Bittel: Bioethics Flashcards
What is bioethics
The study of ethical issues emerging from advances in biology and medicine
Study of our moral choices relating to medical and biological research
What is the IRB
Institutional review board
Independent body made up of medical, scientific and non scientific members, whos responisbility it is to ensure the protection of the rights, safety and well-being of human subjects
Research misconduct
Fabrication, falsification or plagiarism in proposing, performing or reviewing research
Serious adverse advents
Any experience that suggests a significant hazard, contraindication, side effect or precaution that develops during a clinical trial
Dr. James Lind
Published first widely known controlled clinical trials- treatment of scurvy
Dr. John Haygarth
First demonstration of placebo effect with metal tractors
Biologics control act
Regulated production of vaccines and antitoxins
Pure food and drug act
Required medications to report ingredients
Therapeutics trials committee
Considered applications by companies for trials of new products
Tuskegee syphilis study
Kids treated with something that they knew would not treat syphilis to see how disease progressed
Led to the belmont report
Declaration of Helsinski
Developed by The World Medical Association
Outlines ethical principles of medical research
(benefit>risk, patients must volunteer, research protocol must be reviewed by independent committee)
National research act
Created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research- A group that was tasked with writing basic ethical principles for research in the united states
This group created the Belmont report in response to the Tuskegee syphilis study
The Belmont Report
Ethical principles and guidelines for the protection of human subjects Identified 3 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 benefit, minimize risk
Justice
Benefits and risks must be distributed equally
Informed consent
Consent to participate in medical experiment after achieving and understanding of what is involved. Participation is voluntary, subjects can withdrawal at any point
1987 IND revisions
Allowed patients with terminal illnesses and no alternative therapies, access to experimental drugs
Goals of HIPAA
Make health insurance portable anywhere in country
Make patient information private and secure
Reduce health care fraud and abuse
Human subjects
Legally defined term for living persons about whom an investigator obtains specimans or data through direct interaction or through identifiable, private information
NIH will consider your research to involve human subjects unless
You are not collecting samples by interacting or intervening with living people
None of the investigators can identify subjects through coded private information or specimens
Investigator initiated clinical trial
A trial run by a clinical sponsor but without a company taking the role as the sponsor
IRB compassionate approval
Emergency approval for use of a test drug
Informed consent
Consent is written document that must be explained to patient and signed by them
Includes written/verbal explanation, questions, info on risk/benefit
Cannot be done over phone, but can send written document to legal representative and consent by phone
Questions asked by IRB
Does proposed research seem scientifically sound?
Has it received prior scientific review?
Are potential risks clearly presented?
Are research personnel qualified to conduct this study?
Are facilities adequate for study?
Is confidentiality of data/participants provided?
