Subject: Special Categories of Research: Other Participants Who May Be Vulnerable to Coercion or Undue Influence

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – to ensure that additional safeguards have been included in the research to protect the rights and welfare of subjects who are likely to be vulnerable to coercion or undue influence. These subjects might include mentally disabled persons, or economically or educationally disadvantaged persons, or other persons as determined by the IRB. ^[1], ^[2]

^[1] 45 CFR 46.111 (b)

^[2] 21 CFR 56.111 (b)