Institutional Reviewing Board (IRB)
A committee established to review and approve research involving human subjects, the International Review Board or simply IRB is designed to protect the rights and welfare of the human participants by means of minimizing or avoiding ethical dilemmas of conducting research. The three levels of IRB review – full board, expedited, and determining if exempt from continuing review – were determined on the basis of the nature of the protocol, the level of potential risk to human subjects and the subject population. Anyhow, regardless of the type of review, applications shall use the same submission forms. Further, specific student and class projects are also subjected to the approval of the committee.
The ethical principles that researchers must adhere into are respect for persons, beneficence and justice, as stipulated in the Belmont Report. Compliance with the Belmont Report is the necessary first step in acquiring IRB approval. This is carried out in order that the persons conducting research shall comply with the regulations about conflicts of interest, ensuring that the research is not biased financial-wise and/or any other interest which will endanger public trust. Violation of ethical considerations resulting to death was a scenario so rampant during the 1960s, and still is, so the call for regulating investigation involving human subjects (Parvizi et al, 2007).
Inherent to the IRB process are philosophical issues which are among the sources of criticisms. According to Burke (2005), IRB strives at maintaining the reliability of committees by means of reducing prejudices while also sustaining notable linguistic, cultural and socioeconomic quality of the research subjects. What is becoming an integral problem, however, is the variability of the review process with respect to the weak relationship between IRB and investigators. Such issue points to another criticism of the IRB which is problematic, conflict-laden and non-standardization of processes, impacting the results of the studies (Larson, et al, 2004). Wolf et al (2002) noted that there is the necessity of centralization of reviews and practice-based research especially when the principal investigators are not affiliated with an institution.
Further, it was also argued that the conduct of IRB is more tended on accelerating genetic research discoveries rather than focusing on real research breakthroughs and findings. Dziak et al (2005) stress that a relatively large variation exists especially with regards to the number of required forms to be submitted; the number of days from submission to approval; and the process of approval itself. Nonetheless, there is the questionable fit between the variability and the procedures of governing research.
Funding of research is also another criticism to IRB mainly because of the increased workload and time constraints unique to each study for those who are reviewing and monitoring research in an ongoing basis. Likewise, the increased number of submissions both for low-volume institutional review and high-volume institutional board review impacts performance of the committee as well as the investigators, aside from incurring federal costs. The committee membership is also being questioned because of the fact that there might be an intrinsic prejudice with respect to approving projects without realizing the severity of hazily approved researches (as cited in Parvizi et al, 2007).
The submission process is a laborious task which may implicate the degree of relationship between reviewer and researchers. Important to note is that the committee relies on member’s ability to discern the extent to which human subjects will be subjected to ethical constraints. However, there are no clear-cut measures or even guidelines in assessing the success or efficacy of the board. As such, the modifications of applications are inclined on specific areas of inappropriately designed consent forms, poor study design, unacceptable risks to human subjects and ethical issues and scientific merit (Parvizi et al, 2007; Jones et al (1996).
Managing conflicts of interests is also an inevitable ethical issue in discussing IRB process. This is because the financial or personal considerations of the investigators which could potentially implicate compromise or bias professional judgment or objectivity are not covered in the IRB approval. Though such endeavour is obviously a difficult area to administer, reviewers should realize that the investigators are in a position whereby several factors might influence their decisions. What’s worst is the possibility of inflicting harm and dangers to the subjects for the purpose of dredging especially when giants are sponsoring/financing the study.
The involvement of vulnerable populations must be supported with scientific rationale. While such population might participate in the research, investigators, through IRB, must guarantee that risks are acceptable concerning the anticipated benefits. According to Parvizi et al (2007), “an important point worth mentioning relates to the potentialabuse of patients by subjecting them to multiple simultaneousresearch projects that may place an undue burden on their time,energy, and attention.” Indeed, because the subjects are vulnerable, the most common ethical issue surrounding this is the exploitation of the subjects apart from the lack of proper mechanisms to ensure that such subjects are not abuse in whichever way possible.
Reference:
Burke, G. S. (2005). Looking into the institutional review board: observations from both sides of the table. Journal of Nutrition, 135: 921-924.
Dziak, K., Anderson, R., Sevick, M. A., Weisman, C. S., Levine, D. W. and Scholle, S. H. (2005). Variations among Institutional Review Board reviews in a multisite health services research study. Health Services Research, 40: 279-290.
Jones, J. S., White, L. J., Pool, L. C. and Dougherty, J. M. (1996). Structure and practice of institutional review boards in the United States. Academic Emergency Medicine, 3: 804-809.
Larson, E., Bratts, T., Zwanziger, J. and Stone, P. (2004). A survey of IRB process in 68 hospitals. Journal of Nursing Scholarship, 36: 260-264.
Parvizi, J., Tarity, T. D., Conner, K. and Smith, J. B. (2007). Institutional Review Board Approval: Why It Matters. Journal of Bone and Joint Surgery, 89: 418-426.
Wolf, L. E., Croughan, M. and Lo, B. (2002). The challenges of IRB review and human subjects protections in practice-based research. MedCare, 40: 521-529.
Credit:ivythesis.typepad.com
0 comments:
Post a Comment