Bioequivalence and Bioavailability Forum • Re-consenting volunteers?

Re-consenting volunteers? [Off Topic]

posted by ElMaestro – Denmark, 2016-06-21 18:42 (3197 d 10:43 ago) – Posting: # 16433
Views: 38,146

Hi all,

I am not a native French speaker but I think I sometimes understand a little bit of written French.

(and I am not too hot on Google translate)

Does the inquest into the Bial/Biotrial incident suggest that the volunteers should perhaps, possibly, maybe have been asked to re-confirm their consent after the initial SAE in their dosing group? I have no idea legally, but I am not aware of any clear clause in ICH E6 or Eudralex etc. that would require it. I think the need to re-consent is solely a matter of interpretation and that is sometimes a dangerous tool is the hands of people who look over the shoulder with little regard to the present.

Did I get the document right about re-consent? I foresee a lot of trouble if CROs in the future need to preemptively re-consent study volunteers. In the absence of firm specfic written guidance it will be very difficult to decide when a re-consent is justified and necessary.
e.g.
-When any SAE's occur? If no, which then?
-When any AE occurs? A broken toenail? Headache? Absence of info from a volunteer who has retracted her/his consent without telling why? Someone being discontioued by an investigator? Etc.

Is there a French guideline or legal document specifically discussing re-consenting?

Thanks for any input. As they say in France: Muchas gracias.

—
Pass or fail!
ElMaestro

Complete thread:

Death in phase I cannabinoid? nobody 2016-01-15 16:49 [Off Topic]
- Death in phase I cannabinoid? Helmut 2016-01-15 17:25
  - Death in phase I cannabinoid? nobody 2016-01-15 17:45
    - Death in phase I cannabinoid? Helmut 2016-01-15 17:48
      - Death in phase I cannabinoid? nobody 2016-01-15 18:02
      - Structure Ohlbe 2016-01-18 13:42
        
        Structure nobody 2016-01-28 15:29
  - Death in phase I cannabinoid? Ohlbe 2016-01-18 09:58
    - Death in phase I cannabinoid? nobody 2016-01-18 15:07
- Protocol Ohlbe 2016-01-22 17:18
  - Protocol nobody 2016-01-23 18:37
    - Protocol Ohlbe 2016-01-28 12:16
      - Protocol ElMaestro 2016-01-28 15:07
        
        Protocol nobody 2016-01-28 15:40
        
        FIM / FIH Helmut 2016-01-28 17:10
        
        FIM / FIH nobody 2016-01-28 17:55
        
        There is something rotten in the state... nobody 2016-02-26 21:05
        
        Rotten or not rotten ? Ohlbe 2016-02-27 05:49
        
        Rotten or not rotten ? nobody 2016-02-27 10:56
        
        Rotten or not rotten ? Ohlbe 2016-02-27 14:00
        
        Rotten.. nobody 2016-04-25 17:21
        
        Blame game... nobody 2016-05-23 12:27
        
        FDA: "unique toxiciy" nobody 2016-08-15 16:38
      - Chronology - English version Ohlbe 2016-01-29 18:30
        
        Chronology - English version Helmut 2016-01-29 19:04
        
        Administrative inspection preliminary outcome Ohlbe 2016-02-04 23:30
- Re-consenting volunteers?ElMaestro 2016-06-21 16:42
  - Re-consenting volunteers? Ohlbe 2016-06-22 05:06
    - Re-consenting volunteers? nobody 2016-06-22 11:26
      - Re-consenting volunteers? Ohlbe 2016-06-23 04:51
        
        Re-consenting volunteers? ElMaestro 2016-06-23 08:23
        
        Re-consenting volunteers? nobody 2016-06-23 10:36
        OT: strike d_labes 2016-06-23 11:31
        
        OT: strike Helmut 2016-06-23 13:01
- Paper in the NEJM Ohlbe 2016-11-03 12:21
- Death in phase I cannabinoid? nobody 2017-06-09 10:01