ReviewThe ethics of secondary data analysis: Considering the application of Belmont principles to the sharing of neuroimaging data
Introduction
The sharing of data has become important across many different fields of science, and in some cases (such as molecular biology and genomics) has radically transformed the pace of scientific progress. It has long been hoped that the sharing of neuroimaging data could provide a similar benefit to the field of cognitive neuroscience (cf. Poline and Poldrack, 2012, Van Horn and Gazzaniga, 2012). However, the sharing of human neuroimaging data poses potential ethical issues that are not encountered when sharing data from non-human samples. Researchers have unique responsibilities to ensure that subjects are protected, including by following the principles of respect of persons, justice, and beneficence. Researchers also have a responsibility to use data to produce “knowledge, products, and procedures to improve human health” (National Institutes of Health, 2003). The core argument of this article is that sharing data for secondary data analysis aligns with the Belmont principles that underlie the protection of human subjects. In this paper we will outline some of the potential ethical issues that can arise in the context of secondary analysis of human subject data. We will provide some context for currently proposed changes to regulations that researchers must follow, then lay out some basic principles that underlie human subject protection, and discuss how each of these interacts with data sharing and secondary data analysis. To provide support for the public trust, researchers have an obligation to share research data with other scientists; human subject ethics do not conflict with this obligation but rather provide added support for it.
In this paper, we will focus on the sharing of data from nonclinical studies, which are those in which subjects are individuals who are not receiving treatment from any personnel associated with the research or from that institution. That is, these research subjects are not also patients of the researcher. Data collected in the context of treatment are subject to more restrictions than data collected solely for research, such as the U.S. Health Insurance Portability and Accountability Act (HIPAA) (42 USC §, 1320d-2) or the U.S. Patient Safety and Quality Improvement Act of, 2005 (Pub.L. 109–41, 119 Stat. 424–434), as well as FDA regulations (21 C.F.R. 50, 56, 312 and 812).
Section snippets
The 2011 ANPRM and the principles of human subject research
In 2011, the US Office of Human Research Protections (OHRP) released an Advanced Notice of Proposed Rule Making (ANPRM) outlining proposed changes in regulations on human subject research (OHRP, 2011a). This ANPRM was created to solicit opinions and information about potential changes in human subject regulations from the public at large, including IRB members, research administrators, and investigators. One of the areas of change is how the secondary use of biospecimens will be regulated and
Conflict of interest
The authors declare no conflict of interest.
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