Crossing an Ethical Frontier:
Research on the Brain Dead

By Suria Santana

Arun Singhal, M.D., Assistant Professor of Surgery and Physiology Temple University

Most people have a difficult time dealing with death in its conventional forms.

But having to grasp and accept the passing of a loved one who does not display the usual characteristics of a dead person can be even more troublesome.

Family members of patients who are declared brain dead need accept the fact that their relative is medically and legally dead, even though the heart is still beating and the lungs are functioning with the aid of a ventilator.

Add the possibility of being asked for permission to use that loved one’s body for medical research, and a tense situation becomes emotionally charged.

As Ayeesha Kamal, M.D., an assistant professor in neurology at Temple University’s School of Medicine, describes the dilemma, perhaps the most difficult aspect of performing research on brain-dead patients is the public’s perception of what brain death is.

“It is hard to see someone you love dead, and even more difficult to see them looking lovely, as though they are simply sleeping, on a ventilator,” Dr. Kamal said. She is one of a handful of researchers engaged in studies that involve brain-dead patients.

The mass media’s portrayal of patients who undergo severe brain trauma only to wake up fully recovered the next day does not help doctors seeking to educate the public about the reality of brain death and massive brain injury, she added.

Once brain death sets in, the irreversible loss of all brain functions takes place. Brain death is characterized by a lack of electrical activity and blood flow to the brain, which results in no bodily movement, response to stimulation, breathing or brain reflexes. It is a process that could last from just a few hours to a couple of days.

Some theorize that the above happens due to a flight-or-fight response on the part of the brain. “Unfortunately, we still don’t know how to protect patients from brain death,” Dr. Kamal said.

Unregulated Research

According to federal law, a brain-dead body is legally dead. The 1987 Uniform Anatomical Gift Act, which governs organ transplants, allows research on brain-dead patients. But although this kind of research is legal, it is still unregulated.

“In our society, we have agreed that it is okay to perform research on the brain dead as long as no one is harmed, and as long as we have the proper permission to do it,” said Stuart Youngner, M.D., chairman of the department of bioethics at Case Western Reserve University.

But despite the fact that this type of research is becoming increasingly accepted, the medical community still has a lot of explaining and convincing to do, he added.

Nationally, research on brain-dead patients is scarce, partly because the technology to keep these patients’ bodies alive is new. Dr. Kamal and Arun Singhal, M.D., assistant professor of surgery and physiology at Temple, are currently studying the process of brain death and how it leads to organ deterioration. The pair’s research led to several successful heart donations.

The two researchers are comparing what happens to the bodies of patients who have undergone brain death with victims of massive brain injury. As a transplant surgeon, Dr. Singhal is par-ticularly interested in finding ways to improve donation rates. The brain-dead patient population is a potential organ donor pool, so finding ways to protect the organs of such patients could result in the increased availability of organs.

“Because of the work we have done, we have been able to salvage some hearts that otherwise would not have been useful,” Dr. Singhal said. “I was not able to use the hearts for some of my own patients because of the way transplant regulations work in this country, but I know that they were used on others.”

The research also has another potential benefit. It could eventually help save the lives of some massive brain injury victims. “In about 1 to 2 percent of the death cases related to brain injury, patients die because of heart problems that are similar to what brain-dead patients experience,” Dr. Singhal explained.

As recovery from severe brain injury is medically possible, it is hoped that figuring out the reasons for heart failure in the brain dead will eventually help stop heart failure in patients with massive brain injury, resulting in a few saved lives.

Dr. Kamal is quick to point out that the research performed on brain-dead patients is non-invasive.

“We don’t plug anything into the patient,” Dr. Singhal explained. “We look at the tests that are done throughout the process of trying to figure out whether the patient is experiencing brain death — blood tests, ultrasounds, cardiograms, etc.”

At Temple, research involving brain-dead patients is evaluated by the university’s Institutional Review Board (IRB), which has a subcommittee that deals specifically with brain testing.

Stuart Youngner, M.D., chairman, Department of Bioethics, Case Western Reserve University

Pittsburgh’s Efforts

But at the University of Pittsburgh, another institution that is home to research on brain-dead subjects, this type of study is reviewed by a special academic entity: the Committee for Oversight of Research Involving the Dead (CORID).

Established in 2002, the committee reviews not only research on brain-dead subjects but also studies involving cadavers, body parts and tissues.

The committee was formed after a Pittsburgh investigator wanted to test a new medical device and determined that the best subjects for his study would be brain-dead patients. However, after requesting permission from the school’s IRB, the board concluded that this study was not in its jurisdiction because IRB review is limited to living human subjects.

Pittsburgh is currently the only institution that has a special committee to deal with research involving dead and brain-dead patients. The committee has 22 members, including academicians, clergy, lawyers and community members.

The committee has received 37 submissions for research, three of which were for research on brain dead patients, according to Laurel Yasko, director of the Office of Clinical Research at Pittsburgh and coordinator of CORID. Currently, two of the three studies are taking place while the third is pending approval.

“One of the two studies explores a device that can improve the quality of organs for transplantation,” Yasko said. The other study examines the process of brain death and how it leads to deterioration of organs, similar to the Temple study.

Yasko was heavily involved in the formation of CORID and the development of the committee’s policies, which include the requirement that consent be acquired from either the subjects prior to their passing or from appropriate surrogates. In addition, CORID’s guidelines state that organ donation should always take precedence over research since it saves lives directly.

“All studies are reviewed [by CORID] individually and the committee determines if the proposed study is permissible or not,” said Yasko. “I am sure we will come across a study that is not permissible someday, but so far the researchers have demonstrated remarkable sensitivity in terms of choosing important work and limiting intrusion.”

Case Western’s Youngner said members of committees in charge of reviewing such studies should be independent from any ongoing research project.

“Institutions should handle research on brain dead by having an interdisciplinary committee that includes people who are not going to benefit from the research,” said Dr. Youngner.

Further, the research should only be conducted after the committee develops a policy and shares it with the community. Dr. Youngner thinks that making the policy and the research available to the public would help in assuaging concerns patients and the community may have.

“The hospital should invite the press to ask relevant questions and definitely not make a secret out of it,” he said.

But some things that are not necessarily considered “immoral” still upset people because they are unusual.

“If dissection of cadavers isn’t something that most people would volunteer to do, research on brain dead is even less likely,” Dr. Youngner said.

At the root of people’s reluctance is the fact that not everyone agrees that brain dead is “dead enough.”

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