Ethical Principals found in The Nuremburg Code, Belmont Report & Declaration of Helsinki

Question 1

10 ethical principals for human experimentation

Answer 1

Voluntary consent of the human subject is absolutely necessary ​

The experiment should yield useful results for the good of society​

The experiment should be designed and based on results of animal experimentation and/or knowledge of the natural history of the disease​

The experiment should avoid all unnecessary physical and mental suffering and/or injury ​

No experiment shall occur if death or disability is likely

The degree of risk should never exceed humanity​

Proper preparations should be made and adequate facilities provided to protect the subject from injury, disability or death​

The experiment should be conducted by qualified persons using the highest degree of skill and care throughout all stages​

The human subject should be at liberty to end their participation in the experiment if they reach a physical or mental state where continuation seems impossible to them ​

The scientist in charge must be prepared to terminate the experiment if believed it is likely to result in injury, disability or death to the subject

Question 2

Informed Consent: Participants must give voluntary, informed consent without coercion​

Beneficence and Non-Maleficence: Research should benefit society and avoid harm​

Scientific Basis: Experiments should be based on sound scientific knowledge​

Avoidance of Unnecessary Suffering: Researchers must minimize suffering and risk​

No Experiment Without Prior Animal Testing: Human experiments should follow animal testing​

Avoidance of Random of Unnecessary Harm: Risks should be justified by potential benefits​

Qualified Researchers: Only qualified scientists should conduct experiments​

Freedom to Withdraw: Participants can withdraw at any time​

Researcher Responsibility: Researchers are accountable for ethical conduct​

Human Rights Supersede State Interests: Individual rights take precedence over state rights

Answer 2

Nuremberg Code Summarized

Question 3

Developed in 1964 by the World Medical Association (WMA)​

Set of ethical principals for medical research involving human subjects​

Addressed primarily to physicians ​

Amended multiple times since its creation

Answer 3

Declaration of Helsinki

Question 4

Respect for the Individual​

Participant Welfare​

Ethical Consideration Over Laws​

Special Vigilance​

a. Vulnerable individuals and groups require special protection​

Thorough Scientific Knowledge​

Ethical Oversight

Answer 4

Declaration of Helsinki Summarized

Question 5

Created in 1979 to assure that research involving human subjects would be carried out in an ethical manner ​

Ethical principals and guidelines to protect human subjects ​

Created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Answer 5

The Belmont Report

Question 6

Basic Ethical Principals ​

Respect for persons ​

Beneficence ​

Justice

Answer 6

Basic Ethical Principals ​of the Belmont Report

Question 7

Practice

Answer 7

Refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success

Question 8

Research

Answer 8

Designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge. This is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach an objective

Question 9

Ensure the study is approved by an IRB​

Obtain informed consent from the patient ​

Ensure the patient understands the full extent of the experiment​

Ensure the patient wasn’t coerced into doing the experiment via threatening or bullying ​

Be careful of other effects of the clinical trial that were not mentioned, and report it to the proper study coordinator if discovered ​

Support the privacy of the patient’s identity, and their motivation to join/decline the experiment ​

Ensure that all patients at least get the minimal care needed for their condition

Answer 9

Brief summary of the Belmont Report:​

Question 10

Belmont Report Question 2: Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects?​

A) Ensuring that confidentiality is maintained​

B) Determining that the study has maximized benefits and minimized risks​

C) Ensuring that the selection of subjects includes people from all segments of the population​

D) Providing detailed information about the study and obtaining the subject’s consent to participate

Answer 10

b) Determining that the study has maximized benefits and minimized risks

Question 11

Which of the following best describes the principle of informed consent as described in the Belmont Report?

A) Comprehension, conflicts of interest, risk/benefit ratio​

B) Voluntariness, risk/benefit assessment, selection of subjects​

C) Risk/benefit assessment, justification of research, comprehension​

D) Information, comprehension, voluntariness

Answer 11

d) Information, comprehension, voluntariness

Question 12

The statement “In research on man, the interest of science and society should never take precedence over considerations related to the well-being of the subject” can be found in:​

The Belmont Report ​

The Tuskegee Report ​

The Nuremburg Code​

The Declaration of Helsinki​

None

Answer 12

The Declaration of Helsinki​

​Study Declaration of Helsinki, Section III (4)​

III. Non-Therapeutic Biomedical Research Involving Human Subjects (Non-Clinical Biomedical Research)​

​
4. In research on man, the interest of science and society should never take precedence over considerations related.

Question 13

The Belmont Report’s definition “an activity designed to test hypothesis, permit a conclusion to be drawn, and thereby develop or contribute to generalized knowledge” refers to:​

Practice​

Research​

Clinical Trial ​

Procedure ​

Experiment

Answer 13

Research

Study The Belmont Report: ​

Ethical Principles and Guidelines for the protection of human subjects of research​

(2) By contrast, the term “research” designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.

