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 research46.102(m) – Defines Written (or, in writing) as paper or electronic format|
|Assurance 45 CFR 46.103||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 Research 45 CFR 46.104||Exempt categories 1-2 and 5 are further defined, and 6 remains the same 1: Normal educational practices not likely to adversely impact students’ opportunity to learn2: Criteria iii specifies that an IRB can conduct a limited review for studies in which identifiable information is obtained/recorded5: New section for research conducted by Federal employeesNew categories are 3-4, and 7-83: Research involving benign behavioral interventions with adult subjects, in conjunction with the collection (verbal, written, data entry, audio/visual recording) of information is permitted with prospective consent and at least one of three additional criteria are met4: Secondary research for which consent is not required is permitted if at least one of three additional criteria are met7: Store/maintain identifiable private information/specimens for potential secondary research permitted by a limited IRB review8: Research involving the use of identifiable private information/specimen for secondary research use for which broad consent is required, is permitted when 3 additional criteria are met|
|IRB Review of Research 45 CFR 46.109||46.109(a) – Exempt Research that require *limited IRB review as a condition of exemption. 46.109(f) – Continuing review is not required when:Research eligible for expedited reviewResearch reviewed by the Limited IRB review processResearch limited to only: data analysis, or accessing follow-up clinical data (performed as part of clinical care).*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 45 CFR 46.111||46.111(a)(3) & 46.111(b) – Vulnerable populations: Pregnant women and handicapped/mentally disabled populations are no longer considered vulnerable.Individuals with impaired decision-making capacity and economically/educational disadvantaged are considered vulnerable population.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|
|Informed Consent 45 CFR 46.116||This entire section has been revised. A brief summary is outlined below: 46.116(a) – New requirement of Key Information at the beginning of the consent form46.116(b) – One (1) new Basic element of informed consent46.116(c) – Three (3) new Additional elements of informed consent46.116(d) – Seven (7) elements of a Broad consent form46.116(f) – Revised criteria for a General Waiver or Alteration of Consent46.116(g) – New exception to Informed Consent: Screening, recruiting, determining eligibility is permitted under specific circumstances46.116(h) – A copy of the template consent form must be posted on a federal website after the clinical trial (sponsored by a federal department or agency) is closed to recruitment and no later than 60 days after the last study visit by any subject. DHHS guidance is forthcoming||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 45 CFR 46.117||46.117(a) – Includes electronic format46.117(b) – Ensures that Key Information was presented first to the subject46.117(c) – New criteria for a waiver of documentation (signed) 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.