Drugs Placebo

Drug Treatment Studies – Placebo Use

Use of placebos in lieu of an approved FDA indicated drug may be appropriate where the investigator demonstrates that:

• standard therapy is unavailable or is of unproved efficacy, OR
• standard therapy possesses unacceptable side effects, OR
• minimal harm may result from the use of placebo (e.g., ongoing disease has little adverse effect on the patient during the course of the trial and is reversible), OR
• placebo itself may be an effective therapy, OR
• the disease process is characterized by exacerbation and remission.

If an investigator proposes a study in which a placebo is given for any length of time in lieu of an approved FDA indicated drug, the investigator must include risk management procedures in the research plan for the IRB for review.

The risk management procedures should be in the written protocol, with the same level of detail as in the protocol itself. The following issues should be specified:

• the frequency of monitoring,
• whether monitoring is in person or by telephone,
• the criteria for managing a subject in the event of worsening, and
• how 24 hour-per-day, 7 day-per-week, medical care is made available in the event of questions, emergencies, worsening, or withdrawal from the protocol.

IRB Determination

• The IRB may make its decision based upon the extent to which the above factors are demonstrated and upon a relative weighing of these and other factors.
• In discussing potential harm from the use of placebos, the investigators must provide a procedure for adequate monitoring of subjects to ensure their safety.
• To the extent that the investigator demonstrates that the subjects' safety is monitored at all times and provisions are made for immediate rescue if needed, the IRB will consider approval of the study.
• Once an approval is granted, the investigator is bound to follow the risk management procedures as with any other provision of the approved protocol.