Re-Consent or Notification of
Significant New Findings
Developed During the Course of
Research
WHEN WILL YOU NEED TO ‘RE-CONSENT ’ STUDY SUBJECTS AND HOW?
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ON THE STATUS B AR BELOW:
Questions and Considerations
When New Information Emerges
Who/What/When/Where/How
Who needs to be notified or re-consented?
When must notification or re-consent occur?
•All subjects?
•Immediately
•Subjects on active treatment?
•Before next study visit/specific study procedures
•A group of subjects?
Where and How should notification be implemented?
What is the change that requires communication?
•In-person visit
•New risks/inconveniences
•letter with phone follow-up
•New procedures
•revised consent form/addendum
•New costs
•Other significant findings
Active Study Participants
PARTICIPANT AFFECTED BY THE CHANGE
PARTICIPANTS NOT AFFECTED BY THE
CHANGE

New risks

Changes in date/version control

Additional study procedures (not previously
described in the consent form)

Modifications to the arm of the study that the
participant is not enrolled in

Changes in the study drug administration


Addition of procedures that the subject will not
be asked to undergo e.g. baseline MRI
Changes to payments or cost for participation

Minor editorial changes in the consent/protocol
for clarity
RE-CONSENT/NOTIFICATION REQUIRED
RE-CONSENT/NOTIFICATION NOT REQUIRED
Previously Enrolled Study Participants
PARTICIPANT AFFECTED BY THE CHANGE
PARTICIPANT NOT AFFECTED BY THE CHANGE
 Newly discovered long term side effects of
the study drug
 New short term side effects of the study
drug/procedure
 New adverse events associated with the
implanted study device
 Changes to the study design
RE-CONSENT/NOTIFICATION REQUIRED
 The information that would not affect
currently enrolled individuals
RE-CONSENT/NOTIFICATION NOT REQUIRED
Re-consenting when research participant needs to make a decision
Consent addendum
•short, focuses on the new information only
•a template available on http://www.yale.edu/hrpp/forms-templates/biomedical.html
Full Revised Consent Form
• used when changes to the consent form are extensive
•can be used with a cover letter highlighting the changes
Verbal consent/notification only
Documented phone call
•when subject’s participation concluded and there is no need to provide continued consent OR
•when the IRB determines that research participant’s verbal agreement to continue to participate
in the study is sufficient
Informational Letter
• receipt should be acknowledged and documented in the study file, can be followed by a phone
call
Immediate Notification Required
Phone Call
• when the study participants are at immediate risk
• when immediate action is required e.g. stopping the study medication
• done prior to the approval of the notification documents by the IRB
• should be documented and followed by written notification/re-consenting
Course of Action
PI:
•Revises a plan for re-consenting/notification
•Submits it for IRB review
IRB:
•Makes final determination about re-consenting
•Communicates the determination to the PI in a letter
Questions?
See Guidance 200GD3 on Re-consenting at http://www.yale.edu/hrpp/policies/index.html
Speak to your IRB Representative at 203-785-4688
Email HIC Office at hrpp@yale.edu