Francis P . Crawley - Academia.edu (original) (raw)

Francis P. Crawley is a philosopher with a career in bioethics and expertise in research policy, regulation, ethics, integrity & methodology as well as in data/AI/virtual twins ethics and law with particular attention to the life sciences: clinical trials, genomics/omics, new technologies. Expertise in EU, US, international and country-specific ethics, law, and patient and community interests in health-related research. Strong experience working closely with patients, communities, researchers, and policymakers across disciplines. domains, and geographic regions in establishing consortia, developing patient registries, contributing to the development of biobanks, drafting data management and data protection plans, and contributing to building data repositories. A strong background in the methodologies for designing and reviewing health-related research supported by effective communication and leadership skills as well as diplomacy with the ability to influence changes in bioethics and law. Additional strong background in the development of research, guidance, and ethics related to global diseases affecting resource-poor settings and orphan diseases in the context of leading and/or contributing to challenging projects. Wide experience (e.g., UNAIDS, WHO, UNESCO, European Commission, Council of Europe, and others, including local organizations and industry) in developing health-related research projects, collaborative engagements, regulatory and policy outreach, and education and training in Europe, Africa, Asia, the Americas, and Eastern Europe & Central Asia. Leading roles in the development of international and national guidelines, capacity-building, empowerment, and education programmes for health research; including GCP, ethics review systems, genetics and biobanks, and data privacy & management (a GDPR DPO), with expertise in the ELSI aspects of data AI, digital twins, and organoids. Since January 2020 highly active in the research, ethics, data sharing, and policy discussions on COVID-19, particularly in the areas of vaccines, repurposed medicines, and genetic modelling, having organised more than 40 global webinars and coordinating research across HICs and LMICs. Recently engaged in the policy, ethics, and regulation of data and AI in times of crisis. Founded and coordinates the Ukraine Clinical Research Support Initiative (UCRSI) in cooperation with leading Ukrainian, European, and international organizations. He is at the forefront of the European and global movement to reform and advance research assessment in the universities and other research institutions, with a particular emphasis on research ethics and research integrity in developing policy for data and AI in the research assessment process.
Address: Leuven, Belgium

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Papers by Francis P . Crawley

Zenodo (CERN European Organization for Nuclear Research), Jan 22, 2023

Background (e.g., academic institutions, extramural, intramural researchers, private sector, and ... more Background (e.g., academic institutions, extramural, intramural researchers, private sector, and the public):

International Journal of Pharmaceutical Medicine, 2003

BMJ, Mar 22, 2022

The decision by Prime Minister Boris Johnson to end covid-19 restrictions was clearly political. ... more The decision by Prime Minister Boris Johnson to end covid-19 restrictions was clearly political. The imposition of public health restrictions is, should be, and can only be through politics. Scientific evidence and the best considered opinions of the medical community can never provide the single argument for further limiting citizens’ rights and liberties. Doctors (including the BMA, scientists, and the Scientific Advisory Group for Emergencies1) have limited influence on health policy.2 This is correct in a society that values human rights, basic freedoms, the rule of law, and the sovereignty of its citizens. In his response to Oliver,3 McKee insists that doctors should raise their voices to government and speak truth to power.4 True, but there are many voices and many truths in this conversation: that of the father who buried a child who died by suicide, of the single mother who lost her job because of mandates, of the teenager who left school because of masks, of the family of the grandmother who died in isolation. These truths, these voices, are no less factual than the truths of scientific evidence and the advice of learned counsels. Asking a politician to “show us the evidence” fails to understand politics. Scientific evidence alone cannot possibly lead to just political decisions. More importantly, this also misunderstands science: good, robust, and trustworthy science is limited. Perfect consensus is impossible and even undesirable. Scientists should speak truth to power: truth that is inclusive of all the evidence and is open minded regarding the diversity of interpretations across their ranks. The evidence that challenges their conclusions should be shared. Those drawing other conclusions should not be shouted down, attacked with ad hominem arguments, or shunned through cancel culture. This serves only to undermine the trustworthiness of science, medicine, and public health. It is not only the politicians, industry, social media, and the legacy media that have tested public trust in science and medicine during this pandemic. Science too has played its part by failing to recognise the appropriate limitations of its evidence, its truths, and its role.

