HIPAA Related Forms and Documents

		Letter To Research Community 11/12/02
		Letter to Research Community 11/12/02 - Full Text
		HIPAA Authorization Form Addendum
		Revisions to Chapter 8 of IRB Reference Manual
		Office of Civil Rights HIPAA Privacy Rule
		UPMC Business Associate Agreement for Honest Broker (3/11/03)
		Application for Certification of Honest Broker Systems (2/28/03)
		HIPAA Authorization for Sharing Health Information (9/2/03)
	---	Request for Exempt Review - Medical Record Research (8/28/03)
		Guidance for Requests for Waiver of HIPAA Authorization and Federal Policy Informed Consent Requirements Associated with (1) Identification and Recruitment of Research Participants and (2) Conduct of Retrospective Research Studies Involving the Use of Medical Record Information (12/19/03)
		Model Request for Waiver of Informed Consent to Use Medical Record Information (PHI) to Identify Potential Research Subjects: Researcher Who Accesses and Uses Medical Record Information for the Purpose is Involved Directly in Providing Health Care to the Respective Patients. (12/19/03)
		Model Request for Waiver of the HIPAA Authorization Requirement for the Sharing of Contact Information (i.e., Linked to Study-Specific Health Information [subject's medical diagnosis or condition]) for the Purpose of Recruiting Potential Research Subjects (12/19/03)
		Model Request for a Waiver of the Requirements to Obtain HIPAA Authorization/Informed Consent to Access, Record, and Use Protected Health Information/ Patient Medical Record Information for a Retrospective Research Study: Investigator(s) Who Access and Use Such Information for Research are Involved Directly in Providing Health Care to the Respective Patients. (12/19/03)
		Sample Research Registry Protocol
		Sample Research Registry Informed Consent
HTML		HIPAA - Frequently Asked Questions

The Data Use Agreement is a contract between the Investigator and the covered entity (UPMC). It will need to be completed and accompany any IRB submission requesting use of a Limited Data Set.

The UPMC Honest Broker Certification Policy addresses Honest Broker requirements. As per UPMC HS policy, schools, departments, divisions and centers will need to establish Honest Broker systems/processes if individuals within these entities wish to conduct retrospective research using medical record information or use medical record information to identify potential research study participants. Also as per UPMC policies, the honest broker systems will need to be prior approved by the IRB and the Privacy Officer, UPMC. (Note: the IRB and Privacy Officer, UPMC, will not approve honest broker systems/processes established on an investigator-by-investigator or study-by-study basis.) An IRB application form for the approval and certification of honest broker systems/processes is currently under development and will be posted on this site as soon as it is completed.

The HIPAA Research Agreement for the Use of PHI Preparatory to Research will need to be completed by the involved investigators and provided to the UPMC medical record department if the investigators desire access to medical records for the review of PHI preparatory to research (i.e., limited to designing a study and/or determining the feasibility of completing a study) . Note that this agreement does not come to the IRB since it applies to review of PHI prior to the actual research.

DHHS: Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule (NIH Publication Number 03-5388)
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Revised May 5, 2005