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HESP724 research design > Exam 1: Research Ethics > Flashcards

Exam 1: Research Ethics Flashcards

1
Q

Two types of ethics

A
  • Professional issues

* Protection of human participants

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2
Q

Scientific misconduct - what’s the most serious example?

A
  • Most serious: fraudulent or false data
  • Retracted papers cost $58 million in NIH funding from 1992-2012 (Stern et al., 2014)
  • Less than 1% of the budget
  • Median 91.8% decrease in publication rate and large declines in funding

• http://retractionwatch.com/

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3
Q

Consequences of scientific misconduct

A
  • Retraction of published papers
  • Ban on government grants for years
  • The end of your career (trust is everything!)
  • Legal (felony) charges
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4
Q

Correct Attribution of Ideas

A
  • Cite the ideas of others appropriately
  • Anything that is not “common knowledge”
  • Whenever possible, paraphrase don’t quote (paraphrase ≠ replacing a few words)
  • https://owl.english.purdue.edu/owl/resource/563/1/
  • If you do quote, cite the page number!
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5
Q

Reasons people use direct quotes

A
  • They don’t understand the material
  • There’s no other way to say the information without plagiarizing
  • When making a point about who said the information, or contrasting it with another view
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6
Q

Authorship (general)

A

• Authorship establishes credit and accountability
-Could the project have been accomplished without that particular person (vs. any research assistant)?

  • Authors must share responsibility for the entire paper
  • Avoid honorary authors
  • Talk about expectations EARLY- A little awkwardness now will save you a lot of awkwardness later
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7
Q

Authorship by fields

A

• Psychology: First author is the most critical to the project
• Neuroscience: First author and last (senior) author are
most critical
• Mathematics: alphabetical order
• Humanities: typically single authorship
• Hearing and Speech: ?

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8
Q

Partial publication

A

(piecemeal publication)
• Collecting data for one study and publishing several articles on this one large data set rather than publishing all the findings in one paper

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9
Q

Duplicate publication

A

publishing the same data and results in more than one publication - maybe in MRI situations this is ok

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10
Q

Conflicts of Interest (COI)

A 
• Roles
-Balancing your roles as a clinician
and researcher
• Experimental treatments vs. standards
• Recruiting participants from your clinics (must not impact care)

• Financial
-When outside financial
interests compromise, or have the appearance of compromising, the professional judgment of a researcher

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11
Q

“The Common Rule”

A

Federal Policy for Protection of
Human Subjects

  • Participation must be voluntary, not coerced
  • Participants must be safeguarded from harm (physical and psychological)
  • Participants must provide informed consent
  • Must maintain participant’s confidentiality and privacy
  • Must understand participation can be discontinue at any time
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12
Q

Iowa “Monster” Study

A
  • MaryTudor&WendellJohnson (1939)
  • Investigated the idea that environmental feedback could cause a normally speaking child to stutter
  • Four groups of participants (orphan children from Davenport, Iowa): Those who already stuttered vs. those who did not & Control group vs. experimental group
  • Typically developing children were assigned to an experimental group and labeled stutterers
  • Received intense negative feedback for any disfluency
  • These children changed their speech behavior: became reluctant to speak, spoke more slowly, became shy and embarrassed, accepted that there was something wrong with their speech
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13
Q

Tuskegee Syphilis Study

A

• 1932-1972
* 399 poor African-American men from Macon County, AL, were told they were being treated for “bad blood”
• For participating, given free medical exams, meals and burial insurance
• They actually had syphilis. At the time, there was no treatment for it.
• Penicillin became a standard cure in 1947 and was withheld from them so that scientists could continue to study the disease
• Continued until public health workers leaked it to the media
• 28 had died of syphilis, 100 of syphilis complications, wives (40) & children (19) had been infected
• In 1973 the NAACP filed a lawsuit, and a $9M settlement was divided among
participants, with free health care to those still living, and their family members
• In 1997, Clinton made a formal apology from the government

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14
Q

3 components to the Belmont Report (1979)

A

respect for persons
beneficence
justice

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15
Q

Respect for Persons - Belmont Report

A 
• Principle:
- Acknowledge autonomy
- Protect those with diminished autonomy
•Practice: Informed consent
- Provide information about the study at a level the participant can comprehend, must be voluntary (no coercion), must be able to withdraw at any time
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16
Q

Informed consent

A

• Investigator ensures the participant understands: Risks and benefits, Any aspects that might influence willingness to participate
• Informed consent is a PROCESS, not a signature on a piece of paper
• Even if a therapy that HELPS the person, must have their consent, and must know about alternatives – Needs to be told about all options, even if this makes it
less likely they’d agree to do your experimental one

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17
Q

Concealment or deception

A

• The investigator must determine whether there are any alternatives, determine whether the risk is justified, ensure that participants are provided with an explanation as soon as possible

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18
Q

Deception may be OK if….

