Aims & perspectives of the workshop

Healthy volunteers have always played a vital role in medical research to serve as controls for patient groups allowing them to define the limits of "normal." They are also required to test new medical strategies, including more or less invasive medical tests, drugs or medical devices. Their role has been exemplified during the COVID-19 pandemia allowing the rapid development of effective vaccines. However, exposing healthy people to unknown risks raises complex ethical issues.

Initiated by a working group of Inserm ethics committee, this meeting aims at paving the way to elaborate an international consensus and guidance in biomedical research involving healthy volunteers. It will allow discussion between the major actors of the biomedical research involving Healthy Volunteers, from the public and private sectors, for-profit or not, coming from industrialized countries and from countries with lower economic incomes. Our objectives are, on the one hand, to identify the various research projects that expose these highly vulnerable participants and on the other hand, through exchanges between the actors gathered, to propose recommendations to allow a comprehensive ethical and responsible management of these researches.

Because most attendees will remotely participate in this meeting, discussions and interactions will be limited. We expect this first meeting to lay the foundations of a second in-person workshop that will be set up once international travel is possible again. We anticipate that from this first workshop we will be able to organize thematic working groups and will meet remotely to provide guidelines for concrete good practice on the ethical involvement of healthy volunteers, which will be approved during the second workshop.

To register and attend the workshop, you will need to create a personal account on sciencesconf.

Agenda

Online event from the UNESCO House in Paris, France

Hours shown in France/Central Europe Time (GMT+1) 

DAY 1 – SETTING THE SCENE

February 15th, 2022

 

 

10H00 – 10H45 • Welcoming remarks

Hervé Chneiweiss, President, Inserm Ethics Committee

François Hirsch, Inserm Ethics Committee

Irakli Khodeli, Unesco, Bioethics and Ethics of Science and Technology Section

 

 

10H45 – 12H30 • Roundtable 1

Clinical studies with administration of pharmaceutical compounds

Moderator

François Bompart, DNDi

Speakers

Pierre Demolis, ANSM, European Medicines Agency

Mukesh Kumar, Cipla (India)

Aude Le Roux, Sanofi (France)

Deepa Arora, Clinexel (India)

Nicolas Fauchoux, Biotrial (France/USA)

Q & A

 

12H30 – 13H30 • LUNCH BREAK

 

13H30 – 14H50 • Roundtable 1 (continued)

Clinical studies with administration of pharmaceutical compounds: Key ethical issues

Moderator

Pierre Mallia, Chair, Health Ethics Committee of the Ministry for Health (Malta)

Speakers

Shadreck Mwale, University of West London (UK)

Jill A Fisher, University of North Carolina (USA)

Nandini Kumar, FERCI (India)

Wei Zhu, Shanghai Ethics Committee for Clinical Research (P. R. China) 

Q&A

 

14H50 – 15H50 • Roundtable 2

Studies in vulnerable populations

Moderator

Tumani Corrah, Africa Research Excellence Fund (Gambia)

Speakers

Emmanuel Baron, Epicentre/MSF

Mukandu Basua Babintu Leyka, Institut supérieur des techniques médicales, Kinshasa (Democratic Republic of Congo)

Samuel Verges, Université Grenoble Alpes (France)

Q&A

 

15H50 – 16H05 • BREAK 

 

16H05 – 17H05 • Roundtable 3 

Human infection challenge studies

 

Moderator

Lionel Cavicchioli, The Conversation (France)

Speakers

Katherine Littler, WHO

Odile Launay, Inserm, AP-HP (France)

Jonathan Pugh, University of Oxford (UK)

Ingrid Callies, CCNE (France)

Q&A

 

17H05 – 17h35 • Further steps

Moderator    Mylène Botbol-Baum, Inserm Ethics Committee

Speaker        François Eisinger, Inserm Ethics Committee

Open discussion with all participants

 

DAY 2 – DRAFTING RECOMMENDATIONS

February 16th, 2022

 

11H00 – 12H00 • Roundtable 4 

Ethical issues raised by non-clinical research involving healthy persons

Moderator

Dirk  Lanzerath,  European  Network  of  Research  Ethics  Committees (EUREC)

Speakers

Caroline Ollivier-Yaniv, Université Paris-Est Créteil (France)

Karim Ndiaye, ICM (France)

Marie-Noëlle Ungeheuer, Institut Pasteur (France)

Q&A

 

12H00 – 13H00 • Roundtable 5

Non-drug related clinical studies: vaccines, living cells donation, medical devices

Moderator

Hélène Espérou, Inserm (France)

Speakers

Wali Diouf, Anrs-MIE (Guinea)

Antony Fuhr, Fraunhofer (Germany)

Thierry Chevalier, Inserm (France)

Q&A
 

 

13H00 – 14H00 • LUNCH BREAK

 

14H00 – 15H40 • Roundtable 6

Regulations to protect healthy volunteers Key features and lessons learned

Moderator

Christiane Druml, Austrian Bioethics Commission & Medical University, Vienna (Austria)

Speakers

François Eisinger, Institut Paoli-Calmettes (France)

Henri Caplain, Association Françaisede Pharmacologie Translationnelle (AFPT) (France)

Chun Keat Chew, Clinical Research Centre (Malaysia)

Malcolm Boyce, Hammersmith Medicines Research (UK)

Nandini Kumar, FERCI (India)

My Elhassan Elkarimi Anti-Poison & Pharmacovigilance Center (Morocco)

Q&A

 

15H40 – 15H55 • BREAK

 

15H55– 17H15 • Towards Good Practices

Aiming for 4Rs: Respect, Reduce, Refine and Replace healthy volunteers

Moderators

Paul-Loup Weil-Dubuc & Vincent Israel-Jost, EERIdF, Univ. Paris Saclay (France)

Speakers

Jill A. Fisher University of North Carolina (USA)

David B. Resnik, NIEHS (USA)

Pierre Demolis, ANSM, European Medicines Agency 

Marylore Chenel, Pharmetheus (Sweden)

Lembit Rägo, CIOMS

Q&A

 

17H15 – 17H45 • Keynote Lecture

Introduced by Hervé Chneiweiss, President of the Inserm Ethics Committee

Ezekiel Emanuel, Vice Provost for Global Initiatives, Co-Director, Healthcare Transformation Institute, University of Pennsylvania (USA)

 
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