Foundations
Established in 1947, this outlined the following rules for the protection of human subjects:
1. Voluntary consent to participate in a trial
2. The right to know what will be done in the trial
3. The right to stop participating in a trial.
4. Must have the potential for benefit to the subject or society, and the risks involved must be proportionate to the potential benefit.
What is The Nuremberg Code
These clinical trials are designed and directed by the person with the new idea or theory. They are usually designed for limited numbers of subjects, and can be performed at the Principal Investigator’s (PI) institution. Data is collected and statistical analyses performed by the PI.
What are Investigator Initiated Trials
This agency oversees all medical trials of drugs and devices trying to gain approval for commercial use
What is the Food and Drug Administration
A set of ethical principles regarding human experimentation.
Fundamental principles include:
Respect for the individual
Their right to self-determination
The right to make informed decisions regarding participation in research, both initially and during the course of the research.
The investigator's duty is solely to the patient.
The subject's welfare must always take precedence over the interests of science and society.
What is the Declaration of Helsinki
This clinical trial phase helps define a Maximum Tolerated Dose (MTD)
What is a Phase 1 trial
A group that is formally designated to approve, monitor, and review biomedical and behavioral research involving human subjects
What is the Institutional Review Board
This lists the ethical principals to be adhered to in the conduct of clinical trials:
Beneficence (does the study benefit outweigh the potential risks involved),
Respect for persons (voluntary participation and informed consent), and
Justice (no discrimination in who can be treated or how treated on clinical trials).
What is the Belmont Report
Trials where multiple treatment Arms are involved to avoid bias - those involved in the direct patient care do not know which therapy a subject is receiving
What are Blinded Trials
An independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing
What are Data and Safety Monitoring Boards (DSMB)
The result of this unethical clinical study led to the creation of the Belmont Report and the establishment of the Office for Human Research Protections
What is the Tuskegee Syphilis Experiment
Outcome measures referring to occurrence of disease, symptom, sign or laboratory abnormality constituting a target outcome in clinical research trials.
Independent agencies or companies that provide support and manage clinical trials to prevent any bias in the results.
What are Contract Research Organizations
Passed in 1938, this gave the FDA authority to oversee the safety of food, drugs, medical devices, and cosmetics.
What is the Federal Food, Drug, and Cosmetic Act
In this kind of study, all patients are given both placebo and active doses in alternating periods.
What is a Double Dummy Study Design
The mission of this agency is to advance public health through guidance on health research including ethics, medical product development and safety.
What is the Council for International Organizations of Medical Sciences (CIOMS)