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October 8, 2013 | Posted By John Kaplan, PhD

My last blog, written just a few weeks ago, discussed the case of two neurosurgeons who had purposely introduced bowel bacteria into the brains of patients with glioblastoma, a process they termed “probiotic intracranial therapy”. In that blog I expressed the opinion that the physicians had inappropriately exposed their patients to excessive risk and compared the incident to assault. In the brief time since then high risk research has been covered in both the biomedical literature and the popular press. We have also seen more news regarding treatments with bowel bacteria indicating that fecal bacteria may well have their place in medical treatment. Their place, however, is in the gut not the brain.

In the journal Lancet, David Shaw argues that Institutional Review Boards “should never reject a study because it poses too high a risk to participants.” Institutional Review Boards are the mechanisms that review research protocols designed to be conducted with human subjects. Among the charges to Institutional Review Boards is to evaluate the balance between the potential benefits and potential risks of a proposed research project. When assessing protocols of prospective therapies they need to identify that there is adequate reason, both theoretical and experimental, to think the therapy might work. They should also assure that the risks of the proposed study do not endanger the participants out of proportion to the potential benefits. These dangers were excessive in the well known Tuskegee syphilis studies and similar studies in Guatemala as well as the supposed research in the Nazi atrocities. This horrendous history drove many of the protections we now use to safeguard human research participants.

Dr. Shaw argues that protection against risk denies individuals the “right” to participate in risky research. He argues that this right is protected by autonomy and that denial of the opportunity for choosing such risk is paternalistic. He likens these choices to the right to choose to be a fire fighter or go hang gliding or bungee jumping. I am just not buying this line of reasoning. To establish a right to participate in high risk research seems as if it might obligate researchers and their institution to offer such opportunities to people. No, no, no! Additionally autonomy has consistently been interpreted as the right not to allow others to do things to you, not a right to access whatever opportunity you seek. In just the last few weeks we have seen the issue of excessive research risk reach the news in both trials of experimental drugs for ovarian cancer and in studies of risk of blindness and death in oxygen therapies for premature infants.

It is important to add after the horrendous use of bowel bacteria in the brain that it may have a place in treatment of other serious disease. Science magazine has published an article entitled “The Promise of Poop” that reviews the promising research on fecal transplants. This technique appears to have been useful in certain types of infections and is now the subject of a series of clinical trials. It should be noted that both the Food and Drug Administration and Health Canada have asserted that evaluation of this protocol is research and must be done in the context of the mechanisms in place to protect people participating in these trials.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

0 comments | Topics: Ethics in Clinical Trials, Research Ethics, Risk


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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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