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Thread: Sending copies of anonymised consent forms to sponsor

  1. #1

    Sending copies of anonymised consent forms to sponsor

    Hi,
    We are the sponsor of a multicentre, non-CTIMP, non commercial trial with little funding for monitoring. We would like to check the consent forms, and it has been proposed that sites anonymise these by blacking out the name and initials, write the participant number on the top, and request that sites send us a copy. After this the copies of the consent forms would be destroyed. i am interested to know whether others have done this and if considered acceptable?
    Many thanks

  2. #2
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    This question has already been answered on this forum in the monitoring section. As you can see the MHRA has given a responses recently but you will also see my response below.

    21st Apr 2016, 08:17 AM MHRA Moderator As stated in the MHRA GCP Guide, a formal system should be in place that complies with the Data Protection Act 1998 to ensure access to the confidential information is restricted and that the subjects of the clinical trial are aware that a sponsor or third party may have access to their data (as mentioned in the earlier MHRA post). Therefore, the process used to transfer the information following a subject’s consent should be considered and risk assessed to ensure that only the intended recipient receives the fax/email containing identifiable data.

    14th Jun 2013, 09:39 PM a123456
    I'm still not sure I understand the worth of such a risky process.
    Many GCP auditors and inspectors feel that reviewing wet ink signature consent forms has a lot of meaning and aids them in their job. None of them think that faxed copies, supplied by the investigator, provide anywhere near the same decree of worth. A faxed copy is much more open to obfuscation, particularly when supplied by the very people who may be responsible for its probity. If the rationale, for sending vast amounts of PII (Personally Identifiable Information) away from the investigator site, is to better assure the rights of the subject, then it may not be fulfilling this objective, if the faxed copies are not necessarily very reliable and there may be a greater risk to the subject's right of privacy and confidentiality.

    The MHRA has been providing guidance on risk based and proportionate alternatives to expensive on-site monitoring for low risk studies. In their GCP Guide (2012) they propose that other investigator sites could monitor each other. Hence research teams could validate each other's research work. Similarly, if the risk assessment allowed, a proportion of the wet ink signed & dated consent forms, could be reviewed by a person who was independent of the research team, but resident at the same institution. This would then validate the veracity of the recruitment/enrolment form process and hence provide some assurance as to the veracity of consent. This independent element would make deception by the research team much more difficult (certainly more difficult than them scanning the forms which they provide). Such review processes would be cheap in the extreme and may even be virtually free if alternative research teams build reciprocal monitoring and/or consent form review into their resources.

    Other alternatives such as electronic consent (with PII only held by the PI site) is one area that is being looked into.

    The risks of sending around consent forms with PII are so high, that there needs to be a water-tight rationale for this process and no viable alternates available. As there are alternates, it may be wise to ask if such risks are warranted given that the worth of the process may be viewed as low by many

    14th Jun 2013, 11:53 AM a123456
    The big question is why are copies of consent forms being sent to a coordinating centre?
    What is the coordinating centre doing with all this Personally Identifiable Information (PII)? How is the information used? If it is only used for project management logistics, is this a suitable use of sensitive personal information and all the attendant risks involved?
    Should alternatives be considered? For instance faxing or E-Mailing a recruitment/enrolment form that details that subject 12345 gave consent on date, time and whether they then qualified to be enrolled after subsequent screening, etc. This way no PII is transmitted, but project management information is available to the coordinating centre. In fact eCRFs or IVRS or IWRS are good systems to use to collect data on subjects status.
    Faxing documents that contain Personally Identifiable Information (PII) is a risky process. The fax may go to a wrong number and also not all fax machines are password protected such that only the authorised recipient has access to the output. If using fax technology it is always advisable to get verification of the safe receipt by the authorised recipient of all faxes.

    How are the faxes stored? Handling PII always includes the risk that there may be a violation of subject confidentiality. Suitable measures must be taken to ensure that PII is securely and confidentially maintained. How will they be archived in the long term or will these copies be confidentially destroyed? Long term storage of PII also includes long term risks that confidentiality could be violated at a later date.
    As copies are faxed it must be true that the originals are safely stored by the PI at the investigator site.