International Journal of Pharmaceutical Medicine, 2005

Zenodo (CERN European Organization for Nuclear Research), Apr 18, 2023

Recent events of global impact have led the scientific community to re-evaluate and reaffirm the ... more Recent events of global impact have led the scientific community to re-evaluate and reaffirm the role of science in crisis situations. In particular, the Covid-19 health emergency required the abrupt (re-)allocation of scientific resources to address a pandemic, which demonstrated the vulnerability of sciences as well as the essential role of data science in responding to the health crisis. In a digital world, data collection, data processing, and data reuse is critical to scientific investigation and the development of evidence-based science and its use for critical decision-making in society's response. This paper reports a workshop undertaken by the CODATA International Data Policy Committee (IDPC), together with leading international partners, on the role of data policy in times of crisis. A leading group of scientists and data experts representing a wide audience of various scientific disciplines and expertise from intergovernmental organisations led a critical investigation of the role of data policy in crisis situations. This paper presents preliminary results as to how data policy specifically designed to address the need for science in crisis situations can contribute to building a more robust scientific enterprise that is appropriately prepared for and capable of acting with confidence in the urgencies of crises. The workshop identified a need for establishing principles for data policy in time of crisis as developing concrete recommendations from the international scientific community and leading governmental and intergovernmental organisations.

Zenodo (CERN European Organization for Nuclear Research), Sep 8, 2020

On July 16 th, 2020, the Court of Justice of the European Union issued a landmark decision in the... more On July 16 th, 2020, the Court of Justice of the European Union issued a landmark decision in the case of Data Protection Commissioner v. Facebook Ireland Ltd, Maximillian Schrems (Schrems II) concerning the legality of Facebook's transfers of personal data from the EU to the US. The decision has potentially significant effects on the ability of researchers to legitimately transfer personal data for health research purposes from countries inside the EU, to third countries outside the EU. 11 This article aims: i) to outline the consequences of the Schrems II decision for the legitimate sharing of personal data for health research between the EU and third countries, particularly in the context of the COVID-19 pandemic; and, in light of this elaboration, ii) to consider the avenues that might be pursued to remedy challenges posed by the decision and to facilitate international data exchange for health research moving forward.

International Journal of Clinical Practice, Aug 27, 2015

Journal of the Pakistan Medical Association

Objective: To map literature on research ethics committees, institutional review boards and ethic... more Objective: To map literature on research ethics committees, institutional review boards and ethics review framework in Pakistan to identify key insights during public health emergencies and normal times. Method: The systematic scoping review was conducted in April 22, and comprised literature search on PubMed, World Health Organisation Global Index Medicus and Summons databases for articles published between January 2005 and February 2022. Information extracted included authors’ names, year of publication, title, study methodology, and key insights under the heads of challenges and solutions. Due to data heterogeneity, key themes were identified and analysed. Results: Of the 2,190 studies initially identified, 21(0.95%) were subjected to full-text review, and, from among them, 9(45%) were analysed in detail. There were 4 key insights identified: research ethics committees and institutional review boards in Pakistan remain unregulated as they are currently not registered or accredite...

Frontiers in Genetics

Advances in genomic research have significantly enhanced modern drug development. However, equita... more Advances in genomic research have significantly enhanced modern drug development. However, equitable benefit sharing of the results of scientific advancement has not always been achieved. This paper shows how molecular biology has modified medicines development while also leaving open significant challenges for benefit sharing. Presented here is a conceptual modeling describing the processes in genetic-related medicines development and how these are related to specific ethical considerations. The focus is on three important areas: 1) population genetics and the need for discrimination prevention; 2) pharmacogenomics and the need for inclusive governance; and 3) global health to be achieved in open science frameworks. Benefit sharing is taken as the ethical value that underlies all these aspects. The implementation of benefit sharing requires a value shift in which the outcomes of health science are not viewed simply as trade commodities but also as a “global public good”. This appro...

