Ms Sonja Read1, Dr Lisa Eckstein
1MinterEllison, Brisbane, Australia
Biography:
Bio to come
Abstract:
In clinical and biomedical research, the Patient Information and Consent Form (PICF) plays a pivotal role in informing potential participants about the study's details and securing their voluntary agreement to participate. However, a fundamental question arises: does signing a PICF constitute a legal contract between the researcher (or research site) and the participant? If so, what are the implications of a PICF being a contract? To the best of our knowledge, this question has never received judicial attention in the Australian context.
This presentation begins by examining the essential legal components of a contract and compares these with the typical content and structure of a PICF. Key aspects such as offer, acceptance, consideration, and mutual intent are scrutinized against the unique characteristics of research PICFs. This includes the common lack of monetary consideration, regulations that position PICFs as performing an ethical rather than legal purpose, and the pre-eminence of consent discussions as a means of supplementing written information.
We conclude by discussing the implications of any recognition of research PICFs as a contract, including ethical, legal, and practical considerations.