Ethical Issues in Intraoperative Neuroscience Research: Assessing Subjects’ Recall of Informed Consent and Motivations for Participation

ABSTRACT

Background

An increasing number of studies utilize intracranial electrophysiology in human subjects to advance basic neuroscience knowledge. However, the use of neurosurgical patients as human research subjects raises important ethical considerations, particularly regarding informed consent and undue influence, as well as subjects’ motivations for participation. Yet a thorough empirical examination of these issues in a participant population has been lacking. The present study therefore aimed to empirically investigate ethical concerns regarding informed consent and voluntariness in Parkinson’s disease patients undergoing deep brain stimulator (DBS) placement who participated in an intraoperative neuroscience study.

Methods

Two semi-structured 30-minute interviews were conducted preoperatively and postoperatively via telephone. Interviews assessed participants’ motivations for participation in the parent intraoperative study, recall of information presented during the informed consent process, and participants’ postoperative reflections on the research study.

Results

Twenty-two participants (mean age = 60.9) completed preoperative interviews at a mean of 7.8 days following informed consent and a mean of 5.2 days prior to DBS surgery. Twenty participants completed postoperative interviews at a mean of 5 weeks following surgery. All participants cited altruism or advancing medical science as “very important” or “important” in their decision to participate in the study. Only 22.7% (n = 5) correctly recalled one of the two risks of the study. Correct recall of other aspects of the informed consent was poor (36.4% for study purpose; 50.0% for study protocol; 36.4% for study benefits). All correctly understood that the study would not confer a direct therapeutic benefit to them.

Conclusion

Even though research coordinators were properly trained and the informed consent was administered according to protocol, participants demonstrated poor retention of study information. While intraoperative studies that aim to advance neuroscience knowledge represent a unique opportunity to gain fundamental scientific knowledge, improved standards for the informed consent process can help facilitate their ethical implementation.

KEYWORDS:

• Research ethics
• neuroscience
• Parkinson’s Disease
• deep brain stimulation
• neurosurgery
• informed consent

Acknowledgments

The authors would like to thank Marie Kerr and Hanane Chaibainou for their assistance with this study.

Conflict of interest

GB and JG acknowledge support from the National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke grant number U01NS103799. The content is solely the responsibility of the authors and does not necessarily represent the views of the NIH. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The authors report no conflict of interest.

Ethics approval

Study procedures for both the intraoperative study and ethics study were approved by the University of Pennsylvania’s Institutional Review Board.

Additional information

Funding

This study was supported by the National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke (NINDS) via grant number U01NS103799.