The Department of Health and Human Services (DHHS) issued the Final revisions to the Common Rule for the Protection of Human Subjects. The majority of these changes go into effect on January 19, 2018. The remaining changes go into effect in January 2020.
Major Regulations Changes
Informed Consent -
- New process requirements for the content, organization and presentation of information and the process to facilitate a prospective subject's decision about whether to participate in research.
- New requirements for the basic and additional elements of consent
- Electronic Consent is allowed, but must provide written copy
- New option for broad consent or storage, maintenance or secondary research use of identifiable private information and identifiable biospecimens.
- Changes in the waiver and alteration criteria for consent
- New consent provisions that allows IRBs to approve a research proposal without individual's informed consent for screening, recruiting or determining eligibility
- New requirement to post, to a federal website, a copy of an IRB approved version of the consent form that was used for enrollment purposes for each clinical trial conducted or supported by a federal department or agency
- For details, see MCRI Informed Consent webpage
- New categories and existing categories clarified. Some exemptions may now require "limited IRB review", while others will not be utilized at Marshfield Clinic Research Institute (MCRI) at this time. For details, see the MCRI: Exemption Changes webpage.
Continuing Review -
- No longer required for some minimal risk research, including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data. For details see, MCRI Continuing Review webpage.
Single IRB of Record (sIRB) -
- IRB oversight for most federally funded collaborative research projects located in the U.S. will be required to use a single IRB starting January 20, 2020. For details see, MCRI Single IRB webpage
For more details on the Common Rule & MCRI see, Common Rule - What to Expect webpage