It is the policy of the Committee for the Protection of Human Subjects, the Institutional Review Board of The University of Texas Health Science Center at Houston, that patient/subject initials are not forwarded to the study sponsor. This policy has been in place since at least 1991, and the enactment of HIPAA regulations has not changed that policy.
It is the contention of CPHS that the use of study code numbers is quite sufficient for documentation purposes. Adding the patient/subject initials to the case report forms, or any other forms, does not increase the quality or accuracy of the data being collected. So long as the investigator or study coordinator maintains a master list of names and study code numbers, a common and necessary practice, then records can be easily accessed in the event of data confirmation. The notation of initials adds nothing to this process.
Furthermore, one purpose of HIPAA is to maximize privacy by minimizing the amount of information disclosed about an individual. Names are considered identifiers and as initials are derived from names, they too are considered identifiers. Therefore to truly de-identify information that is forwarded to a study sponsor, initials must not be included.
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