FOI Reference: FOI/2021/3389
You asked
I have two requests for you at this stage,
Can you please provide me with the ethics committee for which this study was approved? I would like to get in touch with them to request their opinion on the information that I have received related to the errors that have been made.
I would be very grateful to your team if you can advise me of:
(1) The known number of instances where participants in the covid infection survey have been informed of a positive diagnosis in error
(2) The mean, minimum and maximum compensation to participants where these cases have occurred (this should include all compensation including vouchers or any other financial recompense). If it is possible, I would also appreciate the average and total number of days between receiving the diagnosis and being informed that it was false.
We said
Thank you for your request.
The Covid Infection Study (CIS) has been given approval by South Central -- Berkshire B Research Ethics Committee (20/SC/0195).
(1) To date, of the 7,417,004 swabs and 1,676,745 blood tests recorded across 3,899,661 households (267,826 unique households), there have been 130 results where a laboratory error has meant that a positive result has been shared with a participant. Of these, 129 were corrected to be negative and 1 to a Not Determined (Test Failure).
(2) We do not offer compensation to participants in relation to laboratory errors, however we have offered £100 in recognition of the impact this error has caused in seven cases.
As we have strived to deal with these lab errors as soon as we have been notified, of the 130 participants who have received positive results in error, the shortest time was 2 days and the longest was 9 days. The average time between the initial result and the communication of the correct result was 4 days.