Helping to quell a storm of a controversy, the FDA has issued new guidelines describing the circumstances when informed consent can be waived for clinical trials in emergency or ambulatory settings. It's a big issue. Informed consent is a 'sacred cow' in today's clinical trial industry, and rightly so.

The 30-page document entitled “Guidance for Institutional Review Boards, Clinical Investigators and Sponsors: Exception from Informed Consent Requirements for Emergency Research", lays down the criteria where such consent is not explicitly required.

For instance, the drug or device being studied cannot be for a disease or injury where there is an approved or more appropriate treatment option available. The document also requires such trials to have a direct benefit to patients, have no other recruitment recourse (i.e. similar patients who can provide consent) and go through some attempts to determine -- or in some cases infer -- whether a patient would or would not consent (i.e. familiarity with patients their beliefs).

A large part of the document discusses the importance of community disclosure so that patients and family members may individually opt in or opt out of a trial beforehand, essentially consenting to the trial if the situation should arise.

The issue has been raging for a number of years, and it has been wrought with controversy. One such clinical trial completed this summer, testing the blood substitute PolyHeme, has received the brunt of recent criticisms. PolyHeme is a solution of chemically modified hemoglobin derived from human blood. Starting with the military in the 1970’s, blood substitutes have been heavily researched but with little success. Yet, the death rate from blood loss due to trauma is staggering. The trial was conducted at 30 level 1 trauma centers, by the Illinois-based pharma Northfield Laboratories. Patients in hemorrhagic shock were not required to give consent, sometimes receiving the experimental product in route to emergency rooms.

The company was working under a special FDA provision to 21CFR (21CFR 50.24) dating back to 1996 which allows for some flexibility in obtaining consent in these trials. The company also contacted the communities where the trials were conducted, and ran ads in local newspapers and radio stations. Patients could opt out by wearing a wrist band. Their efforts in getting that information out to the public is also under criticism. The study took over three years to run, but was finally completed this summer.

While the draft guidelines are still open for comment, they create a frame work for IRBs and investigators to research treatments that must be studied in crisis or emergency situations, often with little or no possibility of obtaining explicit patient consent. Such research is difficult to conduct in controlled settings, but is nonetheless vital to advancing medical science that could save millions of lives.