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

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.

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?

Ethical and Legal Parameters

Drug development and distribution are critical processes that must take into consideration ethics and legal provisions in the healthcare industry. The researchers in the case study should have considered a number of ethical provisions prior to distributing the trial drug at the health fair. One of the ethical aspects that the researchers should have considered is the principle of non-maleficence. Non-maleficence is an ethical principle that strives to ensure that no harm is caused to the patients using the drug under trial (Overman et al., 2018). The principle of beneficence should also be considered in this case study. The researchers should promote the wellbeing of the population (Kalkman et al., 2017).

This is achieved by promoting values of honesty, veracity, and respect for diversity. Informed consent is the other ethical principle that is relevant to the case. The attendees should participate in using the trial drug voluntary and not due to the provision of incentives or coercion (Turner, 2020). The principles of justice and autonomy also apply to the case study. The participation of the attendees in utilizing the drugs under trial should occur after being informed about the risks and benefits of the drug. The researchers should also provide evidence of legal approvals for the drug (Nugent et al., 2017). The approval should provide accurate information related to the benefits, risks, and conditions for using the drug.

One of the steps I would take in this case study is acting as the advocate for the populations at risk. I will seek clarifications from the researchers and inform the attendees about the risks of taking trial medications without being informed about its benefits and risks. I will also inform the authorities involved in regulation of drug use, research, and trials. I will also explore interventions such as educating the community members about the risks of unsafe use of medications and their roles in promoting safe use of medications.

Important information for writing discussion questions and participation

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Hi Class,

Please read through the following information on writing a Discussion question response and participation posts.

Contact me if you have any questions.

Important information on Writing a Discussion Question

• Your response needs to be a minimum of 150 words (not including your list of references)
• There needs to be at least TWO references with ONE being a peer reviewed professional journal article.
• Include in-text citations in your response
• Do not include quotes—instead summarize and paraphrase the information
• Follow APA-7th edition
• Points will be deducted if the above is not followed

Participation –replies to your classmates or instructor

• A minimum of 6 responses per week, on at least 3 days of the week.
• Each response needs at least ONE reference with citations—best if it is a peer reviewed journal article
• Each response needs to be at least 75 words in length (does not include your list of references)
• Responses need to be substantive by bringing information to the discussion or further enhance the discussion. Responses of “I agree” or “great post” does not count for the word count.
• Follow APA 7th edition
• Points will be deducted if the above is not followed

• Remember to use and follow APA-7th edition for all weekly assignments, discussion questions, and participation points.
• Here are some helpful links
• The is a great resource

References

Kalkman, S., Kim, S. Y. H., van Thiel, G. J. M. W., Grobbee, D. E., & van Delden, J. J. M. (2017). Ethics of Informed Consent for Pragmatic Trials with New Interventions. Value in Health, 20(7), 902–908. https://doi.org/10.1016/j.jval.2017.04.005

Nugent, A. C., Miller, F. G., Henter, I. D., & Zarate, C. A. (2017). The Ethics of Clinical Trials Research in Severe Mood Disorders. Bioethics, 31(6), 443–453. https://doi.org/10.1111/bioe.12349

Overman, M. J., Ellis, L. M., & Joffe, S. (2018). Ethics and the Underreporting of Research Biopsy Findings in Clinical Trials. JAMA Oncology, 4(8), 1041–1042. https://doi.org/10.1001/jamaoncol.2018.1002

Turner, J. H. (2020). Ethics of Pharma Clinical Trials in the Era of Precision Oncology. Cancer Biotherapy and Radiopharmaceuticals. https://doi.org/10.1089/cbr.2020.4129