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Research 3900 > Unit 2: Ch. 5 > Flashcards

Unit 2: Ch. 5 Flashcards

1
Q

What’s the most famous example of recent disregard for ethical conduct?

A

Nazi medical experiments

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2
Q

Codes of Ethics

A

Developed in response to human rights violations

Examples include Nuremberg Code and Declaration of Helsinki

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3
Q

Nazi medical experiments

A

Used POWs and racial “enemies” in experiments designed to test human endurance and reactions to untested drugs

Unethical b/c they exposed people to harm and even death and b/c subjects couldn’t refuse participation

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4
Q

Tuskegee Syphilis Study

A

1932-1972

African American men w/ syphilis were tracked to study the dz. This study started out as an ethical study (before PCN developed) –> years later PCN developed but the men being studied weren’t told so that researchers could watch dz progression

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5
Q

Dr. Herbert Green Study

A

Study of women w/ cervical cancer. The women were denied tx

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6
Q

Willowbrook

A

An institution for the mentally retarded

Children were deliberately infected with the hepatitis virus to see what happened

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7
Q

Jewish Chronic Dz Hospital Study

A

Study in which nursing home pts were injected with live liver CA cells
-some physicians didn’t know this was going on

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8
Q

US Government sponsored radiation studies

A

Hospitalized pts and prisoners were exposed to radiation to see what happened

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9
Q

Nuremberg Code

A

Came out of WW2 and Nazi experiments. 1947

ID’d criteria to protect human subjects. Some criteria include informed consent, justification of social good (something good has to come out of study; can’t just be research), voidence of injury, right of subjects to withdraw (you can pull ourself out of that study)

Nuremberg was one of the first ethical codes

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10
Q

Declaration of Helsinki

A

Provided guidelines for physicians conducting research

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11
Q

Governmental bodies that regulate ethics?

A

National Commission for the Protection of Human Subjects

Department of Health and Human Services

FDA

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12
Q

Examples of ethical codes for professional disciplines?

A

ANA, AMA, APA…

Lots of organizations have ethical codes

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13
Q

Belmont Report

A

1978

Provided a model for many guidelines adopted by disciplinary organizations in the US

Also served as the basis for regulations affecting research sponsored by the US government, including studies supported by the NINR

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14
Q

Dilemma

A

A choice that must be made between equally unattractive, poor, or disagreeable alternatives

Run into dilemmas a lot in healthcare

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15
Q

Ethical dilemma in research

A

When the rights of study participants are in direct conflict w/ study requirements

Ex: conducting a study on sexual abuse but you as a nurse are mandated to report sexual abuse. If you report it, who is going to want to participate in your study? Had to find a way around the mandate - “work-around”

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16
Q

The Belmont Report articulated 3 primary ethical principles on which standards of ethical research conduct are based. Name them.

A
  1. Beneficence
  2. Respect for human dignity
  3. Justice
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17
Q

Research ethics are based on human rights. Name the 5 rights discussed in class

A
  1. Right to self determination
  2. Right to privacy
  3. Right to anonymity and confidentiality
  4. Right to fair tx
  5. Right to protection from discomfort and harm
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18
Q

Right to self-determination

A

Humans are autonomous agents with freedom to conduct their lives as they choose. You have the RIGHT to make these responsibilities but you also have to live with the RESPONSIBILITY of your decisions (good/bad)

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19
Q

Right to privacy

A

Freedom of an individual to determine the time, extent, and general circumstances in which info is shared with others

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20
Q

Right to anonymity and confidentiality

A

Anonymity: identity is unknown

Confidentiality: right to keep your private info private; don’t have to share your personal info unless you want to

To uphold this right in research, the researcher doesn’t share info w/ others

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21
Q

Right to fair tx

A

Based on the principle of justice. Make sure when you select subjects that everyone is treated equally

22
Q

Right to protection from discomfort and harm

A

Don’t want to unnecessarily hurt people
-key word: unnecessarily: some studies may require you to start an IV/give injection. Inform person that you’re going to start IV/give injection (or whatever) and it will cause some pain

23
Q

In ____ research, the risk of exploitation may become high b/c the psychological distance between investigators and participants typically declines as the study progresses.

A

Qualitative (narrative)

24
Q

Beneficence

A

Duty to minimize harm and maximize benefits

Human research should produce benefits for participants themselves or for other individuals or society as a whole

25
Q

Self determination

A

Prospective participants have the right to decide voluntarily whether to participate in a study, w/o risking penalty or prejudicial tx

Also means people have the right to ask questions, to refuse to give info, and to withdraw from the study

Includes freedom from coercion

26
Q

Coercion

A

Involves explicit or implicit threats of penalty from failing to participate in a study or excessive rewards from agreeing to participate

27
Q

Protection of vulnerable populations

A

Right of people who can’t protect themselves to be protected by the researcher
-ex: children and the elderly

28
Q

Justice

A

fair and equal distribution of benefits/risks across all groups in the study

Includes right to fair tx and their right to privacy

29
Q

Full Disclosure

A

Researcher has fully described the study, the person’s right to refuse participation, and possible risks and benefits.

