Is it ethical to prevent secondary use of stored biological samples and data derived from consenting research participants? The case of Malawi

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dc.contributor.authorMungwira, Randy G
dc.contributor.authorNyangulu, Wongani
dc.contributor.authorMisiri, James
dc.contributor.authorIphani, Steven
dc.contributor.authorNg’ong’ola, Ruby
dc.contributor.authorChirambo, Chawanangwa M
dc.contributor.authorMasiye, Francis
dc.contributor.authorMfutso-Bengo, Joseph
dc.date.accessioned2021-10-08T06:20:33Z
dc.date.available2021-10-08T06:20:33Z
dc.date.issued2015
dc.description.abstractBackgroundThis 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.DiscussionThe 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.SummaryIn 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.
dc.identifier.apacitationMungwira, R. G., Nyangulu, W., Misiri, J., Iphani, S., , Chirambo, C. M., ... Mfutso-Bengo, J. (2015). Is it ethical to prevent secondary use of stored biological samples and data derived from consenting research participants? The case of Malawi. <i>BMC Medical Ethics</i>, 16(1), 174 - 177. http://hdl.handle.net/11427/34302en_ZA
dc.identifier.chicagocitationMungwira, Randy G, Wongani Nyangulu, James Misiri, Steven Iphani, , Chawanangwa M Chirambo, Francis Masiye, and Joseph Mfutso-Bengo "Is it ethical to prevent secondary use of stored biological samples and data derived from consenting research participants? The case of Malawi." <i>BMC Medical Ethics</i> 16, 1. (2015): 174 - 177. http://hdl.handle.net/11427/34302en_ZA
dc.identifier.citationMungwira, R.G., Nyangulu, W., Misiri, J., Iphani, S., , Chirambo, C.M., Masiye, F. & Mfutso-Bengo, J. et al. 2015. Is it ethical to prevent secondary use of stored biological samples and data derived from consenting research participants? The case of Malawi. <i>BMC Medical Ethics.</i> 16(1):174 - 177. http://hdl.handle.net/11427/34302en_ZA
dc.identifier.issn1472-6939
dc.identifier.ris TY - Journal Article AU - Mungwira, Randy G AU - Nyangulu, Wongani AU - Misiri, James AU - Iphani, Steven AU - Ng’ong’ola, Ruby AU - Chirambo, Chawanangwa M AU - Masiye, Francis AU - Mfutso-Bengo, Joseph AB - BackgroundThis 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.DiscussionThe 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.SummaryIn 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. DA - 2015 DB - OpenUCT DP - University of Cape Town IS - 1 J1 - BMC Medical Ethics LK - https://open.uct.ac.za PY - 2015 SM - 1472-6939 T1 - Is it ethical to prevent secondary use of stored biological samples and data derived from consenting research participants? The case of Malawi TI - Is it ethical to prevent secondary use of stored biological samples and data derived from consenting research participants? The case of Malawi UR - http://hdl.handle.net/11427/34302 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/34302
dc.identifier.vancouvercitationMungwira RG, Nyangulu W, Misiri J, Iphani S, , Chirambo CM, et al. Is it ethical to prevent secondary use of stored biological samples and data derived from consenting research participants? The case of Malawi. BMC Medical Ethics. 2015;16(1):174 - 177. http://hdl.handle.net/11427/34302.en_ZA
dc.language.isoeng
dc.publisher.departmentDepartment of Medicine
dc.publisher.facultyFaculty of Health Sciences
dc.sourceBMC Medical Ethics
dc.source.journalissue1
dc.source.journalvolume16
dc.source.pagination174 - 177
dc.source.urihttps://dx.doi.org/10.1186/s12910-015-0077-x
dc.subject.otherBiomedical Research
dc.subject.otherClinical Protocols
dc.subject.otherEthics Committees, Research
dc.subject.otherEthics, Research
dc.subject.otherGuidelines as Topic
dc.subject.otherHumans
dc.subject.otherInformed Consent
dc.subject.otherMalawi
dc.subject.otherResearch Personnel
dc.subject.otherResearch Subjects
dc.subject.otherSpecimen Handling
dc.subject.otherTissue Banks
dc.titleIs it ethical to prevent secondary use of stored biological samples and data derived from consenting research participants? The case of Malawi
dc.typeJournal Article
uct.type.publicationResearch
uct.type.resourceJournal Article
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