Abstract
Background:
Biobankers have been unexpectedly involved in the pandemic of COVID-19 since early 2020. Although specific guidance was not available, the International Society for Biological and Environmental Repositories (ISBER) Best Practices and the ISO 20387 document have been utilized to deal with the pandemic disaster. The ISO experts and best practice experts in ISBER teamed up to share the available information and learn the experiences of biobanks concerning COVID-19 through organizing webinars, surveys, and town hall meetings. Four ISBER regional ambassadors (RAs) from the Indo-Pacific Rim (IPR) region were also actively involved at one of the town hall meetings. These RAs, who are from Australia, India, Indonesia, and Japan, and the Director-at-Large of the region, have summarized their experiences in this article.
Materials and Methods:
The ISBER Standards Committee COVID-19 Task Force has kindly provided the survey results. The extracted glossary from the results was categorized into 10 factors: (1) crisis management; (2) sample-related issues; (3) logistics-related issues; (4) equipment-related issues; (5) ethical, legal, and social implication-related issues; (6) operation-related issues; (7) personnel-related issues; (8) management-related issues; (9) infection-related issues; and (10) research-related issues. Each IPR RA has provided a case considering these 10 factors.
Results and Discussion:
Two key points have emerged from the scenarios, which are as follows: (1) impacts of the biobanks in low- and middle-income countries (LMICs) are similar to those in high-income countries (HICs) and (2) tolerance of the biobanks in LMICs is not so robust as those in HICs. Furthermore, communication strategies with internal and external stakeholders are critical for a biobank to manage this crisis. This article summarizes the impacts, indicates the opportunities that COVID-19 has brought to the biobank community, and highlights the usefulness of the network beyond biobank services. Lastly, the biobanks need to turn the challenges into opportunities to overcome the crisis.
Introduction
The COVID-19
Although specific guidance to manage a pandemic disaster was not available, the information from the International Society for Biological and Environmental Repositories Best Practices, fourth edition (ISBER BP)1,2 and ISOs 20387:2018 Biotechnology—Biobanking—General requirements for biobanking (ISO 20387) 3 provided some fundamental considerations in managing the disaster.
The ISBER BP cover the guidelines for biobanking on universal and safety precautions, personal protective equipment (PPE), business continuation planning, disaster recovery planning, and emergency (response) planning.
On the contrary, ISO20387 describes the requirements of a variety of operational plans such as disaster, emergency, and contingency plans. 4 Although the plans are different in concept between the ISBER BP and ISO 20387, they have some overlaps.
During this chaotic situation, the ISO and best practices experts in ISBER decided to work together to share the available information and learn about the experiences among the biobanking community, through organizing webinars, 5 surveys, 6 and town hall meetings. Regionally, four regional ambassadors (RAs) from the Indo-Pacific Rim (IPR) region actively participated at one of town hall meetings that discussed the impacts of COVID-19 toward biobanking. 7 The town hall meeting has inspired these RAs from different countries (Australia, Japan, India, and Indonesia) and the Directors-At-Large (DAL) of the IPR region to share their experiences through this article. The RA program was introduced by ISBER in 2019. Despite being a relatively brand-new program, communications between regional and international representatives were closer compared with previous time since its introduction. Although RAs are selected based on voluntary applications, currently 20 ISBER members from 15 countries are serving as RAs. The roles of RAs are to serve as regional contacts working in conjunction with the relevant DAL.
Methods and Case Scenarios
The ISBER Standards Committee COVID-19 Task Force 8 did a survey to gather the responses of biobanks to COVID-19 during the month of April to May 2020. 6 This Task Force has kindly provided their survey results. One of the authors (K.F.) categorized the extracted glossary by this Task Force into 10 factors, such as (1) crisis management; (2) sample-related issues; (3) logistics-related issues; (4) equipment-related issues; (5) ethical, legal, and social implication (ELSI)-related issues; (6) operation-related issues; (7) personnel-related issues; (8) management-related issues; (9) infection-related issues; and (10) research-related issues. All the IPR RAs summarized the COVID-19 impacts for their local environment (e.g., their own biobanks). The following four case scenarios were provided by IPR RAs.
