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 .