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Medical Research Threatened

Changes to the ACC laws raise doubts as to the future of medical research in New Zealand.

By Janine Griffin

Changes this year to accident compensation laws have grave implications for the continuation of medical research in this country, with some health boards suspending or drastically cutting back their research.

The changes mean that most people injured in the course of medical research are no longer covered by ACC and face the prospect of hefty user part-charges for treatment of any injuries. The legal and ethical issues involved, as well as the costs of high insurance premiums, have researchers, administrators and health officials concerned.

In the past, people participating in research could feel safe in the knowledge that should anything go wrong, they could make a claim to the Accident Compensation Corporation for medical misadventure. That changed with the Accident Rehabilitation and Compensation Insurance Act (ARCI) which came into effect on July 1st. The act excludes from medical misadventure any drug or clinical trial where the injured person has agreed in writing to participate in the trial.

In effect, the act excludes all medical research from cover, says Dr John Holmes, the professional advisor for medical services to the Canterbury Area Health Board (CAHB).

The Health Research Council (HRC) and voluntary organisations such as the Cancer Society and the National Heart Foundation fund much of the research in New Zealand. Pharmaceutical companies also fund some drug trials. These organisations would not be legally liable for injuries unless they were negligent, says medical law specialist David Collins.

Pharmaceutical companies generally have indemnity cover if a subject is injured, says Holmes, as they have insurance which covers research subjects in the event of injury. However, subjects participating in clinical trials, which are not usually sponsored by drug companies, have no cover.

In August, the Canterbury Area Health Board suspended all research because of the lack of cover for subjects. Since that time, projects in which the risk is seen to be very low have continued, although subjects have been asked to sign a disclaimer.

Clinical Research

Clinical research involves actual patients rather than laboratory work. It is a fundamental component in the delivery of quality health services, says the CAHB in a submission to the Ministers of Health, Science and Technology, ACC and Education. This view is reflected in Your Health & the Public Health, a 1991 government health policy paper.

"Much research has to be carried out in provider settings (for example, hospitals)," the paper says. "Without [this research], providers will not be as effective or innovative in the services they provide."

Research is essential to the well-being of New Zealand, says Holmes. "If you...go away from doing research then the ultimate outlook for the country is actually very poor."

Because the act does not define "clinical trial", there is confusion about what is excluded from cover.

"The dividing line between research and ordinary service medicine is often not clear," says Professor Rick Donald, the Associate Dean of Research at the Christchurch School of Medicine.

Research can be divided into biomedical and therapeutic research. In biomedical research the subjects are healthy, and their health does not usually benefit from the trial. The subjects for nontherapeutic trials generally volunteer "for the good of mankind".

Therapeutic research involves subjects who have a condition for which a new treatment may be used as an alternative to the standard treatment. This happens all the time in cancer research, says Donald. Patients are given drugs, perhaps in different combinations with other drugs or for conditions for which they aren't normally used. These aren't necessarily new drugs, but they are being used in new ways.

This is research, he says. "But if you're going to stop that because of this ACC act, then it means cancer patients aren't getting their treatment."

Classification Problems

Another problem arises when accepted treatments are compared with one another. Whether or not such treatments are considered research is unknown. If classed as a clinical trial, subjects would not be covered under the ARCI act. If, however, the same treatment were to be used in normal clinical practice and injury occurred, the patient would be covered under medical misadventure, says the board's submission.

The people who stand to benefit from research should be prepared to compensate people who suffer the misfortune of personal injury while participating in research, says Holmes. In general, the people who benefit the most from research are the people of New Zealand.

Compensation wasn't a foregone conclusion under the old law, and the criteria were quite strict, says Anne Scragg, chairperson of the CAHB's ethics committee. But subjects weren't automatically locked out from cover as they are now.

It is important to note that researchers can't undertake research on people without the approval of an ethics committee, and the Health Department issues guidelines for ethics committees. Ethics committees are very careful in their screening process, says Scragg, and the chances of something happening to the subject are very low.

