Good Clinical Practice Guide
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Thread: Duration of informed consent after death

  1. #1
    Forum Member
    Join Date
    Dec 2011

    Duration of informed consent after death

    If a patient has consented to a trial and has given permission for researchers to review source medical records, is there anything to prevent researchers having access to the medical records after the patient's death?
    Many thanks for your input.

  2. #2
    Forum Member
    Join Date
    Nov 2011
    Would be interesting to rear what the inspectors say.

    I thought that the subjects rights to data privacy (GDPR) end upon death as GDPR only covers "natural persons" . Then other laws take over such as local laws about archiving and access to medical records of deceased persons but I don't know what these are. NHS might be able to help. Ethics Committees might have an opinion.

    NHS website says:- Can I access the medical records (health records) of someone who has died?
    If you want to see the health records of someone who has died, you can apply in writing to the record holder under the Access to Health Records Act (1990).
    Under the terms of the act, you will only be able to access the deceased's health records if you're either:
    a personal representative (the executor or administrator of the deceased person's estate)
    someone who has a claim resulting from the death (this could be a relative or another person)
    Only information directly relevant to a claim will be disclosed
    After a person has died, their GP health records will be passed to Primary Care Support England so they can be stored.

    To access their GP records, apply to the records manager in the relevant local area. The deceased person's GP can tell you who to contact.

    Alternatively, you can access a list of local services on the Primary Care Support England website, where you can also find information about any fees that may apply and an application form.
    GP records are generally retained for 10 years after the patient's death before they're destroyed.
    For hospital records, the record holder is the records manager at the hospital the person attended. Fees may apply for accessing these records".

    Application form is useful

    One of the sections is :-- C. I require the records for health purposes and have provided written details below.

    As the sponsor is required by law to document certain information (such as details of death in a SAE/SUSAR) then this might be a party which has a claim resulting from the subjects death; or require the records for health purposes . But I have no idea, just a hunch.

  3. #3
    Forum Member
    Join Date
    Nov 2011
    Interesting that after 10 years after death medical records are destroyed. As current GCP legislation requires 15 years retention (in the case of PLA trials) and in future it will be 25 years, it may be wise the plan ahead.

    Your Risk Assessment might show that for many trials there is a little risk to the data integrity of a small amount of data that may only be stored for 10 years after a subjects death. However for high mortality trials and/or trials where death is an outcome, there may be a very high risk. In this case serious consideration should be made to requiring (perhaps through contractual arrangements) the investigator/institution to apply and retain in the TMF/ISF, certified copies of the relevant parts of the medical records before destruction.

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