“Hepatic four doses everyday.1 This paper is
“Hepatic Dysfunctionand Jaundice in Patients Receiving Triacetyloleandomycin” isa study that was conducted by Ticktin and Zimmerman toknow the adverse events that are associated with TriA drug and its effects onthe liver.1 So, this study wanted to know the relationship betweenthe hepatic dysfunction and the TriA drug by giving the patients 1 gm of TriAdivided by four doses everyday.1 This paper is going to discuss theethical issues that were associated with conducting the study by applying therules of the Tri-Council Policy Statement on Ethical Conduct for ResearchInvolving Humans 2014 (TCPS2).2 The TCPS2 and other frameworks havebeen formed as principles to give every party in the research his/her right andassigned to them him/her own duties.2 TCPS2 declare that anyresearch shall meet both the scientific and ethical standers to be conducted.2The scientific standers cares about protecting the participants from any harm,or at least minimizing the harms due to conducting the research on them.2The ethical standers means being respectful, and honest with the participants.2 Article1.1 from the TCPS2 apply because it states that the participants in anyresearch shall have their own liberty to participate in the research.2However, the Ticktin study wasconducted on 50 inmates who spent two months or more in Laurel Children’sCenter.1 So, this study did not consider taking the consent of theparticipants.1 Article 3.1 from the TCPS2 apply here too; becausethe participants should be volunteering to give their own consent.2 Onthe other hand, the Ticktin studyconducted the research on patients aged from 13 to 39 years old.1 Inthis group, there are individuals who does not meet the legal age to take sucha decision to themselves.1 In regards to this matter, article 1.1 fromthe TCPS2 declare that the individuals who can not take the decision forthemselves, there should be extra criteria that illustrate how to take aconsent for them.2 A case in point, the researchers can take theconsent from an authorized third party like the parents.2 Article1.1 from the TCPS2 also concerned about the welfare of the participants.2This means the influence of conducting the study on their physical, spiritual,and social circumstances.2 The outcomes of the Ticktin study were as follows: eight of the patients had ahepatic dysfunction and jaundice after taking theTriA drug.1 They were transferred to the hospital and undergo aliver biopsy under general atheistic for more investigation.1 Halfof these patients in the hospital underwent the liver biopsy again.1After their liver condition had return to normal, they continue to have achallenge dose of the TriA drug again.1 After the challenge dose,the hepatic dysfunction had returned.1 And again, the hepaticfunction returned to normal after stopping the challenge dose.1 Theseresults were far from what article 1.1 from the TCPS2 states.2 The Ticktin study did not take into consideration the physicalcondition of the participants.1 If some patients had a hepaticdysfunction for the first time, why would the Ticktinstudy continue to gave them a challenge dose after they had returned to normal.1This affected the welfare of their physical condition.2 Besides,conducting the study on inmates in Laurel Children’s Center who were far awayfrom their families affected their social and spiritual welfare.2 Givingthe patients a challenge dose even with the worse physical conditions break therules of both article 2.9 and article 3.7A from the TCPS2.1,2 Bothof these articles state that conducting a research shall meet the scientificstanders which means minimizing the risks and protecting the participants fromany harms.2 Article 2.9 from the TCPS2 stresses the importance ofdoing an assessment before conducting any research to know the potential risks.2The Ticktin study carried on doing theresearch even though they knew there was a hepatic dysfunction when taking theTriA drug.1 After just two weeks of the study, the majority of the patientsstarted to experience some adverse events like abnormal bromsulfalein excretionand abnormal levels of glutamic pyruvic transaminase.1 Theycontinued to apply the TriA drug for extra three or four weeks and the numberof patients who were experiencing the adverse events increased significantly.1A case in point, there were 54% of the patients who experienced abnormalbromsulfalein excretion after two weeks.1 After three or four weeks,the amount of patients with abnormal bromsulfalein excretion increaseddramatically to 61%.1 TheTicktin study broke the ethical rules byconducting their research on inmates in Laurel Children’s Center without takingthe consent from the participants or their third party authorization.1,2Article 3.3 from the TCPS2 confirms that it is not enough to just have a consentat the beginning of conducting the research, but this consent shall bemaintained during the whole progress of the research.2 Additionally,article 3.5 and 3.9 from the TCPS2 apply because they both state that anyresearch shall not be conducted unless there is a consent from all theparticipants and their third party authorization.2 Article 3.9 fromthe TCPS2 also confirms contributing those who do not have the ability to givea consent in the decision making as much as possible even when they have theirthird party authorization.2 Even when their third partyauthorizations gave a consent, the researchers should take into consideration anydemands and desires that the participants have, according to the article 3.10from the TCPS2.2 The Ticktin studydid not take the consent of the inmates, nor their families.1 Inconclusion, the Ticktinstudy committed an unethical study by applying the TriA drug and undergoing aliver biopsy to the inmates in without any regards to their physical or psychologicalconditions.1 The participants of the Ticktin study experiencedunethical actions mandatorily without taking their consent or their third partyauthorizations.1