Injury is very rare, she says. "The situation, of course, is unlikely to arise...but when it does arise, then there should be some form of compensation available to these people."

"It is research," says Holmes, "and there is the slight chance it could go wrong. The subject wouldn't want to carry the liability of that."

The Cost of Research

Injuries to subjects of medical research used to fall under the definition of medical misadventure. Medical misadventure, however, covers more than just injury from research.

"Most medical misadventure cases are simply injury arising from treatment," says Scragg. "There probably will be some [cases due to research] but I'm not aware of them."

The actual cost of medical misadventure due to medical research is difficult to determine. Total medical misadventure costs for the ACC were $2 million in 1990 and $5.8 million in 1991.

How much of this is attributable to medical research is unknown, as the codes used to classify claims don't specify if injury was the result of research. The cervical cancer research at National Women's Hospital, which was the subject of the Cartwright Inquiry, seems to be the only example of medical misadventure in the course of medical research. Whether the patients involved in the National Women's case were involved in a clinical trial is unclear though.

"It was rather different from actual research of the normal sort," says Margaret Vennell, a senior lecturer in law at Auckland University and member of the HRC national ethics committee.

In fact, it would seem that medical misadventure arising from ethical research which has been properly carried out has cost ACC very little.

"We [the Health Research Council] understand that since 1988 there have in fact been no claims," says Bruce Scoggins, HRC's director.

Insurance Premiums and Disclaimers

The CAHB's indemnity premium was increased by $10,000 in July, and the underwriters now require the board to keep a list of incidents which could result in claims.

The board has also added a disclaimer to research consent forms. The disclaimer states that there is no cover from ACC and that the CAHB will not be held liable for any injury incurred during research. There is concern that this disclaimer could discourage volunteers from participating in research.

"If I were a member of the lay public wanting to help out with research," says Donald, "I would find the present situation intolerable."

Another concern, says Holmes, is that if private trusts such as the Heart Foundation or the Cancer Society have to use money for insurance premiums rather than research, people will think twice about donating money.

"One of the effects is that you pay your premiums to the insurance company which may well take it offshore," he says. "In the ACC, in some ways, it's kept in the community."

The Canterbury Area Health Board has made submissions to the Health Department asking for a review of the Act and its effect on medical research, particularly clinical trials. The submission suggests several solutions to the problem. One is for the Department of Health to take out no-fault insurance for subjects of medical research. Another would be for the department to accept liability for claims made by people injured during approved clinical trials. A final option is that ACC cover be extended to people injured in the course of research.

The insurance-based options would divert money from research to insurance premiums to cover an event that may never occur. One of the effects could be that, as premiums rise, providers may be faced with the option of stopping research, says Holmes.

The providers may decide to concentrate all their resources into treating patients rather than insuring against unlikely events, he says.

"If you follow that course of action and effectively go away from research then the ultimate outlook for the country is actually very poor, because you will stifle research, and research is something that clinicians like to be involved in."

Current Situation

If people are injured while participating in research that could ultimately benefit all New Zealanders then, some argue, there is a moral obligation to care for those people.

Currently, subjects are responsible for their own medical costs in the event of injury, and must pay user part-charges where applicable. In law, researchers would only be liable if they could be proven negligent.

Insurance cover of some kind would benefit the subject rather than the researchers. People may be more willing to participate in research if they know they will be cared for in the unlikely event of injury. The situation is not, therefore, so much a legal issue but a moral one.

ACC cover should be extended to research subjects, says Holmes. Cover would provide security for subjects at a low cost to the corporation as the possibility of claims appears to be small.

The Minister of Health, Simon Upton, and the minister in charge of the ACC, Bill Birch, are aware of the problem. Officials from the Department of Health and the ACC are to soon make recommendations to the ministers which may provide some solution to the problem.

Janine Griffin is a freelance journalist specialising in science issues.