Why should researchers and IRBs be concerned with the legal status of GSD people?
Legal vulnerabilities may increase the risks to subjects from a breach of confidentiality
.
Which of the following studies would need an IRB approval?
Which of the following studies need IRB approval?
Studies collecting data about living individuals
. If a study intends to collect data or information about the living individual, an IRB review and approval must be obtained.
Which of the following is something an IRB should do with respect to review of GSD research?
Which of the following is something an IRB should do with respect to review of GSD research?
Seek consultants with expertise in specific segments of GSD communities to provide information on research in those communities
.
What action can he expect by the IRB?
The researcher submits the research proposal to the institution’s IRB. What action can he expect by the IRB?
The IRB will not review this study because
it is not research as defined by the federal regulations. You just studied 35 terms!
Which type of IRB review does not require IRB approval?
“Exempt” human subjects research
is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.
What statement about risks in social and behavioral sciences research is most accurate:
Risks are specific to time, situation, and culture
. The primary purpose of a Certificate of Confidentiality is to: Protect identifiable research information from compelled disclosure.
Which of the following is considered a SBR?
Short-barreled rifle
(SBR) is a legal designation in the United States, referring to a shoulder-fired, rifled firearm, made from a rifle, with a barrel length of less than 16 in (41 cm) or overall length of less than 26 in (66 cm), or a handgun fitted with a buttstock and a barrel of less than 16 inches length.
What is the primary purpose of a certificate of confidentiality?
Certificates of Confidentiality are issued by the National Institutes of Health (NIH) and other HHS agencies
to protect identifiable research information from forced or compelled disclosure
.
What is the common rule in clinical research?
The Common Rule is
the baseline standard of ethics by which any government-funded research in the US is held
; nearly all U.S. academic institutions hold their researchers to these statements of rights regardless of funding.
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 are the three types of IRB review?
IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major types of review:
Exempt, Expedited, and Full
.
What is IRB and its process?
Under FDA regulations, an IRB is an appropriately constituted group that has
been formally designated to review and monitor biomedical research involving human subjects
. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.
What does IRB stand for?
What is the IRB? IRB stands for “
Institutional Review Board
”. The IRB is a committee established to review and approve applications for research projects involving human subjects. The primary purpose of the IRB is to protect the rights and welfare of the human subjects.
Which type of research does not need to get an 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 happens if you don’t get IRB approval?
What’s the worst that can happen if I don’t get IRB approval? Aside from potential ethical implications for the subjects and for the researcher, bypassing IRB review brings other risks: Students: …
Degrees will not be awarded for work based on research involving human subjects
that was not approved by the IRB.
How do you know if you need IRB approval?
The Regulations
IRB review and approval is required for projects that:
Meet the definition of research
.
Involve human subjects
and. Include any interaction or intervention with human subjects or involve access to identifiable private information.
