Under the revised Common Rule, the requirements for informed consent will change, with the addition of:
- "Key information" to be presented at the beginning of the consent form found on our new templates if a consent form is over 3 pages.
- New consent elements
- Changes to waiver criteria and documentation
- Broad Consent
The intent of these changes is to facilitate the subjects' understanding of the proposed research and also ensure that they understand how their data and biospecimens may be used.
Key Information
The preamble to the Final Rule lists five factors suggested as “key information” that would likely assist a potential subject in understanding the nature of the project and in determining participation.
- A statement that the project is research and participation is voluntary.
- A summary of the research, including: Purpose, duration, list of procedures
- Reasonable, foreseeable risks or discomforts
- Reasonable, expected benefits
- Alternative procedures or course of treatment, if any.
Many SBER studies already employ a brief informed consent document, thus, including the “key information” section would be redundant.
New Consent Elements
When your study involves the collection of identifiable private information or identifiable biospecimens the informed consent must include a statement indicating whether:
- identifiers may be removed, and
- de-identified information or biospecimens may or may not be used or shared for future research.
When your study involves use of biospecimens the informed consent should include a statement indicating whether:
- biospecimens may be used for commercial profit, and
- the subjects will share in the profit
When your study involves clinically relevant results the informed consent should include a statement indicating whether the clinical results, including individual research results, will be returned to the subject, and if so, under what conditions
When your study involves whole genome sequencing the informed consent should include a statement indicating that the research will or might include whole genome sequencing
Consent Process Changes
- A waiver of informed consent for the secondary use of identifiable private information/biospecimens (not covered by Broad Consent) must justify why the use of identifiers is necessary to carry out the research.
- Use of identifiable information/biospecimens to identify potential subjects is allowed without informed consent under certain circumstances
- For federally sponsored clinical trials, a copy of the consent form must be posted to a “publicly available, federal website” (TBD) post-recruitment and no later than 60 days after the last study visit by any subject.
Broad Consent
UC Merced will not implement Broad Consent, and therefore the related Exemption Categories 7 & 8) at this time. The tracking requirements are overly burdensome.
Transition Process
CONSENT TEMPLATES
2018 Common Rule consent templates are available at our Forms website.
EXISTING STUDIES
Existing studies will not transition to the 2018 Common Rule unless they receive federal funding after January 21, 2019 or if agreed upon by the IRB and researcher. If the study transitions to the 2018 Common Rule, the informed consent forms will need to be revised for studies actively enrolling new subjects.
NEW STUDIES
New studies submitted after January 21, 2019 must utilize an updated informed consent template.
