New IRBMED Informed Assent Document Template
On 9/13/08 the IRBMED posted an Assent Template (MS Word) recommended for children ages 10- to 14-years-old on those studies where assent is required. The assent template is posted on the Web site with informed consent templates. A template for children ages 7- to 9-year-olds is in the works. We also posted the Guidelines for Use by the IRBMED in Determining When Assent of Children Should be Waived or Required. These are on the Guidance page under “Children in Research, Assent Guidelines. (PDF)”
Use of the assent template is a recommendation rather than a requirement. Although there will not be a requirement for existing studies to change-over to using it, investigators should be aware that the IRB may ask questions about or require changes to a study’s assent process at the next amendment or at the time of renewal. We recommend investigators review the new template and the information below, and then review the information in their IRB applications and current assenting processes and documents. Consider if any adjustments are appropriate to the study prior to submitting the next amendment or renewal.
The new assent template and guidance are part of a larger effort to make it easier for investigators to implement and follow the federal regulations regarding assent.
Regulations require that for each study involving children the IRB determine:
- If some or all children are capable of providing assent.
- If a waiver of assent is appropriate for some or all subjects.
- When assent is required:
- Determine adequate provisions are made for soliciting assent
- Assess the form and content of the information conveyed to the prospective subjects
- Decide if assent should be documented and, if so, how
If an assent process is approved for a study that means it is required for all children (unless exceptions to this general rule are also indicated in the application and approved by the IRBMED). When assent is required the researchers must honor a child’s dissent, even if the parents want the child to be in the research.
There are 3 conditions under which the regulations permit assent waiver:
1. Capabilities of some or all children is so limited they cannot be consulted.
2. Study offers important benefit unavailable outside of the research (when the study offers a treatment that is thought to be a better option than those currently available, or it offers the only alternative). Note, this is a more stringent standard than ‘potential of direct benefit.
3. Assent may also be waived under the same criteria as a consent waiver:
- the study is minimal risk
- subjects’ rights and welfare aren’t adversely affected
- assent is not practicable (for reasons other than children’s capabilities)
- when appropriate, the subjects will be provided pertinent information
Please contact the office if you have any questions about the assent template, regulations regarding assent, or the assent process. If you would like to schedule an educational session for your unit or department on this topic we will be happy to provide that as well.
Posted 9/26/08