2018 Common Rule: Consent Form Revisions
On January 19, 2017, the Health and Human Service (HHS) rules regulating human subjects research known as the Common Rule were revised with the goals of better protecting research subjects and reducing administrative burden. After several delays, the effective and compliance date of the revised Common Rule is now January 21, 2019.
Note: On October 15, 2018 FDA issued guidance on the Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations. FDA intends to harmonize, to the extent applicable, with the revised Common Rule.
Impact on the Consent Form Template
OHRS has revised the DF/HCC consent form template to comply with the new Common Rule requirements and it is available now on the OHRS website. Studies approved or altered (conditionally approved) by an IRB on or after January 21, 2019 will be governed by the new rule and new consent form requirements. The new version of the consent form can be accessed below. Please note: The revised template must be used with all new submissions to OHRS, on or after December 1, 2018.
Amendments to ongoing research studies that received initial IRB approval prior to January 21, 2019 do not need to use the new consent template.
Some of the changes required under the new rule include:
- Consent forms 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 considered “Key Information”.
- A statement that biospecimens, even if identifiers are removed, may be used for commercial profit and whether the subject will or will not share in this profit.
- All required elements are outlined in OHRS Information Sheet, “Required Elements of Consent.”
Posting of the Consent to ClinicalTrials.gov
Under the Revised Common Rule (45 CFR Part 46), one version of the consent form used to enroll participants must be posted on a publicly available Federal website. The form must be posted after recruitment closes, and no later than 60 days after the last study visit. Only one version is needed. There is no requirement to post all consent form versions or to update the posted version with any revisions.
DF/HCC sponsor-investigators are expected to comply and post the informed consent document(s) to ClinicalTrials.gov. At this time, ClinicalTrials.gov and Regulations.gov are the only publicly available federal websites that have been confirmed to satisfy the consent form posting requirement.
Generally, studies that were approved by the IRB prior to January 21, 2019 are not subject to the new Common Rule requirements; however, this is not always true. Please continue to check this page for updates and contact DFCIODQClinicalTrials@partners.org if you have any questions.
Please refer to the Office for Human Research Protections website for more information regarding Clinical Trial Informed Consent Posting.