Case Scenarios
Impacts to low- and middle-income countries
Indonesia
Impacts
The Biobank Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada (FK-KMK UGM) Yogyakarta-Indonesia (“UGM Biobank”) has been in operation since 2018. This biobank provides long-term storage service for noncommunicable disease-clinical biospecimens from various scientists in −80°C freezers and LN2 tanks. While the UGM Biobank closed between end of March–May 2020, the SARS-CoV-2 molecular diagnostic laboratory UGM was opened and the leftover diagnostic materials were stored in −80°C freezers. The SARS-COV-2 repository is operated separately from the UGM Biobank. Our discussion focuses on the UGM Biobank.
Crisis management
Electricity, freezer breakdown, database security, and physical security are included in emergency plans, but not in natural disaster or pandemic plans. During a lockdown, staff can monitor freezers' temperature stability through SMS reports, as well as biweekly physical monitoring. Electricity is supported by a generator and there have been no technical problems with the freezers.
Sample-related issues
During the lockdown, a request from fellow clinical researchers for COVID-19 biospecimen storage was declined. The biobank was only able to advise colleagues concerning the methods to preserve the samples.
Logistics-related issues
Regional and international transport restrictions cause disruptions in laboratory logistics. Distribution of personal protection equipment has resumed gradually. The UGM Biobank stocks consumables for at least 6 months and have not been used due to the lockdown. Reinventory is underway for adjusted consumables.
Equipment-related issues: bidding
Financial constrictions and the devaluation of Indonesian rupiah to the U.S. dollar caused the institution to cancel the purchase of laboratory equipment, and research laboratories are suggested to maintain their current activities.
Operation-related issues
Resuming biobank operation requires an adjustment of infrastructure and manpower. This needs a reassessment of budgeting and reorganizing activities to meet the current situation.
Personnel-related issues
The 2020 planned capacity building is canceled due to travel and financial restrictions until the end of 2020. However, payrolls for three biobank staff will remain safe for the rest of 2020.
During the university lockdown, biobank personnel are working from home, with weekly planning and reporting. The activities include renewing standard operating procedures (SOPs), further developing an in-house database system, and refreshing the biobank website. Online discussions (e-mail or WhatsApp) are not as effective as face-to-face discussions. Furthermore, training for new SOPs needs to wait until the biobank resumes its operation. Also, working from home is easily disturbed by personal affairs. On the contrary, with the time available, the UGM Biobank 9 helps to set up the UGM SARS-CoV-2 diagnostic laboratory data management system and can be consulted for information technology (IT) problems.
Management-related issues
The UGM Biobank is managed financially through a budget from the R&D (research and development) and infrastructure offices. Forecasting reduced faculty income due to COVID-19, and the biobank was required to adjust the budget, particularly related to storage units and personnel training/trips.
For the reopening of service, the UGM Biobank has conducted a biosafety self-risk assessment, as required by faculty for all research units that handle human samples. Further day-to-day adjustments will be made with regard to the WHO standards suggested by the biosafety team, and within the biobank budget.
Infection-related issue
Standard operational and retraining protocols need to be in place for the biobank and other staff working with human biospecimens. Understanding and the application of current universal safety precautions need to be understood and included in training for biobank staffs and related scientists/technicians.
Research funding-related issues
The UGM Biobank does not rely on research funding for its operation, in the short and medium terms. However, standardized operational uses will prove the usefulness of the biobank for sustainable research.
India
Biobank: National Liver Disease Biobank, ILBS, New Delhi, India.
Impacts
Although the National Liver Disease Biobank (NLDB) is a liver-specific biobank, the Government of India (GOI) designated it as 1 of the 17 COVID biobanks around the country, permitting it to collect and store COVID-19 biosamples for research and developing diagnostics and vaccines after the pandemic was declared.
Crisis management
NLDB emergency planning revolved around maintaining cryopreservation of biosamples at the time of events, which may cause the breakdown of storage systems. The planning included handling the natural calamities, not a pandemic situation such as COVID-19. Now, an extensive emergency plan consisting of business, financial, and operations strategy is being developed, based on researching the current situation.
