Human Research, Human Dignity
Human organs in medical research
Robin Rowland, CBC News Online

hat happens in Canada when pathologists or researchers want to use human tissue in research?

That question comes after the British government said it would tighten the law in that country following a report detailing how hospitals kept thousands of patients' organs, often without the consent or knowledge of patients or their families.

The doctor at the centre of the case in Britain, Dr. Dick van Velzen, also worked in Halifax between 1995 and 1998. He is currently facing Canadian charges of offering an indignity to and improperly storing remains after children's organs were found in a warehouse in Dartmouth.

Van Velzen, who has denied any wrongdoing, is suing the Halifax hospital where he worked for wrongful dismissal.

In theory, all research in Canada involving human beings is covered by a series of guidelines from a council made up of the major federally sponsored research councils. The general guidelines say, for example, "It is unacceptable to treat persons solely as means (mere objects or things), because doing so fails to respect their intrinsic human dignity."

The federal government created an agency in 1999 to fund and govern health research in this country. The Canadian Institute for Health Research (CIHR) began operations in June, 2000.

A spokesman for CIHR says federal laws, including the Criminal Code and the Privacy Act, as well as provincial laws and regulations govern human tissue research in Canada. Ethical standards are governed by guidelines from a committee that oversees most of the research on human subjects in Canada, covering everything from the arts and humanities (such as biography) to medical research.

The Tri-Council, as it is known, has members from the Medical Research Council (MRC), the Natural Sciences and Engineering Research Council (NSERC), and the Social Sciences and Humanities Research Council (SSHRC). In almost all cases of human research, the procedures are governed by a Research Ethics Board (REB) that has expertise in the type of research that is being done.

The Tri-Council guidelines specifically note:

Research involving human remains, cadavers, tissues, biological fluids, embryos or fetuses shall also be reviewed by the REB.

The Ethics of Research

The Tri-Council says any research on human beings, including research on human tissue must satisfy certain conditions:

• Respect for Human Dignity: including "protecting the multiple and interdependent interests of the person -- from bodily to psychological to cultural integrity."
• Respect for Free and Informed Consent: "Individuals are generally presumed to have the capacity and right to make free and informed decisions. Respect for persons thus means respecting the exercise of individual consent."
• Respect for Vulnerable Persons: includes the idea that "Children, institutionalized persons or others who are vulnerable are entitled, on grounds of human dignity, caring, solidarity and fairness, to special protection against abuse, exploitation or discrimination."
• Respect for Privacy and Confidentiality: The guidelines call for standards of privacy and confidentiality [that] protect the access, control and dissemination of personal information."
• Respect for Justice and Inclusiveness: The guidelines call for "fairness and equity," including "the distribution of benefits and burdens of research" and state that "no segment of the population should be unfairly burdened with the harms of research. [Research] …imposes… particular obligations toward individuals who are vulnerable and unable to protect their own interests in order to ensure that they are not exploited for the advancement of knowledge."
• Balancing Harms and Benefits: The guidelines call for "a favourable harms-benefit balance -- that is, that the foreseeable harms should not outweigh anticipated benefits."
• Minimizing Harm: The guidelines say the researcher has "the duty to avoid, prevent or minimize harms to others."
• Maximizing Benefit: According to the guidelines a researcher has "a duty to benefit others and, in research ethics, a duty to maximize net benefits." They note that "human research is intended to produce benefits for subjects themselves, for other individuals or society as a whole, or for the advancement of knowledge."

Importance of Guidelines

The Tri-Council and CIHR both note that ethical guidelines overseeing medical research involving human beings are becoming more important as research develops in new fields beyond the examination of human organs by pathologists and other researchers, including genetic research, research involving embryos or fetuses and research using human stem cells.

The Tri-Council has detailed guidelines for both genetic and embryo/fetal research. CIHR has appointed a special committee to look into the ethical problems involved with stem cells.

The Tri-Council guidelines for human tissue research say:

In Canadian society, it is generally held that human tissue itself deserves some degree of respect, for reasons of the dignity of the person from whom tissue is obtained. These principles are reflected in Canadian law and public policy, which generally allow competent individuals to donate, but not sell, human tissues for research. In this context, it is reasonable to draw the ethical conclusion that the use of tissue for research depends on an individual's altruism in donating the tissue with the expectation that social good will be advanced and human knowledge increased.

The guidelines also note that in a multi-cultural society such as Canada, researchers have to be aware of how different groups, religions and cultures view the use of human tissue.

Researchers' dilemma

The guidelines say the research must respect both the privacy of individuals and the confidentiality of medical information. But the guidelines, with an eye on how quickly research is moving, also warn: "genetic testing has greatly narrowed the concept of anonymous tissue... [T]he concept of traceable tissue is now wider, since it is now possible to identify biological relatives by using genetic markers."

The guidelines note one dilemma that may be faced by a researcher who uses tissue:

A researcher may request …approval for use of non-traceable tissue in research when such tissue was left over from different research or, for instance, from a pathological examination. In giving approval, the REB should address such issues as privacy, confidentiality, and, where appropriate, continuing consent or free and informed consent concerning the new research project.

The researcher and the REB should also address how likely it is that traceable tissue will be traced back to an individual. Although rendering tissue anonymous has the advantage of increasing confidentiality, it has the disadvantage of making it impossible to offer the benefits of research to donors and their families. This is particularly significant when research may disclose previously undiagnosed conditions, such as HIV infection or an inherited predisposition to breast cancer.

Once a researcher proposes a project, it is reviewed by the Research Ethics Board, which consists of five people, including both men and women. In case of biomedical research, at least one member of the board must be "knowledgeable in the relevant law." The board must then consider both the benefits and the harm possible from the research. Board members are "told the more invasive the research, the greater should be the care in assessing the research."

A board may approve the research project or suggest modifications. If the research is turned down, the researcher can ask the board for reconsideration of the proposal and, if that fails, appeal the decision to a special appeal board.