Research Involving Terminally Ill Patients

Research involving terminally ill patients presents additional concerns in that potential subjects tend to be more vulnerable to coercion or undue influence, and the research is likely to present greater than minimal risk. As a result, special attention should be given to the informed consent process. The following elements must be emphasized:

• Accurate information concerning eligibility for participation and risks and benefits should be conveyed clearly and in a manner that will not either engender false hope or eliminate all hope;
• Patients should be fully informed of the availability of treatment alternatives, including at what point their participation in the research study should or may be terminated to permit a treatment alternative, and that an alternative may include no additional treatment;
• Any costs to the patient associated with research study participation should be stated explicitly.