Table 2 Summary of bio-genomics and ethical issues studied and main findings of included studies
From: Ethical considerations for biobanking and use of genomics data in Africa: a narrative review
Authors (Year) | Specific Genomic Issue studied (General, biobanking and the use of genomic data) | Specific Body Tissue(s) involved | Specific Ethical Issue (Including Ethical Guidelines and frameworks elicited/ used) | Main Findings/ Conclusion |
|---|---|---|---|---|
Akinyemi (2016) [8] | Genetic and environmental factors that interact to produce the peculiar phenotypic and clinical characteristics of stroke as seen in people of African | Blood, serum, plasma, buffy coat, DNA, red cell concentrates | Informed consent, Material processing and transfer, Governance, | Consent to participate also meant consent for storage of samples Standard operating procedures (SOPs) for sample collection and Material transfer agreements (MTAs) for shipment of samples, were developed and complied with by all sites The project has enormous biospecimen resource for future genomic research stored with the H3Africa biorepository, in compliance with H3Africa guidelines Frequent visits and effective communication channels established Data and biospecimen from the project are freely and widely available within the framework of safeguarding participant safety and confidentiality |
Abdelhafiz (2019) [9] | Governance of Biobank | Blood or tissue samples | Informed consent, Confidentiality Community participation (benefits and barriers) | There was scanty knowledge about biobanking among Egyptian patients Many had positive attitude towards sample donation with no religious or cultural barriers. There was no significant relationship with willingness to donate samples and sociodemographic factors Most believed there were benefits in participation but had concerns with sharing their samples across borders or with pharmaceutical companies. They wanted their information to remain private and confidential. Law enforcement agents must have access to their data when necessary |
O’Neill et al. (2016) [10] | Sample Collection for research | Blood | Participation (perceptions about donating blood for research) Informed consent | About 42% of inhabitants accepted having a bloodspot taken to screen for malaria Rumours play a key role in anxiety. Although trial recruitment was initially high in the village, some families refused screening when rumours started spreading that the trial team was taking too much blood Women are more vulnerable to weakness after blood donation Some thought blood taken for research would be donated for therapy They believed they had increased nutritional need after donating samples to replace lost blood Concerns about ‘loss of blood’ were equated to loss of strength and lack of good food. Loss of blood can lead to fainting and weakness which will not allow them to work on their farms |
Schalkwyk et al. (2012) [11] | Sample storage and re-use | Blood, Saliva, Sputum | Informed consent, Community benefit, Keeping participants informed | Participants expressed a wide and complex range of views about issues of sample storage and re-use and consent regarding these Majority supported one time consent for storage and reuse of samples They generally had limited understanding of genetic research and were not in favour of “for-profit” research They demonstrated a great deal of trust in researchers and reuse of samples. However, they indicated that certain types of re-uses were more acceptable than others |
Tindana et al. (2012) [17] | Enrolment of participants into genomic research (health facility and community) Consent for genetic and genomic research | Blood | Community engagement Informed Consent | Education of subjects on genomic studies was better during community enrolment than hospital enrolment. It was difficult explaining genomic research in local languages Participants and staff seeking consent were less aware of the methodologies employed during genomic research and their implications, such as the breadth of data generated and the potential for future secondary research Community engagement processes involved fewer women, so meetings were intentionally organised for women groups |
Moodley and Singh (2016) [13] | Biobanking, | Blood Cells Tissues Organs | Competence of research ethics committees (RECs) Governance, Informed Consent, Export and Material Transfer Agreements (MTAs), Community engagement | Researchers articulated serious concerns over standardised regulatory approaches that failed to consider the heterogeneity of biobanks Guidelines and Research Ethics Committees (RECs) need to stratify risk accordingly and governance processes and structures must be flexible While broad general consent was preferred, tiered consent was thought to be more consistent with respect for autonomy and building trust Material Transfer Agreements (MTAs) were often lacking when bio samples were exported, and this was perceived to impact negatively on trust. Authentic community engagement would help to build trust |
Tindana et al. (2014) [14] | Export, storage and reuse of human biological samples | Cells, tissues, organs, blood, and sub-cellular materials such as DNA | Informed consent Research governance Sample export | Participants emphasised the importance of sample export, storage, and reuse, and acknowledged the existence of some structures governing these research practices There is the need for several practical ethical concerns to be addressed to ensure high standards of practice and to maintain public confidence in international research collaborations. These concerns relate to obtaining culturally appropriate consent for sample export and reuse, understanding cultural sensitivities around the use of blood samples, facilitating a degree of local control of samples and sustainable scientific capacity building |
Igbe and Adebamowo (2012) [15] | Biobanking (sample donation) | Biological Sample -Blood | Informed consent Benefits from research | Participants had limited knowledge of the concept of biobanking but accepted it once they were educated about it Half of study participants supported use of broad consent; a quarter supported restricted consent while the remaining quarter were in favour of tiered consent Most support shipment of their samples to other countries for further research, but they prefer those collaborations to be done only with competent, ethical researchers and they would like to receive feedback about such projects. Participants emphasized the need to ensure that donated samples were not used for research that contradicts their religious beliefs Majority of respondents preferred health care as a benefit from participation, particularly for any unexpected condition that may be discovered during the research instead of financial compensation |
Mwaka & Horn (2019) [16] | Biobanking | Tissue, organs, blood and genetic material | Informed Consent Ethical review Regulation | Generally, the attitudes of researchers on informed consent and ethics review of biobank research were mostly ethically well informed, expressing opinions that were in line with national guidelines. Researchers were unanimously in agreement that issues concerning informed consent are very crucial in biobank research and require considerable discussion during ethics review process. They opined that broad consent is acceptable to biobank research and research participants should have the right to establish acceptable limits on the utilization of their samples for research |
Wendler et al. (2005) [17] | Storage and re-use of samples | Blood | Informed Consent | Most of the respondents were willing to provide samples that had codes which can be traced to their children, while future use of samples would require IRB approval Most respondents were willing to share their samples with local and international researchers for future research They were also willing to have samples used for any research |
Barchi et al. (2015) [18] | Collection, use and storage of Biosamples for research | Human Biological Material | Informed Consent, Privacy and confidentiality Export of specimen Potential benefits; Regulatory guidance | Culture, norms, and beliefs play a role in community perspectives on biospecimen collection and use in research Belief systems about bodily integrity and strong national identity in the construct of benefits may be at odds with initiatives that involve foreign biorepositories There is lack of understanding among patients and providers about the use of biospecimen in clinical care and research; reuse of biospecimen, particularly issues of consent, ownership, and decision-making Several respondents were okay with broad consent at the time of sample collection but believe individuals do not fully understand such choice Others had concerns about export of specimens and loss of control over reuse and potential benefits were also areas of concern; and felt need for regulatory guidance and IRB-member training |
Moodley et al. (2014) [19] | Use, storage, and export of biosamples | Blood | Informed Consent, Confidentiality, Ownership Export, | Most participants were supportive of providing samples for research, but had serious concerns about future use, benefit sharing and export of samples While researchers view the provision of biosamples as a donation, participants believe that they still have ownership rights and are therefore in favour of benefit sharing Almost half of the participants expressed a desire to be re-contacted for consent for future use of their samples 25% of participants had concerns about sample export |