30
Q

Risk/Benefit Assessment

A

Designed to evaluate whether the benefits of participating in a study are in line w/ the costs, be they financial, physical, emotional, or social - i.e., whether the risk/benefit ratio is acceptable.

31
Q

Informed Consent

A

Participants have adequate info about the study, comprehend the info, and have the power of free choice, enabling them to consent to decline participation voluntarily.

Typically 1 page (but can be a couple of pages). Means participants have adequate info about research, have freedom of choice to decline being participant

32
Q

Confidentiality procedures

A

Must be planned and in place so info about participants aren’t leaked at any time. Results are reported in aggregate; data kept in locked file behind locked door. If taping interviews, transcribe the interview tape and destroy the actual tape

33
Q

Minimal Risk

A

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

34
Q

Implied consent

A

Researchers may not obtain written informed consent when data collection is through self-administered questionnaires. Researchers often assume implied consent (i.e., the return of a completed questionnaire reflects the person’s voluntary consent to participate).

However, this assumption may not always warranted (e.g. if pts believe that their care might be affected by failure to cooperate)

35
Q

Process Consent

A

In a qualitative study

Consent may be an ongoing process, called process consent, in which consent is continuously renegotiated

36
Q

Anonymity

A

Most secure means of protecting confidentiality

Occurs when researchers can’t link participants to their data

Rarely possible in qualitative studies
-b/c the results are narrative someone has to be there to write down responses

37
Q

Confidentiality

A

A pledge that any info participants provide will not be publicly reported in a manner that ID’s them and will not be made accessible to others

38
Q

Certificate of Confidentiality

A

The certificate (obtained from NIH) allows researchers to refuse to disclose info on study participants in any civil, criminal, administrative, or legislative proceeding

39
Q

Confidentiality is especially important in ____ studies b/c of their in-depth nature, yet anonymity is rarely possible.

A

Qualitative

40
Q

Debriefing

A

A session following data collection so that participants can ask questions or air complaints. Especially important when data collection has been stressful or when ethical guidelines had to be “bent” (e.g., if any deception was used)

Must be in place so that if researcher stirs up feelings during the study participants have somewhere to go to contact/talk about it

41
Q

Vulnerable Populations

A

Protection of groups who can’t protect themselves

Includes children, mentally disabled, pregnant women (really protecting the unborn), terminally ill

Vulnerable populations may be incapable of giving fully informed consent or may be at high risk of unintended side effects

42
Q

External Reviews (e.g. Institutional Review Board (IRB))

A

Before undertaking a study, researchers must submit research plans to the IRB, and must also undergo formal IRB training. An IRB can approve the proposed plans, require modifications, or disapprove them

The IRB is there to deal w/ ethical issues (not to mess w/ science…but it’s a gray area. IRB may have to suggest changes to science behind the study)

43
Q

Informed Written Consent

A

Each section of the consent form must address a research issue

1st paragraph usually discusses what the research is about. Risks/benefits also addressed. Some of this is standard, some will be tailored to specific research being done.

IRB has various ways of labeling consent forms so that not just anyone can print one up (may be a stamp/seal, may be something else)

Consent form has to be renewed annually if the study isn’t completed w/in a year

44
Q

Other ethical issues

A

Ethical use of animal subjects

  • there’s a whole different board concerning animal research
  • IRB is for humans only (not going to discuss animal research in this class)

Research misconduct

  • plagiarism/originality
  • fabrication of results
  • falsification of data
  • other types of scientific misconduct
45
Q

Research Misconduct

A

Fabrication, falsification, or plagiarism in proposing, conducting, or reviewing research, or reporting results

Betrayal of the trust of the public

Includes:

  • plagiarism/originality
  • fabrication of results
  • falsification of data
  • other types of scientific misconduct
46
Q

Fabrication

A

Involves making up data or study results

47
Q

Falsification

A

Involves manipulating research materials or processes; it also involves changing or omitting data, or distorting results

48
Q

Plagiarism/Originality

A

Involves the appropriation of someone’s ideas, results, or wording w/o giving due credit

Intentionally or unintentionally claiming ideas as your won

Can’t cite a citation –> must cite original author (more of an issue w/ finding things online)

49
Q

Other types of scientific misconduct

A

Conflict of interest: look at funding sources of research to see if there is one (there may be a “no conflict of interest” statement at the end of the article)

Inappropriate financial arrangements, failure to comply w/ research regulations, unauthorized use of confidential data

50
Q

Critiquing the ethics of a study (6)

A
  1. Was the study approved by the appropriate IRB?
    - first think to ask. Usually only 1 line in the article (“this study was approved by IRB BEFORE data collection began.”). IRB must approve BEFORE data collection begins
  2. Was informed consent obtained from subjects?
    - or was it implied consent? do you have consent forms signed?
  3. If subject is incompetent, did legally authorized representative give consent?
  4. Were rights protected during sampling, data collection, and analyses?
    - typically if there’s an IRB approval, a lot of these things are implied. But ask/critique anyway
  5. Was privacy protected during study and in final report?
  6. Was benefit/risk ratio of the study acceptable?

Research 3900 (15 decks)

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