1. Ethical Principles and Relevant Regulations and Guidelines

Question 1

4 principles of biomedical ethics

Answer 1

Autonomy
Nonmaleficence
Beneficence
Justice

Question 2

2 principles of autonomy

Answer 2

1. Right to choose (requires decision making capacity, lack of capacity should be proven not assumed)
2. Right to accept or decline information (disclosure, understanding, voluntariness)

Question 3

3 principles of beneficence

Answer 3

1. To prevent harm
2. To remove harm
3. To do or promote good

Question 4

5 principles of justice

Answer 4

Fairness in distribution

1. To each person an equal share
2. To each person according to individual need
3. To each person according to individual effort
4. To each person according to contribution
5. To each person according to merit

Question 5

Name 3 landmark documents

Answer 5

1. Nuremberg code of 1947
2. Declaration of Helsinki
3. Belmont Report

Question 6

What is the Belmont Report?

Answer 6

Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, DHEW April 1979

Question 7

What are the 3 principles of the Belmont Report and their associated requirement?

Answer 7

1. Respect for persons - informed consent
2. Beneficence - Risk/Benefit ratio
3. Justice - subject selection

Question 8

What is the Declaration of Helsinki?

Answer 8

“Ethical principles for medical research involving human subjects”

Added major influential points to the Nuremberg Code.

Guidance to medical professions in human research around the world.

Original 1964, last revised 2013

Question 9

CIOMS guidelines definition of health related research

Answer 9

Activities designed to develop or contribute to generalizable health knowledge within the more classic realm of research with humans, such as observational research, clinical trials, biobanking, and epidemiological studies.

25 guidelines

Question 10

Definition of “research” by Tri-Council statement

Answer 10

An undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation

Question 11

Tri-Council statement principles

Answer 11

1. Respect for persons
2. Concern for welfare
3. Justice

Question 12

General definition of research

Answer 12

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge

Question 13

General definition of human subjects

Answer 13

A living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private data information

Question 14

Definition of minimal risk

Answer 14

The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests

Question 15

Definition of a legally authorized representative

Answer 15

And individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure involved in the research