Obtaining Consent More Efficiently

Obtaining Consent for a Clinical Trial

Anonymous asks about obtaining consent… 

Feb 19, 2012 12:55 PM

Hi Nadia, I am very grateful for such an amazing site. I am regularly reviewing your site to know more about CRA responsibilities. I have one question regarding the patient consent form, as per GCP can the patient sign the consent form in home and then doctor can sign the form?

The Lead CRA responds…

Feb 24, 2012 04:10 PM

I have written a Q&A response post to provide additional guidance on the consent process here (link). Your question is specifically, can a patient bring in a signed consent and then the doctor could counter-sign. I don’t think that the regulations prohibit this and I am aware that there is a trend for study sites to either let the patient take home a copy of the consent to think about and discuss with their family or to mail out a blank form in advance of an upcoming visit where the study will be offered. The investigator does have a responsibility to ensure that the subject has adequate time to ask questions and also that the consent process is a discussion, not just paperwork (GCP 4.8; 21 CFR part 50b & part 312.60).

If I were monitoring a site where the subjects have been instructed to sign the forms at home before the screening visit I would recommend to the PI that this process be revisited as it is not adequate.

Don’t forget to remind your sites that there is a requirement in 21 CFR 312.62(b) that “the case history for each individual shall document that informed consent was obtained prior to participation in the study.” So it doesn’t say that you have to consent at the clinic, but remember an ICF form is a document that supports that the consenting process took place appropriately and in accordance with the law and regulations.

To re-state, shortcuts to the consenting process are a really bad idea and I would recommend you train your sites to demonstrate greater vigilance and attention to the ICF process.

About The Author

The Lead CRA

Nadia started The Lead CRA blog in 2007. She is now lead author for ClinOps Toolkit. Nadia is currently working as a Clinical Program Manager at a small specialty pharmaceutical company in the San Francisco Bay Area. You can reach Nadia via email at [email protected] anytime.

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