Mod 4, Research Ethics Flashcards
Define the Tuskegee studies.,
Tuskegee Studies: study of untreated syphilis, men in Africa were not told that they had syphilis just that they were being treated for “bad blood”; studied by US psychologists; not given penicillin as a treatment because they wanted to see what would happen with untreated syphilis, only 8 survived out of 399
Define the Belmont Report.
In response to the Tuskegee studies, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research began work on ethical research issues
Produced the Belmont Report: made an important distinction between research and practice, which is still very influential today
Define the difference between research and practice.
Practice: such as medicine/psychotherapy, involves interventions that are intended for the sole purpose of enhancing the wellbeing of an individual and have a reasonable expectation of success
Research: contributes to general knowledge by testing hypothese
Define the three principles of ethical research.
RBJ: respect for persons, beneficence, justice
Respect for Persons: researchers must treat potential participants as autonomous agents, or individuals with the right to make decisions for themselves—as well as provide extra protection for vulnerable populations
Beneficence: researcher should do no harm
Justice: both the benefits and burdens of the research should distribute fairly
Define the 1974 Common Rule.
Established in 1974
Introduced requirements for informed consent, the ethical conduct of research, and institutional review boards
Revised Common Rule: made revisions to it in 2018
Define Revised Common Rule.
CHANGED IN THE REVISED COMMON RULE: Benign Interventions: non offensive, non damaging or embarrassing behavioral interventions like surveys, interviews, educational tests and observation of public behavior where there is no expectation of privacy DONT NEED TO FOLLOW COMMON RULE
When do Common Rule Standards?
Common rule standards apply whenever data has the potential to be matched to an individuals identity
ABOUT WHO Research questions: must fall under common rule standards because it focuses on the opinions, characteristics, and behavior of individuals
Define the requirements of an institutional review board.
Minimum of 5 members
One member must be a non-scientist, one must be unaffiliated with the institution (free to be a whistleblower)
May not review studies where there is a conflict of interest
In addition to IRBS< research is also evaluated by the funding agencies providing money for the research
Power to approve research, disapprove it, require modifications, conduct ongoing reviews, suspend or terminate approval
Define research that is exempt from Common Rule Guidelines.
research that does not require Common Rule guidelines (researching how many students went to a conference), basic statistical calculations
Define a limited review in IRB.
method for dealing with newly defined exempt research that doesn’t quite fit the spirit of exempt review (still requires some evaluation as it cannot be fully exempt as it might compromise confidentiality)
DEFINE expedi
available for studies that involve minimal risk, which is defined as the same level of risk most of us experience in everyday life (reviewers of an expedited research plan can approve the plan, but they cannot disprove a plan on their own)
Define equitable recruitment (Common Rule)
Equitable recruitment: researcher should have a representative sample (anyone who could be affected by the research findings should have a chance to participate) COERCIVE INCENTIVES CANNOT BE USED/ ENSURING NO POWER DYNAMICS BETWEEN RESEARCHER/PARTICIPANT, other guidelines for vulnerable populations are codified
Define Informed Consent (Common Rule)
Informed consent: participants must have sufficient knowledge of the study’s details to make a good decision (debriefing form: description of what the researcher plans to tell participants about the deception at the conclusion of their participation)
Difference between active and passive consent.
ctive (Opt in) Consent: requires a parent or legal guardian’s permission for child to participate
Passive (opt out) consent: all children will participate unless a parent/guardian provides a statement saying they don’t want their child to participate
When can parental consent be waved for research?
PARENTAL CONSENT CAN ONLY BE WAIVED when the research involves minimal risk, the rights/welfare of participants will not be affected, the research could not be carried out without a waiver, and the participants receive appropriate debriefing
