May a healthy Jew participate in a phase 1 clinical study used to determine the safety of an investigational drug? Would Jewish parents be allowed to consent to have their healthy child participate in such a study?

This is frankly a tough question.  On one hand, Jewish law requires us to guard our own safety by, among other things, avoiding unnecessary risks.  On the other, the Jewish tradition has had a virtual love affair with medicine for the last two thousand years, including not only clinical practice but also research.  If the question were instead whether a person affected with a disease may participate in a research trial that might produce a way to cure or at least alleviate that person's disease, then it would be easier to justify taking part in the research protocol, despite the risks involved, for the person already is suffering from the disease and the research may produce results that will benefit him/her. 

 

The questioner, however, asks whether a healthy person may participate in a phase 1 study or permit his or her healthy child to do so.  If no healthy people participate in research studies, then scientists can never know whether the intervention they are testing is safe, and then we all become guinnea pigs. That is exactly what happens with most interventions -- especially drugs -- for children and pregnant women because drug companies do not want to take the liability for testing the drugs on those especially vulnerable populations.  As a result, pediatricians use drugs approved for adults and, at least at the beginning of a given drug's use, they guess what the appropriate dose would be for children until experience with the drug (that is, trial and error on all children who take it) gives them guidance as to how much to use -- or whether the drug is safe for children altogether. 

 

At the same time, I was on a federal government commission -- the National Human Resoruces Protections Advisory Commission -- from 2000-2002, which President Clinton appointed in the waning months of his term of office to review and revise the federal guidelines on research on human subjects after two young people in their twenties died as a result of research experiements at top-notch hospitals -- Jesse Gelsinger at the University of Pennsylvania and Ellen Roache at Johns Hopkins.   As a result of the work of governmental commissions such as that from the end of World War II to our own time, there are quite strict guidelines in place to regulate medical reserach. This includes the requirement that an Institutional Review Board approve the protocol and the stipulation that subjects may withdraw from a study at any time without pressure or penalty.  The legal requirements for medical research do not guarantee that subjects will be safe, of course, for by definition in phase 1 studies we are talking about testing some drug or intervention that we do not yet know to be safe.  Still, there are considerable precautions that researchers must take to satisfy the legal and funding requirements to do their research.  

 

Given that we all have a vested interest in having drugs available that prevent, cure, or alleviate diseases, and given that Judaism is committed to medical research and is communtarian in emphasis as well, I would balance these concerns of preserving one's own health and that of one's child but also advancing the ability of medicine to prevent and cure diseases by saying that yes, a healthy Jew may volunteer to be a reserach subject or allow his/her healthy child to be one once or twice, especially if there is some family reason to do this (e.g., a family member with a disease that may be cured by the drug or intervention being tested).  Beyond that, however, I think that one should not volunteer to do this because your own health -- and that of your child -- is also an important consideration, and there is a limit to how often and how much one should put that at risk.  Clearly, the degree of risk, to the extent that that is known, should also be a factor in deciding whether to participate in a research protocol or not.   

 

Rabbi Elliot Dorff

An answer to these questions is difficult because there are so many factors that are unknown.  What kind of drug is being tested? For what disease or illness? What kind of medical supervision is necessary to ensure safety and relative well being of the study participant?  What is the level of risk to the healthy person? Are you looking simply for permission or if this is a mitzvah (an obligation)?

There is some precedent in Jewish text and tradition that helps gauge the response, and allows us to examine both sides of the question.  One such example comes from David Ibn Zimri of Egypt in the 16th century, who wrote about the following incident: a government official told a certain Jew to allow his leg to be amputated or else he (the official) would kill another Jew. May this man endanger his life (since the amputation was dangerous) in order to save the life of a fellow Jew? David Ibn Zimri considered this beyond the call of duty (from his responsa, Vol. III, #627).

On the other hand, patients who serve as subjects in experimental therapies are participating in a legitimate medical procedure. Whether the tests succeed or fail to develop a new drug, the patients contribute toward the fulfillment of the goal of medicine as the Torah conceives it: the mitzvah of pikuach nefesh, the saving of life.  There is also the mitzvah of rofei cholim (healing the sick).

Therefore, if there is no clear and present danger one could volunteer for a Phase 1 clincal study.  

The second question is even more challenging to answer.  Certainly the parents would be informed of the medical treatment and would make the best determination for their child, though in the case of a healthy minor I believe it is harder to justify the mitzvah of pikuach nefesh or rofei cholim.  I am not sure what circumstances would permit a healthy child to participate in a Phase 1 clinical study.

According to Jewish thought the life of the patient is the primary consideration.  Since there in an absence of additional information my reply is on the cautionary side.