Preparatory to Research

Access to Health Information in Order to Prepare a Research Proposal

Investigators who are members of the covered workforce (BMC, BU Dental Clinic, BU Dental Health Plan, BU Dental Pathology Lab, BU Human Genetics Lab), may gain access to protected health information in order to prepare a research application or protocol and/or identify subjects who are eligible for a study. Investigators may not remove protected health information from the BU/BMC covered entity or any of the covered entity’s data sources, including medical records and information technology databases.

To access protected health information for these purposes, the researcher must:

  • Indicate that the use of the health information will be limited to the preparation of a research protocol or similar purpose,
  • Agree not to remove any protected health information from the covered entity,
  • Ensure that the protected health information being requested is necessary for the research purpose.

Investigators from other institutions who are not part of the BMC workforce and are working with research teams at BMC may not take protected health information from BMC. A researcher who is not a part of the covered entity may not use the Prepatory to Research provision to contact prospective research subjects.

If an investigator intends to use the Prepatory to Research form to identify eligible subjects, before contacting the subject the investigator must:
 

 

  • Contact the Primary Care Physician about the study and potential enrollment of each eligible subject
  • Obtain approval of the study from the BU Institutional Review Board (IRB)
  • Use an acceptable HIPAA Authorization form along with IRB required consent forms to enroll subjects

The completed Preparatory to Research Form should be sent to the Research Privacy Advocate in the Office of the Institutional Review Board where it will be reviewed. The investigator will receive an accepted, signed copy from the Research Privacy Advocate that can be given to the “covered entities” that are holding the needed protected health information.

An additional important point: Investigators who receive health information under Preparatory to Research and disclose any of that information to other investigators, institutions, or agencies, the investigator is responsible for keeping an accounting of disclosures. Under HIPAA, subjects can request a record of how often their health information was released to others in the previous six (6) year period. For health information obtained under a Preparatory to Research, it is the investigator’s responsibility to provide this record of disclosures.

Minimum Necessary applies: When using or disclosing protected health information(PHI) or when requesting protected health information from another covered entitiy, a covered entity must make reasonable efforts to limit PHI to the minimum necessary to accomplish the intended purpose of the use, disclosure, or request.

To acquire health information from BMC for research purposes, present your approved request form to: Ellen Jamieson, Grants Administration, Gambro 2, 617-414-5646. She will direct you to the source of information you need.

 


 

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July 29, 2012
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