Discussion: What ethical or legal parameters should the researchers have considered prior to distributing the trial drug at the health fair?

Discussion: What ethical or legal parameters should the researchers have considered prior to distributing the trial drug at the health fair?

Discussion: What ethical or legal parameters should the researchers have considered prior to distributing the trial drug at the health fair?

You attend a local health fair organized by several health care research companies. You notice that a company is distributing a trial drug to other attendees at one of the booths. When you approach one of the researchers, you are offered a waiver to sign for participation in the trial.

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What ethical or legal parameters should the researchers have considered prior to distributing the trial drug at the health fair? If you were on the translational research team, what steps would you have taken to maintain ethical and legal guidelines?

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Ethical and Legal Issues Surrounding Clinical Trials

Clinical trials serve to develop verifiable knowledge on various aspects of drug testing, including efficacy and safety. The information collected in trials enriches clinical data banks. Study participants thus play a key role in clinical trials. Therefore, the ethical and legal constraints of clinical research demand consent and informed decisions since the trials expose participants to toxicity risks, among other issues. The distribution of waivers cuts back on participants’ capacity to make informed decisions regarding their consent (Tseng, & Angelos, 2017). Disseminating a clinical trial drug at a health fair is thus a cause for alarm. Also, local health fairs often have huge attendance and closely positioned booths. The environment does not permit physical examinations and the questioning required before considering subjects for trials (Tappan, 2016). Another critical issue would be the lack of confidentiality since the participants are chosen randomly and contacted publicly.

The first step towards ensuring ethical and legal compliance would entail verifying the qualifications of the researchers. Ensuring that researchers are trained and qualify for the positions would go a long way in championing subject value and upheld methodology. Following up on the recruitment process for participants would also help me understand the essence of the study. I would also emphasize participant autonomy and the need to make informed decisions. Requiring that the researchers conduct patient education rather than merely handing them waivers would enhance proper consent (Tseng, & Angelos, 2017). Client education should range from the benefits of the drugs, projected risks, adverse reactions, drug interactions, safety concerns, timelines for the trials, and participant rights, among other issues. I would also stress avoiding coercing people into participating in the clinical trials (Tseng, & Angelos, 2017). The researchers must also collect and give their contact information before initiating the clinical trials.

References

Tappan, R. M. (2016). Advanced nursing research: From theory to practice (2nd ed.). Burlington, MA: Jones &BartlettLearning. ISBN-13: 9781284048308

Tseng, J., & Angelos, P. (2017). Ethical Considerations in Clinical Trials. In Clinical Trials Design in Operative and Non Operative Invasive Procedures (pp. 199-203). Springer, Cham.