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I was interested to hear if any other trials had come across a situation where consent forms have been lost at the investigator site? What would be the advisable course of action for this, as without consent forms in the Invetsigator File there is no real evidence other than the copy with the trial participant, to state consent has been given.
Any other examples and advice would be great to hear.
Many thanks,
Chris
Hi Chris
I have recently encountered such a situation and wondering if you received any response on the advisable course of action if this happens? Taking it a step further, what if the patient fails to provide a copy to the site as well (lost in error etc.) what would be the advisable course of action in this case?
Usually consent is documented in the patients notes as an evidence that the patient has consented to participate in the study. Is this evidence enough supplemented by a file note to explain what has happened? Just a suggestion.
Many thanks
Priyanka
The usual answer is that it depends.
If it is an isolated case of one consent form which is missing, there are several things that you should do, in compliance with the protocol, your SOPs , your deviations escalation policy and GCP. First establish the facts and the extent of the problem and document this assessment. The investigator should inform the sponsor/monitor and their local management. The subject may still be in the study or still visiting the centre and so a copy of his ICF can be taken. If this is also lost then it would be wise to get the subject to re-consent with a signed explanation of when he first consented. The Ethics Committee should also be informed. Then a Route Cause Analysis should be performed and a CAPA set up such that this error does not happen again. More monitoring and co-monitoring (& training) of the centre(s) will be required.
If the error is more widespread, then this may be a Serious Breach of GCP and need reporting. You may need to institute an audit to see how widespread this is. Follow your Serious Breaches and Protocol Deviation escalation policy. If the centre has lost a lot of ICFs, then consideration about closing the centre should be made.
The big problem is regarding the data, if you do not have a copy of the consent form or re-consent form. If you don't have evidence of the consent of the subject, then you cannot hold the data. A note by the investigator in the subjects medical notes, stating that consent was obtained, may not be sufficient, as there is no independent confirmation. On the other hand if there was independent confirmation then you have firmer ground. A risk assessment should be performed where the risk to the subject's rights (& confidentiality & privacy) and the integrity of the data are examined. The Ethics Committee may have an opinion about how best to safeguard the subject's rights. Before removing the data it would be a good idea to contact the MHRA.
If a signed informed consent form has been lost, consider contacting the participant to establish if they are able to resign the consent form or provide a copy of the consent form they initially retained. The approach taken to resolve the issue should be clearly documented and retained as part of the trial records. In addition, any relevant actions be prevent this issue from reoccurring should also be taken, for example, staff training or closer monitoring of consent processes, this will depend on what caused the issue.
If this issue affects several participants, and is classified as a serious breach (as per Regulation 29A, UKSI 2004/1031, as amended) then the MHRA GCP Inspectorate and Ethics Committee should be informed. In addition, the sponsor/CRO and investigator site procedures for addressing and escalating serious non-compliance should be followed.
If you are unable to obtain a copy of the consent form/reconsent the participant, then a decision will need to be made as to whether the participants data can be used. This should be reviewed on a case by case basis and the additional evidence available to support that consent did occur should be considered (for example, supporting entries in the participants notes, evidence that the informed consent form was reviewed by sponsor/CRO staff as part of monitoring processes). However, prior to any decision being taken regarding the use of this data, it is recommended that the ethics committee is consulted and their advice taken.