Sample-related issues
A significant decline in the number of samples collected occurred, because access to biosamples and co-ordination became difficult, due to limited staff from the both the host institute and the satellite centers. This was because the NLDB works as a “decentralized collection, centralized storage, and informatics” network. Not all patients are screened for COVID-19, so there is a high chance of collection of COVID-contaminated samples from asymptomatic patients. Separate space for processing and storage of COVID and non-COVID samples was urgently required to avoid cross-contamination, which was later accommodated. Difficulty in sample transportation was faced as the BSL2+ facility and the biobank are on different floors.
Logistics-related issues
The sudden nationwide lockdown affected the NLDB operational chain of biosamples from satellite centers. A drastic shortage in supply of PPE kits, face masks, consumables, and LN2 affected the day to day functioning of the biobank, which was later stabilized by local production and supply.
Equipment-related issues
Purchase of equipment is a convoluted process. However, due to the pandemic, a fast-track purchase committee was constituted to speed up the purchase process. NLDB purchased storage equipment before the pandemic started, delivery of which was delayed due to the prioritization of essential items at the main ports in India.
ELSI-related issues
NLDB always collects biosamples after obtaining informed consent from patients or donors. However, due to inevitable situations, some leftover diagnostic samples are stored at the biobank without having consent, which could be utilized for research after approval of the ethics committee.
Operation-related issues
Routine work was affected due to reduced attendance of staff by almost 40%, and some staff had additional duties in the COVID-19 testing laboratory. A visible interruption was noticed in resolving of minor errors due to limited staff. SOPs are being revised as per the guidelines of the Indian Council for Medical Research (ICMR), GOI, for collection, storage, and distribution of COVID-19 samples for research.
Personnel-related issues
NLDB is following safety guidelines issued by the Ministry of Health and Family Welfare, GOI, to maintain social distancing at the work place. Thermal scanning, a sanitizing machine, and touch-free mechanism installed at all entry and exit points and common areas. Personnel processing COVID samples are concerned substantially about their families concerning COVID infection.
Management-related issues
A financial grant from the funding agency was delayed due to the pandemic and subsequent to the designation of NLDB as a COVID biobank; an urgent requirement of additional funds to support the COVID facility was escalated. No specific guidelines are available for highly infectious samples in ISO20387, NIH, or ISBER, and sharing of COVID biosamples is not as easy as non-COVID samples, and thus, the National Oversight Committee was constituted by ICMR to review and approve the proposals.
Infection-related issues
Handling the informed consent forms duly signed by COVID patients is a big issue. Intensive communication and training on good hygiene practices and donning and doffing of the PPE kit have been provided to biobank personnel. It was made compulsory to sanitize work areas daily and disinfectant storage areas twice a week.
Research-related issues
The GOI assured large amounts of funds for research focused on diagnostics, vaccines, novel therapeutics, repurposing of drugs, or any other intervention for control of COVID-19, and so funding is not an issue.
Impacts to High-Income Countries (HICs)
Australia
Biobank: Victorian Cancer Biobank (VCB) Consortium, Melbourne, Australia.
Crisis management
Since the VCB is a consortium of five tissue bank sites based at different health care institutions and its Central Operations is located at the lead agency (Cancer Council Victoria), communication was critical for crisis management.
At the commencement of the COVID-19 pandemic in March 2020, the VCB institutionalized regular meetings between Central Operations and site managers. The meetings enabled collaborative business continuity planning and consideration of the varied institutional directives. The scenario-based continuity plans provided contingencies for reduced staffing, full site shutdown, stakeholder and client communication, offsite/alternative work priorities, and disaster recovery for resumption of core activities.
Sample-related issues
As a cancer biobank, the VCB has not accepted any COVID-19 patient samples.
Furthermore, Central Operations has issued a directive to sites to temporarily suspend the release of archival samples procured starting from January 23, 2020. Quarantine policies, which include retrospective review of medical records for COVID-19 status, are being developed to mitigate the risk of releasing infectious specimens.
