Bioethics Flashcards
What is bioethics?
The study of the ethical issues emerging from advances in biology and medicine.
Moral discernment as it relates to medical policy and practice. It includes the study of our moral choices relating to medical and biological research.
It is concerned with the questions that arise in the relationships among life sciences, biotechnology, medicine, politics, law, and philosophy.
Institutional Review Board (IRB)
An independent body made up of medical, scientific, and nonscientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by reviewing, approving, and providing continuing review of trials, protocols and amendments, and of the methods and materials to be used in obtaining and documenting informed consent of subjects.
Research Misconduct
A fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
Serious Adverse Effects (SAE)
Any experience that suggests a significant hazard, contraindication, side effect or precaution that develops during a clinical trial.
Informed Consent
Consent to participate in a medical experiment by subject after achieving an understanding of what is involved. It is essential that participants understand that participating in a research study is completely voluntary, that they can withdraw from the study at any time or choose not to participate without it having any impact on their clinical care.
Autonomy
The capacity of an individual to make an informed, non-coerced decision.
Clinical Trial
The systematic investigation of the effects of materials or methods on a disease state conducted according to a formal study plan..
Good Clinical Practice (GCP)
A standard by which clinical trials are designed, implemented, and reported to assure that the data are scientifically sound and the rights of subjects are protected.
Dr. James Lind (1747) and the Treatment of Scurvy
Tested on 12 sailors with scurvy, 2 each assigned to groups: quart of cider, elixir TID, seawater, garlic/mustard/horseradish, vinegar, and citrus fruits. 4 groups had no improvement, cider group improved slightly, fruit groups recovered completely.
Dr. John Haygarth (1799) Metallic Tractors
One of the first studies of the placebo effect.
Tractors were drawn over the afflicted area and downward for 20 minutes to extract the disease.
Some had metal bars, others a pencil. Positive result was generally the same across the board, showing placebo effect.
Nuremberg 10 Points
- Consent must be voluntary
- Possibility of important results, with no other means to get information
- Trial must be justifiably based on past knowledge
- Avoid all unnecessary physical and mental suffering
- No trial con be conducted where reason to believe that death or disabling injury will occur
- Trial must be of more benefit than risk
- Provisions must be made to protect patients from injury or death
- Trial conducted by scientifically qualified persons
- Right of patient to withdraw from study
- Doctor must discontinue trial if new information suggests probable cause that trial could result in injury, disability, or death
What led to the creation of the Belmont Report?
1974 National Research Act
- Created the Nat Com for the Protection of Human Subjects of Biomed and Beh Research
- Group was formed to write the basic ethical principles for research in the US
- In response to the Tuskegee Syphilis Study
The Belmont Report
Ethical principles and guidelines for the protection of human subjects.
Named after Smithsonian Institution’s Belmont Conference Center where meetings were held to discuss the report.
Three Fundamental Principles:
- Respect for Persons
- Beneficence
- Justice
Respect for Persons
Autonomy of individuals
persons with diminished autonomy are entitled to protection
Beneficence
Do no harm
Maximize the benefit and minimize the risks
Justice
Benefits and risks must be distributed equally (between different subjects and within subject)
Declaration of Helenski (1964)
Developed by the World Medical Association
Outlines the Ethical Principles of Medical Research
Basic Principles:
- Doctor’s duty to protect life, health, privacy, and dignity of patient
- Research protocol must be reviewed by an independent committee (IRB/IEC)
- Benefit>Risk; study must be stopped if risks outweigh benefits
- Patients must volunteer for research and give consent
- Assent must be obtained from minors, if capable assent
The Belmont Report identified these two distinct things for IRB review:
Clinical Practice-
Interventions designed solely to enhance the well being of the individual and that have a reasonable expectation of success
Research-
Activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalized knowledge
Full Board IRB
More than minimal risk
Not covered under other categories
Collection of heart tissue at time of surgical repair for transciptome analysis
Intervention with phys/emo discomfort or sensitive data
Expedited IRB
Not greater than minimal risk
Fits one of 9 expedited categories
Collection of buccal cells (spit) for DNA analysis
Noninvasive biospecimen collection
Identifiable past research
Exempt IRB
Less than minimal risk
Fits one of 6 exempt categories
Searching deidentified medical records for post op outcomes
Anonymous surveys
Compassionate approval
Emergency approval for use of a test article
Eg- dying patient and new drug
IRB must be informed within 5 days of occurence
