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Prior to conducting studies, it is critical to give necessary consideration to the potential ethical issues and the degree to which they are safe and ethically appropriate. The Institutional Review Board (IRB) was established to protect human rights by reviewing planned research on human subjects and giving approval to organizations willing to conduct research (Takamura & Petrigliano, 2019). Before implementing DPI and QI projects in any clinical site, including the family doctor’s office, researchers should consider the characteristics of the planned intervention to decide whether approval from IRB needs to be obtained.
The first step involves defining the project’s nature to determine subsequent actions. For activities that are solely focused on QI and do not involve research (randomization, potential risks, actions to prove a hypothesis), no IRB approval is required (The Virginia Commonwealth University Office of Research and Innovation, n.d.). Some QI projects, however, qualify as research, which is why each case should be analyzed individually.
If it has been found that the planned QI or DNP project involves research and potential physical, psychological, or any other risks to participants, researchers should proceed with the next steps. For the second step, researchers should get acquainted with requirements for materials to be submitted and make sure that they have the necessary training to implement the project (The Penn State Office of the Vice President for Research, n.d.).
The third step is making a submission to the IRB, which involves preparing and uploading a range of documents, including study protocols, descriptions of different team members’ roles in research, as well as their professional qualifications (The Penn State OVPR, n.d.).
Researchers should also submit sample recruitment materials, informed consent forms, any grant application forms, and any documents to demonstrate data collection tools and materials that will be used by participants (The Penn State OVPR, n.d.). Researchers may use the services of IRB analysts to receive the results of preliminary reviews and speed up the process. After submission, a project is assigned one of three review levels, which impacts the number of business days that the review process takes. After getting approval, researchers may be required to report information on unexpected cases and occurrences during the study.
References
Takamura, K., & Petrigliano, F. (2019). The ethical approval process. In V. Musahl, J. Karlsson, M. T. Hirschmann, O. Ayeni, R. Marx, J. L. Koh, & N. Nakamura (Eds.), Basic methods handbook for clinical orthopaedic research (pp. 75–81). New York, NY: Springer.
The Penn State Office of the Vice President for Research. (n.d.). IRB basic steps. Web.
The Virginia Commonwealth University Office of Research and Innovation. (n.d.). Quality improvement vs. research – Do I need IRB approval? Web.
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