Logistics-related issues
The VCB has not experienced major issues with consumable suppliers, including LN2 and PPE. Supply chain contingencies were considered during continuity planning.
Equipment-related issues
Interdepartmental emergency contacts at each site were established as a contingency should the VCB staff be unable to attend to emergencies (e.g., freezer/LN2 tank alarms).
ELSI-related issues
COVID-19 sample. Not applicable.
Informed consent
The efficacy of the current ethically approved consenting practices, including alternative approaches (e.g., telephone consent with signature obtained on day of surgery), is yet to be determined. A long-term strategy (e.g., teleconsenting) 10 to overcome the current limitations of face-to-face procedures is needed.
Operation-related issues
The majority of biobanking activities at the VCB were suspended by the end of March except for clinically rare cases and essential project services (e.g., clinical trial support).
Prepeak to peak
All VCB staff were directed to work from home when possible and work priorities were shifted to tasks that can be performed remotely, for example, annotation of clinical data. Other issues were as follows: (1) temporary reduction in physical workspace and (2) assignment of staff (at different sites) to assist with hospital pandemic response.
Postpeak
In May, the VCB resumed the release of archival specimens and staff alternated attendance on-site to action dispatches.
Throughout this period (March–mid-June), the VCB continued to create an impact on the research community by supporting 26 existing projects, initiating 4 new projects, and servicing 53 new enquiries (35 for a similar period last year).
Personnel-related issues
Staff concern about the impact of COVID-19 on their health, safety, and job security remains a personnel-related issue. The VCB has committed to support the staff members in coping with the COVID-19 crisis by sharing online and institutional resources, organizing regular team meetings, implementing workplace safety actions (e.g., risk assessment), and encouraging access to the “Employee Assistance Program,” a benefit program for confidential counseling.
Management-related issues
Finance
The long-term impact on subsequent funding for the VCB remains unclear.
IT issues
Unstable remote access to secure servers, slow adoption of new IT platforms, and doubt in security of teleconferencing tools.
Infection-related issues
Staff members from each site are following the health and safety policies from their institutions as well as government directives.
Research funding-related issues
Short term
The impact appears minimal considering the consistent amount of project interests and national grant application openings.
Long term
With the backdrop of the impending financial recession, the government's funding model is unclear. Due to the economic downturn, it is expected that the available philanthropic/university funding will decrease substantially.
Japan
Japanese hospital-integrated biobanks have been networked for the promotion of sample usability through the project that was organized by the Japan Agency for Medical Research and Development (AMED). A sample information retrieval system, including COVID-19-related samples, has recently been opened with registered data that include associated details such as the condition of stored samples and clinical data sets.
Crisis management
University hospital-integrated biobanks in Japan refer to ISO20387 and ISBER best practices. However, crisis management for infections remains limited. In the event of contamination by a sample infected with COVID-19, use of the storage facility may be prohibited for a specified period according to the guidelines of the pathology department. However, the recovery plan of biobanking activity is still unclear.
Sample-related issues
Samples in Kyoto University hospital have always been treated with the suspicion of infection. Information on whether samples have been infected with HIV-1, HTLV-I, prions, hepatitis B virus, heptitis C virus, Epstein-Barr Virus, syphilis, and tuberculosis is obtained from the medical record chart and is shared with biobank staff. Information about COVID-19 infection will undoubtedly also be shared.
Logistics-related issues
The entry of cryogenic agents into parts of hospital-integrated biobanks in Japan was limited to prevent the spread of COVID-19. Therefore, securing sufficient dry ice and liquid nitrogen may become a critical issue.
Equipment-related issues
If equipment is contaminated by infected samples, the cleaning procedure is specified in the manual. However, there are no specific national guidelines for cleaning equipment.
ELSI-related issues: COVID-19 sample
While all of the COVID-19 infection data should be handled as carefully as personal information, the provision of the information will be obligatory by law from a public health perspective. The Japanese Ministry of Health, Labor, and Welfare has stated that “information should be disclosed if it has any epidemiological significance.” Currently, the infected person's residence information is limited and local governments are discussing how more detailed information should be disclosed.11,12
Operation-related issues
When transferring samples that are susceptible to infection by COVID-19, staff may need to use individual tight containers (especially for respiratory diseases).
