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