Download - The Use of the General Consent in CHUV/UNIL
Plateforme de soutien à la recherche clinique
The Use of the General Consent in CHUV/UNIL
Vincent Mooser MD Charles Joye, PhD Chris>ne Currat PhD
Jeanne-‐Pascale Simon, lic. iur
SCTO mee>ng on General Consent Bern, January 28th, 2014
1. Harmonize existing biobanks and align them with the new Human Research Act (HRA) and its Ordinances
2. Establish a general consent for a prospective, systematic biobank designed to support research in genomic medicine (Lausanne Institutional Biobank), which shall be equally applicable for re-use of biological material, as well as genetic and health-related data
Objectives
1. Working group including • CHUV lawyer : Mme Jeanne-Pascale Simon • Biobank manager : Christine Currat PhD • Medical direction : Mirela Caci MD (also lawyer) • Consulting Lawyer : Me Charles Joye • + various experts
2. Start of work in 2011 à 2012
3. Alignment with the preliminary version of HRA, adjustment with amendments and final version of the HRA and Ordinances
Process
General consent for research Ins/tu/onal rules on crea/on,
management and use of biobanks
Documents delivered
BIL
General consent Dedicated team
Includes for full genome sequencing and future contact (social network)
Blood 9 ml
For DNA and plasma
Tissues LeV-‐over from pathology
Clinical data Minimal ques>onnaire
EMR
Formal approval from the local IRB 10/17/12
Design of the Lausanne Institutional Biobank (BIL)
BIL Website : www.chuv.biobanque.ch
1. Staff 1. Operational direction (recruitment unit and
laboratory) :1.5 FTE 2. Team of recruiters : 7.4 FTE 3. Team of specimen management : 2.6 FTE
2. Partners : IT, Medical, Nursing, Patients 3. Perimeter : inpatients admitted electively or
through emergency, outpatients
Opera>onal Aspects of Implementa>on of GC
Pa/ents recruited : n = 15’214
BIL : Recrutement au 5 février 2013 BIL : Recruitment on December 31st, 2014
07.01.2013 31.12.2014
Nb de
pa>
ents
No semaines
0
2000
4000
6000
8000
10000
12000
14000
16000
BIL : Recrutement au 5 février 2013 BIL : Participation Rate (Patients contacted by Dec 31st, 2014 : 20’317)
BIL : Recrutement au 5 février 2013 BIL : Participation Rate according to Site where Consent was Presented
n =786 n = 3765 n = 4959 n = 5613
%
Swiss Non-‐Swiss <40 40-‐49 50-‐59 60-‐69 70-‐79 >80 Male Female Catholic Protestant Other
Origin Age Gender Religion
0.1
OR (log) 1 10
BIL : Factors Associated with Par>cipa>on
Murielle Bochud and Cindy Roth, ms in prepara>on
Acceptance higher Refusal higher
n = 11’099
BIL : Recrutement au 5 février 2013 BIL : Proportion of Patients who Want to be Informed about Clinically Actionable Findings
n = 11’099
-‐ Approved by ethics commicee on Dec 15th, 2014 -‐ A model which will be used by SwissPednet
Latest development
A new brochure for pediatric popula/on
1. General consent established in CHUV : significant, multidisciplinary effort
2. Implementation : labor- and ressource intensive
3. High participation rate in a systematic hospital-based genomic research project
4. Large proportion of patients want to be informed about clinically actionable findings
5. Documents and expertise available for construction of Swiss Biobanking Platform.
Conclusions