Chapter 5 Flashcards
What is an ethical dilemma?
When two outcomes of a situation both have the potential to violate ethical principles, and both may have merit.
What guides Ethical Practice?
Ethical principles
What are Ethical Principles?
Focuses on ethical principles from the Belmont Report for research and will not encompass all ethical principles.
What Ethical Principles should a research study have?
1) Beneficence
2) Respect for Human Dignity
- Self-determination (Autonomy)
- Full disclosure (Informed consent)
3) Justice
For a Research study to have human participants, all forms of ____ must be negated or minimized as much as possible.
Harm
Harm can include:
physical, emotional, spiritual, social, or financial stress
Beneficence & Research:
A study should aim to benefit or improve something for the participants or others.
Justice & Research:
A subject’s right to:
1) privacy
AND
2) fair treatment
Participants Right to Privacy:
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.
What does Fair Treatment mean?
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.
Respect for Human Dignity & Research:
1) Self-determination
2) Full-disclosure
What is the Right to Self-determination?
Right to participate
Right to refuse or drop-out
-be free from prejudice if they refuse or drop out of a study.
What is an issue related to Self-determination?
Coercion
A participant can’t be forced with threats of negative actions or given excessive rewards for participating.
What is Full-disclosure?
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.
What is an ethical issue related to Full-disclosure?
Withholding any information regarding the study’s purpose to avoid subjects potentially refusing to participate
________ and _______ relate to the right to informed consent.
1) Self-determination
2) Full disclosure
What is included in Informed Consent?
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
What is “Implied Consent?”
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.
What are some possible Risks from a study that could be measured?
Physical harm, physical discomfort, emotional distress, social risks, loss of privacy, loss of time, and monetary costs.
What is Minimal Risk?
A risk expected to be no greater than those ordinarily encountered in daily life or during routine procedures
It is difficult to say a study would have Minimal Risks unless _______.
the patients were already in a particular environment for care.
What are some techniques for working with vulnerable populations?
1) Debriefing
2) Referral
3) Using the correct party to get consent from
When does debriefing occur?
Occurs after data collection and allows participants to ask questions or share concerns.
When might we make a referral?
If a participant needs one for a particular service, the researcher should facilitate that process.
Who CAN independently give consent?
Requires being older than 18 and neurologically intact and oriented
Who can NOT independently give consent?
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
What emphasis would we include for prisoners?
Participation is Voluntary and is upheld
THE RIGHT TO REFUSE WITHOUT CONSEQUENCES
What emphasis would we include for the terminally ill?
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
What emphasis would we include for pregnant persons?
research needs to safeguard both the woman and fetus
What method is best and the most common to ensure a study is ethical?
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.
Guidelines for critiquing the ethical aspects of a study:
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?
What does IRB approval suggest?
That the committee thoroughly reviewed the study for ethical concerns and accounted for them.