    11th Jun 2013, 03:16 PM #2 a123456
    With regard to the sponsor organisations having copies of subject consent forms there is a division of opinion.
    The MHRA in their GCP Guide (2012) have said that this is acceptable in special circumstances:- “When using central monitoring,... For example, when collecting signed consent forms, laboratory results with subject identifiers or collecting contact details for follow-up telephone calls/questionnaires, a formal system should be in place that complies with the Data Protection Act 1998 to ensure access to the confidential information is restricted and that the subjects of the clinical trial are aware that a sponsor or third party may have access to their data. This may be explicitly detailed in the subject information sheet or consent form approved by the... (REC)" MHRA GCP Guide (2012) Chapter 7; 7.5.3.2 & Fig 7.2 (& 7.6). You will notice that the MHRA do require that the REC application has this on it. You state that the REC application and monitoring plan does not have this process on it.


    In contrast EMA Volume 10 Chapter 5, 3.2.12 (& ICH E6 8.3.12) states that signed informed consent forms are only located at the investigator site, not the sponsor organisation. Elsewhere in the MHRA Guide it states that (10.2.1):- "it is essential to segregate those documents that are generated or held by the sponsor ... from those of the investigator, as some documentation held by the investigator should not be provided to the sponsor. .. For example, the sponsor must2,3not have documents such as consent forms and subject identification lists..” .. “ under certain circumstances subjects can specifically consent to this information being sent outside the investigator site, for example if required by the protocol or central monitoring procedures.”
    Elsewhere in the GCP guide it also states that diaries must5,6 be checked to remove personal identifiers before they are supplied to sponsors (8.2.7) and it quotes 2 UK regulations.
    The MHRA has previously been very sensitive about confidentiality; “... release of patient sensitive information outside of the research team is considered a critical issue” (06Jul2007). In fact the MHRA has often presented in their frequent inspection findings list, the finding of "subject details sent outside investor site". These frequent inspection findings may change in light of the MHRA GCP Guide proposal where it will only be a finding if details are sent to a sponsor organisation without explicit consent of the subject, data protection processes in place and REC application information.

    We do not know what other EU Inspectorates think of this MHRA proposal and what sponsor organisations should do if they are claiming compliance with ICH E6 or EMA Vol 10? To be cautious, it may be wise to follow the international guidance of ICH E6 and EU guidance of Volume 10.

  3. #3
    Hi
    Thanks for posting this response below. I am keen to hear specifically about anonymised ICFs (name completely removed), with the intention of destroying once checked (i.e. not to be stored by the sponsor). I have since found out that on another study, this method was approved by an ethics committee.
    The main things we would review on the consent form are as follows:
    -Confirming that the person delegated to receive consent is the person signing off the form and the signature matches the delegation log
    -Checking that dates are signed on the correct date
    -Checking the existence of the form
    - Being able to see any changes made post consent (eg to dates – were they changed later? Was the date the participant signed the same date as the clinician signature?)

    During monitoring we often see errors in consent, so it would be good to be able to check this.

    Thanks for the other ideas, which we will certainly consider as well, as certainly agree that sending over consent forms is best to be avoided. Eg a form to complete with tick boxes to check details of consent and send (though extra work for staff?). The other option of asking site staff from other studies to cross check and ‘self-monitor’ is also very useful, though we are not a large organisation and don’t always run more than one study at a site, so again asking other staff to do this may cause some challenges.

    Many thanks.

  4. #4
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    I'm not sure of the utility of this process.
    If all possible identifiable information is removed, it may cause a problem with the site carrying out this operations satisfactory. Second, the information provided is by the very people who gain the information in the first place. An independent element is always a great advantage (see previous). The two key questions you will be interested in are:- is there prospective written informed consent by this subject rather than any other subject?; has genuine written informed consent been correctly gained for each and every subject? These questions will be difficult to answer with your procedure and I'm not sure if the amount of work required by your procedure is worth the slight gains that you suggest. In fact a Risk Assessment of the whole consent process might be a good idea (see MHRA & EMA guidance on this). I still favour getting other individuals to check and report to the sponsor (as per MHRA GCP guide 2012). Other researchers (not just your researchers) are always happy to help because they are in the same boat. Also their institution often has a research office that can help. A Risk Proportionate process would be best and for that (depending what the Risk Assessment, the IEC states) and that would mean that perhaps (depending on acceptable risks) not all consent forms need checking.

    You say problems with consent have seen on monitoring. Then it will be important to launch a Corrective and Preventive Action plan to correct these problems. Obviously GCP training will be a key element.

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