History and Ethical Principles - SBE CITI Training questions
A student is conducting a research project that involves using a survey. it asks participants about their highest level of education, political affiliation, and views on various social issues. No identifiable info will be collected. What is this?
exempt review (no consent)
Studying coping with adults who experienced abused as a child. There will be a consent form, the most likely additional risk is...
experience emotional or psych distress
Where could student researchers and/or student subjects find additional resources regarding the IRB approval process?
faculty advisor/research mentor or the IRB office
A student working on his dissertation plans on interviewing 15 principles in neighboring high schools. The student will collect data about personal experiences they had with disruptive students, disciplinary action and feelings/thoughts. Identifiers will be collected. What is this?
full board review
A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent info after the study. In which of the following studies would it not be appropriate to provide subjects with info about missing elements of consent:
A study in which subjects were assigned to study activities based on an undesirable physical characteristic as assessed by members of research team
According to the federal regulations, which meets criteria for human subjects?
A study of 20 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessment for each for three months another answer: a developmental psych videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggressions
Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects?
Determining that the study has a maximization of benefits and minimization of risks
Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?
Ensuring that risks are reasonable in anticipated benefits
the researchers failure to protect subjects from deductive disclosure is the primary ethical violation in which of the following studies?
Harvard, "tasts ties and time (t3) study (2006-2009)
The history of ethical regulations in human subjects research began with...
Nuremberg code
Which of the following are the three principles discussed in the belmont report?
Respect for persons, beneficence, Justice
All of the following are true regarding the belmont report except:
The belmont report indicates that it is necessary to rigorously avoid conflicts of interest.
A researchers data is stolen from her car. Files contained aggregated data. Consent form said no identifying info would be retained ad researchers adhered
There was neither violation of privacy or breach of cofidentiality
According to federal regulations, which of the following studies meets the definition of research with human subjects?
a cognitive psych enrolls undergrad students for comp. based study about the effect of mood on problem solving behaviors
Which element is to be included in informed consent?
all foreseeable risks and discomforts
Risk of harm should be evaluated by...
both magnitude and the probability
A researcher is examining the quality of life for prisoners who are HIV positive using surveys followed b interviews. The IRB must ensure that:
confidentiality of the prisoners health status maintained
Data are made anonymous by...
destroying all identifiers relating to the data
Which type of IRB review does not require an IRB approval but does require a determination by the IRB or and IRB designee
exempt
Researcher gains info through...
identifiable private info
Which constitutes a breach of confidentiality and a violation of subjects privacy?
making identifiable data about sexual behavior available to grad students, although subjects were told it would be de-identiable
Continuing review of an approval and ongoing protocol...
must occur within 12 months of approval
What is the IRB charged with?
protecting the rights and welfare of human subjects assuming that all applicable institutional policies and federal regulations related to research with human subjects are followed reviewing subjects recruitment materials and strategies
How can faculty researchers avoid coercion of student subjects?
Avoid using their own students in their research
A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for s case based research project. Which of the following research statements about parental permission is correct?
The parents of the children might feel pressure to give permission to use their child's data so that she will continue to provide services
Which of the following studies is linked most directly to the est. of the national research act in 1974 and ultimately to the belmont report and federal regulations for human subject protection?
The public health service tuskegee study of untreated syphilis in the negro male
A researchers uses a data set of prisoner demographic characteristics/ No interaction with prisoners. The IRB chair agrees that the study is exempt from IRB review.
This review is wrong because 45 CFR 46.101 (B) states that prisoner research MAY NOT be exempt
A masters degree candidate needs to conduct a research project for her masters thesis. She is interested in junk food available to public. She plans on going to the grocery stores and asking for highest sellers. Identifiers will not be collected. What is this?
no human subjects
Expedited review process may be used when the study procedures pose..
no more than a minimal risk and research activities fall within regulatory categories identified as eligible
If a grad student speaks to a super (family friend)for a prisoner population. This students IRB should...
not approve this project because the prisoners are merely a population of convenience for the student
If disclosure of a subjects involvement is risky and the consent form is the only one thing linking the subjects...
obtain a fee waiver of documentation of informed consent
which of the following statements about the relationship between an institution and an institutions IRB is correct?
officials of the institution may overrule IRB approval
The belmont principle of beneficence requires that...
potential benefits justify the risks of harm
DHHS regulations provides protection for...
pregnant women, fetuses, prisoners, and children
certificate of confidentiality?
protect identifiable research from compelled disclosure
As part of the consent process, the federal regulations require some researchers to...
provide potential subjects with into at the appropriate reading comprehension levels
What statement about risks in social and behavioral sciences research in most accurate?
risks are specific to time, culture, situation
In a longitudinal study that will follow children from K to HS and collect info about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable info?
securing a certificate of confidentiality
Which of the following studies needs IRB approval?
studies collecting data about living individuals
A general requirement for informed consent is that no informed consent may include any exculpatory language. Waives or appears to wave the subjects leg l rights or releases or appears to release those conducting the research from liability from negligence. Which is an example of exculpatory language?
taking part in the research voluntary, but if you choose to take part, you waive your right to legal redress for any related injuries
A waiver of the requirement for documentation of informed consent may be granted when...
the only record linking the subject and the research is the consent document and the principal risk is a breach if confidentiality
According to federal regulations, research is eligible for exemption if..
the research falls into one of the six categories of research activity described in the regulations
When a focus group deals with a potentially sensitive topic, providing confidentiality means:
the researchers cannot control what participants repeat about others outside the group