*****Please reply to my classmate as me. Please do not criticize my classmate’s post
****references must be within 4 years.
The Institutional Review Board (IRB) was designed to review and monitor biomedical research involving human subjects (Center for Drug Evaluation and Research, 2019). In compliance with FDA regulations, IRB can approve or disapprove research or require modifications to obtain approval. IRB review takes appropriate steps to protect the welfare and rights of humans participating as subjects in the study. Ethical considerations related to research on human subjects include respect for persons, beneficence, and justice. These principals make up the Belmont Report. Respect for persons recognizes a patient’s autonomy. The amount of protection for an individual depends on a patient’s capacity for self-determination, the risk of harm, and the likelihood of the benefits offered by the research (Center for Drug Evaluation and Research, 2019).
Before IRB approval and conducting a study, researchers must analyze potential risks and benefits to the research participants and appear in the written informed consent (Barrow et al., 2022). Potential hazards include physical harm, loss of privacy, unforeseen side effects, physical discomfort, emotional distress, costs, and loss of time. Potential benefits include increased understanding of a medical condition, access to a potentially valuable intervention, and satisfaction of helping others with similar issues (Barrow et al., 2022). During the 19th and 20th centuries, the burdens of serving as research subjects fell considerably upon poor ward patients, while the benefits of improved medical care transferred to private patients. This is an example of disruptive justice and violates a patient’s autonomy.
References
Barrow, J. M., Brannan, G. D., & Khandhar, P. B. (2022, September 18). Research ethics – statpearls – NCBI bookshelf. Retrieved January 22, 2023, from https://www.ncbi.nlm.nih.gov/books/NBK459281/
Center for Drug Evaluation and Research. (2019, September 11). Institutional review boards (IRBs) and protection of human subjects in clinical trials. U.S. Food and Drug Administration. Retrieved January 22, 2023, from https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials
