding/research-involving-human-subjects
CFR Citation (2018): 45 CFR Part 690
Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).
Status under Pre-2018 Requirements: Common Rule Signatory
Status under 2018 Requirements: Common Rule Signatory
Applies Subparts? No Subparts in CFR.

CFR Citation (2018): None
Authority: EO 12333 (1981), amended by EO 13284 (2003), EO 13355 (2004), and EO 13470 (2008)
Status under Pre-2018 Requirements: Follows Common Rule because of EO 12333, as amended.
Status under 2018 Requirements: Follows Common Rule because of EO 12333, as amended.
Applies Subparts? Complies with all Subparts per EO 12333, as amended.

CFR Citation (2018): 20 CFR Part 431
Authority: 5 U.S.C. 301; 42 U.S.C. 289(a).
Status under Pre-2018 Requirements: SSA and HHS split in 1995. Pursuant to the transition rules provided in Section 106 of title 1 of Pub.L. 103-296, SSA has been required to apply the Common Rule to its research.
Status under 2018 Requirements: Common Rule Signatory
Applies Subparts? Apply all Subparts.

CFR Citation (2018): 49 CFR Part 11
Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).
Status under Pre-2018 Requirements: Common Rule Signatory
Status under 2018 Requirements: Common Rule Signatory
Applies Subparts? No Subparts in CFR.

Relevant Website: Human Research (va.gov), Human Research Protections - Office of Research Oversight (va.gov)

CFR Citation (2018): 38 CFR Part 16
Authority: 5 U.S.C. 301; 38 U.S.C. 501, 7331, 7334; 42 U.S.C. 300v-1(b).
Status under Pre-2018 Requirements: Common Rule Signatory
Status under 2018 Requirements: Common Rule Signatory with codification of the 2018 Common Rule as 38 CFR part 16 located at eCFR :: 38 CFR Part 16 -- Protection of Human Subjects.
Applies Subparts? VA did not adopt and codify Subparts B, C, and D in their entirety.  VA applies portions of Subparts B, C, and D as described in VA’s implementing policy for VA human subjects research: VHA Directive 1200.05(3); Requirements for the Protection of Human Subjects in Research located at VHA Publications (va.gov).
Additional Information: Broad consent can only be obtained for the use of information or biospecimens that are collected initially for research purposes.

VA has a required basic element of consent based upon VA regulations in 38 CFR Part 17.85 in which no VA subject will pay for a research-related injury.  VA also has an additional element of consent stating that no VA subject (or his or her insurance) will be billed for any costs related to research procedures required for a VA approved study.  A description of VA specific informed consent requirements is included in the table: VA Specific and Selected 2018 Common Rule Informed Consent Requirements When Using an Independent-Commercial IRB.

VA has an intramural research program which is centered on Veterans’ health issues.  Inclusion of non-Veterans in a VA research approval requires specific approval by the VA Facility institutional governance committee called a VA Research and Development Committee in addition to IRB approvals for subject recruitment for VA research.

Research that uses human fetal tissue or that focuses on either a fetus, or human fetal tissue, in-utero or ex-utero cannot be conducted by VA investigators while on official VA duty, at VA facilities, or at VA-approved off-site facilities.  Use of stem cells is governed by the policy set by NIH for recipients of NIH research funding.

Research involving prisoners cannot be conducted by VA investigators while on official VA duty, at VA facilities, or at VA-approved off-site facilities unless a waiver has been granted by the Chief Research and Development Officer (CRADO) in addition to any IRB approvals.

VA promotes use of a single IRB whenever possible in alignment with the cooperative research provisions.  VA uses a variety of different types of IRBs to review VA research, including VA and non-VA IRBs, including commercial IRBs. Approval by the VHA Office of Research and Approval (ORD) is required prior to a VA Facility entering in a new IRB reliance as described at https://www.research.va.gov/programs/orppe/irb_relationships.cfm.

VA has the ability to grant a single IRB exception for VA facilities participating in cooperative research activities when it is not appropriate for the specific study as also permitted by the 2018 Common Rule.  Additional information about VA’s implementation of the cooperative research provisions is located at https://www.research.va.gov/programs/orppe/irb_relationships.cfm.

VA has worked with NIH to clarify that VA and Department of Defense (DoD) sites can participate in NIH-funded multisite studies if the VA or DoD makes a determination that the use of a single IRB for the VA or DoD site(s) is not appropriate.  The FAQ, located at Frequently Asked Questions (FAQs) | grants.nih.gov, clarifies that NIH will accept determinations by the VA or the DoD that the use of a single IRB is not appropriate for specified VA or DOD site(s) participating in NIH-funded multisite studies. A special exception request issued by NIH is not necessary.

VA has national policies for reporting of apparent serious and continuing noncompliance and unanticipated problems involving risks to subjects or others. These policies are described in VHA Directive 1058.01: Research Compliance Reporting Requirements located at VHA Publications (va.gov).