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What is ethics?
The morak principles that govern the conduct of an activity, usually referring to the protection of participants or to the honesty in reporting results. Field experiments may create ethical issues, as they often involve direct intervention in people’s lives.
What is the main ethical concern in field experiments?
The most common concern is the act of ‘denying’ some participants the treatment, which is why the randomization strategy is essential to fairly allocate the scarce treatment resources.
What is the risk of harm?
The knowledge that the program is beneficial, then delaying its introduction to all eligible participants, delays the benefits to those participants. It is not known harm though, as we do not know for sure that the program will be beneficial. It is important to offset the risk of harm against the potential benefits.
What was the Belmont Report (1978)?
Produced by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Prompted by the Tuskegee Syphilis Experiment (1932-1972), which studied the effects of untreated syphilis in 600 African-Americans, where researchers promised free medical treatment, but instead only delivered placebos and diagnostics
Had the chharacteristics of an unethical study (deception, no informed concern, dubious benefit to soceity as a whole)
What are the Belmont Principles of Ethics?
Respect for persons
Benefice
Justice
What does ‘‘respect for persons’’ entail?
This says that individuals should be treated as autonomous agents, and that we must seek informed consent. It also means that people with diminished autonomy (children, cognitively ill individuals, prisoners, etc.) are entitled to additional protection.
What elements does informed consist of?
Information: Research purpose, procedures, risks and benefits, and opportunity to ask questions
Comprehension: Information delivered to facilitate understanding
Voluntary participation: No coercion or undue influence
What are the challenges to informed consent?
Potential participants may be overly optimistic about the potential benefits
Recgonize the power dynamics between study teams and target population
How to document it
What is the difference between a participation information leaflet and a participation consent form?
An information leaflet answers all of the why and how questions, explaining benefits, risks, and procedures. The consent form explains the participants' rights as well as confirmation of agreement and data use.
What is beneficence?
Refers to the researcher's obligation to strive to improve the status, rights, or well-being of participants; i.e., the potential benefits must outweigh the potential harms.
What is the principle of non-maleficence?
This is counted under beneficence, and requires researchers to do no harm, avoid harm and injury to participants by minimizing risk.
How can beneficence minimize risk?
Do no harm: Do not administer treatment known to be harmful and do not withold benefit unnecessarily
Consider the adverse effects, emotional and mental burdens, privacy, etc.
Plan in advance to minimize and mitigate any risks
How can beneficence maximize benefit?
Choose interventions that are likely to have positive effects
Make findings as applicable as possible
Justify why inclusions of vulnerable populations are needed for benefit
What does standard of care mean?
This means that the control group receives the staus quo, they are not denied access to care to which they are entitled.
What is a dosage experiment?
An experiment in which there is no pure control, and all participants are given some treatment.
What is ‘‘justice’’?
This principle focuses on the distribution of research costs and benefits. It seeks to avoid a situation where one group bears all the risks while another receives all the benefits. The study population needs to represent the population experiencing the problem and the population that stands to benefit. Research that imposes risk on some for the sake of society is ethical, if the individuals understand and agree to the risks.
Ex: It is unethical to test drugs on poor people and only sell drugs to rich people. It is, however, ethical to test a program designed to help poor farmers with poor farmers.
What was the McDermott and Hatemi (2020) study?
This study found field experiments that violate the principles of respect for persons, justice and beneficence, finding a rise in these cases.
What was the Nickerson & White (2013) study?
This examined the effectiveness of radicalized Get-Out-The-Vote messages at mobilizing black voters and found that they resulted in a reduction of voter turnout, which disadvantaged minority representation.
What was the Gerber, Green & Larimer (2008) study?
Their treatment group was promised that they would publicize their voting turnout to their neighbors, essentially publicly shaming individuals. This reduced the turnout of the least advantaged, leading to even less political representation.
What is the purpose of an ethical review?
Protect the rights of the participant
Minimize the risk which participants may be exposed to
Promote the best ethical practice in research
Protect researcher
Protect institutional repuation
Help improve the quality of research
What are some common ethical issues?
Consent
Vulnerable groups
Risk to participants
Data managment and confidentiality
What needs to be included in an ethical application?
Research objectives, purposes, and methods
All materials that participants will be exposed to
Study participants (selecion method, numbers)
Recruitment process and informed consent
Data confidentiality and participant privacy
Assesment risk