Week 9 Diss DDHA 8600
Post an explanation of what steps you, as a current or future healthcare administration leader, might take to address the issues with IRB as presented in the scenario.
The current leadership need to defer IRB oversight to another IRB until corrective action
has been taken to ensure the IRB is functioning in an ethical manner. The use of external IRB is
very common practice in many institutions. When relying on an external IRB, whether it is for a
single research project or a portion of the organization's research portfolio, the external IRB will
meet Federal regulations for the conduct of research and IRB review.
Studies on human are imperative for medical progress and have expanded our
understanding and capability to treat serious diseases and entities. However, research with
humans needs to consider the ethical dimensions of the reasons for running an experiment and
the proper procedural steps to ensure that the results reflect good science. Protecting human
participants in research is top priority and has been given great consideration in the ethical
conduct of research because the exact risks and benefits of research are uncertain (Wolf, 2005)
Researchers must effectively organize their resources to efficiently assess the many issues
that arise during a clinical study. There are numerous ethical standards that govern research with
human participants in the United States which are codified in the CFR. While regulations may
evolve over time, the primary IRB responsibility of protecting the rights and welfare of humans
participating in research studies will continue(Kim, 2012).
Unfortunately, instances where clinical investigators fail to acquire proper IRB oversight
have occurred. In these cases, the investigator is often dismayed to find out an IRB cannot
retrospectively review their study and, because of such, they cannot publish results in a peer-
reviewed journal or use the data in a regulatory submission. Questions that arise often
include(Parker, 2016):
- Does an IRB need to oversee my research study?
- Will my project require continual IRB oversight?
- What level of IRB review does my investigation require?
- Do I need to let the IRB know when my project is done?
References
Kim, W. (2012). Institutional review board (IRB) and ethical issues in clinical research. Korean
Journal Of Anesthesiology, 62(1), 3. https://doi.org/10.4097/kjae.2012.62.1.3
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
Wolf, L. (2005). Human Subjects Issues and IRB Review in Practice-Based Research. The
Annals Of Family Medicine, 3(suppl_1), S30-S37. https://doi.org/10.1370/afm.302
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 fii.e. employees or