Risks and Inconveniences

The investigator must describe any reasonably foreseeable risks and inconveniences associated with participation. The probability of the risk should be disclosed to the subject, as well as a ranking of the risks according to their likelihood of occurrence. In general, the “reasonable-person” standard is followed; that is, disclosure of the risks that a “reasonable person” would want to know about the research before deciding to participate. These risks may be physical, psychological, social, economic, and/or legal. The risks listed in this section of the consent form must match the risks listed in the protocol. The list of inconveniences in this section of the consent form, should also match that in the protocol. If there are currently unforeseeable risks of a research intervention, drug, or procedure, such as risks to a pregnant women or fetus, these should be mentioned in this section of the consent form. In addition, this section should include stipulations for females of childbearing age, i.e., ineligibility for those who test positive for pregnancy, disclosure of plans for contraception, and notification of the investigator if these plans for contraception are altered in some way. This section should also include risks to individuals associated with the research subjects, e.g., risks to the health or well-being of a spouse or partner.