Certification of Waiver/Alteration of Patient Authorization

*Forms are subject to change. Check for the latest forms on the Tulane IRB web site. Certification of Waiver/Alteration of Patient Authorization

Tulane University Human Research Protection Program Certification of Waiver/Alteration of Patient Authorization For Research Purposes

On the day of , 20, a duly constituted quorum existed of Tulane University’s Institutional Review Board (“IRB”), whereupon a meeting was called to order to review the following research initiative:

Protocol Study #:

Name of the Test Drug/Investigational Product:

Name of Researcher:

Check all that apply:

The research pertains to living individuals: Yes No The research pertains to deceased individuals: Yes No The research pertains to preliminary research: Yes No

To the extent any item is checked off as “yes,” the corresponding section below has been fully satisfied.

Brief description of PHI necessary for research use/disclosure:

The IRB evaluated the proposal to determine whether the use and/or disclosure of individual protected health information (“PHI”) conforms with the legal requirements of section 164.512(i) of the Health Insurance Portability and Accountability Act. As is set forth in greater detail below, the IRB concluded that all legal requirements have been satisfied to eliminate the need for individual authorization of each study participant for the use and/or disclosure of PHI relevant to the research efforts.

A. Researcher Assurances Regarding Research Pertaining to Living Individuals: The Researcher provided adequate assurances to the IRB that: 1. The use and/or disclosure of PHI involves no more than minimal risk to the privacy of the study participants, based on, at least, the presence of the following criteria: (a) an adequate plan to protect the PHI from improper use and/or disclosure; (b) an adequate plan to destroy PHI at the earliest opportunity consistent with the conduct of the research, unless there is a health or research justification for retaining the PHI or such retention is otherwise required by law; and (c) the proposal provides adequate written assurances that the PHI will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use and/or disclosure of PHI is permitted by 164.512(i); 2. The research could not practicably be conducted without the need to waive or alter the requirement that each participant provide authorization for the use and/or disclosure of PHI for research purposes; and 1 Issued: 11/13/09 Last Reviewed: 11/13/09 Effective: 11/13/09 Last Revised: 11/13/09 Form #: 721 *Forms are subject to change. Check for the latest forms on the Tulane IRB web site. Certification of Waiver/Alteration of Patient Authorization

3. The research could not practicably be conducted without access to and use of PHI.

B. Researcher Assurances Regarding Research Pertaining to Decedents: In addition to the assurances listed above in Section A, the Researcher provided additional adequate assurances to the IRB that: 1. The use and/or disclosure of PHI is solely for research on the PHI of decedents; 2. The PHI for which use and/or disclosure is sought is necessary for the stated research purposes, all as outlined in the protocol submission to the IRB; and 3. Documentation would be provided to the IRB, at the request of the IRB, to substantiate the death of the research subjects.

C. Researcher Assurances Regarding Preliminary Research: The Researcher provided adequate assurances to the IRB that: 1. The use and/or disclosure of PHI is sought solely to review PHI to prepare a research protocol, or for other preparatory purposes in anticipation of and to facilitate future research; 2. No PHI will be removed from during the review; and 3. The PHI sought is necessary for research purposes.

I CERTIFY THAT THE ABOVE IS A TRUE AND CORRECT EXTRACT OF THE DULY REVIEWED, APPROVED AND AUTHORIZED MINUTES OF THE IRB FOR AND WILL BE RETAINED FOR AT LEAST SIX (6) YEARS FROM THE DATE OF APPROVAL

______Chairman, Institutional Review Board Date

2 Issued: 11/13/09 Last Reviewed: 11/13/09 Effective: 11/13/09 Last Revised: 11/13/09 Form #: 721