FAIR and ethical data and sample reuse research group
Our multidisciplinary research team focuses on understanding and addressing barriers to data and sample reuse in biomedical research. Our research and applied work include retrospective and prospective harmonization of biomedical research data, identifying and addressing ethical, legal, and social issues (ELSI) in data and sample reuse, measurement error, and evaluating and building the adoption of the FAIR (findable, accessible, interoperable, reusable) principles for data resources and on FAIR convergence, the shared adoption of FAIR. We work closely with data partners, health authorities, and related consortia to maximize the utility of data and samples collected in the context of routine clinical care and biomedical research in keeping with the principles of ethical data and sample management, including real consideration of research participant community values and benefit sharing.
Group Leader
Projects
ECRAID Base
HIGH scientific leads: Lauren Maxwell, Thomas Jaenisch
HIGH contributing scientists: Ankur Krishnan, Priya Shreedhar
European Clinical Research Alliance on Infectious Diseases (ECRAID) Base generates rigorous evidence to improve diagnosis, prevention and treatment of well characterized infectious diseases and facilitate the detection of and response to emerging infectious diseases (EIDs). ECRAID-Base is a European wide network that includes five perpetual observational studies in ICU, ER, and primary care settings. POSs focus on European public health priority IDs, including those relevant to AMR (ventilator-associated pneumonia and complicated urinary tract infections) and emerging infectious diseases (acute respiratory infections and unexplained febrile illnesses). POSs provide a "warm base" for RCTs, including adaptive platform trials, effectively linking academic and industry-sponsored resesarch.
ECRAID-Base continues and extends large-scale European research consortia including: PREPARE, COMBACTE, RECOVER, and ECRAID-Plan. The POS network and associated platform trials will improve Europe's ability to rapidly respond to public health threats both through improved surveillance and the framework for the rapid initiation of adaptive platform trials that leverage existing teams, data flows, and agreements.
Select publications
Hassoun-Kheir N, van Werkhoven CH, Dunning J, Jaenisch T, van Beek J, Bielicki J, Butler CC, Francois B, Harbarth S, Hernandez Padilla AC, Horby P, Koopmans M, Lee J, Rodriguez-Baño J, Tacconelli E, Themistocleous Y, van der Velden AW, Bonten M, Goossens H, de Kraker MEA; ECRAID-Base consortium. Perpetual observational studies: new strategies to support efficient implementation of observational studies and randomized trials in infectious diseases. Clin Microbiol Infect. 2022 Dec;28(12):1528-1532. doi: 10.1016/j.cmi.2022.07.024. Epub 2022 Aug 5. PMID: 35940566; PMCID: PMC9354481.
Project partners
UMC Utrecht – Marc Bonten, Alike van der Velden
University of Antwerp (ClinNet) – Herman Goossens
Erasmus MC – Marion Koopmans, Janko van Beeek
European Clinical Research Infrastructur (ECRIN) – Jacques Demotes
University of Verona, University of Tubingen (EpiNet) – Evelina Taconelli
Universidad de Sevilla - Jesús Rodriguez-Baño
University of Oxford – Peter Horby, Christopher Butler
Université de Limoges – Bruno Francois, Anna Hernandez Padilla
Université de Genève (StatNet) – Stephan Harbath, Marlieke de Kraker
ReCoDID
HIGH scientific leads: Thomas Jaenisch, Lauren Maxwell
HIGH contributing scientists: Heather Hufstedler, Priya Shreedhar, Frank Tobian, Luz Leegstra, Shaila Akter
The Reconciliation of Cohort Data in Infectious Diseases (ReCoDID) consortium brings together a multidisciplinary team from four continents to fast-track the research response to viruses and other pathogens by facilitating data and sample sharing between infectious disease cohort studies.
Select publications
- Maxwell L, Chamorro JB, Leegstra LM, Laguna HS, Miranda Montoya MC (2023) "How about me giving blood for the COVID vaccine and not being able to get vaccinated?" A cognitive interview study on understanding of and agreement with broad consent for future use of data and samples in Colombia and Nicaragua. PLOS Global Public Health 3(5): e0001253. https://doi.org/10.1371/journal.pgph.0001253
- Miranda Montoya MC, Bravo Chamorro J, Leegstra LM, Duque Ortiz D, Maxwell L (2022) A blank check or a global public good? A qualitative study of how ethics review committee members in Colombia weigh the risks and benefits of broad consent for data and sample sharing during a pandemic. PLOS Global Public Health 2(6): e0000364. https://doi.org/10.1371/journal.pgph.0000364
- Hufstedler, H., Rahman, S., Danzer, A. M., Goymann, H., de Jong, V. M., Campbell, H., ... & Bärnighausen, T. (2022). Systematic Review Reveals Lack of Causal Methodology Applied to Pooled Longitudinal Observational Infectious Disease Studies. Journal of clinical epidemiology. doi.org/10.1016/j.jclinepi.2022.01.008.
