Guidance synthesis. Medical research for and with older people in Europe: Proposed ethical guidance for good clinical practice: Ethical considerations

Journal of Nutrition, Health and Aging

Volumn 17, Issue 7, 2013, Pages 625-627

  Diener, L ^a,b   Hugonot Diener, L ^a,c   Alvino, S ^a,d   Baeyens, J P ^a,e   Bone, M P ^a,f   Chirita, D ^a,g   Husson, J M ^a,h   Maman, M ^a,i   Piette, F ^a,j   Tinker, A ^a,k   Von Raison, F ^a,i  

^a European Forum for Good Clinical Practice Geriatric Medicine Working Party (EFGCP GMWP)   (Belgium)

^b REGATES   (France)

^c Paris Descartes University   (France)

^d SYNEOS HEALTH   (United States)

^e UNIVERSITY OF LUXEMBOURG   (Luxembourg)

^f CITY HOSPITALS SUNDERLAND NHS FOUNDATION TRUST   (United Kingdom)

^g GRÜNENTHAL GMBH   (Germany)

^h Novartis ^*

ⁱ NOVARTIS PHARMA AG   (Switzerland)

^j UNIVERSITÉ PARIS DESCARTES   (France)

^k KING'S COLLEGE LONDON   (United Kingdom)

more..

Author keywords

Clinical trials and research; consent; ethics; frailty; gerontology; guidance; inclusion; older people

Indexed keywords

AGED; ARTICLE; AUTHORITY; CLINICAL TRIAL (TOPIC); EUROPE; FACILITATION; GERIATRIC PATIENT; GOOD CLINICAL PRACTICE; HUMAN; INFORMED CONSENT; LEGAL ASPECT; MEDICAL ETHICS; MEDICAL RESEARCH; PATIENT GUIDANCE; PRIORITY JOURNAL; PROFESSIONAL STANDARD; VULNERABLE POPULATION;

ACCESS TO INFORMATION; ADVISORY COMMITTEES; AGED; CLINICAL TRIALS AS TOPIC; COMPREHENSION; DECISION MAKING; ETHICS COMMITTEES, RESEARCH; EUROPE; FRAIL ELDERLY; HUMANS; INFORMED CONSENT; MENTAL COMPETENCY; PATIENT SELECTION; PERSONAL AUTONOMY; RESEARCH DESIGN; TREATMENT OUTCOME; VULNERABLE POPULATIONS;

EID: 84888001117     PISSN: 12797707     EISSN: 17604788     Source Type: Journal    
DOI: 10.1007/s12603-013-0340-0     Document Type: Article

References (8)

1. UEMS-geriatric section (2008). The definition of a "geriatric patient" for use in clinical trials: www.uemsgeriatricmedicine.org/)
2. Report of CIOMS Working Group VI. WHO ed. (2005). Management of Safety Information from Clinical Trials.
3. Rodriguez Manas L., Féart C., Mann G. et al. Searching for an Operational Definition of Frailty: A Delphi Method Based Consensus Statement. The Frailty Operative Definition-Consensus Conference Project. J. of Gerontol. 2012. doi:10.1093/gerona/gls 119. Epub 2012 Apr 16.
4. Revised Questions and Answers on Clinical Trials (Notice to Applicants), Volume 10, April 2006, Chapt V.: 20-33
5. ICH Topic E 7 Studies in Support of Special Populations: Geriatrics, current Step. 24 June 1993 and questions and answers July 6, 2010.
6. Jeste DV, Palmer BW, Appelbaum PS, Golshan S, Glorioso D, Dunn LB, Kim K, Meeks T, Kraemer HC. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007; 64:966-974.
7. Duron E., Boulay M., Vidal JS, Al Bchiri J, Fraisse ML, Rigaud AS, Hugonot-Diener L. Capacity to consent to biomedical research's evaluation among older cognitively impaired patients. A study to validate of the University of California: Brief Assessment of Capacity to Consent questionnaire in French among older cognitively impaired patients. J. Nutr. Health Aging. 2013;17(4):385-389.doi:10.1007/s12603-012-0432-2.
8. Newcastle 85+ study: Collerton J. Biological, clinical and psychosocial factors associated with healthy ageing: study protocol. BMC geriatrics 2007, 7:14, doi: 101186/1471-2318-7-14.