University of Michigan Health System

University of Michigan Medical School

IRBMED Privacy Review Board

SUBMISSION INSTRUCTIONS

FORMS

GUIDANCE

BOARD INFORMATION

LINKS

QUESTIONS/HELP

 

To ensure use of the most current applications, templates, guidance, and forms, revisit this site and download afresh whenever preparing applications for submission.

Submission Instructions

1.      Review the Flow Chart to determine which form to file.

2.      Download needed forms.

3.      Complete Investigator supplied information.

4.      Sign form(s).

5.      Fax form(s) to the attention of the Privacy Board at 615-1622

OR

6.      Send original(s) via campus mail to:

Privacy Review Board

c/o IRBMED Office

517 W. William, Argus I

Ann Arbor, MI 48103-4943

 

Campus Zip 4943

Guidance

Flow Chart to determine if Privacy Board Approval is required

De-Identified Data Sets and Limited Data Sets

Board Information

Standard Operating Procedures (coming soon)

Privacy Board Charge

Forms

*  Certification for Research on Decedents’ Information

For research projects that involve only information of deceased individuals. 

*  Certification for Review Preparatory to Research

For permission to access PHI in order to:

*  Determine whether a research project is feasible (but not record PHI).

*  Design a research study (but not record PHI)

*  Record only name and contact information of potential subjects. (NOTE:  IRBMED must approve specific recruitment procedures prior to use of information gathered under this permission)

*  External Data Use Agreement

For permission to provide a Limited Data Set to an outside user (a non-University of Michigan person or entity)

*  Statement on Use of Limited Data Set for Research (Internal Data Use)

For permission to use a Limited Data Set within the University of Michigan “Covered Entity”

*  Application and Approval for Waiver of HIPAA Authorization

For a waiver of patient authorization to access PHI needed to conduct a research project (e.g. a project on which the IRBMED has granted an exemption. If IRBMED approval is needed for the project, the IRBMED can grant the waiver in its review—submission to the Privacy Board is not needed)

Helpful Links to Other Sites

UMHS HIPAA Information

IRBMED HIPAA website

HIPAA & Research Education Module

U.S. Office of Civil Right (Department of Health and Human Services)

 

             

QUESTIONS?

EMAIL: HIPAA and RESEARCH

General questions about the Privacy Board, mandatory education, education website, HIPAA processes or regulations click here.

 

 

Updated 3/19/04. Email with problems or concerns regarding this webpage.