UCSD Human Research Protections Program
 

Revised Common Rule — Consent Process

As announced, changes to federal regulations for protection of human subjects are scheduled to take effect January 21, 2019. This will include new requirements for the information you provide during the informed consent process. An overview of the changes can be found here.

For the time being, these changes only apply to federally supported research.

For your research that is federally supported, these changes do not apply to studies that:

Please see below for the new requirements and for transition provisions for federally supported studies that are first IRB approved on or after January 21, 2019.

New Requirement — Begin with a Concise Summary

The main change is to require that informed consent:

"...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. This part of the informed consent must be organized and presented in a way that facilitates comprehension." [45 CFR 46.116(a)(5)(i)]

Additional federal guidance is expected, but the preamble to the Revised Common Rule provides two important clarifications:

New Requirements — Additional Elements of Informed Consent

The Revised Common Rule also adds four new elements to the consent process as appropriate [45 CFR 46.116(b)(9) and (c)(7), (8) and (9)]:

Sample Documents

The UCSD HRPP website has been updated with sample documents that guide you through the above new requirements. Updated documents for Biomedical studies can be found here and for Social and Behavioral studies here.

Transition

For your current or future studies that are not federally-supported, you do not need to do anything different at this time.

These changes also do not apply to studies first approved by the IRB before January 21, 2019 or studies that are certified as exempt (regardless of date of exemption).

If you are submitting a new federally supported study for IRB review, please use the appropriate template to guide you in writing the consent form.

If you have a federally supported study currently undergoing IRB review, IRB staff will request that you make targeted changes to bring your consent forms into compliance with the new rules.

Other Changes

The Revised Common Rule includes several other changes related to consent.

The IRB will implement changes to its decision-making process for consent-related waivers, but these changes do not require any action on your part.

You may have heard about new options for broad consent for secondary use of identifiable information and/or specimens. Please note that these options are not currently workable. UCSD and its peer institutions are not implementing these options in the absence of federal guidance. Please note that existing options remain in place for secondary use of coded or deidentified information/specimens or for requesting waivers of consent for secondary use of identifiable information/specimens.

For any questions regarding these changes, please contact hrpp@ucsd.edu. Training presentations will be offered starting in late January.

Contact the Human Research Protections Program Office