The Common Rule (45 CFR 46)
On January 19, 2017, the U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991.
The Final Rule reflecting the 2018 Common Rule Requirements went into effect January 21, 2019, with the exception of cooperative research (single IRB review) which went into effect January 20, 2020.
Summary of changes to the revised Common Rule
|Revised Sections of the Common Rule||Summary of Changes||Notes|
45 CFR 46.101
|46.101(f) – When applicable, American Indian and Alaska Native Tribal Laws will be applied|
45 CFR 46.102
|46.102(e) – Definition of Human Subjects includes identifiable biospecimens
46.102(l) – Examples of what are not considered human subject research
46.102(m) – Defines Written (or, in writing) as paper or electronic format
|The elimination of the requirement that institutional review boards review grant applications or other funding proposals related to the research.||Administrative Review of grant applications will continue to be conducted by IRB administrators.|
|Exempt categories 1-2 and 5 are further defined, and 6 remains the same
New categories are 3-4, and 7-8
|IRB Review of Research
|46.109(a) – Exempt Research that require *limited IRB review as a condition of exemption.
46.109(f) – Continuing review is not required when:
*Limited IRB review is performed through the same mechanism as Expedited Review by members of the IRB committee to determine there are adequate provisions to protect the privacy of participants and maintain the confidentiality of data as well as confirm consent procedures are adequate.
|PI must provide annual certification that study procedures and design have not changed will be required for all research eligible for expedited review. PIs will do so by completing an ER Annual Certification form and submitting to the IRB Office.
Research limited to data analysis will require PIs to annually confirm that data analysis is ongoing.
|Criteria for IRB Approval
|46.111(a)(3) & 46.111(b) – Vulnerable populations:
46.111(a)(7)(i) – Include adequate provisions to protect privacy of subjects / maintain confidentiality of data.
46.11(a)(8) Approval criteria for a limited IRB review
|This entire section has been revised. A brief summary is outlined below:
|UTD template consent forms have been updated in accordance with the revised Common Rule and are available on the IRB Office’s website.|
|Documentation of Informed Consent
UTD Transition Plan
|When was initial IRB Approval issued for the Research?||Is transition to 2018 Common Rule required?|
|Prior to July 19, 2018||NO – research will continue to follow the Pre-2018 Common Rule.
EXCEPTION: Research must transition to the 2018 Common Rule IF a protocol is or will be associated with new or renewal federal funding* awarded on or after January 21, 2019. In this scenario, the Principal Investigator (PI) or Faculty Sponsor (FS) may opt to submit either a Request for Revision (MOD) or a new IRB application.
|July 19, 2018 – January 20, 2019||NO – research will continue to follow the Pre-2018 Common Rule. This research will not be required to transition to the 2018 Common Rule; however, Investigators may opt to transition to the 2018 Common Rule by either submitting a MOD or a new IRB application.|
EXCEPTION: Research must transition to the 2018 Common Rule if a protocol is or will be associated with new or renewal federal funding* awarded on or after January 21, 2019. In this scenario, the PI / FS may opt to submit either a MOD or a new IRB application.
|On or after January 21, 2019||YES, all research (regardless of funding/support) must follow the 2018 Common Rule.|
*New federal funding means an award of funds (i.e., grant, contract, cooperative agreement or other funding mechanism) to support a project not previously funded by the U.S. government. Renewal federal funding means an award of funds to support the next competitive segment of a project previously funded by the U.S. government.