Data are made anonymous by...
  • studies collecting data about living individuals
  • pregnant women, fetuses, prisoners, and children
  • destroying all identifiers relating to the data
  • protect identifiable research from compelled disclosure
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?
  • This review is wrong because 45 CFR 46.101 (B) states that prisoner research MAY NOT be exempt
  • the only record linking the subject and the research is the consent document and the principal risk is a breach if confidentiality
  • A study in which subjects were assigned to study activities based on an undesirable physical characteristic as assessed by members of research team
  • 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
DHHS regulations provides protection for...
  • potential benefits justify the risks of harm
  • destroying all identifiers relating to the data
  • studies collecting data about living individuals
  • pregnant women, fetuses, prisoners, and children
Continuing review of an approval and ongoing protocol...
  • must occur within 12 months of approval
  • studies collecting data about living individuals
  • potential benefits justify the risks of harm
  • all foreseeable risks and discomforts
Where could student researchers and/or student subjects find additional resources regarding the IRB approval process?
  • risks are specific to time, culture, situation
  • faculty advisor/research mentor or the IRB office
  • Ensuring that risks are reasonable in anticipated benefits
  • officials of the institution may overrule IRB approval
As part of the consent process, the federal regulations require some researchers to...
  • Determining that the study has a maximization of benefits and minimization of risks
  • the only record linking the subject and the research is the consent document and the principal risk is a breach if confidentiality
  • provide potential subjects with into at the appropriate reading comprehension levels
  • Ensuring that risks are reasonable in anticipated benefits
which of the following statements about the relationship between an institution and an institutions IRB is correct?
  • Determining that the study has a maximization of benefits and minimization of risks
  • studies collecting data about living individuals
  • Ensuring that risks are reasonable in anticipated benefits
  • officials of the institution may overrule IRB approval
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?
  • A study in which subjects were assigned to study activities based on an undesirable physical characteristic as assessed by members of research team
  • securing a certificate of confidentiality
  • exempt review (no consent)
  • no human subjects
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?
  • faculty advisor/research mentor or the IRB office
  • studies collecting data about living individuals
  • Respect for persons, beneficence, Justice
  • securing a certificate of confidentiality
the researchers failure to protect subjects from deductive disclosure is the primary ethical violation in which of the following studies?
  • confidentiality of the prisoners health status maintained
  • This review is wrong because 45 CFR 46.101 (B) states that prisoner research MAY NOT be exempt
  • There was neither violation of privacy or breach of cofidentiality
  • Harvard, "tasts ties and time (t3) study (2006-2009)
certificate of confidentiality?
  • protecting the rights and welfare of human subjectsassuming that all applicable institutional policies and federal regulations related to research with human subjects are followedreviewing subjects recruitment materials and strategies
  • potential benefits justify the risks of harm
  • pregnant women, fetuses, prisoners, and children
  • protect identifiable research from compelled disclosure
Risk of harm should be evaluated by...
  • studies collecting data about living individuals
  • Avoid using their own students in their research
  • both magnitude and the probability
  • all foreseeable risks and discomforts
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
  • Ensuring that risks are reasonable in anticipated benefits
  • provide potential subjects with into at the appropriate reading comprehension levels
  • a cognitive psych enrolls undergrad students for comp. based study about the effect of mood on problem solving behaviors
A researcher is examining the quality of life for prisoners who are HIV positive using surveys followed b interviews. The IRB must ensure that:
  • officials of the institution may overrule IRB approval
  • confidentiality of the prisoners health status maintained
  • This review is wrong because 45 CFR 46.101 (B) states that prisoner research MAY NOT be exempt
  • Harvard, "tasts ties and time (t3) study (2006-2009)
When a focus group deals with a potentially sensitive topic, providing confidentiality means:
  • experience emotional or psych distress
  • the researchers cannot control what participants repeat about others outside the group
  • full board review
  • 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
  • The belmont report indicates that it is necessary to rigorously avoid conflicts of interest.
  • making identifiable data about sexual behavior available to grad students, although subjects were told it would be de-identiable
  • provide potential subjects with into at the appropriate reading comprehension levels
Researcher gains info through...
  • confidentiality of the prisoners health status maintained
  • both magnitude and the probability
  • identifiable private info
  • destroying all identifiers relating to the data
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
  • Ensuring that risks are reasonable in anticipated benefits
  • The public health service tuskegee study of untreated syphilis in the negro male
  • officials of the institution may overrule IRB approval
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 belmont report indicates that it is necessary to rigorously avoid conflicts of interest.
  • Determining that the study has a maximization of benefits and minimization of risks
  • officials of the institution may overrule IRB approval
  • The public health service tuskegee study of untreated syphilis in the negro male
All of the following are true regarding the belmont report except:
  • Determining that the study has a maximization of benefits and minimization of risks
  • the research falls into one of the six categories of research activity described in the regulations
  • provide potential subjects with into at the appropriate reading comprehension levels
  • The belmont report indicates that it is necessary to rigorously avoid conflicts of interest.
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
  • the research falls into one of the six categories of research activity described in the regulations
  • the only record linking the subject and the research is the consent document and the principal risk is a breach if confidentiality
  • The belmont report indicates that it is necessary to rigorously avoid conflicts of interest.
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?
  • the researchers cannot control what participants repeat about others outside the group
  • experience emotional or psych distress
  • taking part in the research voluntary, but if you choose to take part, you waive your right to legal redress for any related injuries
  • full board review
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
  • taking part in the research voluntary, but if you choose to take part, you waive your right to legal redress for any related injuries
  • full board review
  • securing a certificate of confidentiality
Which element is to be included in informed consent?
  • studies collecting data about living individuals
  • all foreseeable risks and discomforts
  • potential benefits justify the risks of harm
  • risks are specific to time, culture, situation
Which type of IRB review does not require an IRB approval but does require a determination by the IRB or and IRB designee
  • exempt
  • Determining that the study has a maximization of benefits and minimization of risks
  • The public health service tuskegee study of untreated syphilis in the negro male
  • faculty advisor/research mentor or the IRB office
What statement about risks in social and behavioral sciences research in most accurate?
  • studies collecting data about living individuals
  • all foreseeable risks and discomforts
  • risks are specific to time, culture, situation
  • Respect for persons, beneficence, Justice
What is the IRB charged with?
  • potential benefits justify the risks of harm
  • protecting the rights and welfare of human subjectsassuming that all applicable institutional policies and federal regulations related to research with human subjects are followedreviewing subjects recruitment materials and strategies
  • destroying all identifiers relating to the data
  • Determining that the study has a maximization of benefits and minimization of risks
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 cognitive psych enrolls undergrad students for comp. based study about the effect of mood on problem solving behaviors
  • A study in which subjects were assigned to study activities based on an undesirable physical characteristic as assessed by members of research team
  • This review is wrong because 45 CFR 46.101 (B) states that prisoner research MAY NOT be exempt
  • The public health service tuskegee study of untreated syphilis in the negro male
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?
  • no human subjects
  • the researchers cannot control what participants repeat about others outside the group
  • full board review
  • experience emotional or psych distress
According to the federal regulations, which meets criteria for human subjects?
  • the only record linking the subject and the research is the consent document and the principal risk is a breach if confidentiality
  • 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 monthsanother answer: a developmental psych videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggressions
  • a cognitive psych enrolls undergrad students for comp. based study about the effect of mood on problem solving behaviors
  • A study in which subjects were assigned to study activities based on an undesirable physical characteristic as assessed by members of research team
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