Bioethics

Question 1

What is bioethics?

Answer 1

• the study of the ethical issues emerging from advances in biology and medicine
• it’s also the moral discernment as it relates to medical policy and practice.

Question 2

What’s bioethics concerned with?

Answer 2

Bioethics are concerned with ethical questions that arise in the relationships among life sciences, biotechnology, medicine, politics, law and philosophy

Question 3

What is the IRB?

Answer 3

An independent body made up of medical, scientific, and non scientific members, whose responsibility it is to ensure the protection of the rights, safety and we’ll-being of human subjects involved in a trial by among other things.

Question 4

What’s research misconduct?

Answer 4

A fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results

Question 5

What’s informed consent?

Answer 5

Consent to participate in a medical experiment by a subject after achieving an understanding of what is involved.

It’s essential that participants understand participating in research is completely voluntary.

They can withdraw from the study at any time

Question 6

whats the Declaration of Helsinki?

Answer 6

• developed by The World Medical Association

- Outlines the Ethical Principles of Medical Research

Question 7

what are the basic principles of the Declaration of Helsinki?

Answer 7

• doctor’s duty to protect the life, health, privacy and dignity of patient
• research protocol must be reviewed by an independent committee (IRB)
• Benefit > Risk; study must be stopped if risks outweigh benefits
• patients must volunteer for research and give consent
• Assent must be obtained from minors, if capable of assent

Question 8

what is The Belmont Report? what are the 3 fundamental principles of it?

Answer 8

ethical principles and guidelines for the protection of human subjects

the three fundamental ethical principles are

• respect for persons
• beneficence
• justice

Question 9

what does “respect for persons” stand for?

Answer 9

• autonomy of individuals
• persons with diminished autonomy are entitled to protection
• treat everyone with respect regardless of their background

Question 10

what is beneficence?

Answer 10

• do no harm
• maximize the benefit and minimize the risk
• you have to have good reason to believe that the benefit will outweigh the risk

Question 11

what is Justice?

Answer 11

benefits and risks must be distributed equally

when you do clinical trials, whatever benefit comes from this trial, we must be able to distribute equally amongst everybody that is infected

Question 12

what are the levels of IRB review?

Answer 12

Full Board; Expedited; Exempt

Question 13

what renders Full Board review?

Answer 13

• more than “minimal risk” to subjects
• not covered under other review categories
• example: interventions involving physical or emotional discomfort or sensitive data

collection of heart tissue at the time of surgical repair for the purpose of transcriptome analysis

Question 14

what renders an Expedited review?

Answer 14

• not greater than minimal risk
• fits one of the 9 expedited review categories

Examples: collection of bio specimens by noninvasive means, Research with existing documents/ record collected for non-research purposes in which subjects are identifiable; collection of buccal cells (spit) for analysis of DNA

Question 15

what renders an Exempt review?

Answer 15

• Less than “minimal risk”
• fits one of the 6 exempt categories
• example: research with de-identified records, anonymous surveys; searching deidentified medical records for post op outcomes