- Legal Commentary
The issues arising for consideration in this case are:
a). the nature of the investigator-subject relationship that gives rise to an ethical duty to disclose incidental findings;
b). whether the research team in this case (including the principal investigator and co-investigator) has a duty to disclose the incidental finding observed to the research volunteer; and
c). whether the research team has a further ethical duty to ensure that the MRI scans are clinically evaluated to identify potential health problems.
The starting point is to define “incidental findings” for clarity and precision. A good working definition of the same is “a finding concerning an individual research participant that has potential health or reproductive importance and that is discovered in the course of conducting research but is beyond the aims of the study”.1
With regard to incidental findings, Miller, Mello and Joffe in an insightful article2 observe:
… there is little ethical guidance available to steer such efforts, and practices appear to vary widely. Although several articles have catalogued the ethical dilemmas surrounding incidental findings, with the exception of seminal work by Henry Richardson and Leah Belsky on the more general topic of researchers’ obligations to provide ancillary clinical care to research subjects, systematic ethical analysis of the incidental findings problem is lacking.
In this case scenario, there is no concurrent, overlapping physician-patient relationship (even if the research subjects were recruited from patients at the hospital’s memory clinic) that might provide an alternative [End Page 274] source of obligations relating to incidental findings. No representations have been made by the research team to the patient-volunteers. The patient-volunteers did not opt to be kept in the know as to incidental findings. Neither did they express a preference not to be informed of such findings. Had they done so, such a choice would presumably absolve the research team from keeping the patient-volunteers informed. From an autonomy perspective, there is no compelling reason why such a choice by a patient-volunteer should not be honoured.
One view of the first issue outlined above is that the relationship between a research investigator and a research subject is founded in contract. On that premise, investigators have no default obligations, only what is expressed or implied in the terms of the “contracts” for recruiting volunteers. The relevant documents and data to be analysed would be the “contracts” executed by the parties and the informed consent form as well as interactions and iterations between investigators and patient-volunteers. Of particular significance would be representations made by the investigators that could form part of the terms of the contract. Apart from express terms, there would also be some rare implied terms — for example, an implied term of good faith although this has only been recognised in certain sui generis categories of contracts (for example, insurance contracts). Adopting this perspective strips away any fiduciary or professional aspects of the relationship and reduces the relationship to nothing more than a contractual one. Such a view relies on the legal relationship as a springboard for the ethical duties although this perspective would be reductive because very few implied duties are presumed. Unless incidental findings fall within the terms of the contract, investigators are under no obligation to respond to them. In the final analysis, the main objection to this contractual perspective is that it conflates legal duties with ethical duties when these two distinct types of obligations which investigators and a research team have to elucidate.
An alternative approach involves a focus on professional relationships. Concepts of incidental findings and ancillary care presume some sort of professional relationship pursuant to which the findings are analysed as incidental or the care is determined as ancillary. “Professionals” refer to persons who are usually distinguished by their specialised knowledge and training as well as by their commitment to provide important services to patients, clients or consumers.3 Professional relationships are often, but not always, characterised by a service role, sometimes involving a fiduciary relationship.
Although researchers cannot be viewed as having a service role vis-à-vis individual subjects, it is reasonable [End Page 275] to regard research as a professional activity. Researchers possess...