Kliniken &… Institute Heidelberger Institut… Groups & Projects Working Groups

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







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





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


  1. 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
  2. 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
  3. 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.
  4. 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
  5. 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





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


  1. 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
  2. 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
  3. 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 Authorhttp://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)