In the context of the activities of the emergency support group for infrastructure and logistics of research on COVID-19 installed in 2020 by the Board of Directors of FMUSP and the Deliberative Council of HCFMUSP, it was envisioned for the first time in the institution the prospect of large-scale storage of biological material from laboratory tests routinely performed with hospitalized patients, not only to feed scientific studies in the short term but also future research. Taking advantage of the serum and lymphocyte storage work that had already been started at the Central Laboratory Division (DLC) of HCFMUSP, a proposal was then approved to consolidate this laboratory center as an "agency" of the Biobank of the Institute of Tropical Medicine (IMT) dedicated to COVID-19, taking advantage of the documentation already approved by CONEP for the IMT.

Equipment needs and other infrastructure aspects were quickly mapped so that leftover blood tests collected during hospitalizations could be systematically processed and stored at the DLC starting in early June 2020, with the contribution of human resources raised by the LIM Executive Board. By October 2020, serum and plasma samples were collected, processed, and stored from over 2000 patients hospitalized by COVID-19 (for at least 24 hours). In addition, in the context of the multidisciplinary follow-up assessment program between October 2020 and March 2021 (at 6-11 months after hospital discharge), additional vials of serum were stored for more than 700 patients.

In an initiative proposed by the COVID-19 Crisis Committee, with the support of the CEDEM-FMUSP preceptorship and relying on a group of more than 15 FMUSP medical students, a first effort was made still during hospitalizations to seek consent from patients and their families for use of their blood samples in future research. This consent search was continued by teams from the Research Laboratories Executive Board through telephone contacts after the patients' discharge, and completed through face-to-face contacts when the multidisciplinary reassessment program mentioned above took place. We also obtained authorization from CONEP to use samples from patients who died during or shortly after their hospitalizations.

The above efforts have consolidated a collection of thousands of samples for which ethical consent for research use is obtained from 450 patients with samples collected both during hospitalization and at follow-up assessments after 6-11 months; about 550 patients with samples collected exclusively during hospitalization; and about 250 patients with samples collected exclusively during follow-up.

The existence of this material has been widely publicized in the institution and three calls for access have been made, under the supervision of the COVID-19 Steering Committee. To date, just over 2700 samples have been provided for different research, and over 1500 additional aliquots are reserved for studies awaiting funding.

As of March 2021, a committee has been established to direct the release of aliquots extracted from the above samples to research projects, including Leslie Kulikowski and Geraldo Busatto Filho (representing the Scientific Committee and interfacing with the DLC), professors, and researchers from the Institute of Tropical Medicine (Ester Cerdeira Sabino, Maria Cássia Jacintho Mendes Corrêa, Silvia Figueiredo Costa and Andrés Jimenez Galisteo Jr), and postdoctoral fellow Ana Paula Ritto, who works full time on the strategic and executive management of the institutional initiatives described here, in constant communication with the INOVA-HC management team, which funds her fellowship and supervised by the COVID-19 Steering Committee. Through the work of this committee, the samples will remain accessible to our research groups and partners outside the FMUSP-HC System.

Access to biological samples is granted according to CONEP regulations. The Biobank of the Tropical Medicine Institute has an obligation to its participants to ensure that data and samples are stored, retrieved and used with adequate security and protection.

All ethical and data security principles have been applied following current standards of data protection and confidentiality. No identification of patients' personal information is made available. No individually identifiable data is shared with the researchers (i.e., data is "anonymized"). Researchers sign a legal agreement not to make any attempt to identify participants. Research projects applying for access to the HCFMUSP institutional databases must be approved in advance by the Ethics Committee of the institution to which the researcher is affiliated.

The sharing of data and samples for additional research studies is conditional on the strict need for confidentiality of individual participants’ data and samples. Access to our institutional data and samples requires agreement from the researcher in assuming their ethical and legal responsibility. Individually identifiable data is never released.