Informed Consent for RCTs

27 May 2013

The SUPPORT study is causing a split within bioethics between people who think the OHRP was right to object to the way the study was run and those who think the OHRP is out of line. I remain genuinely confused as to why we are even arguing over some issues that strike me as Informed Consent 101.

So after discussing this study with multiple smart doctors and medical ethicists, I have come up with a list I think might be useful in terms of talking about what RCT informed consent is supposed to look like. I am here making no claims to originality or insight; quite the opposite. This is simply what I think everybody already agrees needs to happen with informed consent for RCTs:

  • A consent document for an RCT should include a description of the various arms of the trial, including what interventions the subject might receive or have withheld by virtue of being in the trial.
  • A consent document should include in the “risks” section whatever potential negative outcomes the trial is designed to track.
  • The “benefits” section may name potential positive outcomes the trial is designed to track.
  • If a Data Safety Monitoring Board (DSMB) is set up in conjunction with the trial, the adverse events being monitored by the DSMB should be included in the “risks” section of the consent document.
  • If none of the arms of an RCT involve potential risk or potential benefit different from the risks and benefits from care that is ordinarily delivered, then the trial cannot provide useful data about how care can be improved (because it is no different from the care ordinarily delivered). A good RCT necessarily involves arms that ultimately will differ in their risks and benefits.

In summary, all consent documents for RCTs should include a description of the interventions involved in the RCT, and should include a list of the risks being tracked in the RCT.

For more, see Lois Shepherd’s short and smart analysis and Ruth Macklin’s helpful follow-up comment. You can read about what the consent documents, the study protocol, and the charge to the DSMB actually said in this report, to which Dr. Macklin contributed.

See the consent form here: SUPPORT Study Consent Form.pdf

See the OHRP determination letter here: SUPPORT OHRP determination.pdf