Reconsent for Biobanking During a Pandemic

The term biobank was first used in the scientific literature in 1996 to refer to storage of “human biological material” in a review article about cancer risk and oxidative DNA damage in humans.¹ Since that time, biobanking has grown tremendously. The practice has evolved from small, research project–based repositories to institutional- and government-supported repositories, population-based biobanks, and virtual biobanks. Key features of biobanking include 1) collection and storage of biological material with associated epidemiological and medical data; 2) assurance of donor privacy through de-identification of samples and data, but sometimes enabling reidentification if and when clinically relevant information becomes known and can be provided to a donor who is interested in receiving such information; and 3) governance structures and procedures that protect donors’ rights and serve stakeholder interests, including (but not limited to) national laws, guidelines, and regulations as well as ethical reviews.^2,3,4

Voluntary participation and research transparency are paramount to protecting the rights of every individual involved in research.^3,4 Obtaining informed consent is thus essential for research involving human participants. Informed consent processes and relevant supporting documents should outline adequate information about the research to ensure that participation is informed and voluntary.^5,6 Under certain circumstances, however, a waiver of informed consent can be granted by a research ethics committee (REC) overseeing a research study when obtaining informed consent may not be feasible and other criteria are met.⁶

In a cohort study of long-term epidemiological risk factors to identify populations at risk of cancer, an REC approved a study to be conducted with biospecimens that will be stored in a biobank for 10 years. Study participants were informed of this time frame when they initially consented. The study began in 2012, meaning that the designated storage period for collected biospecimens would end in 2022. In 2021, the study team began re-consenting research participants to extend the storage period and obtain follow-up data. However, because of the COVID-19 pandemic, and because of the fear of COVID-19, most participants were hesitant to travel to the study site (a public hospital) to be re-consented. To resolve this challenge, the study team requested an informed consent waiver for the patients who had previously agreed to participate in the study.