Informed Consent may be written (tangible medium, e.g., paper form or electronic format) or oral and serves to obtain the legally effective permission of the subject and:

  • Must take place only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.
  • The information that is given to the subject shall be in language understandable to the subject
  • The prospective subject must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.

Consent Form Guidelines

Readability for Consent Forms

Risk Guidelines

  • Blood Draw Risks
  • Exercise Stress Test Risks
    • "The exercise stress test is a standard clinical procedure which is routinely performed on many people every year for diagnosis and evaluation of their condition.  Adverse effects are very rare, but have occurred.  The mortality of this test is approximately 1 in 10,000 tests, and the incidence of serious complications including prolonged abnormality of heart rhythm or prolonged chest pain is approximately 4 in 10,000 tests."
  • Reporting Unanticipated Problems, Adverse Events, and Serious or Continuous Non-compliance (docx)

Other Guidelines