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The Institutional review board article mainly discusses about how the board regulatory approval option began and the common rule for secondary research using the identifiable biospecimens, data, their meaning, and the questions that are not answered by the regulations. The article also discusses the suggestions made by the U.S Dept. of Health and Human Services. The Secretary-General of SACHRP, explains this concept and the logistics that are to be placed in order to implement the board regulatory approval and as well as explain the purpose of providing it. The article gives a brief note about the topics that are to be discussed in the research for regulatory approval, and also the issues that are to be researched by us in finding the evidence.
The Common Rule gives the IRB protocols for the human subject research approval, which includes types of research subjects, studies, human subjects, and the risks. It also includes that we stick to the common rule and provide a written guarantee for the same, provides the membership rules for Institutional Review Board, authority, review methods, records, and acceptance and approval criteria.
Data breaches and digital privacy are explained by which researchers can use publicly available information to re-identify the people using unique identifiers such as name, ssn number, address etc, who were been de-identified earlier.
The article entitled “Enterprise risk management application implementation case study” addresses three main issues. The first one is the role of enterprise risk management (ERM) in helping an organization achieve its ultimate vision. From the article, it is established that a proper ERM will enable the organization to speak the same language across all departments, something that will contribute towards the attainment of the project goals. The second issue addressed is the steps that are followed to successfully implement ERM in an organization and any challenges that are faced in the process. The implementation of ERM involves a number of steps such as identification of risks (threats and opportunities), analysis of those risks, and development of risk response measures. The third issue that the article addresses is the importance of proper role distribution. This looks at how collaborative efforts enable the organization to have a successful ERM and enable it to achieve its ultimate vision.
Common Rule is a standard of ethics that any research, particularly those funded by the government, must adhere to (Hudson & Collins, 2015). A number of learning institutions require their researcher to adhere to this standard when conducting any research, even if the funding is not from the government. According to this rule, the researchers should delegate to Institutional Review Board (IRB) the authority to review and stimulate changes in the proposed research. The IRB should also be granted the authority to approve or disapprove the research. Additionally, the researcher should delegate the authority to oversee the protection of human subjects to the IRB. The issue of ERM and Common Rule is closely related to information systems and digital privacy. For instance, Common Rule requires that the privacy of human subject’s digital data used in the research should be properly protected. Proper functioning of information systems and protection of data privacy in any organization will require an effective ERM implementation.
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