Three principles of Belmont Report - ANSWER-Respect for Persons
Beneficence
Justice
The Belmont Report
Principle of Beneficence -
... [Show More] ANSWER-MAXIMIZATION of benefits and MINIMIZATION of risks
T/F
Belmont Report indicates it is necessary to rigorously avoid conflicts of interest - ANSWER-TRUE
The Belmont Report
Respect for Person - ANSWER-Requires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent)
The Belmont Report defines and delineates... - ANSWER-"Practice" and "Research"
The Belmont Report
The Principle of Justice - ANSWER-Research benefit and burden distribution and that selection of subjects is fair.
T/F
The Belmont report describes the necessity to effectively manage conflicts of interest - ANSWER-FALSE
Students in Research
The history of ethical regulations in human subjects research began with the - ANSWER-Nuremberg Code
Nuremberg Code - ANSWER-Human subjects research guidelines and regulations
Year of the Nuremberg Code - ANSWER-1949
Additional resources regarding IRB approval process - ANSWER-Faculty advisor/Research Mentor
IRB office
Human subjects research websites
What element must be included in an informed consent? - ANSWER-All foreseeable risks and discomforts
Which type of IRB review does not require and IRB approval but DOES require a Determination by the IRB? - ANSWER-If the study qualifies for EXEMPTION
Another name for the "Exempt" status - ANSWER-the Common Rule
stated in Title 45 Part 46 Subpart A
How can faculty researchers avoid coercion of student subjects? - ANSWER-Avoid using their own students in their research
Name the type of Review: Research study that involves use of educational tests, survey, interviews, or observations of public behavior without identifiable information. - ANSWER-Exempt Review category 2
Name the type of review: A study involving data collected that could have an impact on human subject's careers and it contains identifiers of the subjects. - ANSWER-Full Board Review
Type of review that qualifies if no identification of subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal - ANSWER-Expedited review
Type of review: data that is collected does not meet definition of human subjects research as stated by federal regulations. No info ABOUT human ie. info about a business - ANSWER-Not Human Subjects
Federal regulations define human subjects as "living individual about whom an investigator conducting research obtains"...? (2 components) - ANSWER-"1.data through intervention or interaction with the individual
2. identifiable private information"
Name the 3 responsibilities the IRB is charged with - ANSWER-1. Protecting the rights and welfare of human subjects
2. Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed
3. Reviewing subject recruitment materials and strategies
T/F
IRB's investigate scientific misconduct - ANSWER-False
T/F
IRB's do not review manuscripts prior to submission for publication - ANSWER-True
DHHS
FDA - ANSWER-Depts. IRB's review for current policies
-Department of Health and Human Services
-Food and Drug Administration
Name the study that links most directly to the establishment of the National Research Act in 1974 and ultimately the Belmont Report and Federal regulations for human subject protection - ANSWER-The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male
The Tuskegee Study relates to which Belmont principle? - ANSWER-The principle of beneficence: Potential benefits justify the risks of harm
Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of: - ANSWER-Respect for persons
Belmont Report
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: - ANSWER-Justice
How is the principle of beneficence applied to a study involving human subjects? - ANSWER-Ensuring that risks are reasonable in relationship to anticipated benefits.
Human subject study or not?
Developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression - ANSWER-Yes
Human subject study or not?
The study of a list with deceased passengers - ANSWER-No:Human subject is a living individual
Human subject study or not?Questioning individuals to acquire data about the number of newly diagnosed HIV cases? - ANSWER-No: 'what' question rather than 'who' question
Human subject study or not?
Conducting linguistic analysis of comments posted on a public blog - ANSWER-Not: involves neither interaction with individuals nor collecting private identified info
Human subject study or not?
A study proposed by developmental psychologist involving interactions with living individuals and designed to contribute to field of knowledge - ANSWER-Yes: humans
Human subject study?
A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors - ANSWER-Yes: Interacting w/ living individuals.
Human subject study or not?
Questioning a superintendent of schools to acquire data about the ethnic composition of a school - ANSWER-No: it is an "about what" question rather than "about whom" question
Human subject study or not?
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 assessments of reading comprehension for each child over 3-month period - ANSWER-Yes: contributes to generalizable knowledge about student performance and research question can only be answered using systematic investigation
Human subject study or not?
Info collected by play ground designer - ANSWER-No: does not involve info about human subjects even though there is interactions between designer and school staff.
Human subject study or not?
An analysis of aggregate data - ANSWER-No: doesn't involve interactions w/ living individuals nor collection of private identifiable data
Human subject study or not?
An economic feasibility study - ANSWER-No: does gather info from people with relevant info and expertise but does not meet the definition of research w/ human subjects, because the intention of the study is to answer "about what" ? rather than "about whom" ?
According to fed. regulations, human subjects are living human beings about whom an investigator obtains data through interactions or intervention with the individual or: - ANSWER-identifiable PRIVATE information
(Public info does not meet criteria)
Subpart of DHHS regulations provides additional protections for which vulnerable populations? - ANSWER-1. Pregnant women
2. Fetuses
3. Neonates
4. Prisoners
Subpart of DHHS regulations Does NOT provide additional protections for which vulnerable populations? - ANSWER-1. elderly
2. students
3. for persons whose decision-making capabilities are impaired
The expedited review process may be used when the study procedures pose: - ANSWER-No more than minimal risk and the research activities fall within regulatory categories identified as eligible
The expedited review process may NOT be used when the study procedures pose: - ANSWER--more than minimal risk, even if the subjects are adults,
-the sponsor is in a hurry
-the study replicates previously approved research
Continuing review of an approved and ongoing protocol...? - ANSWER-Must occur within 12 months of the approval date
(even if no additional risks have been identified)
Continuing review process must include: - ANSWER--unanticipated problems
-number of subjects accrued
-recent relevant literature
-copy of current consent form
T/F
Officials of the institution may overrule an IRB approval - ANSWER-True, however no one may overrule if an IRB disapproved a protocol
An investigator wishes to study generational differences in coping mechanisms among adults who experiences abuse as children. Adequate meausre will be instituted to obtain consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may: - ANSWER-Experience emotional or psychological distress
If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which would be the most helpful? - ANSWER-Obtain a waiver of documentation of informed consent
The primary purpose of a Certificate of Confidentiality is to: - ANSWER-Protect identifiable research info from compelled disclosure
Certificates of Confidentiality protect sensitive info provided by research subjects from: - ANSWER-civil, criminal, or administrative subpoena
T/F
Risk should be evaluated solely by the magnitude or severity of expected harm, not probability - ANSWER-False: Risk must be determined by assessing magnitude (or severity) and probability (or likelihood) of harm. Both elements must be considered. [Show Less]