Attending to Ethics in Research

Question 1

Nazi medical experiments

Answer 1

-Nazi medical experiments of 1930s-40s are most famous example of recent disregard for ethics
-Used prisoners of war and racial enemies in medical experiments
-Exposed people to harm and subjects could not refuse participation

Question 2

Tuskegee syphilis study

Answer 2

-Investigated effects of syphilis among 400 poor African American men
-Tx was withheld to study course of disease
-Doctor inoculated prisoners in Guatemala w/ syphilis

Question 3

Codes of ethics

Answer 3

-Nuremberg Code was developed in 1949 in response to Nazi atrocities
-Declaration of Helsinki was developed afterward

Question 4

Government regulation for protecting study participants

Answer 4

-Important code of ethics adopted by National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
-The commission issues the Belmont Report in 1978, serving as a basis fo regulations affecting research sponsored by US government, including studies supported by NINR

Question 5

Ethical dilemmas in conducting research

Answer 5

-Research that violates ethical principles typically occurs because a researcher believes that knowledge is potentially beneficial in the long run
-Dilemmas may arise if nurse researchers face conflict-of-interest situations, in which their expected behaviors as nurses conflicts w/ standard research behavior

Question 6

Beneficence

Answer 6

-Imposes a duty on researchers to minimize harm and maximize benefits
-Human research should be intended to produce benefits for participants, or more typically, for others

Question 7

Beneficence: the right to freedom from harm and discomfort

Answer 7

-Obligation to prevent or minimize harm
-Participants must not be subjected to unnecessary risks of harm or discomfort
-Participation in research must be necessary for achieving societally important aims
-Harm and discomfort can be physical (injury), emotional (stress, social (loss of social support), or financial (expenses incurred)

Question 8

Beneficence: the right to protection from exploitation

Answer 8

-Involvement in a study should not place participants at a disadvantage
-Information they provide can’t be used against them
-Ex: people reporting using illegal drugs should not fear being reported for a crime
-Patients’ consent to participate in a study may result from their understanding of the researcher’s role as nurse, not as researcher
-Qualitative researchers are in a better position than quantitative researchers to do good bc of close relationship w/ participants

Question 9

Respect for human dignity

Answer 9

-Right to self-determination
-Right to full disclosure

Question 10

Respect for human dignity: right to self-determination

Answer 10

-Right to decide voluntarily whether to participate
-Right to ask questions, refuse answering questions, drop out of study at any point
-Freedom from coercion, or explicit/implicit threats of penalty from failing to participate in a study or excessive rewards from agreeing to participate

Question 11

Coercion

Answer 11

-Issue of coercion requires careful thought from researchers who are in a position of authority
-A generous monetary incentive or stipend to encourage low-income group might be considered mildly coercive

Question 12

The right to full disclosure

Answer 12

-Full disclosure means researcher has fully described study, right to refuse participation, and potential risks and benefits
-Covert data collection and deception

Question 13

Covert data collection

Answer 13

-Covert data collection (concealment) is collecting data without participants’ knowledge and w/o consent
-Used to obtain info out of worry if open disclosure would sway behavior of interest

Question 14

Deception

Answer 14

-Deliberately withholding info or providing participants w/ false information

Question 15

Justice

Answer 15

Participants’ right to fair tx and right to privacy

Question 16

Justice: right to fair tx

Answer 16

-Selection of participants should be based on research requirements and not on their vulnerabilities
-Researchers must treat participants who decline to participate in a non-prejudicial manner, honor all agreements made, show respect for beliefs of different backgrounds, and treat all respectfully

Question 17

Justice: the right to privacy

Answer 17

-Researchers should ensure their research is not more intrusive than it needs to be and that privacy is maintained
-Can expect that any data they provide will be kept in strict confidence
-Info abt ethical considerations is usually presented in method section of research report, often in subsection called “procedures”

Question 18

Risk/benefit assessment

Answer 18

-Consider how comfortable you would have felt being a study participants
-Sometimes risk are negligible
-Minimal risk

Question 19

Minimal risk

Answer 19

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

Question 20

Major potential benefits

Answer 20

-Access to beneficial intervention that might not be available
-Relief in being able to discuss situation w/ objective person
-Increased knowledge about themselves
-Escape from normal routine
-Satisfaction that info used can help others
-Direct gains thru stipends or incentives

