Chapter3- Medical Research on Humans.docx

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Western University
Health Sciences
Health Sciences 2610F/G
Patrick Clipsham

3: Medical Research on Humans February-13-13 1:02 PM MEDICAL RESEARCH ON HUMANS  Nuremberg Code 1946 drawn up as part of judgment against physicians who conducted medical experiments on inmates in Nazi concentration camps o Code consisted of 10 principles, foremost requirement that human subjects give voluntary informed consent before participating in research also appropriate ratio of benefits to risks in the research o These two principles form core of ethical polices governing medical research on humans  World Medical Association 1964 added 3 imp points to Nuremberg code o Distinction b/w therapeutic research, whose aim is to benefit patients, and nontherapeutic research, whose aim is not to benefit patients but generate general scientific knowledge o An institutional mechanism should be in place to ensure that the main ethical principles were followed o Provision for proxy consent by family members when subjects such as children could not consent on their own  Belmont Report 1979- identified respect for persons as autonomous agents, beneficence, and justice as necessary principles for any research to be justified o To be ethical, all medical research on humans must conform to these requirements Design of Clinical Trials  5 conditions must be met for clinical trials to be ethically acceptable 1. Voluntary informed consent must be obtained from subjects 2. Research must involve favourable benefit-risk ratio 3. Must be an equitable selection of subjects that rules out any exploitation and adequately represents both sexes and all social groups 4. Privacy of the subjects must be protected 5. Confidentiality of the data yielded by the research must be protected  Institutional Review Boards (IRBs) have authority and responsibility to monitor research protocols to ensure that these 5 conditions are met  Clinical trials designed to test the safety and efficacy of a drug/surgical procedure before it is used on patients in a clinical setting  Clinical trials involving human subjects consist in the same 4 phase approach process o PHASE I- drug trials, researchers aim to test the toxicity of a drug, the highest dose subjects can tolerate o PHASE II- researchers try to establish an optimal dosing regimen and to find the experimental conditions that will allow the third phase of the trial to yield a definitive result o PHASE III- trials involve the largest number of subjects, aim here is to learn whether the treatment is effective and what its side effects are o PHASE IV- trials take place once the drug has been approved by the Food and Drug Administration (FDA) and has been marketed, trials used to monitor a drugs side effects and to collect more info for possible additional uses  Phase III and Phase IV trials may be therapeutic b/c they can benefit subjects in addition to generating scientific knowledge o May be therapeutic, the researchers main moral obligation is to ensure that there is an appropriate risk-benefit ratio for subjects in the trials  Design of trial becomes esp. imp in Phase II- control group is introduced as a point of comparison with the intervention group receiving the experimental treatment  Placebo: biologically inert pill or substance  Placebo response: physiological changes in our bodies that occur because we expect them to occur  Many trials are "randomized" in the sense that subjects are assigned by chance to either the treatment group or the control group - "gold standard"  Many trials are "blinded" in the sense that neither the researcher nor the subject knows to which group they have been assigned o Necessary to factor out bias in the researcher and the subjects o "double-blind"- when both don’t know Equipoise, Randomization, and Placebos  Main ethical issues in clinical trials concern equipoise, randomization, use of placebo controls  Equipoise: attitude of a researcher, group of researchers, involves in a randomized controlled trial o Researcher in "equipoise" when they don’t know whether one treatment is more effective then another o Research community in "equipoise" when there is disagreement within the community abt the comparative merits of the experimental and control arms of the trial  If patient is a subject in a trial, receives treatment for which the doctor does not have a preference- doctor is not acting in the patients best interests by encouraging participation in the trial  Medical practice must not get ahead of medical science  Researchers can determine whether the benefits of an experimental treatment outweigh the risks only by completing all phases of a trial  There is uncertainty abt the efficacy of any given treatment, randomized trial is the best way to yield objectively valid results  Entering patient in randomized controlled clinical trial, doctor is treating patient as a means for sake of generating scientific knowledge, also treating patient as an end by obtaining consent to participate in the trial and ensuring that the potential risks are equal with the potential benefits  Placebo-controlled trials are scientifically superior to active-controlled trials  Without placebo researchers cannot know whether new treatment causes an improvement in a condition or improvement would have occurred without an active intervention  Placebo-controlled trials require smaller group of research subjects more likely trials will be completed within a shorter period of time  Sick patients receiving placebos may be exposed to greater risk, for a period of time not receiving any active treatment for their condition  Some conditions for which placebos are permissible b/c only placebos can determine which treatment is best for patients o Double-blind placebo-controlled trials for schizophrenia o Improvement rates b/w drug-related and placebo-treated patients is not significant o Placebo-controlled trials preferred to active controls for Alzheimer's  Placebo controls in clinical trials can be ethical 1. No effective therapy for condition exists 2. Trial cannot last too long 3. Placebo cannot expose patients to unacceptable risk 4. Patients must be adequately informed about nature/ risks of placebo-controlled trial and give full voluntary consent to participate  Surgical interventions expose patients greater risks than drug interventions more difficult to justify placebo-controls in surgical procedures  Trials involve incisions into patients bodies; patients not aware of what surgeon is doing and they may have to undergo general anesthesia  Exposing pe
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