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In modern clinical research ethics, it is normally assumed that a certain group of people is more likely to be mishandled, misguided or taken advantage of while participating in research. These groups are given the umbrella term vulnerable. The researchers ought to specially protect these individuals (Solomon, 2013). During research, the vulnerable groups need quite a lot of attention as the study is being designed. Special recruitment consideration must be done for the vulnerable. The strategies of research should likewise be scrutinized to ensure they are both safe and efficient. Instances of ethical dilemma are common in researches involving vulnerable groups (Shivayogi, 2013).
Detailed safety monitoring plans should be should be developed with Data Safety Monitoring Committee (DSMC). Where applicable, Observation Study Monitoring Boards should be used. These should be involved in both early and late trial phases of the research. The vulnerable subjects should be asked to make recommendations for the scientific caliber, safety, integrity, timeliness, integrity quality of data and documentation. The research should comply with the proposed norms and should be monitored regularly by ethical review boards (ERBs), independent DSMC and other governmental agencies. The agencies should also establish the latest security mechanisms for protection of human researchers (Shivayogi, 2013).
According to Shivayogi (2013), the research should include stringent reporting guidelines...
The risks encountered or associated with the research should likewise be interpreted time and again.
To protect the vulnerable groups, guidelines ought to be systematically developed. Evidence should also be translated into recommendations (Guyatt et al., 2008). The guideline used should include the patient’s preference for interventions. This practice has however sparked arguments among the patients. It is normal for patients to want to stay informed by their doctors and take part in making decisions. This wish however depends on the context of research (Llewellyn-Thomas, 2006).
References
Guyatt, G. H., Oxman, A. D., Vist, G. E., Kunz, R., Falck-Ytter, Y., Alonso-Coello, P., & Schünemann, H. (2008). Grade: An emerging consensus on rating quality of evidence and strength of recommendations. BMJ, 336, 924–6. doi: 10.1136/bmj.39489.470347.AD.
Llewellyn-Thomas, H. A. (2006). Measuring patients' preferences for participating in healthcare decisions: avoiding invalid observations. Health Expect, 4, 305–6. doi: 10.1111/j.1369-7625.2006.00418.x.
Shivayogi, P. (2013). Vulnerable population and methods for their safeguard. Perspect Clin Res, 4(1), 53–57. doi: 10.4103/2229-3485.106389
Solomon, S. R. (2013). Protecting and respecting the vulnerable: Existing regulations or further protections? Theor Med Bioeth, 34(1), 17–28. doi:10.1007/s11017-013-9242-8.
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