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Consent rule in EU clinical trial directive triggers concern
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Consent rule in EU clinical trial directive triggers concern Experts fear new consent guidance could harm patients’ rights and leave hospital staff at risk of litigation ust 2 months before the European Union’s much-discussed directive on clinical trials is translated into national law in May, the proposed guidelines are still causing concern among clinicians. The directive (2001/20/EC) stipulates that consent for participation in a clinical trial be given by a “legal representative” whenever potential participants cannot give consent for themselves. But the implications of how this rule is enacted have triggered concern among some experts who worry that it could harm the rights of patients and put hospital staff at risk of litigation. In draft guidance issued last year, the Department of Health explained that, for most cases, the legal representative stipulated in the directive will probably be a family member or someone close to the patient. But for clinical trials done in critical medical situations, it is likely that proxy consent will need to be given by a “professional legal representative”. A physician responsible for the patient’s care could take this part, but only if he or she is not connected to the clinical trial, the guidelines say. It could also be taken by other people, such as hospital chaplains, social workers, or members of patient advice and liaison services. Oonagh Corrigan, from the faculty of social and political sciences at the University of
J
Cambridge, told The Lancet that the legislation threatens to focus too much attention on informed consent. “When you make something into law, you put emphasis on it and I’m rather concerned that the legal requirements might trump other considerations”, she said. “To what extent is this new legislation going to protect incompetent subjects, and are we in danger of losing sight of their need to be protected?”
“are we in danger of losing sight of [patients’] need to be protected?” The British Medical Association (BMA) is also worried that the notion of proxy consent might be an illusory safeguard if a chaplain or social worker who knows nothing about an unconscious patient is asked to decide whether that person can participate in a trial. “Where nothing is known about the individual, it is hard to see on what basis such a decision would be made. This seems tokenism in terms of the whole notion of consent”, a BMA spokeswoman told The Lancet. The BMA also worried that the government was focusing on one small part of the overall picture in relation to treatment of incapacitated adults. “Among all the pressing decisions that might
need to be made on behalf of incapacitated adults, we were doubtful as to whether their participation in a pharmaceutical research project was the most urgent aspect needing legislation to be expedited”, the spokeswoman said. It is now a year after the original consultation, and “in England and Wales we are still awaiting the new Bill on incapacitated adults and draft codes of practice from the Department of Constitutional Affairs”, she added. Su Mason from the clinical trials and research unit at Leeds University said that the provisions might well offer more protection for potential trial subjects in emergency situations, by insisting on the involvement of a person not involved in the trial. “It might be that it offers very good protection”, she said. “But it might also be very problematic, we don’t know yet. It hasn’t been properly thought through.” Another issue is finding hospital staff who are prepared to offer proxy consent. In its guidance the Department of Health stresses that such people should be given appropriate training, and that before deciding whether or not to give consent for a particular patient, the professional legal representative must also be informed of the nature, objectives, and risks of the trials.
THE LANCET • Vol 363 • March 6, 2004 • www.thelancet.com
For personal use. Only reproduce with permission from The Lancet.
“I don’t know how many people would be willing to do such a job”, Mason said. “I think they’re very much open to litigation.” As the government notes in the draft guidance, “Persons who act as professional legal representatives will need assurances that they will be appropriately indemnified when they fulfil this role in good faith.” All of which leaves doctors somewhat baffled, Mason said. “When I talk to clinicians, they ask ‘What do we do?’.” The Department of Health told The Lancet that the current aim was to implement the directive by the May 1 deadline. “The aim in implementing this directive is to provide an environment that is as safe as possible for clinical trial participants while not inhibiting the development of new essential medicines”, a spokesman said. Stephen Pincock
785
New ways with old bones USA won’t sign landmine treaty IBM victorious in employee cancer lawsuit UNICEF calls for action to protect indigenous children Amnesty campaigns to stop gender violence UK Prime Minister launches commission for Africa USA pressured to ease trade demands News in brief UK consultants call for reform of national health service
Consent rule in EU clinical trial directive triggers concern Experts fear new consent guidance could harm patients’ rights and leave hospital staff at risk of litigation ust 2 months before the European Union’s much-discussed directive on clinical trials is translated into national law in May, the proposed guidelines are still causing concern among clinicians. The directive (2001/20/EC) stipulates that consent for participation in a clinical trial be given by a “legal representative” whenever potential participants cannot give consent for themselves. But the implications of how this rule is enacted have triggered concern among some experts who worry that it could harm the rights of patients and put hospital staff at risk of litigation. In draft guidance issued last year, the Department of Health explained that, for most cases, the legal representative stipulated in the directive will probably be a family member or someone close to the patient. But for clinical trials done in critical medical situations, it is likely that proxy consent will need to be given by a “professional legal representative”. A physician responsible for the patient’s care could take this part, but only if he or she is not connected to the clinical trial, the guidelines say. It could also be taken by other people, such as hospital chaplains, social workers, or members of patient advice and liaison services. Oonagh Corrigan, from the faculty of social and political sciences at the University of
J
Cambridge, told The Lancet that the legislation threatens to focus too much attention on informed consent. “When you make something into law, you put emphasis on it and I’m rather concerned that the legal requirements might trump other considerations”, she said. “To what extent is this new legislation going to protect incompetent subjects, and are we in danger of losing sight of their need to be protected?”
“are we in danger of losing sight of [patients’] need to be protected?” The British Medical Association (BMA) is also worried that the notion of proxy consent might be an illusory safeguard if a chaplain or social worker who knows nothing about an unconscious patient is asked to decide whether that person can participate in a trial. “Where nothing is known about the individual, it is hard to see on what basis such a decision would be made. This seems tokenism in terms of the whole notion of consent”, a BMA spokeswoman told The Lancet. The BMA also worried that the government was focusing on one small part of the overall picture in relation to treatment of incapacitated adults. “Among all the pressing decisions that might
need to be made on behalf of incapacitated adults, we were doubtful as to whether their participation in a pharmaceutical research project was the most urgent aspect needing legislation to be expedited”, the spokeswoman said. It is now a year after the original consultation, and “in England and Wales we are still awaiting the new Bill on incapacitated adults and draft codes of practice from the Department of Constitutional Affairs”, she added. Su Mason from the clinical trials and research unit at Leeds University said that the provisions might well offer more protection for potential trial subjects in emergency situations, by insisting on the involvement of a person not involved in the trial. “It might be that it offers very good protection”, she said. “But it might also be very problematic, we don’t know yet. It hasn’t been properly thought through.” Another issue is finding hospital staff who are prepared to offer proxy consent. In its guidance the Department of Health stresses that such people should be given appropriate training, and that before deciding whether or not to give consent for a particular patient, the professional legal representative must also be informed of the nature, objectives, and risks of the trials.
THE LANCET • Vol 363 • March 6, 2004 • www.thelancet.com
For personal use. Only reproduce with permission from The Lancet.
“I don’t know how many people would be willing to do such a job”, Mason said. “I think they’re very much open to litigation.” As the government notes in the draft guidance, “Persons who act as professional legal representatives will need assurances that they will be appropriately indemnified when they fulfil this role in good faith.” All of which leaves doctors somewhat baffled, Mason said. “When I talk to clinicians, they ask ‘What do we do?’.” The Department of Health told The Lancet that the current aim was to implement the directive by the May 1 deadline. “The aim in implementing this directive is to provide an environment that is as safe as possible for clinical trial participants while not inhibiting the development of new essential medicines”, a spokesman said. Stephen Pincock
785