Lecture 34 Flashcards
Define Bioethics
bioethics is the study of the ethical issues emerging from advances in biology and medicine
True or False: bioethics is focused primarily on ethical questions and has little to do with the moral choices that must also be made in various fields of science. explain.
False
bioethics is also concerned with the moral discernment / moral choices that must be made in medical and biological research
What is the declaration of Helsinki? list the 5 basic principles it declares.
an outline of the ethical principles of medical research created by the world medical association
doctor’s duty to protect life, health, privacy, and dignity of patients
research protocol must be reviewed by an independent committee
Benefit > risk ; stop study if risk surpasses benefit during the study
Patients must volunteer for research (consent)
Assent must be obtained for minors
What lead to the creation of the Belmont report? what is the importance of the Belmont report?
The Tuskeegee syphilis study
it was basically created in order to establish ethical principles in the USA
what does the Belmont report include? (state all 3 points and briefly define them)
Respect For Persons: autonomy (persons with diminished autonomy are entitled to protection)
Beneficence: Do no Harm (maximize benefit and minimize the risks)
Justice: Benefits and risks must be distributed equally among subjects
(IRB Definitions) Define Informed consent. include the 2 things that are necessary to fully achieve informed consent.
Consent to participate in a medical experiment by a subject after achieving an understanding of what is involved.
Participation must be completely voluntary and subjects must be able to choose to leave the study at any time
State the term that matches the following definition.
Any experience that sugguests a significant hazard, contraindication, side effect, or precaution that develops during a clinical trial (include the acronym)
Serious Adverse Event (SAE)
what questions does the IRB ask prior to approving research protocols? (6 of them)
Does the proposed research seem scientifically sound?
Has it received prior scientific review?
Are potential risks clearly presented?
Are the research personnel adequately qualified and experienced to conduct this research project?
Are the facilities adequate to complete the study procedures?
Is confidentiality of data and participants provided for?
What happened during the Willowbrook study?
a New York institution intentionally infected mentally ill children with hepatitis in order to study the course of the disease.
The children’s parents consented to this study, however the were blackmailed saying “if you do not consent for your child’s participation, then your child will not be treated in this hospital”
What happened during the Willowbrook study?
a New York institution intentionally infected mentally ill children with hepatitis in order to study the course of the disease.
The children’s parents consented to this study, however the were blackmailed saying “if you do not consent for your child’s participation, then your child will not be treated in this hospital”
State the full name of the ORI and their main purpose. who created the ORI?
Office of Research Integrity
to prevent research misconduct
NIH created the ORI
State the full name of the ORI and their main purpose. who created the ORI?
Office of Research Integrity
to prevent research misconduct
NIH created the ORI
State the 3 levels of IRB Review and describe them
Full Board: research with more than “minimal risk”, involving physical or emotional discomfort, and/or sensitive data (pt identifiers)
Expedited: not greater than “minimal risk” and fits one of the 9 categories for expedited review
Exempt: less than “minimal risk” and fits one of the 6 categories for exempt review
State the 3 levels of IRB Review and describe them
Full Board: research with more than “minimal risk”, involving physical or emotional discomfort, and/or sensitive data (pt identifiers)
Expedited: not greater than “minimal risk” and fits one of the 9 categories for expedited review
Exempt: less than “minimal risk” and fits one of the 6 categories for exempt review
What happened with the Havasupai genetic study?
The study was being conducted on a native american community from the grand canyon, at Arizona state university. The study had originally acquired consent from the subjects to study a high rate of diabetes in the tribe members.
Blood samples from the diabetes study were then used to study other things (schizophrenia), WITHOUT consent and Carletta Tilousi sued Arizona state university for this misconduct.
