Chapter 23

Question 1

What 3 documents have influenced the research laws, policies, and regulations in countries across the globe?

Answer 1

1) Nuremburg Code (consent for experiment human trials)
2) Declaration of Helsinki (guidelines for human trials)
3) Belmont report (Common rule) (protection of human participants)

Question 2

What are the 3 core principles of biomedical research ethics?

Answer 2

1) Respect for persons
2) Beneficence
2) Disributive justice

Question 3

How can you minimize harm in a study?

Answer 3

1) Discontinuation of a study

2) Provide counseling services

Question 4

True or false:

The principle of beneficence requires monetary compensation to be offered

Answer 4

False; the innate reward of contributing to science is a sufficient benefit.

Question 5

Monetary benefits can be given under the principle of ___.

Answer 5

Nonmaleficence (participating shouod not he a burden; “Do no harm”)

Question 6

What are the eight Central consideration and research ethics?

Answer 6

1) Contribution
2) Compensation
3) Consent
4) Confidentiality
5) Community
6) Conflicts of interest
7) Collaborators
8) Committees

Question 7

When is the principle of voluntariness violated?

Answer 7

When an individual feels coerced into participation

Question 8

Coercion includes:

Answer 8

Social pressure, requests from authority figures, or incentives that make it difficult for an individual not to agree to enroll in a study

Question 9

How can we minimize the risk of coercion?

Answer 9

By being very transparent about what participants will gain and not gain from participation in a research study.

Question 10

What are informed consent statements?

Answer 10

They provide essential information about research projects to potential research participants so that they can make a thoughtful decision about whether to enroll in a study

Question 11

The informed consent statement must use:

Answer 11

Clear simple language to describe the study aims, procedures and expectations of participants, and the benefits and risks of participation.

Question 12

The informed consent statement should emphasize that

Answer 12

Participation is voluntary and they can withdraw from the study at any time without penalty.

Question 13

What are the key components of an informed consent statement?

Answer 13

1) Definition of research
2) Explanation of purpose
3) Why they were chosen as participants & how many
4) Description of the procedures and duration
5) Description of benefits
6) Description of risks
7) Description of steps taken to maintain confidentiality
8) Statement that participation is voluntary and participant may withdraw with no penalty
9) Description for the process of withdrawing from the study
10) Contact information for the researchers
11) Space for the participant’s signature

Question 14

True or false:

The goal of the informed consent process is to acquire signatures from potential participants.

Answer 14

False; The goal is to ensure that participants truly understand the research process.

Question 15

What are the steps of the informed consent process?

Answer 15

1) Reading the informed consent statement aloud to a potential participant or along the individual to read a copy of the statement
2) Allowing adequate time for the potential participant to consider whether he or she wants to participate
3) Answering any questions
4) Asking whether the individual wants to participate in the study and is willing to sign an informed consent form

Question 16

True or false:

Acquiring a signature is the end of the informed consent process

Answer 16

False; the lines of communication must remain open during and after the data collection process.

Question 17

What is the goal of the informed consent process?

Answer 17

Understood consent

Question 18

When is consent not required?

Answer 18

In a limited number of observational studies, where participants have no reasonable expectation of privacy and will not interact with the researcher.

Question 19

Anonymous questionnaires do not require an intensive informed consent process when:

Answer 19

1) The responses cannot be linked to individuals
2) The survey instrument does not ask sensitive questions
3) The researchers will not physically examine individuals or collect biological specimens
4) The questionnaire is so short that describing the study will take longer than completing the questionnaire
form
{Completion of the survey form can sometimes be considered adequate proof of willingness to participate.}
5) There are no foreseeable risks to participants

Question 20

When is oral consent (verbal consent) an appropriate alternative to written consent?

Answer 20

When it is deemed inappropriate to ask people who cannot read a document to sign it. This must be witnessed by an independent third person and recorded.

Question 21

What is privacy?

Answer 21

The assurance that individuals get to choose what information they reveal about themselves

Question 22

What us confidentiality?

Answer 22

The protection of personal information provided to researchers

Question 23

What kind of survey does not need any personally identifiable information?

Answer 23

Cross-sectional surveys.

Question 24

When can a waiver of the need to document consent be requested? (ONLY written documentation)

Answer 24

When written documentation of consent is not acceptable because participants can be harmed by being linked to the study

Question 25

What is a certificate of confidentiality?

Answer 25

Protects the identity of participants from being subject to court orders and other legal demands for information.

Question 26

Who can faciliate communication between the community and the research team?

Answer 26

A local advisory board

Question 27

True or false:

Both the legal representative’s consent and The potential participant should assent to participation.

Answer 27

True

Question 28

Everyone who will be in direct contact with research participants and/or their personal data should complete ___.

Answer 28

Formal research ethics training

Question 29

What are responsible conduct of research (RCR) training programs?

Answer 29

They spell out expectations and procedures for disclosing conflicts of interest, avoiding research misconduct, reporting research ethics or personnel violations, and otherwise exhibiting professionalism.