Waiving Informed Consent

There are no strict rules for deciding when it is “appropriate” to provide additional pertinent information; but the IRB will apply some general standards in considering such requests:

• If consent is waived because it is not practicable to obtain consent from large numbers of patients for a retrospective chart review study, generally it also will not be appropriate to attempt to contact those patients to tell them about the study retrospectively.
• If consent is waived because subjects are temporarily incapacitated, it may well be appropriate to provide them with information later, and even, as noted above, to obtain consent for ongoing research.

Study to determine whether some specific blood chemistry values change in people undergoing clinically indicated abdominal surgery, and if there is a correlation of changes with increased incidence of complications after surgery.

Involves review of medical records of all patients who have undergone abdominal surgery in the past two years (about 10,000 surgeries), collecting limited data that will be double-coded so link is known only to researchers. Results of the research will not affect clinical care of the individuals, since they will already have left the hospital.

1. Minimal risk: Fits definition.
2. Would not adversely affect rights and welfare of subject: Surgery and associated blood chemistry values are clinically indicated, therefore would be done regardless of the research. No study results would affect clinical decisions about the individual's care.
3. Research could not be practicably carried out without the waiver: Identifying and contacting thousands of potential subjects, while not impossible, would not be feasible for a medical record review where results would not change care the individuals already would have received. (Note: In smaller studies, it may be harder to argue that obtaining consent is not feasible, especially if subjects have not yet been treated or are still being seen.)
4. Whenever appropriate, subject provided with additional pertinent information after participation: Not appropriate in this case, since results of research would have no effect on the subjects. There is no anticipated benefit to subject that would change what has already occurred.

(Above example adapted from Institutional Review Board: Management and Function, R. Amdur and E. Bankert, Chap. 6-6, "Research without Consent or Documentation Thereof," M. M. Elliott.)

In occasional minimal risk studies, the IRB may waive consent when subjects initially cannot consent for themselves, but require consent for later procedures when subjects recover their capacity to consent.

Examples where follow-up consent might be required: The IRB approves waiver of consent for a minimal risk blood draw from patients arriving unconscious at the emergency room. But if the researchers want any procedures (e.g., blood draws, tests, collection of information from records) to continue after subjects become competent to consent, or want the subjects to participate in follow-up procedures (e.g., interviews, office visits, or additional tests or medical record review), then the IRB would probably require that signed consent be obtained before research on that participant could continue.

Contents of follow-up consent: The consent form should clearly describe what procedures occurred without the subject’s consent, why they were performed, and what additionally will be done if consent is given to continue the subject in the study. The subject must also be given the option of refusing to allow the researchers to use the data already collected.