The Ethical Challenge of Research on Sensitive Issues

The case involved the use of human subjects in which approximately 1,300 infants were subjected to controlled trials (Office for Human Research Protections, 2013). Specifically, the research which was conducted by the University of Alabama aimed at ascertaining the appropriate oxygen dosage for premature infants. The babies were subjected to various oxygen saturation levels using a pulse oximeter. The study which was supported by the NIH (National Institute of Health) was marred with numerous allegations that informed consent process to prepare the parents for any foreseeable risks associated with the randomized controlled trials was not observed. Distinctively, the ethical challenge was that the researchers did not seek informed consent from the parents of the infants before conducting the experiment (Yip, Han & Sng, 2016).         

The analysis of ethical principles breached

The study did not provide a full disclosure to the parents of the premature babies the risk of blindness associated with both low and high oxygen saturation levels. The principle of informed consent dictates that the parents had the right to full disclosure of all risks and benefits of the study (Faden, Beauchamp & Kass, 2014). In this particular case, only the perceived benefits of the study were specified by stating that a lower level of oxygen saturation would help prevent blindness. Deception was the technique used to withhold or provide false information concerning the study details and successive outcomes.

Possible causes of the breaches

The breach of the informed consent process which primarily aimed to give every study participant the freedom to choose whether to participate in the study can be accredited to various reasons. For instance, in this context, it’s clear that the researchers had false expectations that the level of oxygen saturation will not have any serious negative impact on the health of the infants. Correspondingly, the researchers probably feared the prospect of parents rejecting the idea of conducting untested medical procedures on their infants (Yip, Han & Sng, 2016).    

How the research could have been conducted differently to eliminate ethical problems

The parents of the infants could have been provided with relevant documents detailing all the risks of the projected study without withholding pertinent information to facilitate the informed consent process. 

Research on sensitive issues

When conducting a research on a sensitive issue, there must be an informed consent document signed by the study respondents. The researchers should also uphold the beneficence rule that clearly stresses on ensuring that no harm is caused to the research subjects during the trials (Faden, Beauchamp & Kass, 2014).  

References

Faden, R. R., Beauchamp, T. L., & Kass, N. E. (2014). Informed consent, comparative effectiveness, and learning health care. N Engl J Med, 370(8), 766-768.

Yip, C., Han, N. L. R., & Sng, B. L. (2016). Legal and ethical issues in research. Indian journal of anesthesia, 60(9), 684.

Office for Human Research Protections (2013, March 7). Human Research Protections under Federalwide Assurance (FWA) 5960.Retrieved from: https://www.hhs.gov/ohrp/compliance-and-reporting/determination-letters/2013/march-7-2013-u-of-alabama-birmingham/index.html