Exempt Research
Although the category is called “exempt,” this type of research does require IRB review and the determination of exemption must be made by the IRB. The exempt determination process is much less rigorous than an expedited or full-committee review.
When an IRB is reviewing a research study and they are considering if a potential subject is vulnerable?
It is such an administrative body that is founded to ensure the protection of human beings which take part in research projects. So, when an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable,
they will ensure the safety of human subjects involved
.
What are true inducements in research?
Which is true of inducements in research? Inducements constitute
an “undue influence” if they alter a potential subject’s decision-making processes
, such that they do not appropriately weigh the risk-benefit relationship of the research.
Which of the following studies would need IRB approval?
Which of the following studies need IRB approval?
Studies collecting data about living individuals
.
When reviewing research funded by the US Department of Education Ed that involves children with mental disabilities IRB must?
When reviewing research funded by the U.S. Department of Education (ED) that involves children with mental disabilities, an IRB must: – Include
an individual in the review who is primarily concerned with the welfare of these subjects
.
Which of the following are the three principles included in the Belmont Report?
The Belmont Report summarizes ethical principles and guidelines for research involving human subjects. Three core principles are identified:
respect for persons, beneficence, and justice
.
What are the three forms of IRB review that a research proposal may be subject to?
- Exempt Review. Studies that receive an exemption determination from IRB are exempt from the specific regulations and requirements in Title 45, Part 46 of the Code of Federal Regulations. …
- Expedited Review. …
- Full Review.
Does exempt research require IRB review?
Exempt research must be initially reviewed by the IRB
, but is then exempt from further review. Projects that do not meet the criteria for human subjects’ research are excluded from IRB review. Qualified IRB staff or members review applications to determine eligibility for exempt status.
Which statement best describes what an IRB is responsible for reviewing?
Terms in this set (7)
– FDA states that
IRB has the authority to approve, require modifications in (to secure approval)
, or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
When a researcher is conducting an interpreter mediated consent discussion with subjects which of the following is an appropriate action for the interpreter?
When a researcher is conducting an interpreter-mediated consent discussion with subjects, which of the following is an appropriate action for the interpreter?
The interpreter may explain research-related terms to the subject using culturally relevant examples
.
Which of the following is most likely to be considered a conflict of commitment?
Which of the following most accurately describes a conflict of commitment? It occurs
when outside activities interfere with obligations to one’s primary employer
.
What is IRB approval in research?
What is an Institutional Review Board (IRB)? … In accordance with FDA regulations, an IRB
has the authority to approve, require modifications in (to secure approval)
, or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
Which choice best describes the purpose of most pharmacogenomic research?
To evaluate the association between individual genotypes and the safety and efficacy of a particular drug or class of drugs
.
What is expedited review in research?
[1] An expedited review procedure consists of
a review of research involving human subjects by the IRB chairperson
or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.
What information should be provided to an IRB for review at the initiation of a study?
The study protocol (and amendments), the information to be given to the subject (informed consent, advertisements), the Investigator Brochure (or drug label), any other relevant safety information, and
an outline of the qualifications of the investigator
.
Is it ethical to use deceptive methods in research when the scientific goals of the project can be achieved by non deceptive methods?
It is ethical to use deceptive methods in research when the scientific goals of the project can be achieved by
non-deceptive methods
.
What is assessment of consent capacity?
Capacity to consent is defined as
the ability to provide legally effective consent to enroll in a research study
. When an adult does not have the capacity to consent to participate in the research, they cannot take part without the consent of their legally authorized representative (LAR).
What are the 4 important ethical issues IRB guidelines address?
- Respect for persons: respect for patient autonomy.
- Beneficence: maximize benefits and minimize harm.
- Justice: Equitable distribution of research burdens and benefits.
Which discuss the protection of human subjects?
“Human Subjects Protections” is a collective term for the
federal, state, and university policies, procedures, and ethical considerations
that protect the rights and welfare of human beings who participate in research as the subjects of that research.
What are the three 3 main ethical principles from the Belmont Report that are integrated into the common rule provide an example of each?
One of these, the Belmont Report, published in 1978, described the three ethical principles on which the procedural requirements of the Common Rule are based. These principles are
respect for persons, beneficence, and justice
.
