Last Revised: 10.2015
Prior Version: 7.2007
Informed Consent
Re-obtaining Consent of Subjects
Introduction
The IRB requires investigators to re-obtain consent of subjects when specific conditions are met
and/or when specific situations occur.
Definitions
Adult is a person who has attained the legal age for consent to treatments or procedures involved
in the research, under the applicable law of the jurisdiction (e.g., Ohio) in which the research will
be conducted. The specific treatments or procedures involved in the research and the jurisdiction
in which the research will be conducted may determine who is considered an adult.
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, a physical gesture of
affirmation, or a verbal assent are not, in and of themselves, assent.
Child is 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.
Policy
If the re-consent process includes a revised consent form for a current IRB-approved protocol,
that form must be submitted to the IRB as a protocol amendment via the iRIS Electronic System
and must be approved by the IRB before implementation. If the changes increase subject risk,
the change usually requires approval at a convened IRB meeting.
The IRB does not require a subject 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 subject. Federal regulations do not require re-consenting of subjects who have
completed their active participation in the study, or of subjects who are still actively
participating, when the proposed change will not affect their participation.
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Last Revised: 10.2015
Prior Version: 7.2007
However, when changes do occur in the conditions or the procedures of a study that would affect
an individual subject, the investigator should once again seek informed consent from the subject.
Those subjects 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 subject'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 subject would wish to continue in a particular
research activity.
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 subject must
be re-consented as an adult.
Addition of Risks or Significant Revisions to Consent Form
The enrolled subject must sign a revised consent form if the consent has been significantly
revised and/or includes the addition of risks to the subject. The changes from the original
consent form should be explained to the subject.
Decisionally Impaired Research Subjects
If consent has been obtained from a parent, guardian, or legally authorized representative, and if
the subject obtains or regains the capacity to consent, then the subject must be re-consented using
standard consenting procedures. If the subject 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 subject, including the
time frame. Consent must be obtained as soon as possible, once a subject has regained the
capacity to provide consent.
As Part of Compliance Review
As a consequence of a compliance determination by the IRB, a corrective action may require reconsenting subjects before previously collected data can be used for research.
References and/or Regulatory Citations:
45 CFR 46.116
45 CFR 46.117
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