Thank you for outlining so clearly the current basis for "deferred
consent" studies and suggesting good practice in dealing with the issues
it raises.
Unfortunately I believe that the current practice is the worst of possible
worlds: not only do we submit vulnerable subjects to interventions without
the expression of their/their parents' autonomy (ie consent), but also we
risk losing any data obtained because we retrospect...
Thank you for outlining so clearly the current basis for "deferred
consent" studies and suggesting good practice in dealing with the issues
it raises.
Unfortunately I believe that the current practice is the worst of possible
worlds: not only do we submit vulnerable subjects to interventions without
the expression of their/their parents' autonomy (ie consent), but also we
risk losing any data obtained because we retrospectively seek permission
to use their data. In other words we would have put the subject at
risk/burden with no gain.
Current rules of governance for research, based ultimately on the
declaration of Helsinki, are designed to protect the subject/society from
harm, understanding that ends do not justify means. There is no
possibility that the RECs and REC members of which I have experience would
approve a study where undue harm could result.
I believe that if an REC has approved such a study, this is an endorsement
of its relative safety and utility, and should automatically permit
inclusion of the data gathered. Retrospectively inform the
subject/parents, but do not seek permission for inclusion. If they go as
far as requesting withdrawal of the data, then that could be honored.
Thank you for outlining so clearly the current basis for "deferred consent" studies and suggesting good practice in dealing with the issues it raises. Unfortunately I believe that the current practice is the worst of possible worlds: not only do we submit vulnerable subjects to interventions without the expression of their/their parents' autonomy (ie consent), but also we risk losing any data obtained because we retrospect...
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