TY - STD TI - The Global Forum on Bioethics in Research. http://www.gfbr.global/. Accessed 20 June 2018. UR - http://www.gfbr.global/ ID - ref1 ER - TY - STD TI - The Global Forum on Bioethics in Research. Meeting report on emerging epidemic infections and experimental medical treatments, Annecy, France. 2015. http://www.gfbr.global/wp-content/uploads/2016/03/GFBR-2015-meeting-report-emerging-epidemic-infections-and-experimental-medical-treatments.pdf; The Global Forum on Bioethics in Research. Meeting report on the ethics of research in pregnancy, Buenos Aires, Argentina. 2016. http://www.gfbr.global/wp-content/uploads/2017/04/GFBR-2016-report-ethics-of-research-in-pregnancy-FINAL.pdf. Accessed 20 June 2018. UR - http://www.gfbr.global/wp-content/uploads/2017/04/GFBR-2016-report-ethics-of-research-in-pregnancy-FINAL.pdf ID - ref2 ER - TY - JOUR AU - Caplan, A. AU - Plunkett, C. AU - Levin, B. PY - 2015 DA - 2015// TI - Selecting the right tool for the job JO - Am J Bioeth VL - 15 UR - https://doi.org/10.1080/15265161.2015.1010993 DO - 10.1080/15265161.2015.1010993 ID - Caplan2015 ER - TY - JOUR AU - Henao-Restrepo, A. M. AU - Camacho, A. AU - Longini, I. M. AU - Watson, C. H. AU - Edmunds, W. J. AU - Egger, M. PY - 2017 DA - 2017// TI - Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola Ça Suffit!) JO - Lancet. VL - 389 UR - https://doi.org/10.1016/S0140-6736(16)32621-6 DO - 10.1016/S0140-6736(16)32621-6 ID - Henao-Restrepo2017 ER - TY - JOUR AU - Rid, A. AU - Miller, F. G. PY - 2016 DA - 2016// TI - Ethical rationale for the Ebola “ring vaccination” trial design JO - Am J Public Health VL - 106 UR - https://doi.org/10.2105/AJPH.2015.302996 DO - 10.2105/AJPH.2015.302996 ID - Rid2016 ER - TY - JOUR AU - Joffe, S. PY - 2014 DA - 2014// TI - Evaluating novel therapies during the Ebola epidemic JO - JAMA. VL - 312 UR - https://doi.org/10.1001/jama.2014.12867 DO - 10.1001/jama.2014.12867 ID - Joffe2014 ER - TY - STD TI - World Health Organization. Ethical issues related to study design for trials on therapeutics for Ebola virus disease. WHO Ethics Working group Meeting 20–21 October. Summary of discussion. 2014. http://apps.who.int/iris/bitstream/10665/137509/1/WHO_HIS_KER_GHE_14.2_eng.pdf. Accessed 20 June 2018. UR - http://apps.who.int/iris/bitstream/10665/137509/1/WHO_HIS_KER_GHE_14.2_eng.pdf ID - ref7 ER - TY - STD TI - Global Forum on Bioethics in Research. Background paper on the ethics of alternative clinical trial designs and methods in low- and middle- income country research http://www.gfbr.global/wp-content/uploads/2017/04/GFBR-2017-Background-paper_-FINAL.pdf. Accessed 20 June 2018. UR - http://www.gfbr.global/wp-content/uploads/2017/04/GFBR-2017-Background-paper_-FINAL.pdf ID - ref8 ER - TY - STD TI - CRTs are addressed in the Council of International Organizations of Medical Sciences (CIOMS) guidelines 2016 and the 2012 Ottawa statement, although both have limited guidance on specific protection in the case of CRTs conducted in LMICs. There is no specific guidance on SW-CRTs but both Ottawa and CIOMS contain indirect guidance. There is no guidance for adaptive platform or CHIMs. However, the WHO has published a paper in 2016 on ‘Human Challenge Trials for Vaccine Development: regulatory considerations’. See the articles in this Supplement for summaries of relevant guidance. ID - ref9 ER - TY - STD TI - Salas SP. Experiencia en el Foro Global de Bioética en Investigación. Desafíos para la revisión ética en Chile. Rev Med Chile. 2018:146. ID - ref10 ER - TY - STD TI - Saenz C et al La ética de los diseños y métodos alternativos de ensayos clínicos. Una reflexión sobre el Foro Global de Bioética en Investigación del 2017. Rev Panam Salud Publica. 2018 January; 42. doi:10.26633/RPSP.2018.38. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5881927/pdf/nihms952062.pdf. Accessed 20 June 2018. UR - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5881927/pdf/nihms952062.pdf ID - ref11 ER -