Lecture 5

Question 1

What are 3 keys to controlling threats to internal validity?

Answer 1

• Random assignment; Randomization
– Real randomization
– Matched pairs (not matched groups)
– Randomizing treatments or counterbalancing

• Placebos
• Blind setups

Question 2

What are 4 threats to external validity?

Answer 2

1. Selection bias:
   Participants or group selected in a biased manner react to the treatment in a unique way
2. Testing:
   The administration of a pre- test may affect the response to the treatment and subsequently outcomes.
3. Experimental setting:
   Factors like the situation, time of day, location, researchers’ characteristics, etc. limit generalizability of the findings.
4. Multiple treatment interference:
   the administration of more than one treatment to the same subject (s), the effect of one treatment may be influenced by the effect of another treatment

Question 3

What is the key to controlling threats to external variability?

Answer 3

• Random selection

• Selecting from a larger population
– Participants
– Treatments
– Situations

Question 4

What are 3 methods of control?

Answer 4

• Physical manipulation

• Selective manipulation
– Matched pairs and block designs
– Counterbalanced designs

• Statistical techniques

Question 5

• Best way to control extraneous variables
• Researcher attempts to control all aspects of the
research, except the experimental treatment.
• Difficult to control all variables

What type of manipulation is this?

Answer 5

Physical manipulation

Question 6

• Intent is to increase the likelihood that treatment groups are similar at the beginning of study.
– Matched pairs design
– Counterbalanced design

What type of manipulation is this?

Answer 6

Selective manipulation

Question 7

• Applied when physical manipulation or selective manipulation is not possible
• Differences among treatment groups are known to exist at beginning of study.
– Groups may differ on initial ability.
• Analysis of covariance (ANCOVA)
– Adjusts scores at the end of the study based on initial differences

What type of manipulation is this?

Answer 7

Statistical techniques

Question 8

– Hawthorne effect
– Placebo effect
– John Henry effect
– Rating effect
– Experimenter bias effect

What are these examples of?

Answer 8

Common sources of error

Question 9

• A specific type of reactive effect in which merely being a research participant in an investigation may affect behaviour
• Suggests that, as much as possible, participants should be unaware they are in an experiment and unaware of the hypothesized outcome

What type of effect is this?

Answer 9

Hawthorne effect

Question 10

• A threat to internal validity wherein research participants in the control group try harder just because they are in the control group

What type of effect is this?

Answer 10

John Henry effect

Question 11

• The intentional or unintentional influence that an experimenter (researcher) may exert on a study

What type of effect is this?

Answer 11

Experimenter bias effect

Question 12

• A variety of errors are associated with ratings of a participant or group
– Halo effect
– Overrater error
– Underrater error
– Central tendency error

What type of effect is this?

Answer 12

Rating effect

Question 13

• Participants may believe that the experimental treatment is supposed to change
them, so they respond to the treatment with a change in performance.

What type of effect is this?

Answer 13

Placebo effect

Question 14

What is the difference between a single blind and double blind study?

Answer 14

In a single-blind study, patients do not know which study group they are in (for example whether they are taking the experimental drug or a placebo).

In a double-blind study, neither the patients nor the researchers/doctors know which study group the patients are in.

Question 15

What experimental code was developed during Nazi experimentation in WW2?

Answer 15

Nuremberg Code – basic principles to govern research involving human subjects

Question 16

What was the tuskegee syphillis study?

Answer 16

– Public Health Services project related to untreated syphilis
– Highlights deception and informed consent

Question 17

What is the importance of Henrietta lacks?

Answer 17

– Cancerous cells from tumors in her cervix were taken without her knowledge or consent
– Produced the first immortalized cell line and one of the most important in medical research
• still being used today

Question 18

What are the 3 different set of guidelines for ethical human research?

Answer 18

• Nuremberg Code (1947)
– first set of guidelines

• Helsinki Declaration (1964, revised 2008) – used commonly for us
– Ethical principles for medical research involving humans

• Belmont Report (1979)
– Fundamental document outlining basic ethical principles for the protection of human subjects in the USA

Question 19

What is the #1 principle of the nuremburg code?

Answer 19

The voluntary consent of the human subject is absolutely essential

Question 20

What are 9 other tenets of the nuremburg code?

