BME 520,522: Design and Maintenance of Biomedical Device (2024-2024) PDF

BME 520,522: Design and Maintenance of Biomedical Device Prof. Awad Al-Zaben Biomedical Systems and Medical Informatics Department Hijjawi Faculty for Engineering Technology Yarmouk University 2024-10-10 Historical Perspective Human Research Protection Program Historical Perspective 1...

BME 520,522: Design and Maintenance of Biomedical Device Prof. Awad Al-Zaben Biomedical Systems and Medical Informatics Department Hijjawi Faculty for Engineering Technology Yarmouk University 2024-10-10 Historical Perspective Human Research Protection Program Historical Perspective 1 23 Nuremberg Code Introduction The Nuremberg Code is a ten-point statement delimiting permissible medical experi- mentation on human subjects. According to this statement, humane experimentation is justified only if its results benefit society and it is carried out in accord with basic principles that “satisfy moral, ethical, and legal concepts.” 2 23 Nuremberg Code – 10 points The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment 3 23 The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. 4 23 Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury disability or death. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible. 5 23 During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgement required by him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject. 6 23 Declaration of Helsinki Introduction The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifying human material and data. Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles. 7 23 General Principles The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient’s best interest when providing medical care.” It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. Medical progress is based on research that ultimately must include studies involving human subjects. 8 23 The primary purpose of medical research involving human subjects is to understand the causes, development and efects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights. While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects. 9 23 It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable interna- tional norms and standards. Medical research should be conducted in a manner that minimises possible harm to the environment. 10 23 Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. 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. Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured. 11 23 Risks, Burdens and Benefits In medical practice and in medical research, most interventions involve risks and burdens. 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. Measures to minimize the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher. 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. 12 23 Vulnerable Groups and Individuals Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm. All vulnerable groups and individuals should receive specifically considered protection. 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. 13 23 Scientific Requirements and Research Protocols Medical research involving human subjects must conform to generally accepted scientific principles. The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol. In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions. 14 23 Research Ethics Committees The research protocol must be submitted for consideration, comment, guidance, and approval to the concerned research ethics committee before the study begins. The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. 15 23 Privacy and Confidentiality Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information. 16 23 Informed Consent Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. 17 23 When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative. 18 23 Research involving subjects who are physically or mentally incapable of giving consent. The physician must fully inform the patient which aspects of their care are related to the research. For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. 19 23 Use of Placebo The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances: ▶ Where no proven intervention exists, the use of placebo, or no intervention, is acceptable. ▶ The patients who receive any intervention less effective than the best proven one, placebo, or no ntervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best-proven intervention. ▶ Extreme care must be taken to avoid abuse of this option. 20 23 Post-Trial Provisions In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process. 21 23 Research Registration and Publication and Dissemination of Results Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. 22 23 Unproven Interventions in Clinical Practice In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, may use an unproven intervention if in the physician’s judgement, it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available. 23 / 23