Ethics and IRB

Question 1

Which of the following principles states that participants should be informed of risks and given a choice about participation

Answer 1

Respect for persons

Respect for persons is the principle that leads to the practice of receiving informed consent. Research subjects should be able to volunteer to participate, and to be knowledgeable about what they are getting themselves into.

Question 2

IRB approval may be required from…

Answer 2

From a principal investigator’s host institution

From the country where research is taking place

Question 3

In the Belmont report, the line between research and practice ….

Is clearly articulated for both social science and medicine
Is the same in both social science and medicine
Is not a factor when determining whether something requires IRB approval
None of the above

Answer 3

None of the above.

The Belmont report says the line between practice and research is different between medicine and social science, but does not define it in social science. One example of whether the line matters is when a researcher designs a new intervention.

Question 4

When might the IRB deem consent unnecessary?

Answer 4

If the risk of research is low, IRB may deem informed consent unnecessary if it prevents the research from happening.

Vulnerable populations (such as children and prisoners) are given extra protections, not less. While cluster randomized trial means a cluster of people are treated, even if we only collect data from a subsample; however, we will still likely require informed consent from those from whom we collect data.

Question 5

Which of the following can be considered a risk of potential harm from the research (select all that apply)

We do not know whether a commonly practiced intervention is helpful or harmful
The program’s effect is unknown and implemented as part of the research project
The program is known to be effective, but withheld to maintain a valid comparison group
The research leads to different targeting of the program
The research will not be able to distinguish correlation from causation
None of the above

Answer 5

If the intervention is commonly practiced, it is unlikely the research per se would be considered as causing harm. However, if the intervention is being implemented because of the research, the unknown benefit or harm can be considered a risk. Similarly, if the program’s impact on a separate target population is unknown, and tested as part of research, this could be a risk of harm. And if a program is effective and is withheld because of research, that would be considered a harm. Research may not pass our ethical principles because it fails to have sufficient benefits, but that does not mean it causes harm.

Question 6

Which of the following is a violation of the justice principle? (Select all that apply)

Designing an experiment poorly, and failing to obtain valid lessons
Testing medicine only on high-school boys, because the drug’s safety during pregnancy has not been established
Testing a program’s effectiveness in a poor country even though only people in rich countries would be able to afford the program

Answer 6

Testing a program’s effectiveness in a poor country even though only people in rich countries would be able to afford the program

Question 7

The state of California government has the resources to provide low-cost homes for roughly 500,000 families who live below the poverty line in the San Francisco region, and wants to evaluate the impact of this program using a randomized evaluation. Which approach might optimize the ethical cost-benefit trade-off?

Expand program eligibility to the poorest 1 million, and randomize half to receive the program
Provide houses to the poorest 500,000 households, and assign the next 500,000 into the control group
From the 500,000, randomly assign only 250,000 to receive housing, keeping the other half in the control group
Expand program eligibility to the next poorest 100,000 households, and out of the 600,000 poorest households, randomize 500,000 to receive the program.

Answer 7

Expand program eligibility to the next poorest 100,000 households, and out of the 600,000 poorest households, randomize 500,000 to receive the program.

Question 8

What should a Data Management plan include?

Answer 8

Method of recording consent on all surveys
Where paper surveys will be stored
When and how paper surveys will be disposed of
How PII will be encrypted

Question 9

3 Belmont Principles

Answer 9

• Include 3 key principles:
– Respect for persons (consent)
– Beneficence (benefits outweight harm)
– Justice (relevant to study group)