In general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1)
data about the subjects of the research through intervention or interaction with them
; (2) identifiable private information about …
What procedures must be described in an agreement called an assurance?
What procedures must be described in an agreement called an “assurance of compliance” with OHRP?
procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule
, including review by an independent committee comparable to an IRB.
Which is true of 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.
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!
What is engagement in research?
In brief, an “engaged” institution is
one whose agents (faculty, students, or staff) recruit and secure consent from subjects, conduct research procedures, or who receive or share private, identifiable information
. … This definition parallels the federal definition of research with human subjects.
What is public engagement in research?
Public engagement describes
the myriad of ways in which the activity and benefits of higher education and research can be shared with the public
. Engagement is by definition a two-way process, involving interaction and listening, with the goal of generating mutual benefit.
Why do we engage in research?
Research allows you to pursue your interests, to learn something new, to hone your problem-solving skills and to challenge yourself in new ways
. Working on a faculty-initiated research project gives you the opportunity work closely with a mentor–a faculty member or other experienced researcher.
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
.
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.
When the primary potential harm is the?
When the primary potential harm is
the breach of individually identifiable data
, to protect against such disclosure the researcher should. Encrypt the data and store it in password protected files.
What are 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. NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation.
Which type of IRB review does not require?
“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 is an example of a situation where deferential vulnerability might be a factor?
Deferential vulnerability is when
a person feels subordinate to another person due to social class, knowledge, or gender
. Many people feel this way when they compare themselves to medical doctors due to the physicians having more knowledge and being considered to be of a high social class.
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 the IRB 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.
How long does the IRB process take?
How long does IRB review take? An
expedited or exempt review may take about two weeks
. Studies requiring convened review may take three or more weeks. The PI has a significant influence on the length of time between submission and approval.
