title: Is it ethical to prevent secondary use of stored biological samples and data derived from consenting research participants? The case of Malawi.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: College of Medicine, School of Public Health, Master of Public Health Bioethics Major Students, University of Malawi, Blantyre, Malawi. rgmungwira@gmail.com.
authors.forename: Randy G
authors.initials: RG
authors.lastname: Mungwira
authors.affiliation: College of Medicine, School of Public Health, Master of Public Health Bioethics Major Students, University of Malawi, Blantyre, Malawi. wnyangulu@gmail.com.
authors.forename: Wongani
authors.initials: W
authors.lastname: Nyangulu
authors.affiliation: College of Medicine, School of Public Health, Master of Public Health Bioethics Major Students, University of Malawi, Blantyre, Malawi. jamesmisiri@gmail.com.
authors.forename: James
authors.initials: J
authors.lastname: Misiri
authors.affiliation: College of Medicine, School of Public Health, Master of Public Health Bioethics Major Students, University of Malawi, Blantyre, Malawi. iphanisteven@gmail.com.
authors.forename: Steven
authors.initials: S
authors.lastname: Iphani
authors.affiliation: College of Medicine, School of Public Health, Master of Public Health Bioethics Major Students, University of Malawi, Blantyre, Malawi. tionenji2001@yahoo.co.uk.
authors.forename: Ruby
authors.initials: R
authors.lastname: Ng'ong'ola
authors.affiliation: College of Medicine, School of Public Health, Master of Public Health Bioethics Major Students, University of Malawi, Blantyre, Malawi. mahebere.chirambo@gmail.com.
authors.forename: Chawanangwa M
authors.initials: CM
authors.lastname: Chirambo
authors.affiliation: Department of Medicine, University of Cape Town, Cape Town, Republic of South Africa. fmasiye@medcol.mw.|College of Medicine, School of Public Health, Center for Bioethics, University of Malawi, Blantyre, Malawi. fmasiye@medcol.mw.
authors.forename: Francis
authors.initials: F
authors.lastname: Masiye
authors.affiliation: College of Medicine, School of Public Health, Center for Bioethics, University of Malawi, Blantyre, Malawi. mfutsobengo@medcol.mw.
authors.forename: Joseph
authors.initials: J
authors.lastname: Mfutso-Bengo
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D002985:Clinical Protocols; D028744:Ethics Committees, Research; D032984:Ethics, Research; D017408:Guidelines as Topic; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D008295:Malawi; D012108:Research Personnel / Q000941:ethics*; D035842:Research Subjects / Q000706:statistics & numerical data*; D013048:Specimen Handling / Q000941:ethics*; D014015:Tissue Banks / Q000941:ethics