Additional Information Scenarios and Suggested Options
|
Information is: |
Study status is: |
Information represents a minor change (likely would not change the individual risk/benefit calculus or an individual’s willingness to participate): |
Information represents a significant change (some possibility that the individual risk /benefit calculus will be changed or an individual’s willingness to participate): |
Information represents a major change (changes the overall risk/benefit and is likely to affect an individual’s willingness to participate): |
|---|---|---|---|---|
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Not time-sensitive |
Not yet recruiting |
Full consent form |
Full consent form |
Full consent form |
|
Recruitment started and still open |
Verbal communication with documentation in the study record |
[1]Information sheet/addendum with signature for existing participants*, full consent for new participants |
Full consent form |
|
|
Recruitment complete: intervention ongoing |
Verbal communication with documentation in the study record |
Information sheet/addendum with signature. |
Information sheet/addendum with signature. |
|
|
Recruitment complete: intervention complete** |
Verbal communication with documentation in the study record |
Verbal communication with documentation in the study record |
Verbal communication with documentation in the study record |
|
|
Time-sensitive |
Not yet recruiting |
Full consent form |
Full consent form |
Full consent form |
|
Recruitment started and still open |
Verbal communication with documentation in the study record (no change in full informed consent form for any group) |
[1]Information sheet/addendum with signature for existing participants*, full consent for new participants |
Full consent form |
|
|
Recruitment complete: intervention ongoing |
Verbal communication with documentation in the study record |
Verbal communication with documentation in the study record, followed by information sheet/addendum with signature. |
Verbal communication with documentation in the study record, followed by information sheet/addendum with signature. |
|
|
Recruitment complete: intervention complete** |
Verbal communication with documentation in the study record |
Verbal communication with documentation in the study record |
Verbal communication with documentation in the study record |
|
|
Urgent |
Not yet recruiting |
Full consent form |
Full consent form |
Full consent form |
|
Recruitment started and still open |
Verbal communication with documentation in the study record (no change in full informed consent form for any group) |
[1]Verbal communication with documentation in the study record, followed by Information sheet/addendum with signature for existing participants*, full consent for new participants |
Verbal communication with documentation in the study record, followed by full consent for all participants |
|
|
Recruitment complete: intervention ongoing |
Verbal communication with documentation in the study record |
Verbal communication with documentation in the study record, followed by information sheet/addendum with signature. |
Verbal communication with documentation in the study record, followed by information sheet/addendum with signature. |
|
|
Recruitment complete: intervention complete** |
Verbal communication with documentation in the study record |
Verbal communication with documentation in the study record |
Verbal communication with documentation in the study record |
[1] Cells with red background are situations in which two versions of the consent form would be created.
* For studies that have been transitioned to the updated Common Rule, information sheets or addenda would not be “consent forms” considered to be subject to the new §116 requirements.
** There may be interventions that cannot be considered “complete” (e.g. implantable devices). In such circumstances, the judgement of the study team and IRB should dictate whether participants are asked to reaffirm their participation by signing a new information sheet or addendum.
