Department of Anatomy, School of Biomedical Sciences, College of Health Sciences, Makerere University, P.O Box 7072, Kampala, Uganda.
School of Statistics, College of Business and Management, Makerere University, Kampala, Uganda.
BMC Med Ethics. 2022 Mar 29;23(1):36. doi: 10.1186/s12910-022-00776-x.
Human biological materials are usually stored for possible future use in research because they preserve valuable biological information, save time and resources, which would have been spent on collection of fresh samples. However, use of these materials may pose ethical challenges such as unauthorized disclosure of genetic information, which can result in dire consequences for individuals or communities including discrimination, stigma, and psychological harm; has biosecurity implications; and loss of control or ownership of samples or data. To understand these problems better, we evaluated the extent to which tuberculosis (TB) clinical research protocols that were used to collect and store biological materials for future use conform to the requirements stated in the Uganda national guidelines for research involving humans as participants.
This was a retrospective review of TB clinical research projects approved by the Uganda National Council for Science and Technology (UNCST) from 2011 to 2015, to examine whether they fulfilled the requirements for ethical collection and use of human materials. Data were abstracted through review of the project protocols using a template developed based on the informed consent and the Materials Transfer Agreement (MTA) requirements in the national guidelines.
Out of 55 research protocols reviewed, most of the protocols 83.6% had been used to collect the stored samples (sputum, blood and sometimes urine), 28% had a section on specimen collection and 24% mentioned ownership of the biological materials. With respect to review of the consent forms used in the studies that stored materials for future use, only 9% of the protocols had a separate consent form for storage of materials, 4.5% of the consent forms explained the risks, 11.4% explained the purpose of the study while 6.8% mentioned the place of storage for the collected materials.
Many of the studies reviewed did not meet the requirements for collection and storage of biological materials contained in the national guidelines, which indicates a need to additional training on this topic.
人类生物材料通常被储存起来以备将来在研究中使用，因为它们保存了有价值的生物信息，节省了收集新鲜样本所需的时间和资源。然而，使用这些材料可能会带来伦理挑战，例如未经授权披露遗传信息，这可能会给个人或社区带来严重后果，包括歧视、污名化和心理伤害；具有生物安全影响；以及对样本或数据的控制或所有权的丧失。为了更好地理解这些问题，我们评估了用于收集和储存生物材料以备将来使用的结核病（TB）临床研究方案在多大程度上符合乌干达国家人类参与者研究指南中规定的要求。
这是对乌干达国家科学技术委员会（UNCST）在 2011 年至 2015 年期间批准的 TB 临床研究项目进行的回顾性审查，以检查它们是否符合国家指南中关于人类生物材料的伦理收集和使用的要求。通过审查项目方案并使用基于国家指南中知情同意书和材料转移协议（MTA）要求制定的模板来提取数据。
在所审查的 55 个研究方案中，大多数方案（83.6%）用于收集储存的样本（痰液、血液，有时还有尿液），28%的方案有标本采集部分，24%的方案提到了生物材料的所有权。就审查用于储存未来使用的材料的研究中使用的同意书而言，只有 9%的方案有单独的材料储存同意书，4.5%的同意书解释了风险，11.4%的同意书解释了研究目的，而 6.8%的同意书提到了收集材料的储存地点。
许多审查的研究都不符合国家指南中关于生物材料收集和储存的要求，这表明需要在这一主题上进行额外的培训。
