Good Clinical Practice Guide
Results 1 to 3 of 3

Thread: Retrospective Consent for additional samples?

  1. #1
    Forum Member
    Join Date
    May 2016
    Posts
    3

    Retrospective Consent for additional samples?

    Hi, I'm looking for some information on retrospective consent for additional research samples. Say for example the main study consent has been signed but the patient has forgotten to sign the additional research consent form but an extra sample has been taken, is it possible to isolate this one sample until retrospective consent can be taken within a short time frame? Is it more ethical to do this or to destroy the sample and consent at the next visit and re-take the sample? I would love to hear everyone's thoughts on this. Thanks.

  2. #2
    Forum Member
    Join Date
    Nov 2011
    Posts
    121
    Some thoughts off the top of my head;
    A good question that I'm sure your Ethics Committee (IRB/IEC) would be happy to help with. Obviously retrospective consent is not desirable, so there are several questions you should ask yourself.
    Have you got an escalation process that raises these non-compliances? Do you have a process to analyse the route causes of these problems and put in place corrective and preventive plans to stop recurrence of similar problems in this site, at other sites, and in other trials (as required by the new draft ICH E6 R2 (step 2b))? How are you going to ensure that these potential problems are detected in future?

    Is this a significant violation of the subjects rights? The new Clinical Trials Regulation 536/2014 Article 52 (an EU law already, but not yet in application), a breach of GCP "likely to affect to a significant degree the safety and rights of the subjects...."? Once the CTR is applied, it would be necessary to report to the regulators (via the EU Portal) any Serious Breach of subjects rights, within 7 days. However the new Clinical Trials Regulation 536/2014 does protect data already collected - "the withdrawal of the informed consent shall not affect the activities already carried out and the use of data obtained based on informed consent before its withdrawal" (A28.3).

    We can see the sensitivity of the regulators from what they have written about the situation where consent no longer exists. Look at the MHRA paper on (2009) Guidance on the maintenance of regulatory compliance in laboratories that perform the analysis or evaluation of clinical trial samples - "all laboratory personnel that perform work in support of clinical trials must exercise due diligence to ensure that the work they have been contracted to conduct is covered by the consent given by the trial subjects" and "there should be a mechanism to ensure that the laboratory is informed in a timely manner if consent is withdrawn to ensure that no further data is generated or collected".
    This MHRA guidance might have been superseded by the EMA "Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples" (2012). Look at the section regarding withdraw of consent and analysing samples.

    Destroying sample is a sensitive situation and this would be a good question for your IRB/IEC as well as your organisations management.

  3. #3
    Forum Member
    Join Date
    May 2016
    Posts
    3
    Hello A123456

    Thank you for your feedback! We do of course have an escalation process in place and also ensure the isolation of the sample as to ensure it is not analysed before consent is obtained. I will have a look at those references and also will be contacting my IRB/IEC for more information.

    Thanks again.

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •