In 2013, Live Science’s writer Rachael Rettner (2013) reported on the ethical issues surrounding US’ premier infant study dubbed TOP. Now, T.O.P is an acronym for Transfusion of Prematures. The study aims at recruiting over 1800 premature babies as participants to an anemic study. In this case, the researchers attempt to find the best way to offer blood transfusions as a cure for anemia in babies. They hope to assign randomly infants weighing less than 2 pounds to transfusions during mild and severe incidences of anemia (Rettner, 2013).
The T.O.P study is a clinical trial that includes both control and treatment groups. The primary objective of the research is to find a better standard of care for anemic patients. However, critics, led by Public Citizen, have identified an ethical flaw in the study’s consent forms. For one, the form does not address, with clarity, the potential side effects of the research on participants. Public Citizen argues that TOP’s team fails to expose brain injury as a possible side effect of the trial (Rettner, 2013).
The breach may have happened because the researchers assumed that the trial had been part of a standard practice among health care providers. According to Fouka and Mantzorou (2011), their ignorance makes them miss a significant point concerning ethics in medical research. Therefore, they should restructure their consent form in ways that address all the critical elements when seeking permission from participants. For instance, it would be best to discuss the study purpose, its benefits, and risks, and well as the need for voluntary participation.
References
Fouka, G., & Mantzorou, M. (2011). What are the Major Ethical Issues in Conducting Research?: Is there a Conflict between the Research Ethics and the Nature of Nursing? Health Science Journal, 5 (1), 3-14.
Rettner, R. (2013, August 28). Experts Debate Ethics of Studies on Preemies. Retrieved from Live Science Web site: http://www.livescience.com/39240-experts-debate-ethics-of-studies-on-preemies.html