Answer 20

2. The experiment should aim at positive results for society that cannot be procured in some other way.
3. It should be based on previous knowledge (e.g., an expectation derived from animal experiments) that justifies the experiment.
4. The experiment should be set up in a way that avoids unnecessary physical and mental suffering and injuries, except, in experiments where the experimental physicians also serve as subjects.
5. It should not be conducted when there is any reason to believe that it implies a risk of death or disabling injury.
6. The risks of the experiment should be in proportion to (that is, not exceed) the expected humanitarian benefits.
7. Preparations and facilities must be provided that adequately protect the subjects against the experiment’s risks.
8. The staff who conduct or take part in the experiment must be fully trained and scientifically qualified.
9. The human subjects must be free to immediately quit the experiment at any point when they feel physically or mentally unable to go on.
10. Likewise, the medical staff must stop the experiment at any point when they observe that continuation would be dangerous.

Question 21

• Tri-Council Policy Statement:
Ethical Conduct for Research Involving Humans
– Joint policy from Canada’s federal agencies
• Institutional Review Boards (IRB) often called Research Ethics Boards (REB)
– Healthcare institutions
– School boards
– Universities
• Community Ethics Review Boards
– Aboriginal communities (OCAP)

What are these 3 examples of?

Answer 21

Ethical standards for the protection of human research participants

Question 22

What are the 3 basic principles of the belmont report?

Answer 22

• Respect for persons
– Proclaims individuals capable of self-determination; thus voluntary consent is essential

• Beneficence
– Obligates researchers to maximize potential benefits and minimize possible harm

• Justice
– Requires the benefits and burdens of research be fairly distributed

Question 23

What are examples of vulnerable participants that must be protected?

Answer 23

• Children
• Elderly
• Pregnant women
• Individuals with cognitive impairment, intellectual disabilities, physical disabilities
• Welfare recipients
• Prisoners
• Minority groups
• Etc.

Question 24

What are 4 basic rights of all human participants?

Answer 24

• Human research participants should expect the right to:
– Privacy or nonparticipation
– Remain anonymous
– Confidentiality
– Experimenter responsibility

Question 25

What is the difference between privacy and confidentiality? What is the difference between confidentiality and anonymity?

Answer 25

The main difference between privacy and confidentiality is that privacy is about people whereas confidentiality is about information

Confidentiality means a researcher agrees not to reveal the identity of participants to anyone else whereas anonymity is a step further and means researcher isn’t even aware of the identity of the participants

Question 26

What is the definition of informed consent? What are 4 things that consent must include?

Answer 26

• The most important ethical standard
• Informs research participants about all aspects of the research that might reasonably influence their decision to participate

• Consent MUST include:
– Participants are fully aware of nature and purpose of research project
– Consent is given voluntarily
– Person has legal capacity to give consent
– Responsibility for obtaining consent rests with researcher

Question 27

What are 6 key elements of informed consent?

Answer 27

• A fair explanation of the procedures to be followed, including identification of those that are experimental
• A description of the attendant discomforts and risks
• A description of the benefits to be expected
• A disclosure of appropriate alternative procedures that would be advantageous for the participant
• An offer to answer any inquiries concerning the procedures
• An instruction that the participant is free to withdraw at any time
– Participant may withdraw data

Question 28

What is the main ethical concern of the disclosure of results?

Answer 28

Research investigations normally result in some disclosure of the results of the study (e.g., paper, published article, presentation)

– The preeminent ethical obligation in this regard is not to disclose inaccurate, deceptive, or fraudulent research results

Question 29

• REB/IRBs established by a federal mandate to assure compliance with governmental regulations
• REB/IRBs have the authority to approve, require modifications, or disapprove research
• REB/IRB approval required before any aspect of research involving human participants may commence

What are REB’s/IRB’s?

Answer 29

Research Ethics Board (REB) or Institutional Review Boards (IRBs)

Question 30

What are 7 key criteria for REB/IRB approval?

Answer 30

• Risks to participants are minimized
• Risks to participants are reasonable in relation to anticipated benefits
• Selection of participants is equitable in relation to the purpose of the research and its setting
• Informed consent will be sought from each prospective subject or their legal representative
• Informed consent will be appropriately documented
• Provisions for monitoring data collected to ensure safety of participants
• Provisions to protect privacy of participants and to maintain confidentiality of data