Question 14

FDA Regulations on Human Subject Research​ Part 50 is for what? and what subparts?

Answer 14

Protection of human subjects​

Subpart A – Definitions​

Subpart B – Informed Consent ​

Subpart D – Protecting Children in Research

Question 15

FDA Regulations on Human Subject Research​ Part 56

Answer 15

Institutional Review Board

Question 16

FDA Regulations on Human Subject Research​ Part 312

Answer 16

Investigational New Drug App.

Question 17

FDA Regulations on Human Subject Research​ Part 812

Answer 17

Investigational Device Exempt

Question 18

FDA Regulations on Human Subject Research​ Part 11

Answer 18

Part 11 – Electronic Records, signatures

Question 19

21 CFR Part 50, Protection of human subjects​ Subpart A

Answer 19

Subpart A: General Provisions (FDA and Food, Drug and Cosmetic Act)

Question 20

21 CFR Part 50, Protection of human subjects​ Subpart B

Answer 20

Subpart B: Informed Consent of Human Subjects

Question 21

21 CFR Part 50, Protection of human subjects​ Subpart C

Answer 21

Reserved

Question 22

21 CFR Part 50, Protection of human subjects​ Subpart D

Answer 22

Additional Safeguards for Children in Clinical Investigations

Question 23

A Short Form Informed consent is a statement not to exceed one page agreeing to participate in a clinical trial.​

True​

False ​

Answer 23

21CFR50 does not indicate length of the short form ​

Question 24

Identify the manner in which the informed consent form (ICF) can be presented to the subject.​

ICF can be read to the subject or the subjects LAR​

ICF is handed to the subject to read and sign on their own in private ​

ICF is delivered via mail ​

ICF must be delivered electronically to the subject or LAR

Answer 24

a) ICF can be read to the subject or the subjects LAR​

​Study 21CFR 50.27(1).​

(a) Except as provided in 56.109(c), informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative at the time of consent. A copy shall be given to the person signing the form.​

(b) Except as provided in 56.109(c), the consent form may be either of the following:​

(1) A written consent document that embodies the elements of informed consent required by 50.25. This form may be read to the subject or the subject’s legally authorized representative, but, in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed.

Question 25

When using the short form informed consent, the witness and the person obtaining the subject’s consent must sign a copy of oral written summary.​

True ​

False

Answer 25

a) True​

Study 21 CFR 50.27 (2)​

(2) A short form written consent document stating that the elements of informed consent required by 50.25 have been presented orally to the subject or the subject’s legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining the consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative in addition to a copy of the short form.

Question 26

Subjects must be reconsented when: ​

The clinical trial reaches 6 months and is still in progress​

Changes in the research affects the subject’s treatment ​

Changes in administrative staff occurs​

Any protocol change occurs ​

The subjects misses a scheduled visit

Answer 26

b) Changes in the research affects the subject’s treatment

Question 27

During the clinical trial, regulations require that a subject be given the right to:​

Leave the facility ​

Withdraw at any time​

Get financial compensation​

Speak to a Sponsor’s attorney​

All of the above

Answer 27

b) Withdraw at any time

Question 28

Which signatures are required by FDA regulation to be on the consent form?​

The Investigator​

The Subject​

The Investigator and the Subject​

The Subject and a witness ​

The Investigator, the Subject and a witness

Answer 28

b) The Subject

Question 29

In accordance with regulations, before implementation, the informed consent document must be approved by the:​

Sponsor ​

Investigator​

IRB/IEC​

B and C only ​

A, B and C

Answer 29

IRB/IEC

Question 30

The subject must sign the short form written informed consent and the written oral summary.​

True ​

False

Answer 30

b) False ​

​

Question 31

When appropriate, an additional element of the informed consent may include a statement which states “additional costs to the subject may result from participation in the research”.

True ​

False

Answer 31

True

Question 32

FDA Form 1572

Answer 32

Statement of the Investigator

Question 33

FDA Form 3455

Answer 33

Disclosure – Financial Interests and Arrangement of Clinical Investigators ​

Question 34

FDA Form 3500:

Answer 34

For Voluntary Reporting of Adverse Events and Product Problems

Question 35

FDA Form 3500A:

Answer 35

For Use by User-Facilities, Distributors, and Manufactures for MAndatory Reporting

Question 36

FDA Form 3454:

Answer 36

Certification – Financial Interests and Arrangements of Clinical Investigators ​

Question 37

FDA Form 482:

Answer 37

Notice of Inspection

Question 38

FDA Form 483:

Answer 38

Inspectional Observations

Question 39

ICH

Answer 39

International Council for Harmonisation