UNIVERSITY OF MICHIGAN MEDICAL SCHOOL

IRBMED Home Forms Informed Consent Templates Guidance Education About IRBMED Resources IRBMED Members Research Participants

IRBMED
517 W. William, Argus I,
Ann Arbor , MI 48103-4943
Email: irbmed@umich.edu
Phone: (734) 763 4768
FAX (734) 763 9603

Instructions Regarding Signatures on Legacy Applications to the IRBMED
Note that in eResearch the written signature is replaced by the principal investigator's assurance indicated when submitting an application.

Application Type	Principal Investigator	Co-Investigator	Other
Initial Applications
New Project	YES	YES	N/A
Emergency Use Report	YES	YES	Impartial Physician Only when the test article is administered prior to patient's informed consent
Previously Approved Project Applications
Scheduled Continuation Review (Renewal)	YES	NO	N/A
Amend Principal Investigator	YES Both new and previous PI	NO	N/A
Amend Co-Investigator	YES	YES Only new Co-I	N/A
Adverse Event/Other Reportable Information or Occurrence	YES	NO	N/A
Other Amendments (including HIPAA-only)	YES	NO	N/A
Termination	YES	NO	See below

Signatures

Signatures must be original (made by hand, blue ink encouraged). Electronic, faxed, copied, or stamped signatures are not accepted.

Termination

IRBMED studies should be terminated when the study ends. Allowing a study's IRBMED approval to expire does not terminate the study.

• If the investigator has left the University and cannot be located, the department chair's signature may be substituted for the principal investigator's , but this should be explicitly noted on the application.
• The study ends when data-analysis using records linkable to particular subjects is completed (not when enrollment and/or subject interaction ends).

Emergency Use

In emergency circumstances, it may not be feasible to obtain informed consent prior to using the test article. The regulations therefore provide an exemption from the informed consent requirement for such situations. Emergencies qualifying for this exemption are defined as:

1. life-threatening situations necessitating use of the test article;
2. where the subject is unable to provide effective consent;
3. there is insufficient time in which to obtain consent from the subject's legal representative; and
4. there is no available alternative method of approved or generally recognized therapy of equal or greater likelihood of saving the subject's life [21 CFR 50.23(a)(1)-(4)].

Special procedures for documenting the unfeasibility of obtaining consent apply as follows:

1. The Investigator and another physician, who is not participating in the clinical investigation , must certify in writing the existence of all four conditions listed above before use of the test article [21 CFR 50.23(a)].
2. If in the investigator's opinion,
   1. Immediate use of the test article is necessary to save the life of the subject; and
   2. There is insufficient time to obtain the independent determination required by §50.23(a) before using the test article;
   3. The Investigator is to make his or her own written determinations, then obtain the written review and independent evaluation of a physician who is not participating in the clinical investigation within five working days after the use of the test article [21 CFR 50.23(b)].

The documentation required by either 21 CFR 50.23(a) or 50.23(b) must be submitted to the IRB within five working days after the use of the test article [21 CFR 50.23(c)]

Updated 6/13/05