Data Collection using Preparatory to Research Provision 45 CFR 164.512
Guidance
This section of the Privacy rule allows researchers to use or disclose PHI to prepare for a research study without requiring an authorization or a waiver. This provision may be helpful in:
Designing a research study
Assessing the feasibility of doing a particular study
Conducting recruitment activities -in limited situations (e.g. the investigator may wish to obtain a list identifying a subclass of patients who are eligible for a study, (this may be obtained without waiver or authorization under the preparatory to research provision) the treating physician of the patient would then be contacted to discuss the study with their patient and provide contact information of the researcher to the patient. When the patient contacts the investigator an authorization would likely then be required to use and disclose information for the study.)
A written assurance of the following is required between the investigator and the covered entity (holder of the information to be accessed): See: Preparatory to Research Provision Assurance Form.
That the use or disclosure of the PHI is solely to prepare a research protocol or for similar purposes preparatory to research and
That the researcher will not remove any PHI from the covered entity
A researcher may not remove PHI from the covered entity’s site nor can a researcher who is not part of the covered entity contact prospective research subjects under the preparatory to research provision.
That the PHI sought is necessary for the research
Institutional policy regarding recruitment activity will continue to apply.
If you have any questions please contact the IRB Office:
Health Sciences IRB Office 882-3181
Campus IRB Office 882-9585
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