2018 Common Rule Updates

Summary

The Federal Policy for the Protection of Human Subjects or the “Common Rule” outlines specific regulations for human subjects research. The Common Rule is heavily based on the "The Belmont Report," but was revised by the HHS and FDA. The recent revisions to the Common Rule became effective January 21, 2019.

Full Description

2018 Common Rule Updates

The U.S. Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) oversee operations of the IRB.

Federal Regulation 45 CFR 46 Protection of Human Participants: applies to all research involving human participants conducted, supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate administrative action to make the policy applicable to such research. Protection of Human Participants mandates research that involves human participants must be approved by an Institutional Review Board (IRB) to ensure the safety and the appropriate use of humans as participants in research studies.

Please see the US Department of Health and Human Services for more information.

Table displays descriptions of updates to the common rule.
Revised Sections of The Common Rule	Summary of Changes	Timeline of Implementation
Applicability 45 CFR 46.101	46.101.(f)When applicable, American Indian and Alaska Native Tribal Laws will be applied.	January 21, 2019
Definitions 45 CFR 46.102	46.102(e)-Definition of Human Subjects includes identifiable biospecimens. Identifiable human biospecimens and private information are treated similarly. 46.102(I)-Examples of what are not considered human subjects research. 46.102(m)-Defines written (or, in writing) as paper or electronic format.	January 21, 2019
Assurance 45 CRF 46.103	The elimination of the requirement that institutional review boards review grant applications or other funding proposals related to the research.	July 19, 2018
Exempt Research 45 CFR 46.104	Exempt categories 1-2 and 5 are further defined, and 6 remains unchanged Normal educational practices not likely to adversely impact students' opportunity to learn. Criteria iii specifies that an IRB can conduct a limited review for studies in which identifiable information is obtained/recorded, 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 met. Secondary research for which consent is not required is permitted if at least one of three additional criteria are met. New section for research conducted by federal employees. New categories are 3-4 and 7-8. No change Store/maintain identifiable private information /specimens for potential secondary research permitted by a limited IRB review. 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.	January 21, 2019
IRB Review of Research 45 CFR 46.109	46.109(a) - Exempt Research that require limited IRB review as a condition of exemption. Limited IRB Review is performed at an IRB Expedited Subcommittee meeting by an IRB Chair or an IRB Chair-designee. 46.109(f) - Continuing review is not required when Research eligible for expedited review, Research reviewed by the limited IRB review process, Research limited to only: data analysis, or accessing follow-up clinical data (performed as part of clinical care).	January 21, 2019
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. DHHS guidance forthcoming. 46.11(a)(8) Approval criteria for a limited IRB review	January 21, 2019
Cooperative Research 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 form. 46.116(b) - One (1) new Basic element of informed consent. 46.116(c) - Three (3) new Additional elements of informed consent. 46.116(d) - Seven (7) elements of a Broad consent form. 46.116(f) - Revised criteria for a General Waiver or Alteration of Consent. 46.116(g) - New exception to Informed Consent: Screening, recruiting, determining eligibility is permitted under specific circumstances. 46.116(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.	January 20, 2020
Documentation of Informed Consent 45 CFR 46.117	46.117(a) - Includes electronic format. 46.117(b) - Ensures that Key Information (i.e. concise summary) is presented first to the subject. 46.117(c) - New criteria for a waiver of documentation (signed) of informed consent.	January 21, 2019