Institutional Review Boards in Conflict
Introduction
IRB is a committee type that is involved in the application of research integrities by evaluating the proposed strategies for research in ensuring that they are all principled (Cohen & Lynch, 2014). The purpose of this system is to assure that the most suitable approaches are utilized to guard the privileges and welfare of individuals that are to participate in the study investigation (Chin & Lee, 2008). In this case, it is recommended that the US IRB should approve the study since it is focused on creating clinical intervention solutions and also because the South African regulatory standards have been adhered and approved. The study is very helpful for the affected population and thus Tarry’s assistance is highly needed.
- What are the ethical issues and points of conflict in this case?
Based on the case scientific researchers based in South Africa which is one of the developing states have been involved in examining a hereditary illness that mainly affects the in inaccessible and indigenous populace existing in the jungle’s deepest parts. Their hope is that the gene that is associated with the disorder can be established in order to establish the contributing factors and determine the most suitable clinical interventions. So that this can be accomplished a collaboration with Dr. Herod Tarry a US-based qualified researcher is needed as he utilizes genomic technology which is rare particularly in the developing nations and is needed in studying microbiology.
The primary ethical dilemma is on whether IRB should approve the study even though the methods to be utilized are far below the American standards. The regulatory standards in South Africa have approved the study as it meets its requirements. It is acknowledged by Dr. Tarry that the consent documents that the researcher sent are not drafted in a similar way and standards with those of the united states and the reason to why this study should be approved is that he is not the one that is seeking consent regarding the study and he will not be directly involved in the investigation since they are no direct interactions with the researchers. His role is to test the blood samples sent to his laboratory by the researchers and send results based on the analysis. In addition, he highlights to the IRB members that the regulatory standards in SA have approved the study and hopes from the IRB approval on the consent as presented. This raises an ethical issue on whether IRB should approve the consent of the study even though it fails to meet the American based regulation principles. There is a severe conflicting interest in the case as the American standards and those of SA are not equal but the help of the Doctor is necessary.
- Who are the interested parties affected by the issues/conflicts and what are their reasonable expectations?
There are a number of parties that are affected by the conflicts and issues in the case. To begin with, the SA researchers are the ones that are affected most. This is because they are in search of the causative factors that are leading to the disorder among the indigenous and isolated populace but this cannot be achieved prior to establishing the responsible gene. In addition, the genomic technology is very rare based on its expenses and is even harder for developing state researchers to afford it. They, therefore need the assistance of the Dr. based on his qualifications and expertise in a biological examination. If the approval is denied by the IRB then their efforts would be useless and the research cannot be successful. Their expectations are that the consent will be approved in order for the examination of the blood samples can be conducted using the technology by Dr. Tarry who is also affected.
The other affected party is the indigenous and isolated populace that is affected by the disorder. If the approval is denied this implies that they will be forced to live with the disorder for generations which will affect their wellness and growth. Their expectations are that the researchers will be able to establish the causative factors as well as determine the appropriate medical interventions to end their suffering. IRB is also an affected party because given that it is required to approve the consent it is concerned that the standards fail to meet the American regulatory requirements which make the consent to be unreliable. They, therefore, expect that the documents can be modified to suit its standards.
- If the interested parties acting on their expectations what would be the probable consequences?
If all the interested parties acted based on their expectations then a conflict would arise. This is because for Dr. Tarry his expectations are that the IRB should approve the study because his contribution would positively affect the affected populace. If he, therefore, acts on assisting the researchers this would be against IRB’s expectations which are based on the modification of the documents so that they can fully suit the needs of the populace. In satisfied this quest there would be a conflict amid the act by the Dr. and the regulatory standards. This implies that the expectations of the researchers to be assisted in establishing the causative factors would be fulfilled and the affected populace would be satisfied.
However, For IRB it is apparent that their interests and expectations would be violated. The Dr. is expected to wait for the approval by the regulatory standards which seems that it might be denied. He hopes that they will consider the fact that his contributions are highly necessary and that he is not seeking the consent but it is the researchers who are doing so. If the expectation of IRB to await the modification of the consent is adhered to then the process of investigation and research would automatically fail. The health of the affected populace and the efforts of the general populace would also be affected in a negative way. However, they are obligated to ensure the wellness and the rights of those that are to participate in the research and this cannot be done without proper measures being considered.
- What are the obligations of the Amazing IRB?
Amazing IRB has the obligation of applying research ethics to evaluate the proposed research methods in ensuring that they are ethical (Chin & Lee, 2008). Its primary intention is to assure the utilization of the most appropriate strategies for protecting the rights and wellness of humans engaging in the research study (Chin & Lee, 2008). In this case, its obligation lies on ensuring that professional competence is applied in evaluating the specified study’s activities. The individual conducting the study should have adequate knowledge in regard to the subject that will contribute mainly in establishing the threats and benefits within and that consent information is provided to the participants to guard their confidentiality and responses. However, in this case, it is only IRB who is from the US while the researchers involved in the study are SA based.
Thus, the role of IRB is to ensure that the applied strategies in gaining insights about the disorder are ethical and that the participants are fully aware of their rights (Bankert & Amdur, 2006). This is not possible since Dr. Tarry will not be engaging directly with the researchers. However, it has to ensure that the approval meets the standards that seek to guard the rights of those that are engaged. It is expected to either approve or disapprove the study based on its review. In this case, it is recommended that the US IRB should approve the study since it is focused on creating clinical intervention solutions and also because the South African regulatory standards have been adhered and approved. Its main responsibility is to protect the welfare and privileges of all those that are involved in the investigation.
References
Bankert, E. A., & Amdur, R. J. (2006). Institutional review board: Management and function. Sudbury, Mass: Jones and Bartlett.
Chin, R. Y., & Lee, B. Y. (2008). Principles and practice of clinical trial medicine. London: Academic.
Cohen, I. G., & Lynch, H. F. (2014). Human subjects research regulation: Perspectives on the future. MIT Press
