October 17, 2018
The Common Rule News – October 17, 2018
Issue 5: Key Information and the Reasonable Person
HSD’s Common Rule Webpage
– What is the Key Information that must be provided at the beginning of the consent process or form?
– Which studies must provide the Key Information?
Reasonable Person Standard
– What is the reasonable person standard for identifying the information that should be provided in the consent process or form?
– Who decides what information a reasonable person would want?
HSD drew from the Common Rule Preamble and an agency workshop for our just released GUIDANCE: Key Information for Consent Materials. It represents HSD’s current understanding of how to interpret and apply these two changes, including examples. HSD’s guidance document and other materials will be updated as new information is released from federal agencies.
The Key Information Requirement
Informed consent must 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 why one might or might not want to participate in the research. This must be organized and presented in a way that facilitates comprehension.
This applies to all studies that obtain consent or parental permission and that are fully and conditionally approved by the IRB on or after January 21, 2019. Other studies may include a key information section but they are not required to do so. The revised Common Rule does not allow IRBs to waive this requirement.
There is no specific information that must be included. The appropriate information depends on the nature of the study, nature of the subject population, and the other information that is presented.
Structure and Length
It must be concise and focused. In most cases, the Key Information should be relatively short compared with the rest of the consent process or document. The requirement applies to the consent process as a whole – not simply to consent documents. This means there is flexibility in how it is presented and structured.
Key Information Q&A
The Key Information requirement applies to parental permission but not to assent.
No. the revised Common Rule explicitly states that this requirement cannot be waived.
Yes, Key Information should be presented as part of the consent process, unless the IRB has completely waived the requirement to obtain consent.
The requirement for providing Key Information must still be met. But it does not necessarily need to be a new, separate section. If the entire consent form or process is brief, it may satisfy the requirement to present key information in a concise and focused manner without a separate Key Information section. It is HSD policy that consent forms or other documents (for example: Information Statements, oral consent scripts) that are fewer than 2,000 words (not counting any signature sections, approximately five pages, single-spaced, one inch margins) do not require a separate Key Information section, unless the IRB requires otherwise. This policy may be revised in the future due to expected guidance from federal agencies.
The Reasonable Person Standard
The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.
No federal guidance has been issued about this new requirement. Some regulatory experts believe that this requirement is nothing more than an explicit written statement of what IRBs have always expected.
HSD expects that researchers and the UW IRBs will take a flexible approach to this requirement by considering a reasonable person from the specific study population.
Word of the Week
Key Information is the phrase used to describe a new requirement for consent processes and forms: Obtaining consent must begin by presenting the potential participants with the key information that is most likely to assist them in understanding the reasons why they might or might not want to participate in the research.
A reasonable person standard is used by the revised Common Rule to describe the information that should be provided in the consent process and form. That is, consent must provide the information that a reasonable person would want to have in order to make an informed decision about whether to participate.
Question from Campus
Q. I’m confused about why HSD has already released a revised consent template and is encouraging researchers to use it right away, before January 21, 2019. Why make us do the extra work of including the new elements and the Key Information, if we don’t have to?
A. Including the new required consent elements and key information in your consent materials is required only if you think your initial IRB application is likely to be approved (or conditionally approved) on or after January 21, 2019. If your application is likely to be approved prior to January 21, you can choose to leave out the new requirements. However, they are widely considered to be best practices that will provide important information to potential participants. Finally, we want researchers to have plenty of time to consider the new requirements and to ask HSD questions about them. This will help us develop or improve the consent template and accompanying guidance. Please, do keep sending us questions!
Send your questions about the revised Common Rule to email@example.com. Each issue of this newsletter will answer one or more questions.
Summary of Changes
HSD’s Common Rule webpage has a summary of the changes. Each issue of this special newsletter will focus on one of these changes – providing in-depth details about how it will affect researchers, the IRB review process, consent forms, application forms, and the Zipline e-IRB system. It will also link to any resources that are available to help with the change. The schedule of topics and newsletter dates are posted on the HSD Common Rule webpage.
Issue 6: October 24, 2018
Focus: Other Consent Related Changes