Sunday, May 07, 2006

IRB and patient privacy

Local IRB seems to become very picky nowadays. Recently, one of the local IRBs in New York insists that we can not collect patient's date of birth and initials concerning the patient's privacy. We responded to them that these are the industry standard. Then we tried to find the evidence to demonstrate that collecting the date of birth and initials are indeed the industry standard.

It turns out that some pharmaceutical companies (such as GSK) do not collect the patient initials. So collecting the patient's initials seems not to be an industry standard.

However, we will have to collect the date of birth in order to calculate the age accurately. I found some supporting document in ICH guidance.
In the following ICH guideline E2A (page 11), patients initials and age and/or date of birth are listed as items needed for SAE reporting.
Also under the ICH guideline E2B (page 17), it also says for patient identification information "The date of birth should be used if the precise birthday is known; otherwise the age should be used."