Incidental Findings and the Minimal Risk Standard in Pediatric Neuroimaging Research

IRB: Ethics & Human Research (2015) 37(5) 11-19

10 Pages Posted: 12 Dec 2015

See all articles by Matthias Schmidt

Matthias Schmidt

Dalhousie University - Faculty of Medicine, Department of Radiology

Michael Hadskis

Dalhousie University - Schulich School of Law

Jocelyn Downie

Schulich School of Law & Faculty of Medicine

Jennifer Marshall

Dalhousie University - Schulich School of Law

Date Written: September 1, 2015

Abstract

In the present paper, we revisit the minimal risk standard to identify an appropriate benchmark for the nature and magnitude of risk associated with incidental findings (IFs). We review the limited published information on IFs in healthy children who have participated in magnetic resonance (MR) neuroimaging research to date in order to determine the spectrum and frequency of reported IFs. We then categorize IFs broadly according to their implications for participant health and discuss their management, including disclosure. We conclude that IFs in pediatric MR neuroimaging research can meet the minimal risk standard in the best-case scenario, but not in the worst-case scenario. The true risk associated with IFs likely lies somewhere between these two extremes, with IFs distributed among the categories of benefit, minor harm, and major harm in as-yet-unknown proportions. Much depends on the imaging protocol that researchers use and the degree of scrutiny to which they subject images. Much also depends on their approach to management, including diagnosis, disclosure, and referral.

Keywords: ethics, pediatric, neuroimagining

Suggested Citation

Schmidt, Matthias and Hadskis, Michael and Downie, Jocelyn and Marshall, Jennifer, Incidental Findings and the Minimal Risk Standard in Pediatric Neuroimaging Research (September 1, 2015). IRB: Ethics & Human Research (2015) 37(5) 11-19 , Available at SSRN: https://ssrn.com/abstract=2670801

Matthias Schmidt

Dalhousie University - Faculty of Medicine, Department of Radiology ( email )

1278 Tower Road
Halifax, Nova Scotia B3H 2Y9
Canada

Michael Hadskis

Dalhousie University - Schulich School of Law ( email )

6061 University Avenue
6061 University Ave
Halifax, Nova Scotia B3H 4H9
Canada

Jocelyn Downie (Contact Author)

Schulich School of Law & Faculty of Medicine ( email )

Halifax, Nova Scotia B3H 4H9
Canada

Jennifer Marshall

Dalhousie University - Schulich School of Law ( email )

6061 University Avenue
6061 University Ave
Halifax, Nova Scotia B3H 4H9
Canada

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