What aspect of informed consent is required under both HIPAA and Common Rule?

The correct answer hinges on the ethical principles that underpin informed consent within research involving human subjects, specifically those mandated by both HIPAA (Health Insurance Portability and Accountability Act) and the Common Rule (Federal Policy for the Protection of Human Subjects).

Informed consent is fundamentally about ensuring that participants are fully aware of what their participation entails and that they have the right to withdraw from the study without facing any negative consequences. This principle is essential in protecting the autonomy of participants and maintaining ethical standards in research. Both HIPAA and the Common Rule emphasize the importance of this right; they allow participants to withdraw at any time without penalty, thus ensuring their ongoing consent throughout the study. This provision reflects a respect for individuals' rights and acknowledges that consent is an ongoing process rather than a one-time event.

Other options mentioned do not represent requirements under both HIPAA and the Common Rule. For example, the requirement for participants to sign in front of a witness is not a universal standard, and consent can indeed be obtained verbally, particularly in certain contexts or when appropriate. Furthermore, seeking consent after data collection contradicts the basic principles of informed consent, as participants should be informed and agree to the terms before any data is gathered.