Can autopsy tissue be used for study without consent?
Samples often taken during post-mortem exams
Use of donated human tissue from living participants for research is a thorny ethical question faced by many research institutions now that the map of the human genome makes human collection tissue valuable. (See cover story.)
But what about the use of tissue samples taken during autopsies? Organs or representative sample tissues often are taken during post-mortem examinations. Can small samples of that tissue be collected for research? If so, should researchers obtain consent from the person’s next-of-kin for use of the tissue?
The problem arises in hospitals more often than you may think. Tissue samples removed during autopsies are requested for a number of research projects, says Daniel Visgard, PhD, research compliance officer for the Research Foundation of the City University of New York. Visgard was formerly the chair of the institutional review board (IRB) for the New York City Board of Health.
The board must approve research through the city medical examiner’s office. Scientists studying the prevalence of certain diseases or conditions in a general population may request samples from the medical examiner. Researchers in behavioral health may seek brain tissue for behavioral research.
State law in New York prohibits the release of such samples without full disclosure to the person’s next-of-kin when possible, says Visgard. "There are also a relatively small number of autopsies performed at hospitals, and those facilities usually have some sort of fine-print language on hospital forms that allow use of tissue samples for research," he adds.
State laws governing use of human tissue taken from dead persons vary, with some allowing use without consent and some prohibiting it. Federal regulations governing protection of human subjects define such subjects as "living beings." When the tissue is from a person who is no longer alive, the decision, along with the authority to make such decisions, becomes murkier.
There also are regulations governing the use of "archival" or "waste" tissue — tissue that may have been taken from a deceased individual — stored separately for a certain length of time and then designated as waste that will be disposed of, he notes. Some states permit use of such tissue, provided that no identifying information is linked to it, without obtaining consent from relatives.
In the New York City medical examiner’s office, consent is obtained from the families of deceased persons if the tissue is taken at the time the autopsy is performed. Researchers are not permitted to see any identifying information about the person and are only given basic demographic information such as age, gender, race, or ethnicity by a medical examiner’s office staff member.
If the tissue is archival or waste tissue, consent is not sought from the family and no identifying information, other than basic demographic data, is given to the researcher.
"The bottom line is, researchers are never allowed to walk out of that office with any identifying information," Visgard says.
Ethical considerations should govern use
If hospitals or other institutions receive requests for that kind of tissue, legally they should check the requirements in their states. California, for example, specifically permits the use of tissue taken at autopsy, as long as the study protocol is reviewed by an appropriate IRB. There is no mention of the requirement of consent. Even if the law may permit use without explicit consent, there are certain ethical considerations that should govern the use of the tissue, cautions Visgard.
"Even if the federal regulations only specifically cover tissue taken from a living person, I think that you have to look at it as any research that could affect a living person," he says. "And if a person had a disease, HIV for example, or cancer, that information can have consequences for the living relatives. So, you don’t just have carte blanche because the person is deceased."
It is also important that the IRB carefully weigh the goals of the research and why the tissue is requested.
"We would always do a very careful risk-benefit analysis of what the goals of the research were," he says. "There had to be a clear benefit that could be derived from gathering the information. There were very few studies that we turned down; there were some that we asked the researchers to go back and be more specific or do some more research, and I can think of one in which we felt that the request for human tissue was not justified by the goals that the researchers sought."
Tissue bank seeks informed consent
The San Francisco-based PathServe Autopsy and Human Tissue Bank, formed in 1990, supplies a large number of organs and tissue samples to biotech and neuropathological researchers, says Roman Karp, the bank’s executive director. The bank will not accept tissue donated without either the patient’s express consent (obtained before death) or the consent of the patient’s next-of-kin.
"If someone calls us from the hospital and says that they have a patient who wants to donate tissue, we are not only required to get consent, but informed consent, to the extent that is possible," Karp says. "Informed consent should mean that we inform the family that we want to take a bone sample, that the sample will be given to a specific company, and for what type of research."
Because the bank often does not know how the sample will eventually be used in research at the time it is obtained, getting that level of consent is rare, he admits. Bank representatives, however, always get separate consent for the specific tissue donated, consent for testing of blood samples if obtained, and consent for the release of the patient’s medical information, he adds.
"We only seek the basic demographic information: age, gender, brief medical history," he says.
Consent forms for an autopsy should be designed so consent for all procedures can be obtained at once, even though it must ensure that the patient or patient’s family understands that they may consent to part, all, or none of the requested donation.
"For example, a family may feel OK that an autopsy is performed but want no organs retrieved," he says. "Other times, they will consent to a certain organ but not another, or they do not consent at all."
In the event that the bank obtains "waste" tissue, the bank ensures it does not link the samples with any known identifying information.
Government offers guidance
The National Bioethics Advisory Commission in Washington, DC, offers guidance on this issue in its report Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Volume I, Report and Recommendations.
"It might be thought that once the source is dead, no interests remain that require protection," the committee writes. "But, for a number of reasons, this is not the case. For example, the decedent’s family or other loved ones may have an interest in how the material is used, or members of the source’s ascriptive group may have an interest in what happens to it."
Furthermore, the report continues, individuals may have interests that survive their deaths. For example, some have religious or ethical concerns about the uses of the tissue.
"In addition, new information obtained about persons after they have died may affect the memories, perspectives, and relationships of family members and others," it states. "Even if, strictly speaking, the dead do not have interests that require protection, the living may want to establish policies to ensure that some of these outcomes do not occur."
Although recent court decisions have held that donated tissue is not the property of the source, and the source does not necessarily have to profit from any future uses, Karp speculates that the legal and regulatory climate could change.
"At the very least, if you are collecting human tissue for research and it is discovered that you did not attempt to get permission from the person from which you obtained the sample, or their relatives, it could make you look very bad," he says.
PathServe has found it simple to construct an autopsy consent form that allows family members to choose whether they would like tissue donated at the time they are deciding whether they want a post-mortem examination performed.
"The family deals with this as part of the entire process of deciding what will happen to their loved one," he adds.
• Daniel Vasgird, PhD, Office of Research Compliance, Research Foundation of CUNY, 30 W. Broadway, 11th Floor, New York, NY 10007.
• Roman Kahn, PathServe Autopsy and Tissue Bank, P.O. Box 22023, San Francisco, CA 94122-0023.
• National Bioethics Advisory Commission. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance is available on the World Wide Web: http://www.bioethics.gov/pubs.html.