Chapter 5

Question 1

What is an ethical dilemma?

Answer 1

When two outcomes of a situation both have the potential to violate ethical principles, and both may have merit.

Question 2

What guides Ethical Practice?

Answer 2

Ethical principles

Question 3

What are Ethical Principles?

Answer 3

Focuses on ethical principles from the Belmont Report for research and will not encompass all ethical principles.

Question 4

What Ethical Principles should a research study have?

Answer 4

1) Beneficence
2) Respect for Human Dignity
- Self-determination (Autonomy)
- Full disclosure (Informed consent)
3) Justice

Question 5

For a Research study to have human participants, all forms of ____ must be negated or minimized as much as possible.

Answer 5

Harm

Harm can include:
physical, emotional, spiritual, social, or financial stress

Question 6

Beneficence & Research:

Answer 6

A study should aim to benefit or improve something for the participants or others.

Question 7

Justice & Research:

Answer 7

A subject’s right to:
1) privacy
AND
2) fair treatment

Question 8

Participants Right to Privacy:

Answer 8

HIPAA
Personal information about participants has to be kept private
Researchers should not gather any information they do not need for a study’s purpose.

Question 9

What does Fair Treatment mean?

Answer 9

Not selected for a vulnerability (prisoners/elderly)
Diversity is ensured in the study 
Respecting the beliefs of participants, 
RIGHT TO REFUSAL without prejudice
Acting with courtesy at all times.

Question 10

Respect for Human Dignity & Research:

Answer 10

1) Self-determination

2) Full-disclosure

Question 11

What is the Right to Self-determination?

Answer 11

Right to participate
Right to refuse or drop-out
-be free from prejudice if they refuse or drop out of a study.

Question 12

What is an issue related to Self-determination?

Answer 12

Coercion

A participant can’t be forced with threats of negative actions or given excessive rewards for participating.

Question 13

What is Full-disclosure?

Answer 13

Means a participant has the right to:

1) Be fully informed of a study’s purpose
2) Right to refuse
3) Right to drop from the study if they wish.

Question 14

What is an ethical issue related to Full-disclosure?

Answer 14

Withholding any information regarding the study’s purpose to avoid subjects potentially refusing to participate

Question 15

________ and _______ relate to the right to informed consent.

Answer 15

1) Self-determination

2) Full disclosure

Question 16

What is included in Informed Consent?

Answer 16

1) A full understanding of the study’s purpose
2) Understand & Demonstrate the Risks of the study
3) Ensure privacy and confidentiality
4) Must be able to Voluntary agree to Participation

Question 17

What is “Implied Consent?”

Answer 17

When an individual completes an action of their own accord.
-Researchers still have to respect the right to anonymity and confidentiality with implied consent.

Example:
Giving a questionnaire to someone and them filling it out and turning it back in.

Question 18

What are some possible Risks from a study that could be measured?

Answer 18

Physical harm, physical discomfort, emotional distress, social risks, loss of privacy, loss of time, and monetary costs.

Question 19

What is Minimal Risk?

Answer 19

A risk expected to be no greater than those ordinarily encountered in daily life or during routine procedures

Question 20

It is difficult to say a study would have Minimal Risks unless _______.

Answer 20

the patients were already in a particular environment for care.

Question 21

What are some techniques for working with vulnerable populations?

Answer 21

1) Debriefing
2) Referral
3) Using the correct party to get consent from

Question 22

When does debriefing occur?

Answer 22

Occurs after data collection and allows participants to ask questions or share concerns.

Question 23

When might we make a referral?

Answer 23

If a participant needs one for a particular service, the researcher should facilitate that process.

Question 24

Who CAN independently give consent?

Answer 24

Requires being older than 18 and neurologically intact and oriented

Question 25

Who can NOT independently give consent?

Answer 25

Required to get consent from a legal guardian

1) Children (<18 yrs)
- if <7 yrs, need to also assent/agree to participating
2) Mentally or emotionally disabled people
3) Severely ill or physically disabled people

Question 26

What emphasis would we include for prisoners?

Answer 26

Participation is Voluntary and is upheld

THE RIGHT TO REFUSE WITHOUT CONSEQUENCES

Question 27

What emphasis would we include for the terminally ill?

Answer 27

1) the research will most likely not benefit the participant 2) Ensuring minimal risk is important since the benefits for the participant are small to none

Question 28

What emphasis would we include for pregnant persons?

Answer 28

research needs to safeguard both the woman and fetus

Question 29

What method is best and the most common to ensure a study is ethical?

Answer 29

Review by an Institutional Review Board (IRB)

A research proposal is sent to the IRB for approval before the study is conducted.
This ensures that the researchers’ bias does not influence the ethics of the study.

Question 30

Guidelines for critiquing the ethical aspects of a study:

Answer 30

1) Check for approval from an IRB
2) See if the study describes harm or measures to prevent harm
3) Do benefits outweigh risks?
4) Does the study discuss informed or voluntary participation?
5) Is privacy or confidentiality addressed?
6) If vulnerable groups were involved, is it addressed how they were protected?
7) Were any demographic groups removed from the study without reason?

Question 31

What does IRB approval suggest?

Answer 31

That the committee thoroughly reviewed the study for ethical concerns and accounted for them.