Personnel-related issues
In Japanese university hospital-integrated biobanks, it is difficult to completely separate medical care from research areas, and many research staff members also work as the medical staff. Some biobank staff were restricted from moving between the areas. Besides, half of the staff work from home or work part-time. For this reason, it has been difficult for them to access medical and sample-related information.
Management-related issues
Due to the risk management of shipping the sample and the occupational health of the carrier and user, shipping should be considered from an infection risk management perspective. It is necessary to thoroughly confirm the presence or absence of infection by a standardized material transfer agreement (MTA).
Infection-related issues
Japanese university hospital-integrated biobanks are required to refer to the guidelines in the National Institute of Infectious Diseases: the sampling room must be airtight and equipped with a system sufficient to maintain negative pressure in the adjacent corridor. Sampling should be done during weekdays when there is less risk of accidents. Staff should wear N95-type masks. The sample is fixed immediately, and only the minimum required frozen section is collected. The protocol recommends disinfecting samples and organs by immersing them in sodium hypochlorite solution. The Japanese National Institute of Infectious Diseases webpage refers COVID-10: An ACP (American College of Physician) Physician's Guide+ Resources. 13
Research-related issues
Four levels of risk management of research activity were proposed by the Ministry of Education, Culture, Sports, Science, and Technology. Each university has placed restrictions on research activities and probably restricts traffic between the hospital premises and the research institute premises. A central facility will be necessary for research using COVID-19-related samples. 14
Results
Crisis management
No country had prepared a plan for a pandemic infection. Although an emergency plan was in place at both the UGM Biobank and the NLDB, they were prepared for routine various laboratory events, but not a pandemic infection. The VCB had prepared a business continuity plan just before the peak of the COVID-19 pandemic. Disaster recovery plans and/or business strategies for the UGM Biobank, NLDB, and VCB are still under development at end of August 2020 (Table 1).
Summary of COVID-19 Impacts on Each Biobank Based on Case Scenarios
Kyoto Univ Clnical Bioresource C: Kyoto University Clinical Bioresource Center.
ELSI, ethical, legal, and social implications; SOPs, standard operating procedures.
Sample-related issues
Biobank services continued at the NLDB, VCB, and Japanese biobanks but not the UGM Biobank. All four biobanks agreed that handling COVID-19 samples is challenging due to the high infectivity of the virus. The biobanks were following the WHO and/or the U.S.-CDC guidelines15,16 for any human biospecimen handling in their laboratories.
Logistics- and equipment-related issues
The biobanks in LMIC such as India and Indonesia faced more challenges in comparison with those in high-income country (HIC) due to less developed infrastructure and reliance on the importation of consumables. The Japanese biobanks had limited issues with liquid nitrogen supply, while the VCB had managed its equipment and consumables through the predeveloped protocol. The NLDB had purchased the emergency equipment without bidding, while the UGM Biobank had canceled the order due to an increase in price.
ELSI-related issues
In general, the standard ELSI considerations (e.g., informed consent and donor privacy) apply to any biobanking activities in these countries, including banking COVID-19 specimens.
Operation-related issues
The operations of biobanks were impacted by reduced staffing (all), secure server access (NLDB and Japanese biobanks), freezer breakdown (NLDB), and lack of developed protocol for pandemics (all). The authorities in Japan had published a protocol to handle samples with airborne pathogens. In Australia, the VCB remains proactively supporting the researchers where possible during this pandemic.
Personnel-related issues
Biobank personnel from the UGM Biobank, VCB, and Japanese biobanks were working from home where possible and using teleconferencing tools for meeting, discussion, and support. However, most staff members from the NLDB were working in the laboratory routinely, but with less manpower while abiding to all safety guidelines. The staff members from all the biobanks were concerned about their families (India, Australia) and their job security.
