Regulatory Affairs

See the attachment. All listed requirements should be met.
Based on Chapters 4, 6, and 11 of “The Ethics of Research with Human Subjects Protecting People, Advancing Science, Promoting Trust” by Resnik

ANSWER

Ethics of Research with Human Subjects

Trust in research with human subjects goes both ways. In this case, the Amazing IRB feels that the proposal, in this case, is not detailed, and the quality of the ICF is poor (Resnik, 2018). However, they agree that the consent meets all the regulatory elements in the US; although it is below par with the US standards, the consent forms are acceptable by South American standards. The doctor will also not have any contact with the subject. Thus, in this case, the IRB should grant the doctor permission to continue with the research as, despite the documents not meeting the US standards, it meets the SA standards, and thus, they should trust that the doctor will be honest and give constant updates throughout the research.

The main ethical issue, in this case, involves inadequate consent forms from South America. Although the South American IRB has approved the study, the amazing IRB feels it is insufficient to approve the research (Morris MacLean et al., 2019). The IRB, in this case, is conflicted because the subjects, in this case, are South Americans, and their regularity board has approved the research, but the researcher in the study is American, and if anything goes wrong in the study because they approved the research they are to blame for not asking for a more comprehensive proposal.

Dr. Tarry is affected as he is interested in the research and feels it should be approved. However, the proposal does not meet the American standards, it meets the South American standards, and that should be enough to give him the leeway as he will not be directly dealing with the participants in the research (Barrow et al., 2021). He is also interested in the research as it could fast-track his career. The amazing IRB is also affected because they are expected to make the best decision for the participants in the study, but they are also expected to trust the researchers and the SAIRB. They also expected that the proposal would be more comprehensive.

Suppose Dr. Tarry acts on his reasonable expectations to continue with the study. In that case, he could be violating the international IRB standards, and the amazing IRB will be blamed in case of malpractice or any issues with the study (Ross, 2019). If the amazing IRB acts in self-preservation and does not approve the study, it could have protected a malpractice case. Still, it could also have stopped the discovery of the century and a major medical breakthrough.

References

Barrow, J. M., Brannan, G. D., & Khandhar, P. B. (2021). Research ethics. In StatPearls [Internet]. StatPearls Publishing.

Morris MacLean, L., Posner, E., Thomson, S., & Wood, E. J. (2019). Research ethics and human subjects: A reflexive openness approach. American Political Science Association Organized Section for Qualitative and Multi-Method Research, Qualitative Transparency Deliberations, Working Group Final Reports, Report I, 2.

Resnik, D. B. (2018). The ethics of research with human subjects: Protecting people, advancing science, promoting trust (Vol. 74). Springer.

Ross, J. (2019). Research ethics from the inside. Issues in Science and Technology, 35(4), 84-88.