Layers of complexity can spark errors in informed consent documentation, slowing the process and even damaging clinical trials, says Lindsay McNair, MD, MPH, MSB, chief medical officer at WIRB-Copernicus Group in Princeton, N.J. Those engaged in informed consent policy and implementation should ensure the existence of clear descriptions of the eligible population and ought to review protocol and consent template language to make certain it is appropriate in a specific setting, she adds.
To achieve these goals, it is important that the informed consent process involve evaluation of the research proposal’s legitimate need to enroll those potential subjects who lack the capacity to consent for themselves. It’s a complex issue, McNair allows.
On the one hand, in protocols where the intervention is intended to treat the cause of the incapacity to consent, or where there is a robust expectation of benefit for participants, inclusion of that population is ethical and just, McNair says. However, she notes that the issue of allowance for nonreaders is a very different situation; a case can be made that it is unethical to exclude this population.
Learn more about how to address the ethical and logistical challenges of informed consent in a number of scenarios by downloading “Getting the Right Signatures on Informed Consent Documents” by McNair and colleagues from the October issue of Clinical Researcher.
Sponsored by WIRB-Copernicus Group