Informed Consent: One Size Does Not Fit All

Article excerpt

All of us who have been involved in clinical research at one time or another have had to deal with institutional review boards and informed consent. I am sure that most of you, just as I did, find the process demanding, challenging, and sometimes arbitrary.

A lengthy form is forced upon the researcher regardless of what type of trial is being planned, what interventions will be used in the study, and what will be done with the data. There usually is no regard to reasonable exemptions, while an appreciation of what the planned study is actually about is often obscured.

Clearly, for most--if not all--treatment intervention trials, a strong IRB review and a long informed consent are needed. However, it is more difficult to make the same argument for observational or routine care studies. In those cases, most of the measures that would or should be followed in a group of patients are part of routine care. As good examples (especially in the cardiology and neurology literature) show, the act of consent itself can lead to different baseline characteristics in the group that consented and was studied vs. the group that did not give consent and hence did not participate in the trial. These baseline differences can have an important impact on the final results and can limit the external validity of the study.

It might be time to look at individual studies very carefully and try to identify where the process can be simplified without any additional risks to patients. It would also be in our patients' best interest if some valuable observational studies were not impeded by unreasonable IRB and informed-consent requirements.

Another problem to consider is what the patients understand from the informed-consent process. Informed consent is not only for documenting patients' acceptance into enrollment in a clinical trial. It is now the patient's and the public's main source of information regarding the reasons for the planned study, what is known in the field about the proposed trial, and what to expect regarding efficacy and harm.

Clinical trial registries that have been developed over the last 5 years have served to alert researchers, health care providers, and patients to trials. …