IRB: Ethics & Human Research

Consent for Nondiagnostic Research Biopsies: A Pilot Study of Participant Recall and Therapeutic Orientation

Clinical trials that include research biopsies might present challenges for consent validity.

An ethical framework for enrolling patients in studies that include a research biopsy rides heavily on informed consent. In particular, study participants should understand that research biopsies are nontherapeutic and burdensome and that participation is discretionary in studies involving them. Yet little is known about whether decisions to enroll in a study that involves a research biopsy, including those that permit participants to opt out of the procedure, meet thresholds of consent validity, in other words, whether individuals sufficiently understand and appreciate the consequences of their decision and whether they are not unduly influenced.

Clinical trials that include research biopsies might present challenges for consent validity for at least three reasons. First, because procedures are burdensome, individuals who enroll in these trials might do so under the mistaken belief that the biopsies provide a therapeutic benefit to them. Second, biopsies are often conducted proximate to therapeutic encounters, where patients undergoing a biopsy might be focused on a recent diagnosis and on management options, not on their role as a research participant. Last, because research participants often conflate research with clinical care, they might fail to appreciate the nontherapeutic nature of a research biopsy. To investigate these issues, we used semistructured interviews to probe recalled perceptions, motivations, and consent quality for research participants in a cancer biomarker study involving nondiagnostic biopsies.

Abadie R, Kimmelman J, Lafleur J, Lemmens T. Consent for nondiagnostic research biopsies: A pilot study of participant recall and therapeutic orientation. IRB: Ethics & Human Research 2014;36(3):9-15.