Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional. Groups that are underrepresented in medical research should be provided appropriate access to participation in research.
Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.
Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured. In medical practice and in medical research, most interventions involve risks and burdens. Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.
All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation. Measures to minimise the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher. Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed.
When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study. Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm. Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group.
In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research. Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation.
The welfare of animals used for research must be respected. The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol. The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed.
In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions. The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins.
This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration. The committee must have the right to monitor ongoing studies.
Salgo decision. However, it was World War II and the human experimentation done by Nazi Germany doctors that pushed forward the idea of informed consent. Along with judging war criminals, the Nuremberg trials declared 10 ethical principles the Nuremberg Code , with informed consent listed first. The Nuremberg Code is the foundation of research and medical ethics and impacts all international ethical guidelines including the Declaration of Helsinki.
To understand better the origin of informed consent I visited the Auschwitz-Birkenau extermination camps in August Please allow up to 2 business days for review, approval, and posting. The paper provides an example of how informed consent documents are often long, complex and difficult to read.
However, the work leaves out significant details. First, who determined that the content was equivalent, the rewriter or an independent reviewer? We all believe that our own writing is clear and parsimonious. Second, was the revised text reviewed by any IRB to see if it would pass their approval? My experience is that the most complex language is often the boilerplate required by various IRBs. Third, how does this compare to other commonly used consent documents? How does it compare to other vaccine trials?
Without that information, it is impossible to know what we should actually do to improve our consent documents. Richard Reiling, M. Having lived through the era of Institutional Review Boards IRB from the early eighties, informed consent has consistently generated the most time and effort of such boards, especially when lay people are involved. The obvious concern about the need of patients and families to know what they should expect from the intended clinical trial must and have been the primary concern in dealing with informed consent.
However, the supposed need to be all-inclusive has expanded the process, as Emanuel and Boyle's article indicate. Even at best the informed consent is too long.
The heart of the issue resides in the concern about lawsuits and not necessarily about the patient's best interest. In the early years and to some extent today, the only part of the IRB process understood by lay members and even clinical members is informed consent. At times, the worst research can pass the IRB as long as the informed consent has been worked over with constant text re-adjustments. There are many pediatric protocols with informed consent documents greater than 20 pages and presented to a very concerned parent s who really cannot easily comprehend the protocol as well as the cancer in the first place - a real burden, indeed.
In many cancer protocols there are multiple drugs used and every conceivable side effect is listed along with the relative frequency of occurrence, which often consumes several pages themselves. There are obvious repeats of the same side effects with different drugs and no correlation with the other drugs, leaving the patient with no basis on which to attribute the side effect s in the first place.
I have spent considerable time on hospital-based IRBs, one of which I initiated in the early eighties, and eventually on IRBs of larger academic institutions. Only in the latter was there really the expertise to tease out the protocol as well as the informed consent; but frivolous word and concept adjustments still occurred.
Even in the best IRB process, informed consent documents, especially in oncology, are extensive and rarely read by the intended participant. In my own practice, it is necessary to have a nurse or trained associate review the informed consent as well as the protocol itself with the patient and family. This is very time consuming. Furthermore patients suffering from some infectious diseases have limited right to consent and can be detained and treated against their will.
Using the principles of capacity and justice towards other individuals the right to autonomy has been cut in a few well-defined circumstances. When an adult becomes incompetent he loses the right to decide on his medical care.
To allow patients to express their ideas and wishes before they become incapacitated the Mental Capacity Act was introduced in A physician is required to act within this advanced directive unless there is evidence that the patient revoked the will when still competent.
A healthy patient might set up an advance directive to not receive mechanical ventilation without discussing the merits of this intervention with a health care professional. This generally prohibits any doctor from administering such treatment in any situation.
Furthermore the act established the lasting power of attorney LPA concept. This enables the patient to grant rights of consent and refusal to a LPA while still competent. The LPA then takes over these powers when the patient loses capacity. While consent should always be sought for including patients in clinical research, there are conditions that do not allow a delay: Unconscious patients, patients in shock and studies with short therapeutic windows.
While including those patients without consent infringes their right to autonomy society as a whole benefits from such research. The European Union EU allows such studies to recruit patients without their consent under strict regulation.
British law clearly gives competent patients the right to refuse any treatment the very few exceptions have been outlined in the chapter legal framework. In contrast, however, no patient has a right to demand certain treatments. Burke, who suffers from a chronic and progressing neurological illness, challenged this guidance. He wishes to receive artificial nutrition and hydration ANH when he loses his ability to swallow and he does not want doctors to make decisions on his behalf.
Arguing that the relevant GMC guidance infringes his human rights he took the case to court achieving a favourable ruling initially. Two lines of argument were used to justify the decision. Firstly the case of Bland 24 Airedale NHS Trust , an advance directive to withdraw treatment in a case of persistent vegetative state must be respected, does not automatically lead to a reverse decision in opposite cases. Another aspect of demanding treatment is the effect on the wider community.
Graber and Tansey argue that demanding certain more expensive, equally effective treatments leads to injustice. Currently there is no legal right in the UK to demand treatment. Furthermore such demands infringe justice by prohibiting resources to be allocated by need. Practical aspects of consent: understanding and retention of information provided. Informed consent requires the ability to understand and weigh up information.
Several studies have addressed the issue of understanding and retention of information provided. Methods like enhanced consent forms and multimedia interventions during informed consent have shown mixed results, while only additional time spent in one-on-one interviews significantly improved understanding and recall of information.
Informed consent is required for any investigation or treatment proposed to a patient. Understanding of the nature of procedure, benefits and risks are the cornerstones of informed consent.
While autonomy is one of the four main ethical principles, I argue that there is no absolute right to autonomy or consent. On a philosophical basis an absolute right to autonomy and consent contradicts itself. Several restrictions in the right to consent are set by the legal framework in the United Kingdom or England. UK Law regulates the right to consent for minors, mentally ill patients, patients with incapacity and patients with communicable diseases.
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