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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 BMC+Med+Ethics
2015 ; 16
(1
): 83
Nephropedia Template TP
gab.com Text
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English Wikipedia
Is it ethical to prevent secondary use of stored biological samples and data
derived from consenting research participants? The case of Malawi
#MMPMID26626016
Mungwira RG
; Nyangulu W
; Misiri J
; Iphani S
; Ng'ong'ola R
; Chirambo CM
; Masiye F
; Mfutso-Bengo J
BMC Med Ethics
2015[Dec]; 16
(1
): 83
PMID26626016
show ga
BACKGROUND: This paper discusses the contentious issue of reuse of stored
biological samples and data obtained from research participants in past clinical
research to answer future ethical and scientifically valid research questions.
Many countries have regulations and guidelines that guide the use and exportation
of stored biological samples and data. However, there are variations in
regulations and guidelines governing the reuse of stored biological samples and
data in Sub-Saharan Africa including Malawi. DISCUSSION: The current research
ethics regulations and guidelines in Malawi do not allow indefinite storage and
reuse of biological samples and data for future unspecified research. This comes
even though the country has managed to answer pertinent research questions using
stored biological samples and data. We acknowledge the limited technical
expertise and equipment unavailable in Malawi that necessitates exportation of
biological samples and data and the genuine concern raised by the regulatory
authorities about the possible exploitation of biological samples and data by
researchers. We also acknowledge that Malawi does not have bio-banks for storing
biological samples and data for future research purposes. This creates room for
possible exploitation of biological samples and data collected from research
participants in primary research projects in Malawi. However, research ethics
committees require completion and approval of material transfer agreements and
data transfer agreements for biological samples and data collected for research
purposes respectively and this requirement may partly address the concern raised
by the regulatory authorities. Our concern though is that there is no such
requirement for biological samples and data collected from patients for clinical
or diagnostic purposes. In conclusion, we propose developing a medical data and
material transfer agreement for biological samples and data collected from
patients for clinical or diagnostic purposes in both public and private health
facilities that may end up in research centers outside Malawi. We also propose
revision of the current research ethics regulations and guidelines in Malawi in
order to allow secondary use of biological samples and data collected from
primary research projects as a way of maximizing the use of collected samples and
data. Finally, we call for consultation of all stakeholders within the Malawi
research community when regulatory authorities are developing policies that
govern research in Malawi.
|*Ethics Committees, Research
[MESH]
|*Tissue Banks/ethics
[MESH]
|Biomedical Research/*ethics
[MESH]
|Clinical Protocols
[MESH]
|Ethics, Research
[MESH]
|Guidelines as Topic
[MESH]
|Humans
[MESH]
|Informed Consent/*ethics
[MESH]
|Malawi
[MESH]
|Research Personnel/*ethics
[MESH]
|Research Subjects/*statistics & numerical data
[MESH]