Consent
The recommended literacy level for consent forms presented to the lay public
What is 6th Grade?
Pregnant women, fetuses, neonates, children, prisoners, cognitively impaired individuals, and economically or educationally disadvantaged persons
What are vulnerable populations?
Respect for Persons, Beneficence, and Justice
What are the three core principles of The Belmont Report?
Any information about child abuse or intent to harm self or others will be reported to authorities, as required by law
What is the required child abuse language?
A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge
What is the OHRP definition of research?
The age range for assent
What is 8-17?
"persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted."
What is the (NIH) definition of a child?
The Belmont Report was created in response to public outcry over this infamous, decades-long U.S. government-supported study
What is The Tuskegee Syphilis Study?
A common exclusion criterion that this IRB does not accept without justification
What is the exclusion of participants with limited English proficiency?
They provide consent for those participants who are without the capacity to consent for themselves
What is an LAR or Legally Authorized Representative?
"any individual involuntarily confined or detained in a penal institution or other facility by virtue of statutes or commitment procedures that provide alternatives to criminal prosecution or incarceration"
What is the (OHRP) definition of a prisoner?
The Belmont Report identifies three applications for its ethical principles for this application directly linked to the principle of Respect for Persons
What is Informed Consent?
Typo corrections, non-PI personnel changes and continuing reviews of studies in data analysis
What are submissions that can be approved administratively?
A status change that alters the participant's eligibility criteria
What is a reason that a PI might remove a participant from the study?
Undue influence
What is an incentive significant enough to unduly influence a prisoner's decision to participate in a study?
This principle involves the IRB's risk-benefit analysis as a systematic and thorough process of weighing the potential harms against the potential gains
What is Beneficience?
Studies involving only secondary data analysis with a waiver of informed consent can be reviewed in this manner
What is initial expedited review?
Information, comprehension, and voluntariness
What are the three components of informed consent?
This principle requires that the benefits and burdens of research are distributed fairly
What is Justice?
An approval that this IRB makes conditional on third party review
What is a waiver of parental consent?