Table 2.

Challenges identified during the implementation of institutional research initiatives at HC-FMUSP in the COVID-19 pandemic.

Challenges	Barriers	Actions taken
How to disseminate information about the initiatives within the HC-FMUSP system	Fragmented institutional communication	Frequent and detailed internal communication about the initiatives (one-on-one discussions with research leaders, presentations to groups and internal collegiate, repeated electronic memos to mailing lists, progress reports to participating research groups) Building of an open website (https://sites.google.com/view/covid-19-hcfmusp)
How to overcome conflicts regarding leadership, ownership of information and data sharing	Habits of research groups to work either individually or with a few trusted partners	Identification of (and frequent communication with) a few experienced and respected HC-FMUSP researchers willing to manage key components of the institutional collaborative research initiatives Transparent alignment with those leaders to guide the uniform implementation of actions fostering maximal inclusion of (and cooperation between) potentially interested research groups Stressing of the principles of inclusion, transparency and cooperativeness in all communications with research groups Access to data from the REDCap databases provided solely by the direct management team, after swift authorization of the COVID-19 Steering Committee using objective and previously advertised criteria
How to award fair credit and co-authorship opportunities in publications	Frustration of professionals that might not have opportunities to exercise their research interests due to overload of clinical and management work during the pandemic Risk of honorary authorship	Use of a corporate coauthor including members selected according to objective criteria (i.e., professionals who helped significantly in the construction of the hospital databases). Setting of rules whereby individuals from the corporate coauthor were invited to contribute intellectually to (and approve the final version of) original papers that used data from significant numbers (>800) of patients For other key professionals from the crisis committee who had no familiarity with or interests in research on clinical aspects of COVID-19, use of a second corporate name cited in the Acknowledgements sections of manuscripts. Some of those individuals were also invited to contribute intellectually to specific papers evaluating non-clinical aspects of COVID-19 Avoidance of inclusion of coauthors that did not meet the criteria of the International Committee of Medical Journal Editors. Professors whose leadership was restricted to research administration of the initiatives were listed as authors only in specific cases when they did take part in the planning of investigations and analyses, interpretation of results and writing-up of manuscripts
How to facilitate the hands-on use of institutional databases by researchers	Lack of familiarity of the research groups with the databases’ structure	Strengthening of the role of the direct research managing team shown in Figure 1 in the overseeing of the research teams that worked on analyses using the databases. The management team helped researchers to select data fields relevant to their study goals and to understand how those elements were coded in the databases, as well as working to prevent unnecessary duplication of analyses by different groups, errors in the interpretation of numbers and variables, and discrepancies when similar data was reported across separate papers
How to balance the choice of instruments for the multidisciplinary follow-up assessments of patients	Multiplicity of interests of different research groups Risk of duplication/overlap of information collected using different scales Risk that questions proposed by some research groups would not be valued as equally meritorious by other teams	Validation by the COVID-19 Steering Committee of the direct management team as the mediator in the negotiations between research groups, in order to ensure that the assessment battery would be as thorough as possible without overburdening research participants Democratic mediation of decisions, in order to facilitate the inclusion of the largest possible number of research groups with diverse interests
How to deal with ethical issues regarding use of data from hospitalized patients with COVID-19	Risk of privacy breaches, re-identification and misuse of data extracted from medical records Difficulties to obtain informed consent from hospitalized patients or their family members for storing blood samples in the biobank	Recruitment of a team of medical students to seek informed consent during in-hospital stay from patients and family members for storing leftover blood from diagnostic tests Use of the follow-up visit conducted months after hospitalization to retrospectively obtain permission for use of leftover blood from diagnostic tests stored during hospitalization Request for the Brazilian National Research Ethics Committee to grant permission for the scientific use of de-identified healthcare data and biological materials from patients deceased due to COVID-19, considering the invaluable importance of medical research during the extraordinary pandemic circumstances
How to minimize delays in the dispensing and use of blood samples from the biobank	Lack of previous experience of the management teams Overload of the management teams with work on the other fronts of data organization Difficulties of potentially interested research groups to allocate funds to cover costs of processing/analyzing samples	Top-down orientation for individual research groups to work collaborative in the sharing of costs whenever possible Submission of a multidisciplinary grant proposal to FAPESP in order to raise further funds for large-scale analyses of samples Expansion of opportunities for experienced groups outside the HC-FMUSP system to get access to blood samples for collaborative studies

FAPESP, Fundação de Amparo à Pesquisa do Estado de São Paulo (São Paulo Research Foundation); HC-FMUSP, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo; REDCap, Research Electronic Data Capture.