By Shenuka Singh, Rosemary Jean Cadigan and Keymanthri Moodley
Biobanking has the potential to make valuable contributions to health research through the collection, storage and sharing of human samples and data for research purposes. During the COVID-19 pandemic, storing samples for future research is a public health imperative. There are, however, several ethical concerns. These include unspecified future use of biosamples and possible risks to participant privacy and interests, obtaining valid informed consent, global sharing of biosamples and data, and (fair) benefit sharing. The aim of this blog post is therefore to provide some guidance to researchers, biobankers, research ethics committee members and any other interested persons for ethical practice related to biobanking research during the COVID-19 pandemic.
Prior to the pandemic, restrictions on data and sample sharing had become intensified due to exploitation of low-and middle-income-countries (LMICs) by some resource rich countries. This prompted the development of stringent guidelines to protect samples and data from leaving countries in Africa during previous outbreaks like pandemic influenza, SARS and Ebola. The COVID-19 pandemic has highlighted the importance of data and sample sharing in a responsible manner within the context of data transfer agreements (DTAs) and material transfer agreements (MTAs). The additional layer of complexity introduced by the pandemic is reflected in forced national lockdowns that limit human movement physical distancing that renders the collection and sharing of biological samples logistically and ethically problematic.
Obtaining informed consent for COVID-19 biobanking research has numerous logistical challenges, some of which may undermine autonomous decision making. Non-hospitalized patients are instructed to quarantine, making sample collection virtually impossible, and hospitalized patients may be unconscious, heavily sedated, have impaired cognition, or otherwise be too sick to engage with the consent process. Similarly, obtaining proxy consent from a patient’s family may be difficult. In South Africa, as in many countries, hospitalized COVID-19 patients are not permitted visitors, thus limiting opportunities for obtaining proxy consent. Additionally, researchers or others involved in sample collection could be exposed to the virus if proper infection control measures are not in place.
Although additional consent processes were standard requirements prior to the pandemic, consent waivers or limited consent became necessary to consider during hard lockdowns when it was not practically possible to obtain individual consent. If samples are to be collected and stored for COVID-19-related research from hospitalized patients under a waiver of consent, patients who are not severely ill can be informed when they are admitted to the hospital and be allowed an opportunity to ask questions and possibly opt out. Posters informing patients and their families about the biobanking efforts and purpose(s) may be displayed throughout the hospital. Collecting and storing samples for research from COVID-19 positive patients under a waiver of consent will have public health benefits and must be weighed against respecting individual patient autonomy. The waiver of consent should be consistent with the requirements of country-specific legislation on consent for research purposes.
Community Engagement (CE) is particularly important if informed consent for biobanking or repurposing of samples will not be sought (e.g., a REC/IRB waiver of consent). However, engaging with communities in LMICs during COVID-19 is challenging and traditional CE processes may not be possible. Virtual processes may also prove difficult as community members may not have access to electronic platforms or may not have data for use with mobile phones. This, however, should not be a reason to abandon engagement with community members from LMICs and legislative bodies and RECs should make the integration of community engagement a priority. Additionally, there should be mechanisms in place to prevent biopiracy or exploitation of vulnerable participants. This could include MTAs, DTAs and any authentic collaborative relationships in LMICs.
Global sharing of samples and data should be a priority, not only during the pandemic but even when the COVID-19 outbreak has waned. Biobank collaborations between LMICs and HICs to promote capacity building and benefit sharing are mutually beneficial. One possible ethical approach to increase data sharing between institutions could be through the use of secure online data management systems to facilitate collaboration rather than transfer of data propriety rights to third parties. When sharing specimens and data from individuals in LMICs, material transfer agreements should also outline how benefits from any therapeutics or vaccines produced by the research will be shared fairly and equitably with LMICs. At an operational level, biobankers should develop a plan to de-identify or anonymize collected samples and data prior to sharing to mitigate any possible risks to individuals.
Since new information on COVID-19 is constantly emerging, risk-benefit assessments may need to be reviewed on an ongoing basis in both LMICs and HICs. This effort may require additional training, resources, and capacity development of research ethics committees/ institutional review boards (RECs/IRBs) and others in LMICs to better respond to the changing research landscape during pandemics or other public health emergencies.
Finally, the current COVID-19 pandemic provides an opportunity to reflect on ethical considerations in biobanking during public health emergencies, including respect for research participants, promoting the common good, and benefit sharing. This requires a review of research ethics guidance regarding sample collection, storage, and sharing for research so that we are better prepared for the next pandemic or public health emergency.
Authors: Singh S1, Cadigan RJ2, Moodley K1
1Centre for Medical Ethics and Law, Department of Medicine, Faculty of Health Sciences, Stellenbosch University, Tygerberg, Cape Town, South Africa. firstname.lastname@example.org
2Department of Social Medicine, Core Faculty, Center for Bioethics, University of North Carolina, Chapel Hill. North Carolina, USA. email@example.com
1Centre for Medical Ethics and Law, Department of Medicine, Faculty of Health Sciences, Stellenbosch University, Tygerberg, Cape Town, South Africa. firstname.lastname@example.org
Competing interests: None declared