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Kliniken &… Institute Global Health Working Groups FAIR and ethical data…

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.

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. 

 

Selected 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.

 

Selected 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

ORCHESTRA

  • HIGH scientific lead: Thomas Jaenisch
  • HIGH contributing scientist: Shaila Akter, Luz Leegstra

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. 

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). 

Selected 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)

TEAM MEMBERS

LinkedIn

Contact Information

E-Mail: lauren.maxwell(at)uni-heidelberg.de

Lauren Maxwell, PhD, MPH

Junior Group Leader

Personal profile on HIGH website

Bio

I am an epidemiologist, biostatistician, and qualitative researcher with 20 years of experience developing and managing global health research projects. As a knowledge broker, I bring together teams, disciplines, and geographies to address complex challenges in global health.

I lead a multidisciplinary research team at Universitätsklinikum Heidelberg, Germany’s oldest university and highest-ranked medical faculty. Our work focuses on retrospective and prospective harmonization of clinical 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.

LINKS: 

Ankur Krishnan

Bio

I am the Data and Project Manager for ECRAID-Base, a pan-European network of perpetual observational studies designed to improve the detection and response to European infectious disease concerns. I have worked closely with Lauren to develop ECRAID Base’s FAIR-by-design approach, which uses CDISC to ensure the observational studies in ECRAID Base can easily transition into intervention studies. I have over 5 years of experience in data standards, harmonization, collection and management within the translational and evidence-based clinical research landscape. I hold Master’s degrees in Forensic Science (2011 – 2013: NICFS, New Delhi, India) and Applied Biotechnology (2016 – 2018: McGill University, Montreal, Canada)

LINKS: 

Priya Shreedhar

Bio

I am a project Manager for ECRAID-Base (European Clinical Research Alliance on Infectious Diseases). My work focuses on ethical concerns around data and sample collection and sharing, including developing the ECRAID Base governance framework. My research includes identifying and addressing political, ethical, administrative, regulatory and legal (PEARL) barriers within the ECRAID Base pan European study network and beyond. I have worked with Lauren on several World Health Organization (WHO)-sponsored projects, including collecting metadata and harmonizing data for the first individual participant-level data meta-analysis of Zika virus-related longitudinal studies of pregnant women and their infants. I also conducted a global review of COVID-19-related data-sharing initiatives. Additionally, I worked on several systematic reviews funded by the WHO, including one on pregnancy cohorts and another on measurement tools for patient-reported outcomes. Before joining Lauren’s team, I worked for a community health NGO in Bengaluru, India. There, I developed personal hygiene, sanitation, and nutrition programmes for school children and new mothers in an urban slum and conducted a qualitative study to understand the waste management practices of women in the urban slum. I was on the coordinating committee for the 14th World Congress of Bioethics in Bengaluru. I have a Master of Science in International Health from Heidelberg University in Germany (2019-2020), for which I was awarded Distinction in Academic Performance for the cohort and a Bachelor of Bioengineering (Hons) from Nanyang Technological University in Singapore (2011-2015).

LINKS: 

 

Regina Gilyan

Bio

I have been working as a research assistant and scientist at the Heidelberg Institute of Global Health for the past two and a half years. I recently graduated with a Bachelor of Arts in Sociology from the University of Heidelberg. Through my studies and work with Lauren, I have developed an immense interest in research focused on social inequalities, specifically health disparities across the globe. Thus far, I have been involved with multiple research projects of both quantitative and qualitative nature commissioned by the World Health Organization (WHO) and the European Commission Horizon 2020 Research and Innovation programme (ReCoDID). These projects include, but are not limited to, scoping and systematic reviews on broad consent for future use, measurement properties of survey instruments for assessing knowledge, attitudes, and practices related to data sharing, and a review of pregnancy cohorts to identify gaps in academic research on long-term outcomes of various prenatal and early-life exposures. In the future, I aim to deepen my knowledge in quantitative data analysis through a subsequent Master’s program and contribute to global health research through an interdisciplinary approach.

LINKS: 

LinkedIn

Contact Information

E-Mail: luz.leegstra(at)uni-heidelberg.de

Luz Marina Leegstra

Personal profile on HIGH website

Bio

I am a clinical psychologist with a master's in international health. I have over 10 years of experience working on communicable and non-communicable diseases in LMICs. I have developed and conducted qualitative, quantitative, and mixed methods research in Latin America (Brazil, Nicaragua, Colombia, Argentina), the Western Pacific Region (Cambodia, Fiji, Lao PDR, Malaysia, Mongolia, Papua New Guinea, Philippines, Vietnam) and the Middle East (Yemen). I work on the retrospective and prospective harmonization of clinical data collected during epidemics (ReCoDID) and pandemics (ORCHESTRA). My qualitative research focuses on ethical issues in data and sample sharing and understanding how data and sample sharing during the response to pandemics (COVID-19) and epidemics (ZIKV) can better incorporate community values. I am an experienced project manager specialising in developing and supporting intercultural, multi-country teams.

LINKS: 

Marwah Al-Zumair

Junior Group Leader

Bio

I am a clinician and a public health specialist interested in research and response to emergencies and pandemics. My applied experience covers different health sectors, including healthcare for displaced populations, and integrated health and nutrition projects. I am interested in sexual and reproductive health and women and girls’ empowerment. Currently, I am working with my research team at UHK in collaboration with a network of midwives in Yemen to assess community midwives' knowledge, practices, and experiences related to violence against women and girls during humanitarian crisis.

LINKS: 

LinkedIn

Contact Information

E-Mail: thomas.jaenisch(at)uni-heidelberg.de

PD Dr. med. Thomas Jänisch, PhD

Personal profile on HIGH website

 

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