Which of the following best describes when a protocol may be eligible for expedited review by IRB?
Which of the following best describes when a protocol may be eligible for expedited review by the IRB:
The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified by the federal government
.
Why do research proposals need to be reviewed by an IRB?
The IRB reviews the proposals before a project is submitted to a
funding agency to determine if the research project follows the ethical principles and federal regulations for the protection of human subjects
. The IRB has the authority to approve, disapprove or require modifications of these projects.
What are the three determinations that the IRB makes for each research application?
There are three (3) types of review paths for an IRB application:
Full Board, Expedited, and Exempt
. The review path is determined by: Level of risk to subjects associated with the project. The type of research being conducted (e.g., an educational intervention, a survey, an ethnographic observation, etc.)
What is limited IRB review?
Limited IRB review is
a process that is required only for certain exemptions
, and does not require an IRB to consider all of the IRB approval criteria in §46.111. In limited IRB review, the IRB must determine that certain conditions, which are specified in the regulations, are met.
Do you need IRB approval for qualitative research?
All non-exempt research involving human subjects must have advance IRB approval. …
Qualitative research often does not need IRB
, Meyer said.
Do all studies need IRB approval?
IRB approval is required regardless
of the site of the study or the source of funding (if there is funding).
Which institutional criteria are used to review an IRB application?
Criteria for IRB Approval of Research
Risks
to subjects are reasonable in relation to the anticipated benefits
… Informed consent will be sought from each prospective subject or the subject’s legally authorized representative … as required by #46.116.
What best describes the purpose of the IRB?
What is the purpose of Institutional Review Board (IRB)? The
purpose it to give ethical approval to the study.
Which of the following brought increased public attention to the problems with the IRB system Citi?
Which of the following brought increased public attention to the problems with the IRB system?
Death of Jesse Gelsinger
(Although all of these are related to the problems with the IRB system, the death of Jesse Gelsinger was what received public attention.)
What research does not require IRB approval?
Publicly available data
do not require IRB review. Examples: census data, labor statistics. Note: Investigators should contact the IRB if they are uncertain as to whether the data qualifies as “publicly available.”
What is the role of an Institutional Review Board IRB quizlet?
Institutional review boards (IRBs) are tasked with
reviewing all studies involving human subjects to protect their rights and welfare
.
Is informed consent required?
Informed consent is
mandatory for all clinical trials involving human beings
. The consent process must respect the patient’s ability to make decisions and adhere the individual hospital rules for clinical studies.
What is the institutional review board charged with quizlet?
Institutional Review Boards are charged with
protecting the rights and welfare of human subjects recruited to participate in research activities conducted under the auspices of
the institution to which the IRB is affiliated.
Which of the following issues is the most important for the IRB to consider?
When conducting research that involves collecting biological specimens for genetic testing, which of the following issues is the most important for the IRB to consider? … However,
potential effects of research findings on family members
is the most important consideration.
Which choice best describes the purpose of most pharmacogenomic research quizlet?
Which choice best describes the purpose of most pharmacogenomic research?
Investigator A has biological specimens that are coded and linked to identifiers of the source individuals
.
What is the main focus of NIH conflict of interest policy?
The purpose of the rule is to “
promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under Public Health Service (PHS) grants or cooperative agreements will be free from
bias resulting from Investigator financial …
What position is responsible for overseeing the conflict of interest process?
2.8. 1.1
The President or his or her designee
shall appoint a conflict of interest official who is responsible for overseeing implementation of this policy and who may provide additional procedures and supplementary forms, as appropriate, consistent with this policy and applicable sponsor regulations.
What types of studies require IRB review?
FDA regulations generally require IRB review and approval of
research involving FDA-regulated products
(e.g., investigational drugs, biological products, medical devices and dietary supplements) (21 CFR Part 56).
Why would an IRB not approve a research study?
For example, the IRB must not approve a proposed research project undergoing
initial review
when the IRB (a) is unable to make the required determinations about research risks and benefits, the adequacy of privacy and confidentiality protections, or the adequacy of the informed consent process because the research …
