Who initiates the informed consent discussion & answers questions?

• The Principal Investigator (PI) may be the best person to initiate informed consent and answer all questions and concerns potential research subjects may have, especially for complicated protocols.
• The PI may delegate the consent process to different members of the research team.
• The complexity of the protocol and level of risk must be considered when delegating the responsiblility of obtaining legally effective informed consent.

• Delegated persons must:
  • be key personnel on IRB list for the specific study
  • complete the required IRB human protections training
  • understand the research protocol