Archives of Disease in Childhood, 2014

Objectives We wished to compare acetaminophen (APAP) paediatric pharmacokinetics (PK) after a the... more Objectives We wished to compare acetaminophen (APAP) paediatric pharmacokinetics (PK) after a therapeutic dose and a microdose. We developed and validated a new approach using Accelerator Mass Spectrometry (AMS) bioanalysis in the 0–2 year old age group. Methods [14C] APAP concentrations in small volume blood samples were measured after enteral or IV administration of a single [14C] APAP microtracer dose as a microdose or incorporated in a therapeutic dose (microtracer with similar PK to the unlabelled APAP). Results Dose normalised PK parameters AUC0-t, CL and Vss were comparable between a microtracer incorporated in a therapeutic dose and microdose (dose difference approximately 1.5 million fold) when administered either IV or enterally. Abstract PO-0934 Table 1 Route Tmax Cmax* AUC0-t* t1/2 CL Vss hr mg/L hr*mg/L hr L/kr L IV therapeutic 0.93 (1.84) 0.16 (0.06) 0.54 (0.26) 3.78 (3.09) 2.72 (3.10 7.16 IV microdose 0.47 (0.72) 0.30 (0.19) 0.84 (0.57) 1.69 (0.88) 1.76 (1.07) 2.55 Oral therapeutic 1.05 (0.74) 0.14 (0.12) 0.70 (0.79) 2.62 (3.05) 2.93 (2.08) 8.36 Oral microdose 0.65 (0.36) 0.24 (0.1) 0.90 (0.43) 1.64 (1.02) 1.46 (1.00) 2.65 Data are mean and s.d. * Cmax and AUC0-t are dose normalised. Conclusions Micro dosing using AMS bioanalysis is demonstrated to be both possible and practical in the paediatric population. The developed methods may offer ethical, increased bioanalytical sensitivity and safety advantages over dosing regimens used in paediatric PK studies with therapeutic doses.

First published in 2000 by Berghahn Books www.berghahnbooks.com © 2000 Francis Crawley, Paul Smey... more First published in 2000 by Berghahn Books www.berghahnbooks.com © 2000 Francis Crawley, Paul Smeyers, and Paul Standish All rights reserved. No part of this publication may be reproduced in any form or by any means without the written permission of Berghahn ...

HAL (Le Centre pour la Communication Scientifique Directe), Dec 8, 2022

The community cross-fertilisation workshop, 'RDA for Data Management Planning', brought chairs an... more The community cross-fertilisation workshop, 'RDA for Data Management Planning', brought chairs and members of RDA Working Groups (WGs) and Interest Groups (IGs) together, with members of the wider research data community, to share and discuss challenges, solutions and initiatives associated with data management plans (DMPs). The key findings of the workshop summarised herein will be used to direct the future strategy of the RDA community. Read more about the community cross-fertilisation workshop series in commemoration of the RDA's 10th Anniversary.

Acta Bioethica, Jun 1, 2022

As the COVID-19 pandemic unfolded in early 2020, a global group of ethicists, public health profe... more As the COVID-19 pandemic unfolded in early 2020, a global group of ethicists, public health professionals, scientists, and socially engaged persons came together under the operational title of 'Preparedness Planning for Clinical Research During Public Health Emergencies' (PREP). The purpose was to share knowledge, experiences, and questions to learn, improve performance locally, and teach one another, with greater understanding of and sensitivity to the rapidly changing and dynamic conditions. We believe it was the largest and most inclusive grassroots gathering of its kind during this period.

Frontiers in Medicine

This paper discusses the effects of armed conflict, economic sanctions, and natural catastrophes ... more This paper discusses the effects of armed conflict, economic sanctions, and natural catastrophes on ongoing clinical trials. We suggest that• stopping the accrual of new patients in clinical trials under such extreme conditions is acceptable.• research participants already receiving trial medication in such disruptive situations are to be considered highly vulnerable due to their medical dependency for ongoing treatment according to the approved clinical study protocol.• based on the present experience in Ukraine and Russia, we conclude that finishing ongoing trial treatments according to approved or amended protocols should be considered to be an ethical obligation of trial sponsors irrespective whether trial disruption is due to war, economic sanctions, or natural catastrophes.• it is important to devote more attention to the ethical challenges raised by such fundamentally disruptive situations to clinical trials generally in any region of the world.

