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That's not right! This decision involves MEDIUM RISK.
You are responsible for ensuring that the trial participants have a complete understanding of the purpose, procedures, and benefits and risks of the trial, regardless of the complexity of the trial or the competency of the participants. Relying on your team's knowledge and continuing the trial will be unethical.
You got it! This decision involves NO RISK.
You are responsible for ensuring that the trial participants have a complete understanding of the purpose, procedures, and benefits and risks of the trial. Therefore, you must retrain your team to ensure that they understand the correct and ethical way of obtaining informed consent. You must also revise the informed consent form to ensure that the participants understand the information.
That's not right! This decision involves HIGH RISK.
You are responsible for ensuring that the trial participants have a complete understanding of the purpose, procedures, and benefits and risks of the trial. Simply documenting the issue that the supervisor has reported and ignoring the problem would be unethical, unprofessional, and detrimental.
That's not right! This decision involves LOW RISK.
You are responsible for ensuring that the trial participants have a complete understanding of the purpose, procedures, and benefits and risks of the trial. Providing limited information on the form is unethical and illegal.
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That's not right! This decision involves MEDIUM RISK.
Simply handing over the updated informed consent form to the participants would not be enough. Investigators must share detailed information about the trial. The participants must read, understand, and then sign the updated form. Further, proceeding with the trial without obtaining informed consent will be unethical.
You got it! This decision involves NO RISK.
To carry out the informed consent process ethically, the R&D team should first share detailed information about the trial with the participants and ensure that the participants have a complete understanding of the purpose, procedures, and benefits and risks of the trial. Then the team should obtain the signed informed consent from the participants.
That's not right! This decision involves HIGH RISK.
The participants should have a complete understanding of the purpose, procedures, and benefits and risks of the trial and clarify any doubts they may have before signing the updated informed consent form. Convincing the participants to sign the updated form without explaining the changes is unethical.
That's not right! This decision involves LOW RISK.
It is a fair decision to encourage the participants to read and sign the updated informed consent form before the trial begins. However, this approach is incomplete. Before getting the updated form signed, the R&D team should share the details about the trial with the participants.