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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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The given case example is also referred as community outreach recruitment program for identification of participants and their engagementinto concerned trial studies. The ethical consideration which must be accounted prior to distribution of the trail drug is that it should be safe for attendees to whom it was distributed. With the term “safe” it refers to have no harm for mental or physical health. Furthermore, the information about the drug must be provided to attendees while offering the waiver to sign. The legal requirement include permission from official regulatory authority, documentation that contain explicit information about the drug contents, possible side effects, intended use, and other details about preparation and storage of the drug. The legal content must assure permission for public distribution of trial drug and that the drug should have no complications in healthy, diseased, or allergic condition (Gelinaset al., 2017). Additionally, the drug should also have no contraindication with food, medicines, and environmental agents. The follow up for identifying the effect of trial drug is also an important part of the trial studies. However, for this legal requirement there is limited information provided in the case scenario.

Being apart of the translational research team, the first consideration is to evaluate the attendees, if they are suitable for the trial study. Furthermore, they should also be assessed for any complication in terms of physical or mental health which could be relevant to the undertaken study. Furthermore, in order to comply with legal and ethical guidelines, clear and explicit information about the purpose, probable risk, the objective of study, and the benefits associated should be described to attendees. These information are important because they are key motivators to comply with the informed decision procedure. Importantly, in the situation of random recruitment for trial partnership, it is also important to maintain trust and pave respect to the attendees for their contribution. This requires effective communication for explaining the purpose and rendering consent while distributing the trial drug. According to Vat, Ryan, and Etchegary (2017), the researchers involved in trial studies must have complete knowledge regarding the undertaken study, procedure of recruitment as well as engagement as partners by delivering appropriate information, which also constitutes a legal requirement in the given case. 

Overall it is learned that while recruiting partners for trial studies oh, it is important to comply with legal and ethical requirement which must ensure safety of participants, as well as complete delivery of information regarding the trial, effect of drugs, and probable outcome to participants for the purpose of informed decision.

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