Baseline Data in Clinical Trials - Essay Example

The paper "Baseline Data in Clinical Trials" is a wonderful example of clinical research. The scenario clarifies that Hadley entered the clinical trial in the absence of signing any document. One of the primary requirements in a clinical trial is that the participants must sign the informed consent (Speid, 2010). The essence of this is to show that their participation is voluntary and not out of coercion. Even though Hadley decided to participate in the study voluntarily, authorities cannot ascertain this outcome because of the lack of her signature on the informed consent documents. Hence, they will assume that Hadley was forced to participate in the study.

Whether Hadley committed any ethical violation by entering into the clinical trial in the manner she did
According to Resnik and Ness (2012), a pertinent ethical responsibility of the participants in a clinical trial is avoiding harm to the self and to others. Hadley did not adhere to this ethical responsibility. As the practitioner did not follow the required protocols for inclusion in a study, it follows that Hadley posed harm to Cameron. As such, her inadvertent entry meant that the validity and reliability of Cameron’s study were now questionable. It is also relevant to claim that Hadley engaged in unethical behavior as she did not make her condition known, yet, as shown by Burgess, Gebski, and Keech (2003), information about the baseline situation of the participants in a clinical trial is necessary for comparison purposes. The non-disclosure, therefore, implied that Hadley had contributed towards the diminishing meaningfulness of the study.

Whether Cameron committed any legal or ethical violation by allowing Hadley into the clinical experiment
Just like Hadley, Cameron also engaged in legal and ethical contraventions. According to Pozgar (2014), the researcher in a clinical trial has the mandate to make the risks and benefits of participating in the study process known to all the members of the sample. Such information, according to the scholar, is fundamental because it provides the participants with an opportunity to make informed decisions on whether they will take part in the study or not. However, Cameron did not disclose the benefits and risks of taking the medication.

Therefore, she denied Hadley the right to information necessary to make a proper participation decision. The other problematic ethical/legal issue that comes to the fore is that Cameron engaged in selection bias. In clinical trials, each member of the population is provided with an equal chance of participating through random selection (Martínez-Mesa et al., 2016). However, Cameron did not apply this protocol when selecting Hadley, which then equates to selection bias due to the underlying favoritism.

The legal and ethical issues arising from the nature of genetic testing done on Hadley
The case study illustrates that went for genetic testing to establish whether she was to inherit Huntington’s disease. As revealed by the Genetic Alliance (2010), one of the primary legal/ethical issues is that genetic tests tend to disseminate potentially inconclusive outcomes or estimates. Therefore, the chances of incorrect interpretations are high. Improper interpretation of the genetic test results due to inconclusiveness might unwarrantedly condemn a patient to a long-standing low quality of life characterized by distress.
The Genetic Alliance (2010) also relays that along with genetic tests come issues related to the duty to disclose. The agency expresses that healthcare providers are mandated to the person being tested not to inform other members of the family without the patient’s consent, save for extreme circumstances. In relevance to the case study, genetic testing is harmful to Hadley, however, if the test results are interpreted inappropriately. However, the test is beneficial, if accurate, because they help Hadley to seek medical attention to prolong her life.