Revised Common Rule
Revised Human Subjects Regulations (Common Rule) Wednesday, June 20th 2018
The regulations that human subjects researchers must adhere to (referred to as the Common Rule Regulations) were established in 1991. In 2011, federal agencies began the long-awaited process to revise these regulations and, on January 18, 2017, the final revisions to the Common Rule (Final Rule) were posted in the federal register. The effective and implementation dates have recently changed. As posted in the federal register on June 18, 2018, the revised final Common Rule is both effective and to be implemented on January 21, 2019 with the option of implementing 3 burden-reducing provisions before January 21, 2019.
*The CSU IRB will operate under existing policy until further notice.
Common Rule changes will be in effect on January 21, 2019. Currently, we are not implementing any changes prior to the effective date.
Some of the major areas of change are:
- Updates to the Continuing review requirements
- New categories of studies that do not require IRB review
- Changes to exempt categories
- Additional elements of consent
- Broad consent provisions (Optional, not adopted by CSU)
- Single IRB (compliance date January 19, 2020)
Continuing Review Requirements:
- minimal risk studies, and
- greater than minimal risk studies where interventions/interaction with participants are complete.
Categories of research excluded from IRB review:
Research falling into these disciplines do not need IRB review:
- Scholarly and Journalistic Activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship) including collection and use of information that focus directly on specific individuals about whom the information is collected.
- Public Health Surveillance – authorized by a public health authority.
- Criminal Justice – research by or for a criminal justice agency, authorized by law or court order.
- Authorized Operational Activities – in support of intelligence, homeland security, defense or national security missions.
New categories have been added and some existing categories have been modified:
- 45 CFR 46.104(d)(1): Modified provisions, formally 45 CFR 46.101(b)(1)
- 45 CFR 46.104(d)(2): Modified provisions, formally 45 CFR 46.101(b)(2)
- 45 CFR 46.104(d)(3): New Category
- 45 CFR 46.104(d)(4): New Category
- 45 CFR 46.104(d)(5): Same as 45 CFR.46.101(b)(5)
- 45 CFR 46.104(d)(6): Same as 45 CFR 46.101(b)(6)
- 45 CFR 46.104(d)(7): New Category
- 45 CFR 46.104(d)(8): New Category
Additional elements of consent
There are changes to the required elements of consent with the aim of providing information to potential participants in a clearer format.
For federally funded research, if your consent is longer than 4 pages, the informed consent must begin with a concise and focused presentation of key information that is most likely to assist a prospective participant or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. Currently, there is no federal guidance defining “key information.”
Additional required elements:
One of the following statements about research that involves the collection of identifiable private information or identifiable biospecimens:
- A statement that identifiers may be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the participant or their legally authorized representative, if applicable; or
- A statement that the participant’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future studies.
Additional optional elements:
- A statement that the participant’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the participant will or will not share in this commercial profit;
- A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
- For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
45 CFR 46.114, Cooperative Research
Effective January 19, 2020 – The cooperative research section adds a requirement for institutions located in the U.S. that are engaged in federal cooperative research (projects involving more than one institution) to rely upon approval by a sIRB for the portion of the research that is conducted in the U.S.
Note: For studies that must comply with the National Institutes of Health (NIH 2016) policy on sIRB review, the effective date was 25 January 2018 (with certain exceptions).For more information about collaborative research agreements, visit the new SMART IRB page.
The 2018 Requirements will result in a number of changes to the CSU Human Research Protection Program (HRPP) policies and procedures and you will see some changes to the forms in eProtocol in the next 1-3 months after we have updated and tested our new application form.
Since the Office of Human Research Protections (OHRP) has not provided adequate guidance, decision guides, or templates, we are developing these guidance documents internally and in collaboration with other institutions. Check our website regularly. The IRB will be updating our website with additional guidance documents and templates as available. If/when guidance is issued from OHRP to assist with the understanding and implementation of the revised Common Rule, we will contact you via our email newsletter.