The study set out to evaluate how TB clinical research protocols conform to the requirement by the Uganda national guidelines and found that most of the protocols are non-compliant.
Concerning HBMs collection, majority of the protocols lacked an elaborate section on collection, storage and use. This means that the HBMs collection procedures were not well documented in the protocols which would give way to researchers collecting and handling the HBMs the way they felt. Such undocumented collection and handling can affect the standards of how the HBMs are collected and handled and a potential loophole for possible abuse by the researchers. HBMs collection and use should be part of study procedures in any research protocol intending to collect HBMs and, such procedures are subject to ethical review and approval by the relevant research regulatory agencies before they can be carried out. Non-compliance with the national guidelines requirements had been reported in earlier work which reviewed site monitoring reports in the country .
However, all the protocols reviewed had been approved by the Research Ethics Committee (REC) and cleared by the national regulator, UNCST. This means that implementation of the guidelines was not only flawed by the researchers but also the RECs as well as the UNCST. There is a need for retraining of all the concerned parties on the requirements by the guidelines. Although significant capacity in research ethics and associated research regulation has been built significantly in this setting, the quality of ethical review still needs improvement and this should be a continuous process. The challenge of low quality of ethical review in this setting has been observed in other related work .
The requirement for a separate informed consent form for storage of HBMs came in existence following the launching of the revised national guidelines in 2007. This was in response to challenges of whether participants who consent for storage of biological materials as part of the enrolment consent actually understood the consent process and appreciate what their decisions mean. This study was intended to evaluate the compliance by the researchers and the regulator with the requirement for acceptable collection, storage and eventual use of HBMs during TB clinical research. The evaluation was done on research approved and conducted during at least four years (2007 to 2011) after the revised guidelines came into force. The four years allowed for the time change and appreciation of the revised guidelines. However, the results of this study indicate that implementation of the guideline requirements was not adhered to indicating either a lack of knowledge or understanding of what the guidelines require, or a complete disregard of the requirement. This requirement is violated by both the researchers and the regulators, it is most likely that both these parties were ignorant about the existence of that regulatory requirement. It should be noted that presence of guidelines alone may not necessarily translate in ethical conduct of research as observed in previous literature . Additionally, it has been observed that although RECs globally have a mandate to protect research participant interests such as confidentiality, ownership, export, storage and secondary use of HBMs (individual good) with specific consent, regulations and policies, implementation of such policies varied from one REC to another [20, 21]. An additional challenge in the African context relates to traditional perceptions of blood and the body. It is well-documented that blood carries symbolic value for many Africans. Since blood has been associated with strength, superstition, exploitative relations, colonialism and witchcraft, amongst others. There is need to carefully explain the purposes of blood collection in the consent process and during collection [22–27]. Similarly, other commentators have stated that Africans believe that blood obtained ostensibly for research purposes will be used for sorcery [28, 29].
Although it is a requirement that all HBMs exchanged by researchers from one institution to another must be accompanied by a valid materials transfer agreement (MTA), this was not the case with many of the studies reviewed though exchange did occur. In order to export HBMs for research purposes from Uganda to other countries, it is a requirement to have a valid MTA, and an export permit must be sought from the UNCST. No records of such permits were identified during this records review. It was difficult to confirm if the studies reviewed had MTAs and export permits because this was a retrospective review of records which may miss out some of the documentation due to filing or storage issues.
Additionally, the accessed MTAs lacked the required information for a valid agreement as stipulated in the national guidelines Table 3. There should be a requirement that every research regulator, researchers and ethics review committee members undergoes context specific research ethics training periodically with focus on the national guidelines before getting involved in research that aims to collect and store HBM.. Such requirements have been implemented for other purposes like Good Clinical Practice (GCP) training for clinical research.
There is need for continuing training of the ethics committees, researchers and the research regulators on all the ethical requirements as stipulated in the national guidelines as well as updating on any new changes affecting the research ethics. Hence it should be a requirement that every research regulator and researcher should undergo research ethics training with focus on the national guidelines before getting involved in their activities.