Question 21

Major potential risks

Answer 21

-Physical harm, discomfort, fatigue, or boredom
-Emotional distress from self-disclosure, discomfort w/ strangers, embarrassment r/t questions being asked
-Social risks such as stigma, negative effects on personal relationship
-Loss of privacy and time
-Monetary costs (transportation, childcare, time lost from work)

Question 22

Informed consent

Answer 22

-Participants have adequate info about study, comprehend info, and can consent to decline willingly
-Consent form is signed
-Implied consent and process consent

Question 23

Implied consent

Answer 23

-Researcher assumes participant filling out a self-questionnaire implies consent to participate
-AKA data collection

Question 24

Process content

Answer 24

-Ongoing process in which consent is continuously renegotiated
-Includes repeated data collection

Question 25

Confidentiality procedures

Answer 25

-Right to expect data provided will be kept in strict confidence
-Right to privacy is protected thru confidentiality procedures

Question 26

Confidentiality procedures: anonymity

Answer 26

-Most secure means of protection
-Occurs when researcher cannot link participants to their data

Question 27

Confidentiality procedures: confidentiality in the absence of anonymity

Answer 27

-Promise of confidentiality is a pledge that any info participants provide will not be publicly reported
-Ensure breach of confidentiality will not occur
-Maintain identifying info in locked filed, substituting ID #s for participants’ names on records, reporting only aggregate data for groups of participants
-Anonymity is rarely possible in qualitative studies bc of rich descriptive info
-Can create tension between researchers and legal authorities, especially if participants engage in criminal activity

Question 28

Certificate of confidentiality

Answer 28

-Avoids forced disclosure info such as thru court order
-From NIH

Question 29

Debriefings and referrals

Answer 29

-Offer debriefing sessions following data collections so participants can ask questions or express concerns
-Researchers can demonstrate interest in participants by offering to share stud findings w/ them after data is analyzed
-May have to make referrals to appropriate health, social, or psychological services

Question 30

Tx of vulnerable groups

Answer 30

May be incapable of giving fully informed consent such as cognitively impaired person or may be at high risk of unintended side effects such as pregnant women

Question 31

Tx of vulnerable groups: children

Answer 31

-Don’t have competence to give informed consent
-Consent obtained from parents or guardian
-Obtain child’s assent if at least 7 years (affirmative agreement to participate)

Question 32

Tx of vulnerable groups: mentally or emotionally disabled people

Answer 32

-Cannot legally provide informed consent such as in a coma
-Obtain consent of legal guardian

Question 33

Tx of vulnerable groups: severely ill or physically disabled people

Answer 33

-Very ill or undergoing certain tx such as mechanical ventilation
-Necessary to assess ability to make reasoned decisions abt study participation

Question 34

Tx of vulnerable groups: the terminally ill

Answer 34

-Seldom benefit from research
-Assess risk/benefit ratio

Question 35

Tx of vulnerable groups: institutionalized people

Answer 35

-Prisoners might feel that their care would be jeopardized by failure to cooperate
-Researchers need to emphasize voluntary nature of participation

Question 36

Tx of vulnerable groups: pregnant women

Answer 36

-US gov issues additional requirements governing research w/ pregnant women and fetuses
-Requirements reflect a desire to safeguard both the pregnant woman, who may be at a heightened physical or psychological risk, and the fetus, who cannot give informed consent

Question 37

External reviews and protection of human rights

Answer 37

-Biases may arise from their commitment to an area of knowledge and their desire to conduct a rigorous study
-Based a biased self-eval is possible, ethical dimensions of study are usually subjected to external review

Question 38

Institutional review board (IRB)

Answer 38

-US committee
-Before undertaking a study, researchers must submit research plans to IRB and undergo formal training
-IRB can approve proposed plan, require modifications, or disapprove them

Question 39

Ethical issues in using animals in research

Answer 39

-Informed consent is not relevant
-Public health service has issues a policy statement on the humane care and use of animals
-Guidelines cover transport, pain and distress, appropriate anesthesia, euthanizing animals under certain conditions during or after study

Question 40

Critically appraising ethical aspects of a study

Answer 40

-If refort mentions formal review, it is usually safe to assume that a panel of concerned people thoroughly reviewed ethical issues in a proposed study
-If study involves vulnerable groups, there should be more info about protective procedures
-Concern about omission of certain groups such as minorities from clinical research