Common Rule Revisions
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Federal Policy for the Protection of Human Subjects: Six Month Delay of the General Compliance Date of Revisions
The revised Common Rule was scheduled to become effective on January 19, 2018, with a general compliance date of the same date. By an interim final rule issued on January 17, 2018 and published in the Federal Register on January 22, 2018, federal departments and agencies delayed the effective date and the general compliance date for the revised Common Rule for a 6-month period, until July 19, 2018. As a result of this delay, regulated entities will be required to continue to comply with the requirements of the pre-2018 version of the Federal Policy for the Protection of Human Subjects (the "pre-2018 Requirements") until January 21, 2019. (Read More)
Six Month Delay in the Revised Common Rule
The new compliance date is now July 19, 2018.
Within two days of the effective date the U.S. Department of Health and Human Services have announced a six month delay to the effective date of the Revised Common Rule. This notification mentions that "federal departments and agencies are also in the process of developing a notice of proposed rulemaking (NPRM) seeking public comment on a proposal for further delay in the required implementation of the revised Common Rule. If such an NPRM is published, after consideration of the public comments, the federal departments and agencies will determine whether a final rule to further delay the revised Common Rule will be issued."
IRB has made changes in six policies to reflect the Revised Common Rule. The policy listed includes Revised C. R. after the title. We do not plan to remove these changes. The changes are minor and are easily resolved to align with the pre-2018 Common Rule as published in the 2016 edition of the Code of Federal Regulations internally at the time of the IRBNet submission by RI staff.
563. Continuing Reviews, Expedited states:
These projects will no longer receive expedited continuing review but will receive administrative review. The IRB will confirm the type of report (continuing review or progress report) and level of review going forward in the outcome letter based upon the research status reported in the continuing review/progress report form.
IRB renewal form will be managed as a continuing review/progress report not as an administrative review in the next six months. The information requested in the renewal form remains unchanged. The title of the form changes in the revised common rule not the information in the form.
551. Review Types. Two new categories of exemption #7 and #8 are listed as the Revised Common Rule.
Our current IRBNet forms for Exemption 1-6/Flex do not align with the new exemption categories in the revised common rule. We have revised our forms but are not posting in IRBNet until the effective date. Listing the revised common rule exemption categories helps inform the research community of the rationale behind the pending revised common rule.
Please contact our office if you have questions or concerns. As new information is received, we will share it with the research community.Common Rule Revisions
Common Rule Revisions
Changes to the Common Rule, the primary rule regulating human subjects research, go into effect on January 19, 2018. Investigators will see a number of changes required under the new rule. We have updated our IRB Policy Manual; changes to a policy will be documented as Revised C R. After January 18, 2018, new protocol submissions to the IRB will be required to use updated consent and waiver templates that can be found in IRBNet. These are simply updates to existing forms that contain the new required elements of the rule. If a study is approved prior to the 1/19/18 effective date of the new rule, it will remain on the old rule until its next Continuing Renewal. At that point, it will transition to the new rule. If a study is approved on or after 1/19/18, it will automatically be governed by the new rule.
- Change in the definition of research involving human subjects include information or biospecimens through invention or interaction and identifiable information or biospecimens.
- New standard in disclosure (recruitment, consent or information sheet) to provide information that a reasonable person would want to have in order to make an informed decision about whether to participate in the study.
- Consent forms (over 4 pages in length) will now require a concise summary of study activities, risks, and benefits presented to research participants in advance of the body of the consent document. The IRB will not require re-consent, except when other significant changes are made.
- In requests for waivers to use identifiable data and specimens, the IRB must now find that it would be impracticable to use de-identified data. The waiver request form has been revised accordingly.
- Minimal Risk studies reviewed via the expedited procedure after the new rule goes into effect will no longer require annual continuing review under the new rule, unless the IRB determines the need for check-in with the IRB. Your approval letter will inform you if a status report is required and the due date. IRBNet notifications will prompt you when status review is required.
- Changes to Exemption categories reflect new clarity describing benign behavioral interventions, secondary research and change data and/or biospecimens do not have to be existing at the time exemption is granted.
- Change in the definition of clinical trial to include biomedical or behavioral health-related outcomes
- The new term for vulnerable subjects will be individuals with impaired decision-making capacity.
- Activities deemed not to be research for IRB review-public health surveillance activities, collection of information for criminal justice purposes, operational activities for national security purposes.