Tuesday, August 19, 2014
Guest Blogger Visiting Assistant Professor Valerie Gutmann Koch: How an Obligation to Return Research Results Is (and Should be) Changing the Investigator-Participant Relationship
Technological advances, such as whole genome or exome sequencing, are changing the nature of research protocols. With these advances, the discovery of incidental or secondary findings (“research findings”) – or other information that could affect the research participant’s health or decision-making – will become more likely and frequent. Whether there is an ethical duty to disclose the results of research to individual participants – regardless of whether the results are directly related to the central research inquiry – has consequently become a central question in human subjects research.
Over the last decade and a half, scholars and research participants have increasingly called for disclosure of research findings. This is particularly true in genetics research. For example, a 2009 survey found that 90% of 343 genetic researchers agreed that they had a duty to offer subjects aggregate research results, and a 2013 study concluded that a majority of researchers believe that research participants should have the option to receive at least some incidental genetic research results. The transformation in attitudes regarding the duty to disclose incidental or secondary findings is further manifested in the evolution of national bioethics advisory body recommendations on the subject. As recently as 1999, the National Bioethics Advisory Commission (NBAC) appointed by President Clinton stated that disclosure of individual research participants’ results “represents an exceptional circumstance” and recommended return of research findings only under specific conditions. As evidence of changing perspectives, in December 2013, the Presidential Commission for the Study of Bioethical Issues enunciated a series of recommendations for the management of incidental and secondary findings in both treatment and research and acknowledged the fact that, in certain circumstances, researchers may have an ethical duty to disclose and manage incidental and secondary findings. As participants, too, increasingly express a desire to receive research findings, the ethical – and perhaps, even legal – expectation that research findings should be disclosed may be further intensified.
So what does that mean for the investigator-participant relationship and research generally? In my forthcoming paper, I argue that the evolving expectation that research results should be returned to participants may accelerate the already-occurring transformation in the relationship between the investigator and research participant, rendering it more like the doctor-patient relationship. The emerging consensus that investigators have some obligation to disclose research findings to research participants reflects an appropriate response to the changing nature of the investigator-research participant relationship. In order to make future autonomous and informed health care decisions, the participant has a right to know information discovered about him/her during the course of research. Thus, research involving genetic testing technologies, biological samples, and medical imaging creates a situation in which research projects pose similar threats to participant autonomy as do medical procedures. I argue that the evolving nature of this relationship may open the door for a private right of action for failure to disclose the risks of a research protocol at its commencement.