The introduction of genomics and biobanking methodologies to the African research context has also introduced novel ways of doing science, based on values of sharing and reuse of data and samples. ...This shift raises ethical challenges that need to be considered when research is reviewed by ethics committees, relating for instance to broad consent, the feedback of individual genetic findings, and regulation of secondary sample access and use. Yet existing ethics guidelines and regulations in Africa do not successfully regulate research based on sharing, causing confusion about what is allowed, where and when.
In order to understand better the ethics regulatory landscape around genomic research and biobanking, we conducted a comprehensive analysis of existing ethics guidelines, policies and other similar sources. We sourced 30 ethics regulatory documents from 22 African countries. We used software that assists with qualitative data analysis to conduct a thematic analysis of these documents.
Surprisingly considering how contentious broad consent is in Africa, we found that most countries allow the use of this consent model, with its use banned in only three of the countries we investigated. In a likely response to fears about exploitation, the export of samples outside of the continent is strictly regulated, sometimes in conjunction with regulations around international collaboration. We also found that whilst an essential and critical component of ensuring ethical best practice in genomics research relates to the governance framework that accompanies sample and data sharing, this was most sparingly covered in the guidelines.
There is a need for ethics guidelines in African countries to be adapted to the changing science policy landscape, which increasingly supports principles of openness, storage, sharing and secondary use. Current guidelines are not pertinent to the ethical challenges that such a new orientation raises, and therefore fail to provide accurate guidance to ethics committees and researchers.
Consent processes for clinical trials involving HIV prevention research have generated considerable debate globally over the past three decades. HIV cure/eradication research is scientifically more ...complex and consequently, consent processes for clinical trials in this field are likely to pose a significant challenge. Given that research efforts are now moving toward HIV eradication, stakeholder engagement to inform appropriate ethics oversight of such research is timely. This study sought to establish the perspectives of a wide range of stakeholders in HIV treatment and research to inform consent processes for cure research.
In total, 68 South African stakeholders participated in two qualitative research modalities. In-depth interviews (IDIs) were conducted with a purposive sample of 42 individuals - audiotaped with consent. Twenty-six stakeholders participated in three focus group discussions (FGDs). Thematic analysis of transcribed IDIs and FGDs was conducted.
The majority of respondents indicated that there could be unique challenges in HIV cure research requiring special attention. In particular, given the complexity of cure science, translation of concepts into lay language would be critical for potential participants to adequately appreciate risks and benefits in early phase research with experimental interventions. Furthermore, to aid understanding of risks and benefits against a background of desperation for a cure, specially trained facilitators would be required to assist with a psychological assessment prior to consent to avoid curative misconceptions. Long-term participant engagement to assess durability of a cure would mean that the consent process would be prolonged, necessitating annual re-consent. Building trust to maintain such long-term relationships would be critical to retain study participants.
Unique consent requirements for cure research in South Africa would include significant efforts to maximise understanding of trial procedures, risks and the need for long-term follow-up. However, the psychological dimension of cure must not be underestimated. Beyond an understanding of cure science, the emotional impact of HIV cure advances the discourse from cure to healing. Consequently, the consent process for cure research would need to be enhanced to include psychological support and counselling. This has several important implications for research ethics review requirements for consent in HIV cure research.
Abstract
The coronavirus disease-2019 (COVID-19) pandemic has led to the irrational use of drugs in the absence of clinical management guidelines. Access to individual participant data (IPD) from ...clinical trials aids the evidence synthesis approaches. We undertook a rapid review to infer IPD sharing intentions based on data availability statements by the principal investigators (PIs) of drug and vaccine trials in the context of COVID-19.
Searches were conducted on PubMed (NCBI). We considered randomized controlled trial (RCT) publications from January 1, 2020, to October 31, 2021. IPD sharing intentions were inferred based on the data availability statements in the full-text manuscript publications. We included 180 articles. Of these, 81.7% (147/180) of the publications have arrived from the findings of the RCTs alone, 12.8% (23/180) of the publications were protocol publications alone, and 5.6% (10/180) of the RCTs had both published protocol and publication from the trial findings. We have reported IPD sharing intentions separately in RCT protocol publications (n = 23 + 10) and publications from RCT findings (n = 147 + 10). Among RCT protocol publications, one-third (11/33) of the PIs intended to share IPD. In fact, over half of the PIs (52.2%, 82/157) in their published RCT findings intended to share IPD. However, information to share about IPD was missing for 57.6% (19/33) of RCT protocols and 38.2% (60/157) of published RCT findings.
Stakeholders must work together to ensure that overarching factors, such as legislation that governs clinical trial practices, are streamlined to bolster IPD sharing mechanisms.
Previous public health emergencies (PHEs) have demonstrated the importance in making this data available,2 and early in the COVID-19 pandemic, there were calls for making all kinds of data, including ...clinical trial data, routine surveillance data, genetic sequencing, and data on the ongoing monitoring of disease control programmes, openly and rapidly available.3 As part of this, personal data on age, race, sex, health, ethnic group, and socioeconomic factors have been shared. ...the use of this particularly sensitive data can infringe upon individual and group privacy, increase the risks of individual and group stigma and discrimination, and it may negatively impact already vulnerable, marginalised or minority populations.4 During this pandemic, states of emergency have been declared, and many of our fundamental rights including our right to privacy have been limited as part of national COVID-19 responses.5 Such an approach can be appropriate in a democratic society, but policies that relied on public trust have resulted in increased compliance and improved public health outcomes.6 Thus it is not always a binary choice between privacy and an effective public health response. Rather it is the transparent and accountable governance of data use and digital technologies that can foster this public trust.8 The Access to COVID-19 Tools Accelerator (ACT-Accelerator) was established to respond to the COVID-19 pandemic by scaling up the development and equitable distribution of tests, treatments and vaccines, and strengthening underlying health systems infrastructure. In developing this framework, we were cognisant that the impact of COVID-19 is unequal due to the global context of inequality and asymmetries of power and also that data practices in the past have been exploitative and perpetuate global health inequity.10 We were aware that data practices adopted during COVID-19 will be influential in any pandemic preparedness and future pandemic response and the importance of adopting practices now that drive an equitable global response. ...the framework requires the equitable access to data and equitable access to any tests, treatments and vaccines that are developed from this data.
