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2015 ; 13
(4
): 263-70
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Sharing and Reuse of Sensitive Data and Samples: Supporting Researchers in
Identifying Ethical and Legal Requirements
#MMPMID26186169
Sariyar M
; Schluender I
; Smee C
; Suhr S
Biopreserv Biobank
2015[Aug]; 13
(4
): 263-70
PMID26186169
show ga
Availability of and access to data and biosamples are essential in medical and
translational research, where their reuse and repurposing by the wider research
community can maximize their value and accelerate discovery. However, sharing
human-related data or samples is complicated by ethical, legal, and social
sensitivities. The specific ethical and legal requirements linked to sensitive
data are often unfamiliar to life science researchers who, faced with vast
amounts of complex, fragmented, and sometimes even contradictory information, may
not feel competent to navigate through it. In this case, the impulse may be not
to share the data in order to safeguard against unintentional misuse.
Consequently, helping data providers to identify relevant ethical and legal
requirements and how they might address them is an essential and frequently
neglected step in removing possible hurdles to data and sample sharing in the
life sciences. Here, we describe the complex regulatory context and discuss
relevant online tools-one which the authors co-developed-targeted at assisting
providers of sensitive data or biosamples with ethical and legal questions. The
main results are (1) that the different approaches of the tools assume different
user needs and prior knowledge of ethical and legal requirements, affecting how a
service is designed and its usefulness, (2) that there is much potential for
collaboration between tool providers, and (3) that enriched annotations of
services (e.g., update status, completeness of information, and disclaimers)
would increase their value and facilitate quick assessment by users. Further,
there is still work to do with respect to providing researchers using sensitive
data or samples with truly 'useful' tools that do not require pre-existing,
in-depth knowledge of legal and ethical requirements or time to delve into the
details. Ultimately, separate resources, maintained by experts familiar with the
respective fields of research, may be needed while-in the longer
term-harmonization and increase in ease of use will be very desirable.