If an elderly subject expresses interest in participating in a trial but lacks a signed consent due to their representative being unavailable, what is the best course of action?

When an elderly subject expresses interest in participating in a clinical trial but cannot provide a signed consent because their representative is unavailable, the most appropriate course of action is to send the consent forms to the representative via fax. This ensures that the representative has the opportunity to review and sign the consent, maintaining the integrity of the informed consent process.

In clinical research, informed consent is crucial, as it ensures that participants are fully aware of the study's purpose, procedures, risks, and benefits. By sending the consent forms to the representative, you are respecting their role in the subject's decision-making process and adhering to ethical standards. This approach protects the rights of the elderly subject while also complying with regulatory and institutional requirements regarding consent.

The other options do not adequately address the ethical and legal obligations surrounding informed consent. Simply excluding the subject would prevent them from potentially benefiting from the trial and participating in a decision that may affect their health. Enrolling the subject without a signed consent is not compliant with institutional policies and ethical guidelines, as it violates the informed consent principle. Lastly, requesting the IRB to waive the consent requirement may not be appropriate in this context, especially when consent can be obtained from the representative. Thus, sending the consent forms via fax is the most responsible