–Templates available beginning January 2018; new regulations go into effect January 2019–
General consent templates
The regulations contain some new requirements for informed consent, so we have created a new consent template.
We are also taking this opportunity to simplify the language to be in line with the best practice of writing consent templates at the 6th-8th grade reading level. Please feel free to share your feedback on the new format – what you like, suggestions for improvement, etc.
As before, you are not required to use our template. However, by using the provided template, you can be sure your document includes all the required elements of informed consent.
Changes to the informed consent regulations
- Long informed consent documents must begin with a concise and focused presentation of the key information that helps prospective participants understand why they might or might not want to participate in the research. This requirement is not applicable to consent documents that are relatively short. “Short” is not specifically defined, but we are interpreting this to be anything 4 pages or less.
- If research involves collecting identifiable private information or identifiable biospecimens, the consent document must explain that either:
- The data/specimens could be de-identified and stored for use in future studies, either by the PI or other researchers; OR
- The data/specimens will not be used for any other research, not even if they are de-identified.
- If the research involves biospecimens, there must be a statement explaining whether or not whole genome sequencing might be performed on the specimens.
- If biospecimens (with or without identifiers) collected for the research may be used for commercial profit, the consent document must include an explanation as to whether or not the participant is entitled to any of these profits.
- If clinically relevant research results may be uncovered, the consent document must include whether or not the participant will be told of these results, and under what conditions.
*Note on the delay: Although the new regulations requiring these changes have not yet gone into effect, the new template is still also consistent with current regulations and is available for use now.
Broad consent for data and biospecimen storage / banking
The regulations contain a new requirement for what is called “broad consent”. This will be used for studies designed to store, maintain, and allow secondary use of data/specimens in future research (i.e. banking / repositories).
The broad consent includes several of the same requirements as the general informed consent document, along with a few other additions:
- A description of the types of research that may be conducted with the data/specimens
- What, if any, identifiable data/specimens may be shared and the types of institutions or researchers who will receive it
- How long the data/specimens will be stored, and how long they may be used for research purposes (can be indefinite)
- If applicable: a statement that participants will not be told specific details about any research done with their data/specimens, and that they might have chosen not to consent to some of those specific studies
*Note on the delay: The template for broad consent will be available when the new Common Rule goes into effect (January 2019).
For IRB Members
The existing reviewer checklist will be updated to contain the new required elements, and a separate Broad Consent checklist will be used for banking studies (effective January 2019).