Major Regulation Changes
“The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The Final Rule was published in the Federal Register on January 19, 2017. It implements new steps to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators” (OHRP, 2018). These changes went into effect on January 21, 2019 with the exception of single IRB requirements, discussed below. This is the first change to the Common Rule since it was published in 1991.
Highlights to the New Common Rule
Please see the Revised Common Rule for a full description of the requirements (regulatory text). This guide is intended to highlight the key changes most likely to affect researchers at Siena.
DEFINITION OF RESEARCH
The definition of “research” has been expanded to list activities that are specifically deemed not to be research (e.g., oral history, journalism, public health surveillance, criminal justice or criminal investigative activities, and activities in support of intelligence, homeland security, defense, or other national security missions).
NEW EXEMPTION CATEGORIES
There are now new categories (including “Benign Behavioral Interventions”) and clarification of existing categories of research exemption. Some exemptions may permit minimal risk research in which there is collection of sensitive, personally identifiable data. These exemptions may require “limited IRB review” (similar to an expedited review process).
In December 2018 the Siena IRB adopted a policy, consistent with the federal regulations, that exempt studies do not need a consent form. (Limited review exempt research will still require a consent form.)
Researchers are encouraged to carefully review the new categories, as research previously reviewed as “expedited” will now fall under one of the 8 exempt research categories.
CONTINUING REVIEW
Unless an IRB determines otherwise*, continuing review of research is not required in the following circumstances:
- Research eligible for exempt and exempt limited review
- Research eligible for expedited review
- Full review studies that have completed study interventions and are merely analyzing study data
The researcher must continue to submit amendments (revisions) to the IRB through the end of data collection for the study.
*At Siena, the default for exempt, exempt limited review, expedited research is that no continuing review is necessary. If the IRB determines the need for continuing review, per the new regulations, a rationale will be provided in the approval letter.
INFORMED CONSENT
A new “Key Elements” section and a rearrangement of content is designed to facilitate a potential subject’s decision to participate or not. New Common Rule compliant consent form templates are available under “Application Materials” / “Informed Consent” on the IRB homepage.
VULNERABLE POPULATIONS
The following changes to the categories of subjects that are classified as vulnerable were made:
- “mentally disabled” was replaced with “individuals with impaired decisions-making capacity"
- “handicapped” and “pregnant women” have been removed
In addition, the scope of the definition of “vulnerability” addressed by the rule was limited to vulnerability to coercion and undue influence.
SINGLE IRB FOR MULTI-SITE RESEARCH (Jan 2020)
In an effort to streamline the process and prevent duplication of effort, the use of one IRB for cooperative research will be required for all non-federally funded research. On January 20, 2020, this will extend to federally funded research.
What to Expect
For new studies, expect to see:
- Application changes
- Informed consent template changes
- IRB Policy Manual updates
For ongoing studies, research will remain under the previous regulations (those issued in 1991). There are no changes required. Studies approved before January 14, 2019 (when Siena began implementing the revised Common Rule) must undergo continuing renewal after one year as was the policy when the approval letter was issued. The IRB will issue guidance on how to request transition to the new rules, if desired, and the circumstances where transition might be beneficial.