In the past decade, there has been an increase in genomic research and biobanking activities in Africa. Research initiatives such as the Human Heredity and Health in Africa (H3Africa) Consortium are ...contributing to the development of scientific capacity and infrastructure to support these studies on the continent. Despite this growth, genomic research and biobanking have raised important ethical challenges for key research stakeholders, including members of research ethics committees. One of these is the limited ethical and regulatory frameworks to guide the review and conduct of genomic studies, particularly in Africa. This paper is a reflection on a series of consultative activities with research ethics committees in Africa which informed the development of an ethics and governance framework for best practices in genomic research and biobanking in Africa. The paper highlights the engagement process and the lessoned learned.
'Brustle v Greenpeace' concerns a referral from the Bundesgerichtshof (the Federal Court of Justice of Germany) to the European Court of Justice (ECJ) for an interpretation of three issues under the ...Biotechnology Directive. While the decision of the Court is likely to prohibit the patenting of processes relating to embryonic stem cell research, the decision is also interesting due to the Court's retreat from narrowly interpreting the morality exclusions to a wider examination of the destruction of the embryo and whether it is contrary to 'ordre public'.
The Protection of Personal Information Act (POPIA) 2013 came into force in South Africa on 1 July 2020. It seeks to strengthen the processing of personal information, including health information. ...While POPIA is to be welcomed, there are concerns about the impact it will have on the processing of health information. To ensure that the National Health Laboratory Service NHLS is compliant with these new strict processing requirements and that compliance does not negatively impact upon its current screening, treatment, surveillance and research mandate, it was decided to consider the development of a NHLS POPIA Code of Conduct for Personal Health. As part of the process of developing such a Code and better understand the challenges faced in the processing of personal health information in South Africa, 19 semi-structured interviews with stakeholders were conducted between June and September 2020. Overall, respondents welcomed the introduction of POPIA. However, they felt that there are tensions between the strengthening of data protection and the use of personal information for individual patient care, treatment programmes, and research. Respondents reported a need to rethink the management of personal health information in South Africa and identified 5 issues needing to be addressed at a national and an institutional level: an understanding of the importance of personal information; an understanding of POPIA and data protection; improve data quality; improve transparency in data use; and improve accountability in data use. The application of POPIA to the processing of personal health information is challenging, complex, and likely costly. However, personal health information must be appropriately managed to ensure the privacy of the data subject is protected, but equally that it is used as a resource in the individual's and wider public interest.
South Africa has made great progress in the development of HIV/AIDS testing, treatment and prevention campaigns. Yet, it is clear that prevention and treatment campaigns alone are not enough to bring ...this epidemic under control.
News that the "Berlin patient" and the "Mississippi baby" have both been "cured" of HIV brought hope to people living with HIV/AIDS in South Africa that a cure for HIV/AIDS is within reach. Despite the recent setbacks announced in the "Mississippi Baby" case, protocols aimed at curing HIV/AIDS are being developed in South Africa. However with evidence to suggest that participants in clinical trials do not understand the basic concepts in the informed consent process, there is concern that future participants in HIV/AIDS cure research will lack comprehension of the basic elements of future clinical trials that aims to cure HIV/AIDS and confuse research with clinical care.
Research ethics committees have an important role to play in ensuring that participants understand the basic concepts discussed in the informed consent process, that they understand that research is not clinical care and they are unlikely to benefit from any early phase trials seeking to cure HIV/AIDS.
Despite increasing access to antiretroviral therapy in low- and middle-income countries, only 54% of eligible individuals were receiving treatment in Africa by 2015. Recent developments in HIV cure ...research have been encouraging. However, the complex science and procedures of cure research render the informed consent process challenging.
This study evaluates the impact of a video tool on educating participants about HIV cure.
A questionnaire assessing the content of the video was administered to adults recruited from two clinics in South Africa. Patients and their care partners, who provided voluntary informed consent, were included in the study. The questionnaire was administered in each participant's home language before, immediately after and at 3 months after viewing the video, in an uncontrolled quasi-experimental 'one group pre-test-post-test' design. Scoring was carried out according to a predetermined scoring grid, with a maximum score of 22.
A total of 88 participants, median age 32.0 years and 86% female, were enrolled and completed the pre- and post-video questionnaires. Twenty-nine (33%) completed the follow-up questionnaire 3 months later to assess retention of knowledge. Sixty-three (72%) participants had a known HIV-positive status. A significant increase (10.1
15.1,
=0.001) in knowledge about HIV and HIV cure immediately after viewing the video was noted. No statistically significant difference in knowledge between HIV-positive and -negative patients was noted at baseline. After 3 months, a decrease in performance participation (14
13.5,
=0.19) was noted. However, knowledge scores achieved after 3 months remained significantly higher than scores at baseline (13.5
9.5,
<0.01).
This research showed that a video intervention improved participants' knowledge related to HIV, HIV cure research and ethics, and the improvement was sustained over 3 months. Video intervention may be a useful tool to add to the consent process when dealing with complex medical research questions.
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