Document 10
Date Approved: 05.02.2017
Re-consenting Participants
Introduction:
The IRB requires re-consenting participants when specific situations occur.
Definitions:
Assent means a child’s affirmative agreement to participate in research. Failure of a child to object to participation cannot be construed as assent. Assent is a process involving communication with the child. A signature on an assent document is not, by itself, assent.
Childis a person, who has not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction in which the research will be conducted. For example, in most American states, a child is someone age 17 and younger; however, in Taiwan, a child is someone age 19 and younger.
Informed Consent is an individual’s voluntary agreement, based upon adequate knowledge and understanding of the relevant information, to participate in research either for themselves or for a child for whom they are the parent or guardian (defined as an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.
Policy:
The IRB requires investigators to re-consent participants when specific conditions are met. Study sponsors may also require re-consent of participants. If the re-consent process includes a revised consent form, it must be submitted to the IRB as a protocol Addendum and must be approved by the IRB before implementation. If the changes increase participant risk, the addendum requires approval at a convened IRB meeting. The IRB does not require a participant to re-consent at the time of the protocol continuation approval unless there have been modifications to the consent form that would affect an individual participant. Federal regulations do not require re-consenting of participants who have completed their active participation in the study, or of participants who are still actively participating, when the proposed change will not affect their participation. Note, a sponsor’s requirements may exceed Federal regulations as to when to re-consent participants.
However, when changes do occur in the conditions or the procedures of a study that would affect an individual participant, the investigator should once again seek informed consent from the participant. Those participants who are presently enrolled and actively participating in the study should be informed of the change and re-consented if it might relate to the participant's willingness to continue their participation in the study. Adverse events may occur during a research activity that would directly affect whether prospective or enrolled participant would wish to continue in a particular research activity.
A) Re-consenting Children Who Become Adults While Participating in a Research Study
When a child who has been enrolled in a research study reaches 18 years of age, the participant must be re-consented as an adult.
B) Addition of Risks or Significant Revision to Consent Form
Enrolled participant must sign a revised consent form if the consent has been significantly revised and/or includes the addition of risks to the participant. The changes from the original consent document should be explained to the participant. If the only change to a consent form is an update to the CWRU’s standard research consent language, re-consent is not required.
C) Decisionally Impaired Research Participants
If consent has been obtained from a legally authorized representative, and if the participant regains the capacity to consent, the participant must be re-consented using standard consenting procedures. If the participant refuses consent, any data previously collected cannot be used for research purposes. In protocols where a return to normal cognitive functioning is likely, investigators must include their plan to re-consent the participant, including the time frame. Consent must be obtained as soon as possible, once a participant has regained the capacity to provide consent.
Re-Consent is necessary when the participant’s legally authorized representative changes.
D) As Part of Compliance Review
As a consequence of a compliance determination by the IRB, a corrective action may require re-consenting participants before previously collected data can be used for research.
References and/or Regulatory Citations:45 CFR 46.116
45 CFR 46.117
21 CFR 50.25
21 CFR 50.27