Background: To investigate gender differences in scientometric indices among faculty members in d... more Background: To investigate gender differences in scientometric indices among faculty members in dental schools across Iran. This included overall data and speciality-specific data.Methods: The publication profiles of academic staff in all dental schools were examined using the Iranian Scientometric Information Database (ISID, http://isid.research.ac.ir). Variables analysed were working field, academic degree, total number of papers, papers per year, total number of citations, percentage of self-citation, h-index, g-index, citations per paper, gender, university type, number of years publishing, proportion of international papers, first-author papers, and corresponding-author papers. Mann-Whitney and Kruskal-Wallis nonparametric tests were used to analyse the relationship between background characteristics and scientometric indicators. The extracted data were analysed using R v4.0.1.Results: The database included 1850 faculty members, of which about 60% (1104 of 1850) were women. Men...

Zenodo (CERN European Organization for Nuclear Research), Jan 22, 2023

Background (e.g., academic institutions, extramural, intramural researchers, private sector, and ... more Background (e.g., academic institutions, extramural, intramural researchers, private sector, and the public):

International Journal of Pharmaceutical Medicine, 2003

BMJ, Mar 22, 2022

The decision by Prime Minister Boris Johnson to end covid-19 restrictions was clearly political. ... more The decision by Prime Minister Boris Johnson to end covid-19 restrictions was clearly political. The imposition of public health restrictions is, should be, and can only be through politics. Scientific evidence and the best considered opinions of the medical community can never provide the single argument for further limiting citizens’ rights and liberties. Doctors (including the BMA, scientists, and the Scientific Advisory Group for Emergencies1) have limited influence on health policy.2 This is correct in a society that values human rights, basic freedoms, the rule of law, and the sovereignty of its citizens. In his response to Oliver,3 McKee insists that doctors should raise their voices to government and speak truth to power.4 True, but there are many voices and many truths in this conversation: that of the father who buried a child who died by suicide, of the single mother who lost her job because of mandates, of the teenager who left school because of masks, of the family of the grandmother who died in isolation. These truths, these voices, are no less factual than the truths of scientific evidence and the advice of learned counsels. Asking a politician to “show us the evidence” fails to understand politics. Scientific evidence alone cannot possibly lead to just political decisions. More importantly, this also misunderstands science: good, robust, and trustworthy science is limited. Perfect consensus is impossible and even undesirable. Scientists should speak truth to power: truth that is inclusive of all the evidence and is open minded regarding the diversity of interpretations across their ranks. The evidence that challenges their conclusions should be shared. Those drawing other conclusions should not be shouted down, attacked with ad hominem arguments, or shunned through cancel culture. This serves only to undermine the trustworthiness of science, medicine, and public health. It is not only the politicians, industry, social media, and the legacy media that have tested public trust in science and medicine during this pandemic. Science too has played its part by failing to recognise the appropriate limitations of its evidence, its truths, and its role.

International Journal of Pharmaceutical Medicine, 2005

Zenodo (CERN European Organization for Nuclear Research), Apr 18, 2023

Recent events of global impact have led the scientific community to re-evaluate and reaffirm the ... more Recent events of global impact have led the scientific community to re-evaluate and reaffirm the role of science in crisis situations. In particular, the Covid-19 health emergency required the abrupt (re-)allocation of scientific resources to address a pandemic, which demonstrated the vulnerability of sciences as well as the essential role of data science in responding to the health crisis. In a digital world, data collection, data processing, and data reuse is critical to scientific investigation and the development of evidence-based science and its use for critical decision-making in society's response. This paper reports a workshop undertaken by the CODATA International Data Policy Committee (IDPC), together with leading international partners, on the role of data policy in times of crisis. A leading group of scientists and data experts representing a wide audience of various scientific disciplines and expertise from intergovernmental organisations led a critical investigation of the role of data policy in crisis situations. This paper presents preliminary results as to how data policy specifically designed to address the need for science in crisis situations can contribute to building a more robust scientific enterprise that is appropriately prepared for and capable of acting with confidence in the urgencies of crises. The workshop identified a need for establishing principles for data policy in time of crisis as developing concrete recommendations from the international scientific community and leading governmental and intergovernmental organisations.

