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