When IRBs are applying the federal regulatory criteria for approval to
protocols involving socially or economically disadvantaged persons
: Which of the following describes an alternative method to recruit subjects using technology?
What are the criteria for IRB approval?
- Social or Scientific Value.
- Scientific Validity.
- Fair Subject Selection.
- Favorable Risk – Benefit.
- Independent Review.
- Informed Consent.
- Respect for Potential and Enrolled Subjects.
Which of the following studies would need 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 a general consideration for IRBs reviewing Big Data?
Which of the following is a general consideration for IRBs reviewing big data 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 example of research with prisoners would be allowable under the?
Examining age at the first arrest
is the example of research in which prisoners would be allowable under the regulations. Further Explanation: The age of the criminal is examined because to check the history of the criminal of adult crime. Research on criminals is governed by federal laws.
How do I submit IRB approval?
- Step 1: Determine if your project requires IRB approval. …
- Step 2: Complete the Mandatory Online Certification for Researchers. …
- Step 3: Complete the IRB Research Project Application. …
- Step 4: Prepare the Informed Consent Document(s) …
- Step 5: Submit Proposal Form.
What are some common activities of an Hrpp or IRB office?
Make determinations about whether a research study can be
exempt from the Common Rule Assist investigators with submitting protocols to the IRB for review Conduct audits of research data Provide administrative support for IRB full board meetings Help ensure that.
Which type of IRB does not require 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 must an informed consent form describe?
(21 CFR 50.25(a)(1).)
A description of any reasonably foreseeable risks or discomforts to the subject
. (21 CFR 50.25(a)(2).) The informed consent process must describe the reasonably foreseeable risks or discomforts to the subject.
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 are the best practices to secure big data?
- Protect Authentication Gateways. Weak authentication mechanism is one of the most common factors that contribute towards data breaches. …
- Employ Principle of Least Privilege. …
- Make Use of Retrospective Attack Simulation: …
- Use Latest Antivirus Protection: …
- Schedule Periodic Audits:
What are the three fundamental principles of informed consent?
According to the report, informed consent requires three elements:
information, comprehension and voluntariness
.
Who can grant waivers of informed consent?
The National Statement on Ethical Conduct in Human Research states that a waiver of consent can only be granted by a
fully constituted Human Research Ethics Committee (HREC)
. The HREC can only grant a waiver if sufficient justification is provided, and the necessary criteria are met.
What are the two common structural models used in a research administration office?
What are the two common structural models used in a research administration office? The types of structures used in research administration typically fall into one of three categories:
centralized, decentralized, or hybrid
. Each of these models has distinct strengths and weaknesses.
What three questions must an IRB include in its Ferpa checklist?
What three questions must an IRB include in its FERPA checklist? Is there
written permission to collect the data
? Will the use of the data be for a legitimate educational interest? Will the disclosure be to another educational institution?
What is the term for management controls that are?
What is the term for management controls that are built in to a research study (for example, independent data analysis)?
Inherent controls
.
