Studies in which the subject can be expected to receive a potentially beneficial treatment.
Studies that are carried out for the purpose of generating knowledge. They are not expected to benefit the research subject, but may lead to improved treatment in the future.
The Declaration of Helsinki expanded the principles of the Nuremberg Code to differentiate therapeutic research from nontherapeutic research.
Requires informed consent for ethical research, while allowing for surrogate consent when the prospective research subject is incompetent, physically or mentally incapable of providing consent.
A basic principle of ethics stating that individuals should be treated autonomously, as capable of making their own decisions. Persons with limited autonomy or who are not capable of making their own decisions should be protected.
Respect for persons
Groups of people with diminshed autonomy who cannot participate fully in the consent process. Such groups may include children, individuals with cognitive disorders, prisoners, and pregnant women.
What did the passing of the National Research Act of 1974 result in?
The formation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Published in 1978 and has become the cornerstone statement of ethical principles on which regulations for protection of human subjects are based.
The Belmont Report
Three foundational ethical prinicples relevant to the ethics of human subjects are described in the Belmont Report
Respect for persons
A basic principle of ethics that states that persons should have their decisions respected, be protected from harm, and have steps taken to ensure their well-being
A basic principle of ethics that incorporates a participants right to fair treatment and fairness in distribution of benefit and burden.
A process of information exchange in which participants are provided understandable information needed to make a participation decision, full disclosure of the risks and benefits, and the assurance that withdrawal is possible at any time without consequences. This process begins with recruitment and ends with a signed agreement document.
Reporting as much information about the research as is known at the time without threatening the validity of the study. This allows the subject to make an informed decision as to whether to participate.
Conceived or formulated before an investigation
Derived from judicial decisions made during a trial and often applies rules from early English common law
Formulated by the federal and state governments and other regulatory agencies and obtains its authority from Congress.
Enacted, amended, and repealed by the legistalture
Torts are civil wrongs committed against individuals or their property
The board required in research instituions that reviews and oversees all research involving human subjects and ensures studies meet all federal regulation critieria, including ethical standards.
Institutional review board IRB
Full IRB review must be done under the following conditions:
Studies require direct access to participants
Human subjects are put at more than minimal risk
Protected health info is required
Fed funds are received
Publication is anticipated
Covers proposals that do not require review by the IRB
A review of study proposals that pose minimal risk to subjects; one or two IRB members participate
A review of study proposals that pose more than minimal risk to subjecst that do not qualify for exempt status, and in which the full IRB committee participates