Bittel: Bioethics

Question 1

What is bioethics

Answer 1

The study of ethical issues emerging from advances in biology and medicine
Study of our moral choices relating to medical and biological research

Question 2

What is the IRB

Answer 2

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

Question 3

Research misconduct

Answer 3

Fabrication, falsification or plagiarism in proposing, performing or reviewing research

Question 4

Serious adverse advents

Answer 4

Any experience that suggests a significant hazard, contraindication, side effect or precaution that develops during a clinical trial

Question 5

Dr. James Lind

Answer 5

Published first widely known controlled clinical trials- treatment of scurvy

Question 6

Dr. John Haygarth

Answer 6

First demonstration of placebo effect with metal tractors

Question 7

Biologics control act

Answer 7

Regulated production of vaccines and antitoxins

Question 8

Pure food and drug act

Answer 8

Required medications to report ingredients

Question 9

Therapeutics trials committee

Answer 9

Considered applications by companies for trials of new products

Question 10

Tuskegee syphilis study

Answer 10

Kids treated with something that they knew would not treat syphilis to see how disease progressed
Led to the belmont report

Question 11

Declaration of Helsinski

Answer 11

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)

Question 12

National research act

Answer 12

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

Question 13

The Belmont Report

Answer 13

Ethical principles and guidelines for the protection of human subjects
Identified 3 fundamental principles
-Respect for persons
-Beneficence
-Justice

Question 14

Respect for persons

Answer 14

Autonomy of individuals

Persons with diminished autonomy are entitled to protection

Question 15

Beneficence

Answer 15

Do no harm

Maximize benefit, minimize risk

Question 16

Justice

Answer 16

Benefits and risks must be distributed equally

Question 17

Informed consent

Answer 17

Consent to participate in medical experiment after achieving and understanding of what is involved. Participation is voluntary, subjects can withdrawal at any point

Question 18

1987 IND revisions

Answer 18

Allowed patients with terminal illnesses and no alternative therapies, access to experimental drugs

Question 19

Goals of HIPAA

Answer 19

Make health insurance portable anywhere in country
Make patient information private and secure
Reduce health care fraud and abuse

Question 20

Human subjects

Answer 20

Legally defined term for living persons about whom an investigator obtains specimans or data through direct interaction or through identifiable, private information

Question 21

NIH will consider your research to involve human subjects unless

Answer 21

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

Question 22

Investigator initiated clinical trial

Answer 22

A trial run by a clinical sponsor but without a company taking the role as the sponsor

Question 23

IRB compassionate approval

Answer 23

Emergency approval for use of a test drug

Question 24

Informed consent

Answer 24

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

Question 25

Questions asked by IRB

Answer 25

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?