Revised Common Rule - January 21, 2019
In January 2017, the US Department of Health and Human Services (DHHS) published the “Final Rule,” which is a revised version of the Common Rule (45 CFR 46) first published in 1991. The last time the common rule was revised was 2005. The revisions come after years of discussion of the most appropriate changes in the changing world of research influenced by changes in technology and overall changes in U.S. culture. After several implementation delays, the “Final Rule” will be implemented January 21, 2019, with the expectation that IRBs, researchers, institutions will comply with those “Final Rule” on that date. For ease of communication we’ll refer to the “Final Rule” as the “Revised Common Rule,” and/or “2018 Requirements” below.
If you go to the DHHS site, the currently published regulations are referred to as pre-2018 requirements, and the Revised Common Rule is referred to as the 2018 requirements.
At Emory & Henry, the studies reviewed and either provisionally approved or approved prior to January 21, 2019 will be subject to the current common rule. Those that are reviewed and provisionally approved or approved January 21, 2019 will be subject to the revised common rule.
New forms and consent templates have been developed to facilitate meeting the new requirements for submissions on or before January 21, 2019.
The Final Rule (Revised Common Rule) 2018 Requirements are available for your review.
Summary of Major Changes
Revised Definitions of “Human Subject” and “Research:”
Human subject now includes biospecimens.
Research The definition now specifies certain activities are not considered research. A partial list is included below.
Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
Exempt Categories Broadened:
Many of the existing categories have been revised and new categories have been added
Categories 1, 2, 4, and 5 have been revised. Categories 3, 7, and 8 are new. Category six (taste and food quality remains the same).
A description of the changes to exempt categories can be found in Self Service under the Academics Tab (sub-folder - Human Research, Revised Common Rule Summary)
A full description of the new exempt categories can be found in Self Service under the Academics Tab (sub-folder - Human Research, Revised Common Rule Summary). Or you can also go directly to The Final Rule (Revised Common Rule) 2018 Requirements under §46.104 Exempt research.
Under the previous Common Rule, Expedited (XP) and Full Board (FB) projects must be re-approved by the IRB on an annual basis (at a minimum). However, under the revised Common Rule (45 CFR 46.109(f)(iii)), expedited projects granted initial approval on or after 1/21/19 do not require annual continuing review by the IRB.
Further, if a Full Board project granted initial approval on or after 1/21/19 has progressed to the point that it only involves one or both of the following, then it will not require annual continuing review unless the IRB determines otherwise. However, you still must submit a final continuing Review to notify the IRB that your study status meets one of the two criteria below.
Remaining study activities are limited to data analysis, including analysis of identifiable private information or identifiable biospecimens, or
Remaining study activities only involve accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
Changes to Consent Requirements:
- A new regulation states that “Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research” (45 CFR 46.116(a)(5)(i)). The revised consent templates will explain what must be included in this summary of key information.
- The revised regulations have added new required elements of informed consent which include:
- A statement about whether identifiers will be removed from private information or biospecimens used in the research, and after such removal, the information or biospecimens could be used or distributed for future research studies,
- An explanation of whether biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this profit,
- Clarification of whether the research involving biospecimens will or might involve whole genome sequencing, and
- Notification of whether clinically relevant research results, including individual research results, will be disclosed to subjects and if so, under what conditions.
- Broad consent may be obtained for the storage and maintenance for secondary research use of identifiable private information and identifiable biospecimens originally collected for other purposes (exempt category 7). Secondary research use of such materials may occur under exempt category 8. The new elements of informed consent required by the regulations for broad consent are now incorporated into the repository consent form template, and those projects that qualify for exemption category 7 must use the repository consent form.
- The revised Common Rule will require that for any clinical trial conducted or supported by a Common Rule department or agency, one IRB-approved consent form used to enroll subjects must be posted on a publicly available federal website by the awardee or the Federal Department or agency. HHS has indicated that there are two publicly available federal websites that will satisfy the consent form posting requirement: ClinicalTrials.gov and Regulations.gov. HHS has also indicated that they are developing further instructions, which we are still awaiting.