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  Ethics Matters

Dying to Know

by Jeffrey P. Kahn, Ph.D., M.P.H.
Director, Center for Bioethics
University of Minnesota

The recent deaths of 24 of 52 people involved in research involving artificial blood is the first example of serious harms occurring under changes in federal rules that allow research without the consent of subjects, and raises questions about how such research proceeds.

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Allowing research without consent

Dating from the aftermath of unethical medical research carried out in Nazi Germany, the scientific community adopted the bedrock requirement that research would be carried out only with the voluntary consent of subjects. This cornerstone of research ethics meant that if informed consent could not be obtained, then the research could not be carried out.

In 1996, regulations were changed to allow research in emergency settings where subjects are unable to give their consent. This change was necessary because of a combination of the seriousness of patients' illness or injury, and circumstances when no family member is available to decide on behalf of the patient. This waiver of the consent requirement was motivated by the desire to find new ways of improving the survival of patients in life-threatening situations such as severe head injury or in cardiac arrest, but it required a seminal change in the policies that protect research subjects.

The costs of benefits

While the potential benefits of emergency research may help offset the lack of consent, the vulnerability of the subjects involved requires that careful protections must be in place. As in all research, review boards must assess whether subjects are adequately protected, and may modify research before it goes forward.

Since subjects will not give their consent, two different requirements are in place for this category of research. First, there must be substantial likelihood that the research will benefit the individual subject and be at least as good as whatever standard medical practice has to offer for their condition. Second, there must be "community notification" about each study carried out under the waiver of consent, to avoid 'secret' research on unwitting subjects.

Given the availability of human blood, it is not clear that the artificial blood research meets the requirement that the research offer similar benefit to standard care, so that subjects could be exposed to this level of research risk without consent. However this point is answered, the subjects were grievously harmed as a result of the research, pointing out the importance and difficulty of protecting the rights of research subjects who do not give their consent.

To do so, we must have even greater confidence that the risks are outweighed by potential benefits. We must not allow community notification to take the place of efforts to find family members who can consent to participation on behalf of their loved ones. And we must create ways to allow members of communities to make clear that they choose *not* to participate in "no-consent" research -- a sort of informed refusal, in advance. The model of advance directives for the end of life, such as living wills, serves as an example for how this could be accomplished.

Promoting research, preserving trust

There are important benefits to us all from the information gained by medical research. But carrying out research on our fellow citizens is a privilege -- a privilege that rests on trust. This trust is fostered when subjects and potential subjects understand what research entails, and when society believes that the rights and interests of subjects are served.

At its core, the research enterprise cannot operate without individuals being willing to put themselves in harm's way for the good of others. The new practices for emergency research will only be successful if they respect the trust that subjects and society have placed in such practices and in those that carry it out. Research that substitutes standard and successful treatment for dangerous research of uncertain benefit cannot serve these values, and is as shortsighted as it will be harmful to subjects.

Should research without the consent of subjects be allowed, and if so, under what conditions? Do you accept the possibility of being a subject in research without your consent?
Post your opinion here.

Visit the
"Ethics Matters" Archive
where you'll find other columns from Jeffrey Kahn
on a wide range of bioethics topics.

"Ethics Matters" is a biweekly feature from the
Center for Bioethics and CNN Interactive.

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