Three principles of Belmont Report
Respect for Persons
Beneficence
Justice
The Belmont Report
Principle of Beneficence
MAXIMIZATION of
... [Show More] benefits and MINIMIZATION of risks
T/F
Belmont Report indicates it is necessary to rigorously avoid conflicts of interest
TRUE
The Belmont Report
Respect for Person
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...
"Practice" and "Research"
The Belmont Report
The Principle of Justice
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
FALSE
Students in Research
The history of ethical regulations in human subjects research began with the
Nuremberg Code
Nuremberg Code
Human subjects research guidelines and regulations
Year of the Nuremberg Code
1949
Additional resources regarding IRB approval process
Faculty advisor/Research Mentor
IRB office
Human subjects research websites
What element must be included in an informed consent?
All foreseeable risks and discomforts
Which type of IRB review does not require and IRB approval but DOES require a Determination by the IRB?
If the study qualifies for EXEMPTION
Another name for the "Exempt" status
the Common Rule
stated in Title 45 Part 46 Subpart A
How can faculty researchers avoid coercion of student subjects?
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.
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.
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
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
Not Human Subjects
Federal regulations define human subjects as "living individual about whom an investigator conducting research obtains"...? (2 components)
"1.data through intervention or interaction with the individual
2. identifiable private information"
Name the 3 responsibilities the IRB is charged with
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
False
T/F
IRB's do not review manuscripts prior to submission for publication
True
DHHS
FDA
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
The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male
The Tuskegee Study relates to which Belmont principle?
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:
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:
Justice
How is the principle of beneficence applied to a study involving human subjects?
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
Yes
Human subject study or not?
The study of a list with deceased passengers
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?
No: 'what' question rather than 'who' question
Human subject study or not?
Conducting linguistic analysis of comments posted on a public blog
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
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
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
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
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
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
No: doesn't involve interactions w/ living individuals nor collection of private identifiable data
Human subject study or not?
An economic feasibility study
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:
identifiable PRIVATE information
(Public info does not meet criteria)
Subpart of DHHS regulations provides additional protections for which vulnerable populations?
1. Pregnant women
2. Fetuses
3. Neonates
4. Prisoners
Subpart of DHHS regulations Does NOT provide additional protections for which vulnerable populations?
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:
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:
-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...?
Must occur within 12 months of the approval date
(even if no additional risks have been identified)
Continuing review process must include:
-unanticipated problems
-number of subjects accrued
-recent relevant literature
-copy of current consent form [Show Less]