Zenodo (CERN European Organization for Nuclear Research), Sep 8, 2020

On July 16 th, 2020, the Court of Justice of the European Union issued a landmark decision in the... more On July 16 th, 2020, the Court of Justice of the European Union issued a landmark decision in the case of Data Protection Commissioner v. Facebook Ireland Ltd, Maximillian Schrems (Schrems II) concerning the legality of Facebook's transfers of personal data from the EU to the US. The decision has potentially significant effects on the ability of researchers to legitimately transfer personal data for health research purposes from countries inside the EU, to third countries outside the EU. 11 This article aims: i) to outline the consequences of the Schrems II decision for the legitimate sharing of personal data for health research between the EU and third countries, particularly in the context of the COVID-19 pandemic; and, in light of this elaboration, ii) to consider the avenues that might be pursued to remedy challenges posed by the decision and to facilitate international data exchange for health research moving forward.

International Journal of Clinical Practice, Aug 27, 2015

Journal of the Pakistan Medical Association

Objective: To map literature on research ethics committees, institutional review boards and ethic... more Objective: To map literature on research ethics committees, institutional review boards and ethics review framework in Pakistan to identify key insights during public health emergencies and normal times. Method: The systematic scoping review was conducted in April 22, and comprised literature search on PubMed, World Health Organisation Global Index Medicus and Summons databases for articles published between January 2005 and February 2022. Information extracted included authors’ names, year of publication, title, study methodology, and key insights under the heads of challenges and solutions. Due to data heterogeneity, key themes were identified and analysed. Results: Of the 2,190 studies initially identified, 21(0.95%) were subjected to full-text review, and, from among them, 9(45%) were analysed in detail. There were 4 key insights identified: research ethics committees and institutional review boards in Pakistan remain unregulated as they are currently not registered or accredite...

Frontiers in Genetics

Advances in genomic research have significantly enhanced modern drug development. However, equita... more Advances in genomic research have significantly enhanced modern drug development. However, equitable benefit sharing of the results of scientific advancement has not always been achieved. This paper shows how molecular biology has modified medicines development while also leaving open significant challenges for benefit sharing. Presented here is a conceptual modeling describing the processes in genetic-related medicines development and how these are related to specific ethical considerations. The focus is on three important areas: 1) population genetics and the need for discrimination prevention; 2) pharmacogenomics and the need for inclusive governance; and 3) global health to be achieved in open science frameworks. Benefit sharing is taken as the ethical value that underlies all these aspects. The implementation of benefit sharing requires a value shift in which the outcomes of health science are not viewed simply as trade commodities but also as a “global public good”. This appro...

Archives of Disease in Childhood, 2014

Objectives We wished to compare acetaminophen (APAP) paediatric pharmacokinetics (PK) after a the... more Objectives We wished to compare acetaminophen (APAP) paediatric pharmacokinetics (PK) after a therapeutic dose and a microdose. We developed and validated a new approach using Accelerator Mass Spectrometry (AMS) bioanalysis in the 0–2 year old age group. Methods [14C] APAP concentrations in small volume blood samples were measured after enteral or IV administration of a single [14C] APAP microtracer dose as a microdose or incorporated in a therapeutic dose (microtracer with similar PK to the unlabelled APAP). Results Dose normalised PK parameters AUC0-t, CL and Vss were comparable between a microtracer incorporated in a therapeutic dose and microdose (dose difference approximately 1.5 million fold) when administered either IV or enterally. Abstract PO-0934 Table 1 Route Tmax Cmax* AUC0-t* t1/2 CL Vss hr mg/L hr*mg/L hr L/kr L IV therapeutic 0.93 (1.84) 0.16 (0.06) 0.54 (0.26) 3.78 (3.09) 2.72 (3.10 7.16 IV microdose 0.47 (0.72) 0.30 (0.19) 0.84 (0.57) 1.69 (0.88) 1.76 (1.07) 2.55 Oral therapeutic 1.05 (0.74) 0.14 (0.12) 0.70 (0.79) 2.62 (3.05) 2.93 (2.08) 8.36 Oral microdose 0.65 (0.36) 0.24 (0.1) 0.90 (0.43) 1.64 (1.02) 1.46 (1.00) 2.65 Data are mean and s.d. * Cmax and AUC0-t are dose normalised. Conclusions Micro dosing using AMS bioanalysis is demonstrated to be both possible and practical in the paediatric population. The developed methods may offer ethical, increased bioanalytical sensitivity and safety advantages over dosing regimens used in paediatric PK studies with therapeutic doses.