Management-related issues
The biobanks from LMIC were experiencing financial difficulties, but the biobanks from HIC did not experience direct financial impact during the pandemic. All the biobanks were working on developing biosafety protocols for returning to work. The NLDB and Japanese biobanks were also having difficulties in accessing their databases remotely due to the restrictions of the secured servers.
Infection-related issues
All the biobanks were following health and safety policies from their own institution/country. NLDB had trained its staff to work on COVID-19.
Research-related issues
Research funding was not an issue in HIC and LMIC with the existing preapproved funding. In some countries (e.g., India), the government was providing a large amount of funding for COVID-19 research.
Discussion
Although the factors impacting the biobanks in LMIC are mostly on par with those in HIC, the tolerance to disasters of the biobanks in LMIC was not as robust as those in HIC.
The individual biobank analysis of “the glossary and categorized ten factors” (Table 1) clearly shows that no peculiar differences in initial reactions to this pandemic were observed among individual biobanks.
However, the four scenarios presented in this article clearly showed that there are differences in the social infrastructure between LMIC and HIC, such as human resources with appropriate training, supply chain, information accessibility, funding, communication tools, and their reserve capacity. Biobankers, not only in LMICs but also HICs, may have similar challenges concerning operations and the well-being of staff. However, biobankers in lower resource countries such as LMICs need to spend most of their efforts to solve operational problems. On the contrary, biobankers in resource-rich countries such as HICs may have more support from their existing social infrastructure to address the staff well-being issues, while solving the problems in operational categories.
In a sense, the COVID-19 pandemic was a stress test for many biobanks. These stresses were beyond the tolerance level for some biobanks. An unfamiliar disaster such as a pandemic is unpredictable and often does not have an immediate solution. The biobanks will have to observe the direction of the disaster and decide how to cooperate for their survival. The biobanks will also need to move promptly in the right direction they forecast. 17 Another important lesson from this COVID-19 experience is the communication strategy. Communication and dialogue internally and externally may provide such an environment for cooperation. At the international level, a communication strategy that is inclusive of biobankers from non-English-speaking countries is also important, particularly in LMIC.
Although neither standards nor guidance in biobanking fields mention a plan for a pandemic, the current standards and guidelines1–3,14,15 may provide fundamental strength to biobanks similar to a “vaccine” for an “individual” to allow acquisition of immunity.
In addition to the “social infrastructure,” invisible infrastructure is also critical for the biobanks to manage the crisis such as this pandemic. Invisible infrastructure can be the accessibility to comprehensive guidelines, including various standards that show various directions and possible solutions for emergency situations. “Comprehensive” means that the guidance is understandable to all layers of personnel in biobanking activities. Currently, most of these guidelines are prepared in English, which can be a barrier for the non-English-speaking personnel to access the information. Some international organizations have started to overcome this by introducing certain initiatives, such as the WHO, which has introduced a “translation tool” for distribution of ICD-11 to the international community. 18 This can be an inspiration to other international organizations.
In conclusion, this overview summarizes the impacts, and perhaps also sheds some light on the opportunities for the biobank community to help encounter impacts, thus expanding the usefulness of the network beyond biobank services. We need to turn challenges into opportunities for evolution. Diversity in biobanks, especially in the IPR region, could be an advantage for this evolution.
Footnotes
Acknowledgments
We acknowledge the contributors of case scenarios of each biobank, including the DBT, government of India, Aftab and NLDB staff, Eggy Arguni and Florentina Linda, for UGM biospecimen-related management during this pandemic, Catherine Shang, Samantha Higgins, Maggie Ling, Gavin Higgins, and all other staff members from the VCB consortium.
We appreciate the ISBER Standards Committee COVID-19 Task Force (C.M. Allocca, M.J. Bledsoe, M. Albert, S. Anisimov, E. Bravo, M. Castelhano, Y. Cohen, M. De Wilde, K. Furuta, Z. Kozlakidis, D. Martin, A. Martins, S. McCall, H. Morrin, R. Pugh, B. Schacter, D. Simeon-Dubach, and E. Snapes) for providing their survey outcome.
Author Disclosure Statement
No conflicting financial interests exist.
Funding Information
No funding was received for this article.