A
  • The research can’t be achieved otherwise
  • When being fully informed later (debriefing), participants are expected to find the procedures reasonable and to suffer no loss of confidence in the investigator’s integrity
  • Participants are allowed to withdraw at any time, and are free to withdraw when the concealment or misrepresentation is revealed.
  • Investigator takes full responsibility for detecting and removing stressful after-effects of the experience
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19
Q

Beneficence - Belmont Report

A
  • Principle: Protect the well-being of the person (psychological and physical), Maximize benefits, minimize potential harms
  • Practice: Assess the type and extent of risks and benefits, Protect privacy and confidentiality
20
Q

Beneficial Treatments

A
  • If there are beneficial treatments, control groups must be provided access to them
  • For short treatments, it is legitimate to have one group of patients receive the treatment, and a control group not (and then get it later)
  • But for lengthy treatment, is it right to withhold treatment from people who need it? If not, how can you determine whether a treatment works?
21
Q

Privacy

A
  • Applies to the person

* How are people recruited and their information collected

22
Q

Confidentiality

A
  • Applies to the data

* Maintaining and accessing identifiable information

23
Q

Steps to protect privacy and confidentiality

A
  • Random identification codes (why not 1, 2, 3, 4…?)
  • Who has access to the link? The data?
  • Tricky de-identification: audio/video recordings, MRIs
24
Q

HIPAA

A
  • Health Insurance Portability and Accountability Act
  • Privacy Rule– protected health information (PHI)
  • When might HIPAA be relevant in research studies?
25
Q

Justice - Belmont Report

A 
•Principle: Fair decisions about who
participates (protected classes)
•Practice: Selection of participants
  -Burdened classes
  -Vulnerable participants
  -Consider both individual and social    (in-)justices
26
Q

Special Populations

A
  • Prisoners
  • Children
  • Pregnant women and their fetuses
  • Persons with impaired capacity to provide consent

ex: a person in prison might be overly influenced by the offer of a reward for participation in research and thus more likely than persons outside prison to volunteer to take part in a somewhat risky study

27
Q

What are some considerations in conducting research with special populations?

A

• Assent vs. consent?

28
Q

Coercion

A

• It is unacceptable to coerce a person to participate; must be able to withdraw at any time without repercussions

• Do people feel like they can opt out?
- Is extra credit coercive? What if it is for a class, and the investigator is their
lecturer? What if a professor announces in her class that she has an experiment people can do, if they want to?
29
Q

Milgram study

A
  • Teacher is supposed to give electric shock to learner any time learner makes a mistake
  • Level of shock increases to very high levels
  • Most people continue to remain obedient to the experimenter
30
Q

Participant Pools

A
  • Students must be generally informed of the requirement before registration and given detailed description on the first day of class
  • Alternate opportunities must be provided (Similar in time and effort)
  • Participants must receive some benefit for participation (minimally: educational)
31
Q

Research over the Internet

A
  • Presumably less risk of physical harm, but what of psychological harm?
  • Are survey responses over the internet “confidential”? Can they be identified? What if the email gets sent to the wrong place? Can the data on the internet be accessed by outsiders?
  • If an internet user has a pseudonym or “online persona,” is that pseudonym guaranteed the same kind of confidentiality protection?
32
Q

Facilitated Communication: why did it seem like a good idea?

Jacobson, J. W., Mulick, J. A., & Schwartz, A. A. (1995).

A

Gave people an outlet to be normalized, gave families hope, etc.

33
Q

Facilitated Communication: What research designs were initially used to gauge
its effectiveness?

Jacobson, J. W., Mulick, J. A., & Schwartz, A. A. (1995).

A

qualitative, not falsifiable, anecdotal, or enthographic methodologies (unstandardized)

34
Q

Pseudoscience

A

treating as a science that which is not

35
Q

Antiscience

A

disavowal of scientific methods as epistemologically valid

36
Q

What research designs should have been used?

Jacobson, J. W., Mulick, J. A., & Schwartz, A. A. (1995).

Facilitated communication

A

double-blind - show the facilitator and kid different pictures and they type what the facilitator saw

37
Q

How did facilitated communication have problems with anti-science and pseudoscience

A

“Demonstrations of benefit are based on anecdotes or testimonials; baseline abilities and the possibility of spontaneous improvement are ignored, and related scientific procedures are disavowed; and therapists who use FC unsuccessfully are blamed for not doing it correctly or not believing that it will work.”

38
Q

Institutional Review Board

IRB

A
  • Role: protect the rights and welfare of human research participants
  • (IACUC the equivalent for animals’ protections)
  • Submit protocol information and documentation BEFORE you start the research; you do not decide whether what you’re doing is considered research or not!!!
39
Q

Types of research reviews by IRB

A

IRB MAKES THIS DETERMINATION, NOT YOU!!!
• Full Board Review
• Expedited
• Exempt

40
Q

full board review (IRB)

A
  • More than minimal risk

* e.g., physical/emotional discomfort, sensitive data

41
Q

expedited review (IRB)

A
  • No more than minimal risk

- Most research we do

42
Q

exempt review (IRB)

A
  • Less than minimal risk

* e.g., de-identified or publicly available data, anonymous surveys

43
Q

Components of the initial

application - IRB approval

A
  • Basic study info
  • Application Part 1 (who are the investigators, what type of research)
  • Application Part 2 (detailed study protocol)
  • Supporting documents (consent forms, surveys, ads…)
  • Linked training records (CITI training)
44
Q

Study Protocol

A

• Details of the study’s purpose, procedures (recruitment and testing), risks/benefits, and maintenance of confidentiality

45
Q

Consent Form

A
  • Summary of the study protocol such that the participant can make an informed decision regarding participation
  • When possible, use the IRB-approved template language
46
Q

components of IRB

A 
Title
Purpose 
Procedure
Potential Risks and Discomforts
Potential Benefits
Confidentiality
47
Q

Willowbrook studies

A

deliberate infection of children (with disabilities who live in an institutional environment) with hepatitis

HESP724 research design (8 decks)

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