INVESTIGATOR HELP:

If a waiver or alteration of either the consent process or consent documentation is to be used, you must complete the section of the IRBWise application regarding Waiver of Consent and/or Authorization .

If a protocol is granted a “Waiver of Consent and/or Authorization” by the DOH IRB, and the study involves the disclosure of Protected Health Information (PHI), the Investigator must be prepared to provide the DOH Privacy Office the following information for any PHI disclosed outside DOH:

1. The date of the disclosure;

2. The name, title, and contact number of the DOH workforce member making the disclosure;

3. The name of the entity or person who received the protected patient information, and, if known, the address of such entity or person;

4. A brief description of the protected patient information disclosed; and

5. A brief statement of the purpose of the disclosure that reasonably describes the basis for the disclosure.

This mandate is pursuant to 45 CFR 164.528, which states that an individual has the right to request and receive an accounting from the covered entity (DOH) of all possible disclosures of their private health information that was permitted without the individual's authorization.

IRB POLICIES AND PROCEDURES:

IRB Policy 5.3 - Waiver of Informed Consent or Exception of Informed Consent for Emergency Research

It is the policy of the Department of Health (DOH) Institutional Review Board (IRB) to grant a waiver from informed consent for research or an exception from informed consent for qualifying emergency research in congruence with the Federal regulations and DOH IRB policies and procedures.

IRB Policy 5.6 - Waiver of Informed Consent or Exception of Informed Consent for Emergency Research

It is the policy of the DOH IRB to grant a waiver from informed consent for research or an exception from informed consent for qualifying emergency research in congruence with the Federal regulations and IRB policies and procedures.