First published in 2000 by Berghahn Books www.berghahnbooks.com © 2000 Francis Crawley, Paul Smey... more First published in 2000 by Berghahn Books www.berghahnbooks.com © 2000 Francis Crawley, Paul Smeyers, and Paul Standish All rights reserved. No part of this publication may be reproduced in any form or by any means without the written permission of Berghahn ...

HAL (Le Centre pour la Communication Scientifique Directe), Dec 8, 2022

The community cross-fertilisation workshop, 'RDA for Data Management Planning', brought chairs an... more The community cross-fertilisation workshop, 'RDA for Data Management Planning', brought chairs and members of RDA Working Groups (WGs) and Interest Groups (IGs) together, with members of the wider research data community, to share and discuss challenges, solutions and initiatives associated with data management plans (DMPs). The key findings of the workshop summarised herein will be used to direct the future strategy of the RDA community. Read more about the community cross-fertilisation workshop series in commemoration of the RDA's 10th Anniversary.

Acta Bioethica, Jun 1, 2022

As the COVID-19 pandemic unfolded in early 2020, a global group of ethicists, public health profe... more As the COVID-19 pandemic unfolded in early 2020, a global group of ethicists, public health professionals, scientists, and socially engaged persons came together under the operational title of 'Preparedness Planning for Clinical Research During Public Health Emergencies' (PREP). The purpose was to share knowledge, experiences, and questions to learn, improve performance locally, and teach one another, with greater understanding of and sensitivity to the rapidly changing and dynamic conditions. We believe it was the largest and most inclusive grassroots gathering of its kind during this period.

Frontiers in Medicine

This paper discusses the effects of armed conflict, economic sanctions, and natural catastrophes ... more This paper discusses the effects of armed conflict, economic sanctions, and natural catastrophes on ongoing clinical trials. We suggest that• stopping the accrual of new patients in clinical trials under such extreme conditions is acceptable.• research participants already receiving trial medication in such disruptive situations are to be considered highly vulnerable due to their medical dependency for ongoing treatment according to the approved clinical study protocol.• based on the present experience in Ukraine and Russia, we conclude that finishing ongoing trial treatments according to approved or amended protocols should be considered to be an ethical obligation of trial sponsors irrespective whether trial disruption is due to war, economic sanctions, or natural catastrophes.• it is important to devote more attention to the ethical challenges raised by such fundamentally disruptive situations to clinical trials generally in any region of the world.

Background: To investigate gender differences in scientometric indices among faculty members in d... more Background: To investigate gender differences in scientometric indices among faculty members in dental schools across Iran. This included overall data and speciality-specific data.Methods: The publication profiles of academic staff in all dental schools were examined using the Iranian Scientometric Information Database (ISID, http://isid.research.ac.ir). Variables analysed were working field, academic degree, total number of papers, papers per year, total number of citations, percentage of self-citation, h-index, g-index, citations per paper, gender, university type, number of years publishing, proportion of international papers, first-author papers, and corresponding-author papers. Mann-Whitney and Kruskal-Wallis nonparametric tests were used to analyse the relationship between background characteristics and scientometric indicators. The extracted data were analysed using R v4.0.1.Results: The database included 1850 faculty members, of which about 60% (1104 of 1850) were women. Men...