Attachment A2 - Reconsent Appendix 2

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):

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.

Related Letters

Content created by Office for Human Research Protections (OHRP)
Content last reviewed