Ethical Points during Trial in Patients with Obstructive Sleep Apnea

EthicalPoints during Trial in Patients with Obstructive Sleep Apnea

EthicalPoints during Trial in Patients with Obstructive Sleep Apnea

Ethical issues in conducting research are factors that must beconsidered by researchers. The design of the research should takeinto precedence the positive and adverse effects of the study.Particularly, it is essential to assess the impact of the research onthe participants and the population as a whole in terms of healthrisks (Charles Weijer et al., 2011). Regarding the concept ofethics is the issue about clinical trials conducted for patientssuffering from obstructive sleep apnea. The question arising concernsthe ethics surrounding the design and conduction of CPAP trialsconcerning the selection of the appropriate control method, exclusioncriteria, and follow-up duration.

Problem

The primary issue emanating concerns the need to uphold ethics whileconducting the CPAP clinical trials on patients diagnosed withobstructive sleep apnea. The Declaration of Helsinki recognizes theneed to protect the participants who have been subjected to aclinical trial (Brown et al., 2011). Protection should cover thedecision not to deny participants a treatment that has potential tocure a particular problem. Similarly, it is critical to ensure thatthe treatment regimen employed in the clinical trial does not exposethe participants to a health risk (C Weijer et al., 2011). However,for the case presented, researchers are undecided on denying acontrol group a treatment even though it is suspected to be havingpotential benefits in dealing with obstructive sleep apnea. It is aproblem that investigators have to deal with. Notably, it isessential to uphold ethics at the highest degree possible.

Discussion

Investigators have the mandate to uphold to the establishedguidelines when it comes to conducting research. Clinical trials areespecially sensitive considering the manner in which they aresupposed to be done and the potential health hazards they pose(Helmchen, 2011). For the case of a randomized clinical trialfocusing on the possibility of application of continuouspositive airway pressure`s (CPAP), the investigators need to have acontrol group and participants who will get the treatment option.Notable approaches to be employed in the control group includedelayed CPAP therapy, administration of “sham” CPAP, and an inertplacebo (Brown et al., 2011).Each of the suggested controls presents with benefits and demerits.However, it is essential that the researchers weigh options toascertain the most appropriate and causes minimum harm to theparticipants. However, it is fundamental to consider that in thelong-run, participants in the control group risk benefitting from thedrug administered especially if it has potential to addressobstructive sleep apnea.

Learning Outcomes

The study presents crucial aspects that must beconsidered when conducting clinical trials. As a learner, one getsthe opportunity to appreciate the role of ethics in research and theneed by scientific researchers to conduct themselves with the highestlevel of integrity. Further, as a learner, one gets the opportunityto learn and acknowledge the significance of adhering to variousguidelines established by international bodies regarding the issue ofethics and the need to consider the same while engaging in sensitiveresearch such as the clinical trials in which human subjects takepart.

Conclusion

Scientific investigators have a duty to uphold inexercising clinical trials to determine the efficacy of a particulartreatment regimen. Despite the good intentions of such research, itis essential that one abides by the established rules that seek toprotect the participants from harm. It is vital that researchers seekinformed consent while critically evaluating the impact of thetreatment regimen on the health of participants.

References

Brown, D. L., Anderson, C. S., Chervin, R. D., Kushida, C. A.,Lewin, D. S., Malow, B. A., … Goldman, E. B. (2011). Ethical issuesin the conduct of clinical trials in obstructive sleep apnea. Journalof Clinical Sleep Medicine : JCSM : Official Publication of theAmerican Academy of Sleep Medicine, 7(1), 103–108.Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/21344041

Helmchen, H. (2011). Clinical research ethical issues in naturalisticversus controlled trials. Dialogues in Clinical Neuroscience,13(2), 173–182.

Weijer, C., Grimshaw, J. M., Taljaard, M., Binik, A., Boruch, R.,Brehaut, J. C., … Zwarenstein, M. (2011). Ethical issues posed bycluster randomized trials in health research. Trials, 12,100. http://doi.org/10.1186/1745-6215-12-100

Weijer, C., Grimshaw, J. M., Taljaard, M., Binik, A., Boruch, R.,Brehaut, J. C., … Zwarenstein, M. (2011). Ethical issues posed bycluster randomized trials in health research. Trials, 12(1),100. http://doi.org/10.1186/1745-6215-12-100