Mungwira Randy G, Nyangulu Wongani, Misiri James, Iphani Steven, Ng'ong'ola Ruby, Chirambo Chawanangwa M, Masiye Francis, Mfutso-Bengo Joseph
College of Medicine, School of Public Health, Master of Public Health Bioethics Major Students, University of Malawi, Blantyre, Malawi.
Department of Medicine, University of Cape Town, Cape Town, Republic of South Africa.
BMC Med Ethics. 2015 Dec 2;16(1):83. doi: 10.1186/s12910-015-0077-x.
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.
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.
本文讨论了重复使用过去临床研究中从研究参与者那里获取的储存生物样本和数据这一有争议的问题，以回答未来符合伦理且科学有效的研究问题。许多国家都有指导储存生物样本和数据使用及出口的法规和指南。然而，撒哈拉以南非洲地区（包括马拉维）在管理储存生物样本和数据重复使用的法规和指南方面存在差异。
马拉维当前的研究伦理法规和指南不允许无限期储存生物样本和数据并用于未来未明确的研究。尽管该国已成功利用储存的生物样本和数据回答了相关研究问题，但仍如此规定。我们承认马拉维技术专业知识和设备有限，这使得生物样本和数据有必要出口，同时也承认监管当局对研究人员可能滥用生物样本和数据的真切担忧。我们还承认马拉维没有用于未来研究目的储存生物样本和数据的生物样本库。这为在马拉维的初级研究项目中从研究参与者那里收集的生物样本和数据被滥用创造了可能性。然而，研究伦理委员会分别要求完成并批准用于研究目的收集的生物样本的材料转移协议和数据转移协议，这一要求可能部分解决监管当局提出的担忧。不过，我们担心的是，对于为临床或诊断目的从患者那里收集的生物样本和数据没有这样的要求。总之，我们提议针对在公共和私立卫生机构为临床或诊断目的从患者那里收集且最终可能流向马拉维境外研究中心的生物样本和数据，制定一份医疗数据和材料转移协议。我们还提议修订马拉维当前的研究伦理法规和指南，以便允许对从初级研究项目收集的生物样本和数据进行二次使用，以此最大化所收集样本和数据的利用。最后，我们呼吁在监管当局制定管理马拉维研究的政策时，咨询马拉维研究界的所有利益相关者。
