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

Abstract

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.

A qualitative study exploring stakeholder perspectives on the use of biological samples for future unspecified research in Malawi

“…The ethical and practical concerns expressed in this study are in agreement with literature on various perceptions of sample collection, storage and reuse for future research in Africa [1,3,13,16]. As stipulated by various authors, these concerns reveal how low and middle income settings such as Malawi are struggling with development of guidance documents that respond to ethical issues emerging from advances in science and technology, and also development of fair and effective collaborations.…”

“…The use of the current informed consent model that protects study participants from future unknown harm was seen as both unethical and practically problematic for settings with limited resources such as Malawi. Lack of guidelines and reuse restrictions were similarly seen as unethical and related to prohibiting an exercise to personal autonomy as previously reported in Malawi [3]. However, in this study, study participants do trust researchers to abide by various good research practices outlined in informed consent procedures, for example, issues of confidentiality and sample use.…”

“…In the past decade, Malawi has experienced tremendous growth in hosting research and researchers, collaborating with sponsors and funders from high Income countries (HIC). This has inevitably led to the collection and storage of samples for future research with some left-over samples exported to HICs for unspecified future research [3].…”

“…For example, there are questions regarding specific mechanisms that are employed to safeguard the interests of research participants such as sample donors, [2] and appropriate models of consent for sample storage and reuse. There are also concerns about how to share research benefits in a way that is fair and acceptable to participants, their communities and funders [2][3][4].…”

Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development

“…It should also be taken into account that local laws or culture may be prohibitive to allowing specimens to be stored for future testing. 16,[19][20][21][22][23] A concerted effort and willingness among researchers and companies to share available clinical specimens would be a valuable step forward in EID preparedness. 24 Sample collection & handling are critical to the quality of the specimen and its ability to be used in assays, standards or controls.…”