World without Ethic Committees – Michael Herschel

In history, heretics needed much courage and frequently ended up burnt for their efforts. Nevertheless, they often set the scene, stimulated others, and, ironically, may have been celebrated – had they only lived some decades later. The author of these heresies is somewhat courageous, but prefers other forms of death. He would also prefer to be celebrated alive!

Several decades ago, there was a world without Ethics Committees (EC), or, as they are called in the United States, Institutional Review Boards (IRB’s). Even for years after the Declaration of Nuremberg, condemning the abuse of prisoners for pseudo-medical experimentation, EC’s were the exception rather than the rule.

Let us therefore remember their major remit: to protect trial subjects. For this purpose, a number of critical questions need be answered:

– Is the population able to voluntarily give informed consent?
– Does the expected benefit exceed the risk or at least not be less than the risk?
– Is the information to the trial subject true, clear, and can it be understood?
– Is there any obvious or clandestine coercion on trial subjects to participate?

Looking back over the years, there is little hint that EC’s and IRB’s failed to protect the patients effectively. Where they failed, it was rarely before the trial, but during the trial, as they did not monitor its progress. In some major trials, Data Safety Monitoring Boards (DSMB) have taken over some of these genuinely EC tasks. But as said, the overall record is good, irrespective of whether, or not, their composition was exactly in accordance with the ICH-GCP recommendations. It should be noted, however, that EC’s usually are not controlled or audited by anybody. Therefore, a slight risk remains.

For various reasons, EC’s have taken on other tasks only remotely related to the protection of trial subjects. They have embarked on commenting trial design beyond its acceptability from a subject protection view. They have discussed investigator payments. They have questioned the statistics of a trial. They have, at times, found that any sort of payment to patients is unacceptable.

One of the frequently debated questions is how many EC’s need to have a look at the trial. In, my home country of Germany, the EC of the Principal Investigator is legally, the only relevant one. However, universities also have their own EC’s. Additionally, the regional Physicians Associations also maintain their right to vote independently. Admittedly, among the latter, more are now accepting the opinions of others without going into details. When asked why they do not acknowledge the wisdom of the „primary“ EC, the following reasons are given:

– we have a law or regulation whereby our members must ask us (this law was made by them and could easily be cancelled)
– we do not trust in the opinion of the other EC (which usually as nothing to do with actual poor performance of the other EC but with a feeling of being superior)

The added value of the second and third and umpteenth EC has never been proven. Our own records tell me that only very minor improvements regarding patient protection result from multiple opinions. Nevertheless, the four-eyes principle used in accounting could be extended beyond the one committee to a second (but not any additional ones) if more investigations would support this procedure. I strongly believe that the loss of time currently resulting from infrequently meeting EC’s and their multiplicity is not warranted.

Little quantitative research is available. Therefore, I suggest a research agenda on the value of EC’s to support our assumptions with hard data. But beyond that, and in order to enhance the trust in this institution, I suggest to have them supervised by an accreditation body that is controlled by a democratically elected body, for instance by a ministry or parliamentary subcommittee. This would result in a single, more professional review and probably a shorter review time.

Let us for a moment come back to the title of this article. Although we know little about what may have happened, I would not feel comfortable in a world without Ethics Committees. While most, and especially the global pharmaceutical players have little or nothing to be criticised for by an EC in their trials, there are some „black sheep“. Additionally, there are the many investigations, not sponsored by a pharmaceutical company, frequently without any adequate patient information which are never reviewed by an EC.

It is for these reasons that I suggest to re-direct the focus to the patient. Instead of the inflated „Ethics Committee“ with many questions irrelevant to the physicians dictum „nil nocere“ (do no harm), I would like to suggest Patient Protection Committees (PPC) which are properly accredited, controlled by the accrediting body, and accountable. Furthermore, for a single trial, a single review should suffice.

(C) 2008 – Alle Rechte vorbehalten

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