Feedback Week 9 Diss DDHA 8600
Hi xxx,
The IRB has the power to approve, require modifications to (in order to secure
approval), or disapprove human subjects research. An IRB must review and approve all
research involving humans before the study begins. An IRB may not review projects
retrospectively. This includes proposed research involving previously collected human fluid
and tissue samples and existing data, as well as advertising and recruitment procedures. In
order to approve research, an IRB must determine that risks to subjects are minimized and
reasonable in relation to anticipated benefits, selection of subjects is equitable, subjects are
adequately consented, data are appropriately monitored, the privacy of subjects i
maintained and the resulting data kept confidential, and vulnerable subjects are protected
[3]. In short, the objective of an IRB is to ensure, both in advance and by periodic review
and monitoring, that the rights and welfare of humans participating as subjects in a
research study are protected. To accomplish this goal, IRBs meet to assess research
protocols and their associated materials (e.g., informed consent documents and
advertisements). IRB oversight is complex and includes several activities with numerous
levels of IRB review and supervision. (Parker, 2016)
Reference
Parker, G. (2016). A Framework for Navigating Institutional Review Board (IRB)
Oversight in the Complicated Zone of Research. Cureus, 8(10).
https://doi.org/10.7759/cureus.844
Hi XXX,
An organization is considered engaged in human research 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 the subjects of the research; 3) informed consent of human subjects for the research;
OR 4) a direct federal award to conduct human subject research, even when all activities
involving human subjects are carried out by subcontractors (i.e. employees or agents of
another organization).
HI XXX,
It is common for investigators from two or more institutions to partner to conduct human
subjects research or be involved in multi-site research studies. To conserve resources and
enhance and streamline the institutional review board (IRB) review process when such
collaborations occur, regulations allow institutions to "enter into a joint review arrangement, rely
upon the review of another qualified IRB, or make similar arrangements for avoiding duplication
of effort" (45 CFR 46.114). In other words, regulations allow research partners to agree to rely
on a single IRB for review and approval of their non-Exempt study