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- QUESTION
Answer the following questions with not less than 300 words each answer and at least one reference each.
- Think back on your National Institute of Health (NIH) training and share what you learned. How will this apply to having an IRB form completed and why?
- IRB is an important step in research. State the required components one should look for in a project to determine if IRB submission is needed. Discuss an example of a research study found in one of your literature review articles that needed IRB approval. Specifically, describe why IRB approval was needed in this instance.
- Visit the Yale Center for Bioethics Cases in Research Ethics Choose one of the three cases below to read and respond to in this week’s discussion. Be sure to read the background of the study, the ethical and regulatory issues raised by the IRB, and the comments presented at the end of each case.
Choose from one of these three cases:
Case 1: Payments to subjects who are substance abusers
Case 5: Reasonable right to privacy for patients accessing hospital services
Case 6: An ethnographic study of homeless adolescents
Address the following in your response:
Identify the key ethical issues that are questioned in this case and the category of risk: physical, psychological, social, or economic harm.
Do you feel the level of questioning and concern by the IRB was appropriate?
Were you surprised by any of the IRB’s decisions? Explain.
Identify a risk or red flag in this study that you may not have considered on your own prior to reading this study.
Present a new perspective you gained about the IRB, the type of study you read about, the ethics involved, or human subject research processes
Subject | Nursing | Pages | 5 | Style | APA |
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Answer
IRB Response Paper
The National Institute of Health is responsible for all research programs regarding biomedical and public health in the U.S. Studying at NIH enables an individual to learn new things and develop new knowledge regarding biomedical and public health research particularly human research protection. The NIS training helped me to broaden my knowledge concerning a lot of significant factors in human research including the procedures and regulatory laws. Human research is crucial in facilitating the discovery of new ideas, methods, and procedures in the medical sector. For instance, it helps in the discovery of new and better drugs for particular illness as well as better ways for conducting various procedures in the medical world such as surgical operations, (Grady et al 19-31). Biomedical and public health research play a significant role in the advancement of the health sector across the globe. Control and treatment of diseases get easier and efficient each day due to substantial investments directed on research. However, research does not only entail the work input aimed at achieving results, but it also includes a lot of other aspects including the governing laws and procedures, (Guetterman et al, 52-68) . The training at NIH helps the trainees to learn and understand how the Institutional Review Board (IRB) worK. IRB is the administrative body to protect the rights and human research subjects that take part in research activities. Most research articles in biomedical and public health require the use of human subjects for experiments in their research. The work of IRB is, therefore, to review all research projects whether funded or not that involve human participants prior to their initiation, (Grady et al 19-31). It has the mandate to monitor and regulate all research activities that fall within its jurisdiction. The training at NIH helped to understand this concept that any research involving human participants should complete an IRB form for clearance. This will approve all the activities conducted under the research.
IRB is a crucial step in any biomedical or public health research. Most of the research projects in these areas involve the use of human participants that need protection. Before conducting any research, one should look for several components to determine if IRB submission is necessary. First, determine the level of risk concerning the study, (Grady et al 19-31). Research projects with high risks require IRB approval. Second, the benefit of research determines if the research involves the submission of IRB form. One needs to show and demonstrate the importance of knowledge expected to result from the study. Also, the subject selection process requires approval from IRB. Furthermore, provision to protect the privacy of subjects as well as maintaining the confidentiality of data needs filling of IRB form. All these components focus on protecting the rights of human subjects taking part in the study. An example of a research study that requires IRB is an ethnographic study of homeless adolescents that was conducted in the Northeastern United States. This research aimed to study the homeless adolescents regarding their environmental culture and organizational strategies in a city in of the major urban centers in Northeast U.S, (Banner et al, 12-28). The findings of the research, according to the person who proposed it, will enable fully understanding of how and why these adolescents became homeless as well as how they survive in their circumstances. In this case, the research needed IRB approval to obtain consent information from the youths, who are regarded as minors. Since the study aimed to recruit a youth population that did not have any common forms of identification such as identification, it would be impossible to obtain any information from them unless with permission from parents. Also, the research needed IRB approval regarding the potential risks to these youths from participating in the study. The study could place both the participants and the researcher at any risk depending on how these youths might react to the researchers. For instance, they might mistake the researchers for the police which could jeopardize their social relationships with their peers for involvement with police or might even put them at risk of physical harm.
IRB raised several key ethical concerns on “An ethnographic study of homeless adolescents” case. The physical risk was raised through the potential physical harm that the research study might cause to both the researcher and the youths’ population, (Banner et al, 12-28). How these youths react to any perceived officials might lead to confrontations that might lead to injury. The social risk was raised through the potential social harm that the research would impact on these youths such as rejection by peers due to involvement with perceived officials. These concerns raised by IRB were appropriate since they aimed to protect both the homeless adolescents, who were the human subjects and the researchers as well. I was not surprised by the IRB’s decisions since it was doing its mandate of protecting, monitoring, and regulating research that uses human subjects. This research helped to identify the risk of physical abuse that might arise through interaction with homeless youths in urban areas especially if they are in groups. I have that any perceived official person provokes adverse reactions from these groups. IRB plays a crucial role in regulating research projects. It does not only help to protect the rights of human participants but also facilitate learning and understanding other critical aspects regarding any research such as social relevance. Study ethics change from one state to another due to social factors such as prevalence in the use of drugs or crime.
References
Banner, S., & Banner, S. (2009). The death penalty: An American history. Harvard University Press. Grady, C. (2018). Ethical principles in clinical research. In Principles and practice of clinical research (pp. 19-31). Academic Press. Guetterman, T. C., Creswell, J. W., Deutsch, C., & Gallo, J. J. (2019). Process evaluation of a retreat for scholars in the first cohort: The NIH Mixed Methods Research Training Program for the Health Sciences. Journal of mixed methods research, 13(1), 52-68.
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