- de Jong V M T, Rousset R Z, Antonio-Villa N E, Buenen A G, Van Calster B, Bello-Chavolla O Y…Maxwell L…, et al. Clinical prediction models for mortality in patients with covid-19: external validation and individual participant data meta-analysis BMJ 2022; 378 :e069881 doi:10.1136/bmj-2021-069881
- Campbell H, de Jong VMT, Maxwell L, Jaenisch T, Debray TPA, Gustafson P. Measurement error in meta-analysis (MEMA)—A Bayesian framework for continuous outcome data subject to non-differential measurement error. Res Syn Meth. 2021; 1- 20. https://doi.org/10.1002/jrsm.1515
Project partners
Universidad Industrial de Santander – María Consuelo Miranda Montoya, Luis Villar
EMBL-EBI, Hinxton Campus – Guy Cochrane, Gabi Rinck
Erasmus MC – Marion Koopmans, Janko van Beek
EVA-G – Xavier de Lamballerie
Instituto de Ciencias Sostenibles – Eva Harris
McGill University
McMaster University – Claudia Emerson, Priscilla Cesar
University of British Columbia – Paul Gustafson, Harlan Campbell
UMC Utrecht – Thomas Debray, Valentijn de Jong
Heidelberger Akademie der Wissenschaften - Dr. iur. Fruzsina Molnar-Gabor
ORCHESTRA
The Connecting European Cohort to Increase Common and Effective Response to SARS-CoV-2 Pandemic (ORCHESTRA) is a population-based, prospective and retrospective cohort study coordinated by Dr. Evelina Taconelli at the University of Verona.
HIGH scientific lead: Thomas Jaenisch
HIGH contributing scientist: Shaila Akter, Luz Leegstra
WHO Zika Individual Participant Data Consortium Individual Participant Data Meta-Analysis
HIGH scientific lead: Lauren Maxwell
HIGH contributing scientists: Thomas Jaenisch, Priya Shreedhar
The ZIKV IPD Consortium is a global collaboration to address outstanding questions in Zika virus (ZIKV) epidemiology through conducting an individual participant data meta-analysis (IPD-MA). The aims of the IPD-MA are to (1) estimate the absolute and relative risks of miscarriage, fetal loss, and short- and long-term sequelae of fetal exposure; (2) identify and quantify the relative importance of different sources of heterogeneity (e.g., immune profiles, concurrent flavivirus infection) for the risk of adverse fetal, infant, and child outcomes among infants exposed to ZIKV in utero; and (3) develop and validate a prognostic model for the early identification of high-risk pregnancies and inform communication between health care providers and their patients and public health interventions (e.g., vector control strategies, antenatal care, and family planning programs).
Select publications
- Carabali M, Maxwell L, Levis B The ZIKV IPD-MA Consortium, et al. Heterogeneity of Zika virus exposure and outcome ascertainment across cohorts of pregnant women, their infants and their children: a metadata surveyBMJ Open 2022;12:e064362. doi: 10.1136/bmjopen-2022-064362
- Zika Virus Individual Participant Data Consortium. The Zika Virus Individual Participant Data Consortium: A Global Initiative to Estimate the Effects of Exposure to Zika Virus during Pregnancy on Adverse Fetal, Infant, and Child Health Outcomes. Trop. Med. Infect. Dis. 2020. 5, no. 4: 152. Corresponding Author. https://doi.org/10.3390/tropicalmed5040152
- Wilder-Smith A, Wei Y, Barreto de Araujo TV, VanKerkhove M, Turchi Martelli CM, Turchi Martelli, MD, Teixeira M, Tami A, Souza J, Sousa P, Soriano-Arandes A, Soria-Segarra C, Sanchez-Clemente N, Rosenberger KD, Reveiz L, Prata-Barbosa A, Pomar L, Pelá Rosado LE, Perez F, Passos SD, Nogueira M, Noel TP, Moura da Silva A, Moreira MA, Morales I, Miranda Montoya MC, Miranda-Filho DB, Maxwell L, et. al. Understanding the relation between Zika virus infection during pregnancy and adverse fetal, infant, and child outcomes: A systematic review and individual participant data meta-analysis of Zika virus-related cohorts of pregnant women and their infants and children (IPD-MA Protocol). BMJ Open. 2019.9, e026092. Corresponding Author. http://dx.doi.org/10.1136/bmjopen-2018-026092
Project partners
Zika Brazilian Cohorts Consortium – Ricardo Ximenes
World Health Organization, Department of Reproductive Health and Research
McGill University – Mabel Carabali, Brooke Levis
National Institute of Allergy and Infectious Diseases (NIAID)
US Centers for Disease Control and Prevention (CDC)