Enrolling study personnel in Ebola vaccine trials: from guidelines to practice in a non-epidemic context
Abstract Background Enrolling participants in clinical trials can be challenging, especially with respect to prophylactic vaccine trials. The vaccination of study personnel in Ebola vaccine trials during the 2014–2016 epidemic played a crucial role in inspiring trust and facilitating volunteer enrol...
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doaj-60aa8cb110414ae9adf53ef2a16f49ad2020-11-25T03:02:25ZengBMCTrials1745-62152019-07-012011610.1186/s13063-019-3487-0Enrolling study personnel in Ebola vaccine trials: from guidelines to practice in a non-epidemic contextEdouard Lhomme0Camara Modet1Augustin Augier2Sylvain Faye3Tienhan Sandrine Dabakuyo-Yonli4Claire Levy-Marchal5Eric D’Ortenzio6Yazdan Yazdanpanah7Geneviève Chêne8Abdoul Habib Beavogui9Laura Richert10the PREVAC study teamUniv. Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials PlatformThe Alliance for International Medical ActionThe Alliance for International Medical ActionDépartement de Sociologie, University Cheikh Anta DIOPUniv. Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials PlatformINSERM, Pôle de Recherche CliniqueAP-HP, Hôpital Bichat-Claude Bernard, Service de Maladies Infectieuses et TropicalesAP-HP, Hôpital Bichat-Claude Bernard, Service de Maladies Infectieuses et TropicalesUniv. Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials PlatformCentre de Formation et de Recherche en Santé Rurale de MafèrinyahUniv. Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials PlatformAbstract Background Enrolling participants in clinical trials can be challenging, especially with respect to prophylactic vaccine trials. The vaccination of study personnel in Ebola vaccine trials during the 2014–2016 epidemic played a crucial role in inspiring trust and facilitating volunteer enrollment. We evaluated the ethical and methodological considerations as they applied to an ongoing phase 2 randomized prophylactic Ebola vaccine trial that enrolled healthy volunteers in Guinea, Liberia, Sierra Leone, and Mali in a non-epidemic context. Methods On the assumption that the personnel on site involved in executing the protocol, as well as community mobilizers (not involved in the on-site procedures), might also volunteer to enter the trial, we considered both ethical and methodological considerations to set clear rules that can be shared a priori with these persons. We reviewed the scientific and gray literature to identify relevant references and then conducted an analysis of the ethical and methodological considerations. Results There are currently no regulations preventing a clinical investigator or site staff from participating in a trial. However, the enrollment of personnel raises the risk of undue influence and challenges the basic ethical principle of voluntary participation. The confidentiality of personal medical information, such as HIV test results, may also be difficult to ensure among personnel. There is a risk of disruption of trial operations due to the potential absence of the personnel for their commitment as trial participants, and there is also a potential for introducing differential behavior of on-site staff as they obtain access to accumulating information during the trial (e.g., the incidence of adverse events). Blinding could be jeopardized, given knowledge of product-specific adverse event profiles and the proximity to unblinded site staff. These aspects were considered more relevant for on-site staff than for community mobilizers, who have limited contact with site staff. Conclusion In a non-epidemic context, ethical and methodological considerations limit the collective benefit of enrolling site staff in a vaccine trial. These considerations do not apply to community mobilizers, whose potential enrollment should be considered as long as they meet the inclusion criteria and they are not exposed to any form of coercion.http://link.springer.com/article/10.1186/s13063-019-3487-0Clinical trialsLow- and middle-income countriesEbola vaccineEthicsTrial participantsResearch participants |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Edouard Lhomme Camara Modet Augustin Augier Sylvain Faye Tienhan Sandrine Dabakuyo-Yonli Claire Levy-Marchal Eric D’Ortenzio Yazdan Yazdanpanah Geneviève Chêne Abdoul Habib Beavogui Laura Richert the PREVAC study team |
spellingShingle |
Edouard Lhomme Camara Modet Augustin Augier Sylvain Faye Tienhan Sandrine Dabakuyo-Yonli Claire Levy-Marchal Eric D’Ortenzio Yazdan Yazdanpanah Geneviève Chêne Abdoul Habib Beavogui Laura Richert the PREVAC study team Enrolling study personnel in Ebola vaccine trials: from guidelines to practice in a non-epidemic context Trials Clinical trials Low- and middle-income countries Ebola vaccine Ethics Trial participants Research participants |
author_facet |
Edouard Lhomme Camara Modet Augustin Augier Sylvain Faye Tienhan Sandrine Dabakuyo-Yonli Claire Levy-Marchal Eric D’Ortenzio Yazdan Yazdanpanah Geneviève Chêne Abdoul Habib Beavogui Laura Richert the PREVAC study team |
author_sort |
Edouard Lhomme |
title |
Enrolling study personnel in Ebola vaccine trials: from guidelines to practice in a non-epidemic context |
title_short |
Enrolling study personnel in Ebola vaccine trials: from guidelines to practice in a non-epidemic context |
title_full |
Enrolling study personnel in Ebola vaccine trials: from guidelines to practice in a non-epidemic context |
title_fullStr |
Enrolling study personnel in Ebola vaccine trials: from guidelines to practice in a non-epidemic context |
title_full_unstemmed |
Enrolling study personnel in Ebola vaccine trials: from guidelines to practice in a non-epidemic context |
title_sort |
enrolling study personnel in ebola vaccine trials: from guidelines to practice in a non-epidemic context |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2019-07-01 |
description |
Abstract Background Enrolling participants in clinical trials can be challenging, especially with respect to prophylactic vaccine trials. The vaccination of study personnel in Ebola vaccine trials during the 2014–2016 epidemic played a crucial role in inspiring trust and facilitating volunteer enrollment. We evaluated the ethical and methodological considerations as they applied to an ongoing phase 2 randomized prophylactic Ebola vaccine trial that enrolled healthy volunteers in Guinea, Liberia, Sierra Leone, and Mali in a non-epidemic context. Methods On the assumption that the personnel on site involved in executing the protocol, as well as community mobilizers (not involved in the on-site procedures), might also volunteer to enter the trial, we considered both ethical and methodological considerations to set clear rules that can be shared a priori with these persons. We reviewed the scientific and gray literature to identify relevant references and then conducted an analysis of the ethical and methodological considerations. Results There are currently no regulations preventing a clinical investigator or site staff from participating in a trial. However, the enrollment of personnel raises the risk of undue influence and challenges the basic ethical principle of voluntary participation. The confidentiality of personal medical information, such as HIV test results, may also be difficult to ensure among personnel. There is a risk of disruption of trial operations due to the potential absence of the personnel for their commitment as trial participants, and there is also a potential for introducing differential behavior of on-site staff as they obtain access to accumulating information during the trial (e.g., the incidence of adverse events). Blinding could be jeopardized, given knowledge of product-specific adverse event profiles and the proximity to unblinded site staff. These aspects were considered more relevant for on-site staff than for community mobilizers, who have limited contact with site staff. Conclusion In a non-epidemic context, ethical and methodological considerations limit the collective benefit of enrolling site staff in a vaccine trial. These considerations do not apply to community mobilizers, whose potential enrollment should be considered as long as they meet the inclusion criteria and they are not exposed to any form of coercion. |
topic |
Clinical trials Low- and middle-income countries Ebola vaccine Ethics Trial participants Research participants |
url |
http://link.springer.com/article/10.1186/s13063-019-3487-0 |
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