Talking to the people that really matter about their participation in pandemic clinical research: A qualitative study in four European countries

Health Expectations

Volumn 21, Issue 1, 2018, Pages 387-395

  Gobat, Nina H ^a   Gal, Micaela ^a   Butler, Christopher C ^b   Webb, Steve A R ^c   Francis, Nicholas A ^a   Stanton, Helen ^a   Anthierens, Sibyl ^d   Bastiaens, Hilde ^d   Godycki ćwirko, Maciek ^e   Kowalczyk, Anna ^e   Pons Vigués, Mariona ^f   Pujol Ribera, Enriqueta ^f   Berenguera, Anna ^f   Watkins, Angela ^a   Sukumar, Prasanth ^g   Moore, Ronald G ^g   Hood, Kerenza ^a   Nichol, Alistair ^g  

^a CARDIFF UNIVERSITY   (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^d UNIVERSITY OF ANTWERP   (Belgium)

^e MEDICAL UNIVERSITY OF LODZ   (Poland)

^f Research Institute University Primary Care IDIAP Jordi Gol   (Spain)

^g UNIVERSITY COLLEGE DUBLIN   (Ireland)

Author keywords

epidemic; infectious disease outbreak; influenza; informed consent; pandemic; patient and public involvement

Indexed keywords

ADULT; AGED; COMMUNITY PARTICIPATION; EPIDEMIC; EUROPE; FEMALE; HUMAN; INFORMATION PROCESSING; INFORMED CONSENT; MALE; MEDICAL RESEARCH; MIDDLE AGED; PANDEMIC; PATIENT PARTICIPATION; QUALITATIVE RESEARCH;

ADULT; AGED; BIOMEDICAL RESEARCH; COMMUNITY PARTICIPATION; DISEASE OUTBREAKS; EUROPE; FEMALE; FOCUS GROUPS; HUMANS; INFORMED CONSENT; MALE; MIDDLE AGED; PANDEMICS; PATIENT PARTICIPATION; QUALITATIVE RESEARCH;

EID: 85030642690     PISSN: 13696513     EISSN: 13697625     Source Type: Journal    
DOI: 10.1111/hex.12634     Document Type: Article

References (27)

1. Commission on a Global Health Risk Framework for the Future. The Neglected Dimension of Global Security: A Framework to Counter Infectious Disease Crises. National Academies Press, USA, Commission on a Global Health Risk Framework for the Future; 2016.
2. Lurie N, Manolio T, Patterson AP, et al. Research as a part of public health emergency response. N Engl J Med. 2013;368:1251-1255.
3. Rojek AM, Horby PW. Modernising epidemic science: enabling patient-centred research during epidemics. BMC Med. 2016;14:212.
4. World Health Organisation. Guidance for Managing Ethical Issues in Infectious Disease Outbreaks. Geneva, Switzerland: WHO; 2016.
5. WHO. Guidance for managing ethical issues in infectious disease outbreaks. WHO Press, World Health Organisation Geneva, Switzerland, 2016; Available at http://apps.who.int/iris/handle/10665/250580.
6. United Nations Statistics Division. Composition of macro geographical (continental) regions, geographical sub-regions, and selected economic and other groupings. Secondary Composition of macro geographical (continental) regions, geographical sub-regions, and selected economic and other groupings 2016. http://unstats.un.org/unsd/methods/m49/m49regin.htm - europe.
7. Kitzinger J. Qualitative research: introducing focus groups. BMJ. 1995;311:299-302.
8. Kitzinger J. The methodology of focus groups: the importance of interaction between research participants. Sociol Health Illn. 1994;16:103-121.
9. European Medicines Agency. Guideline for Good Clinical Practice E6(R2). London, UK: EMA, 2016.
10. World Medical Association. WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. WHO Press, World Health Organisation Geneva, Switzerland: World Medical Association; 2013.
11. Ritchie J, Spencer L. Qualitative data analysis for applied policy research. In: Bryman A, ed. Analysing Qualitative Data, London, UK: Routledge, 1993:173-194.
12. Kahneman D. Thinking Fast and Slow. UK: Penguin Books; 2011.
13. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19:349-357.
14. Tuckett AG. Part II. Rigour in qualitative research: complexities and solutions. Nurse researcher. 2005;13:29-42.
15. Lidz CW, Appelbaum PS. The therapeutic misconception: problems and solutions. Med Care. 2002;40(9 Suppl):V55-V63.
16. Gabriel LE, Webb SA. Preparing ICUs for pandemics. Curr Opin Crit Care. 2013;19:467-473.
17. Berry SM, Connor JT, Lewis RJ. The platform trial: an efficient strategy for evaluating multiple treatments. JAMA. 2015;313:1619-1620.
18. Pullman D, Wang X. Adaptive designs, informed consent, and the ethics of research. Control Clin Trials. 2001;22:203-210.
19. van der Graaf R, Roes KC, van Delden JJ. Adaptive trials in clinical research: scientific and ethical issues to consider. JAMA. 2012;307:2379-2380.
20. Hey SP, Kimmelman J. Are outcome-adaptive allocation trials ethical? Clin Trials 2015;12:102-106.
21. Saxman SB. Ethical considerations for outcome-adaptive trial designs: a clinical researcher's perspective. Bioethics. 2015;29:59-65.
22. Lewis C, Clotworthy M, Hilton S, et al. Public views on the donation and use of human biological samples in biomedical research: a mixed methods study. BMJ Open 2013;3:e003056. https://doi.org/10.1136/bmjopen-2013-003056.
23. Christofides E, Dobson JA, Solomon M, et al. Heuristic decision-making about research participation in children with cystic fibrosis. Soc Sci Med. 1982;2016:32-40.
24. Kass N, Faden R, Fabi RE, et al. Alternative consent models for comparative effectiveness studies: views of patients from two institutions. AJOB Empirical Bioethics. 2016;7:92-105.
25. Pope C, Mays N. Reaching the parts other methods cannot reach: an introduction to qualitative methods in health and health services research. BMJ. 1995;311:42-45.
26. European Parliament and Council. Regulation (EU) No 536/2014 of the European Parliament and of the council. Official Journal of the European Union: European Union. 2014;L158:1-76.
27. Council for International Organisations of Medical Sciences. International Ethical Guidelines for Health-related Research Involving Humans. Geneva: World Health Organisation; 2016.