According to research, the Common Rule addresses the requirements needed by researchers to gather, review, and document relevant information (Domenech et al., 2017). Secondly, it outlines the requirements needed for IRB membership, record keeping, operations, and research review. Finally, it outlines the requirements needed by institutions to ensure their compliance with the research institution.
The first primary issue addressed in the article is human subjects. The living individual whom an investigator obtains the bio specimen and later analyzes the information after interacting with the individual. Secondly, the article highlights the clinical trial. According to Clapp, Gleason, and Joffe, human subjects conduct clinical trials by evaluating the impacts of interventions on behavioral health-related outcomes. Thirdly, the article mentions the legally authorized representative of the respective subject. The human subject must be represented by someone complying with the applicable law. Besides, the article state that: the investigator should use methods that do not offend or affect the self-esteem of the human subjects in any way, that is, by ensuring that the interactions do not cause physical injuries, are painless and harmless. Moreover, the investigator should conduct interaction and intervention with the subjects in an effective way. Finally, the article stresses on confidentiality of the subject's information. The investigator must assure the subject that their information will not be leaked to the public, for instance, by not recording.
According to the Information System and Digital Privacy (ISDP), personal data and information must be concealed. Both IBR and ISDS, the confidentiality of subject rights, must be adhered to. However, Information technology has increased the threats of leaking information.
To conclude, this paper discussed the Common Rule, the main issues highlighted, and the relationship between IRB and ISDP. Interdisciplinary courses should be a mandatory requirement for researchers to improve efficiency.
References
Domenech Rodríguez, M. M., Corralejo, S. M., Vouvalis, N., & Mirly, A. K. (2017). Institutional Review Board: Ally Not Adversary. Psi Chi Journal of Psychological Research, 22(2). https://scholar.google.com/scholar?as_ylo=2016&q=Institutional+Review+Board&hl=en&as_sdt=0,5
Clapp, J. T., Gleason, K. A., & Joffe, S. (2017). Justification and authority in institutional review board decision letters. Social Science & Medicine, 194, 25-33. https://scholar.google.com/scholar?as_ylo=2016&q=Institutional+Review+Board&hl=en&as_sdt=0,5
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