BME 520,522: Biomedical Device Design Quiz

BME 520,522: Design and Maintenance of Biomedical Devices

• Course offered by the Biomedical Systems and Medical Informatics Department, Hijjawi Faculty for Engineering Technology, Yarmouk University
• Course dates: 2024-10-10

Historical Perspective of Human Research Protection

• Nuremberg Code (1942): A ten-point statement delineating permissible medical experimentation on human subjects. It's justified only if the results benefit society and carried out with moral, ethical, and legal principles.
• Key points of Nuremberg Code:
  • Voluntary consent of human subjects is essential; subjects must have legal capacity to consent and exercise free will without coercion.
  • Experiments should yield fruitful results that cannot be obtained by other methods.
  • Experiments should be based on animal experimentation and an understanding of the natural history of the disease under study. Anticipated benefits justify the experiment.
  • Experiments should avoid unnecessary physical and mental suffering.
  • Death or disabling injury should not occur unless the experimental physicians are also subjects.
  • Risk should not exceed the humanitarian importance of the problem to be solved.
  • Proper preparations and adequate facilities should protect subjects from harm.
  • Experiments should be conducted only by scientifically qualified persons, with the utmost care, and throughout all stages.
  • Subjects should be able to end the experiment if their physical or mental state deems it impossible.
  • The scientist in charge must be prepared to terminate the experiment if it appears likely to result in harm to the subject.
• Post-War Developments:
  • Declaration of Helsinki (1962)
  • Medical progress is based on research involving human subjects.
  • Food Drug and Cosmatic Act (1962)
  • Human Radiation Experiments
  • The Nazi Experiments
  • Consolidated HHS/FDA Regulations
  • Belmont Report (1979)
  • The Syphilis Study (Expose) 1947
  • The Syphilis Study begins (1932)
  • ICH Guidelines
  • AAHRPP (2001)

Declaration of Helsinki

• Developed by the World Medical Association (WMA)
• Statement of ethical principles for medical research involving human subjects, including research on identifying human material and data.
• Primarily addressed to physicians, encouraging all involved in medical research to adhere to these principles.
• Health of the patient is the primary consideration.
• Physicians' duty to safeguard the health, well-being, and rights of research subjects.
• Medical progress hinges on research including human subjects.
• Primary purpose of medical research involving human subjects is to understand the causes, development, effects of diseases, and improve preventive, diagnostic, and therapeutic interventions.

General Principles

• Protecting the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of research subjects.
• Considering ethical, legal, and regulatory norms, both national and international.
• Minimizing harm to the environment.

Risks, Burdens, and Benefits

• Medical interventions in practice and research involve risks and burdens. Every research study involving human subjects should include a careful risk assessment regarding the individuals and groups involved.
• Measures to minimize risks should be part of the research and these risks should be continuously monitored, assessed, and documented.
• When risks outweigh benefits or definitive outcomes are known, physicians have to evaluate whether to continue, modify, or stop the study.

Vulnerable Groups

• Some groups are more vulnerable to harm and need special protective measures.
• Medical research involving vulnerable groups is justified only if responsive to their health needs, with the research not possible using non-vulnerable groups.

Scientific Requirements

• Medical research must conform to generally accepted scientific principles.
• Research design and performance should be clearly described and justified in the protocol.
• Clinical trials must include post-trial provisions for access.

Research Ethics Committees

• Research protocols must go through ethical committee review and approval before commencing a human subjects study.
• The committee can monitor ongoing trials and require changes to the protocol (with their approval).
• The committee must be provided with information about adverse events during the trial.

Privacy and Confidentiality

• Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.

Informed Consent

• Participation in medical research involving human subjects should be voluntary. Potential subjects need adequate information about the research (aims, methods, funding, conflicts, benefits, risks, discomfort, post-study provisions, etc).
• If a potential subject is incapable of giving consent, the physician must seek the consent of a legally authorized representative.
• Subjects who are unable to consent ought to be given the opportunity to express their assent.
• Research involving subjects who are physically or mentally incapable must fully inform the patient regarding how their health care is related to the research.

Use of Placebo

• The benefits, risks, and effectiveness of new interventions are tested against best-proven interventions, except in cases where no proven intervention exists.
• Patients should never be exposed to additional risks.
• Extreme care is necessary to avoid abuse.

Post-Trial Provisions

• Sponsors, researchers, and host-country governments must make post-trial access to interventions (identified as beneficial in the study) available. This should be disclosed during the informed consent process.

Research Registration and Dissemination

• All research involving human subjects must be registered in a publicly accessible database.
• Researchers, authors, sponsors, editors, and publishers have responsibilities for publishing and disseminating research results ethically.

Unproven Interventions in Clinical Practice

• When proven interventions do not exist or are ineffective, a physician, after consulting an expert, can use an unproven intervention, if, in their judgment, it offers hope for saving life, restoring health, or alleviating suffering.
• Such interventions need subsequent research on their safety and efficacy.
• New information from any clinical interventions should be recorded and (where appropriate) made publicly available.