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

Field of study:  Nursing

(minimum of 250 words with peer review)

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?