West Coast University Facilitating Timely Institutional Review Board Review Responses – Description
Post 1
Hi class,
IRBs are responsible for confirming that research protocols are developed following federal regulations based on Protection of Human Subjects guidelines. The regulation’s guiding ethical principles are respect for individuals, beneficence, and justice. The primary purpose of an IRB is to ensure that the rights, welfare, and well-being of people participating in research activities are protected following federal regulations (Phillips et al., 2017). More specifically, the required component for an IRB review and approval is required for projects that: 1.meet the definition of research, 2. involve human subjects, and include any interaction or intervention with human subjects or involve access to identifiable private information (Phillips et al., 2017).
In a study conducted by Balogun et al (2016), research that needed IRB approval consisted of 28 trials conducted involving 107,362 women in seven countries to identify and evaluate the effectiveness of different health promotion activities intended to increase the early initiation rate of breastfeeding (Balogun et al., 2016). The studies compared professional health worker-led breastfeeding education on women during both prenatal and postpartum periods, to non-healthcare professional-led breastfeeding education. Other comparisons made were of the rates of initiation of breastfeeding.Balogun et al (2016) found low-quality evidence that health worker-led breastfeeding education, non-health worker-led breastfeeding education, and peer support intervention resulted some increase in initiation of breastfeeding.
The study needed IRB approval because it involved human subjects and intervention and is considered research by federal law. Breastfeeding women were evaluated, and the IRB team was required to review the study. The purpose of the IRB review process was to protect the rights of the people who took part in the research and ensure that the study was done ethically and responsibly. The IRB approved the study because the researchers had informed consent from all the research participants.
Balogun, O. O., O’Sullivan, E. J., McFadden, A., Ota, E., Gavine, A., Garner, C. D., Renfrew, M. J., & MacGillivray, S. (2016). Interventions for promoting the initiation of breastfeeding. https://doi.org/10.1002/14651858.cd001688.pub3
Phillips, M. S., Abdelghany, O., Johnston, S., Rarus, R., Austin-Szwak, J., & Kirkwood, C. (2017). Navigating the Institutional Review Board (IRB) Process for Pharmacy-Related Research. Hospital Pharmacy, 52(2), 105–116. https://doi.org/10.1310/hpj5202-105
Post 2
Hi Class,
According to American Psychological Association (2017), institutional review board is the part of a university or organization that receives government research funding and evaluates research proposals. Research proposals will be thoroughly evaluated by the Institutional Review Board prior to project submission to assess whether the research project complies with federal regulations and ethical principles that safeguard human rights and have the authority to whether to approve, disapprove, or request change of the project (American Psychological Association, 2017).
The required components that are needed to determine if institutional review board is first determining if the project requires an institutional review board by reviewing the flow chart that has human subject regulations that is broken down to 14 different charts (University of Rhode Island, n.d.). Looking through the requirements and when you will need to be reviewed by the institutional review board and needs its approval is meeting the definition of research, human participants are involved in the project, and intervention and interaction with human participants that have private identification information (University of Rhode Island, n.d.).
Institutional review board submission is needed for studies that contain the following:
Master’s theses
Dissertations
Pilot studies that involve human subjects
Identifiable information that contain information from medical records, employment records, student records, and private sources.
Research studies that include subjects to examine devices, supplements, foods, products, and drugs (University of Rhode Island, n.d.).
One of the studies from my literature review article, I choose to discuss about is Frank et al (2022) study that used 180 geriatric patients with acute and chronic unipolar depression that have non psychotic features separate the participants in 4 groups that include: antidepressant group, placebo group, antidepressant plus interpersonal therapy group, and placebo plus maintenance interpersonal therapy group. This study requires institutional review board to approve the project because it involves human participants, medication administration, identifiable information, and interaction and intervention with human subjects.
Reference:
American Psychological Association. (2017). Frequently asked questions about institutional review boards. https://www.apa.org/advocacy/research/defending-re…Links to an external site.
The University of Rhode Island. (n.d.). Human subjects protections: Does my research need IRB review? https://web.uri.edu/research-admin/office-of-resea…
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