IRB Waiver – Consent and/or Authorization

SP Code:	Date:

Title:

Describe in detail the specific activity for which a waiver is sought at this time:

Principal Investigator:

Routing Location:	Phone:

Requesting waiver of informed consent and HIPAA Authorization

(Complete Sections 1 and 2)

Requesting waiver of informed consent only (Complete Section 1)

Requesting waiver of HIPAA Authorization only (Complete Section 2)

SECTION 1: Waiver of Informed Consent

The IRB is allowed to waive the requirement to obtain informed consent under several conditions. (Check the regulation applicable to your request and provide the required justification. Please note that informed consent cannot be waived for FDA-regulated clinical investigations of drugs, devices or biologics.)

46.116(c) (1) the research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and (2) the research could not practicably be carried out without the waiver or alteration;

If you checked 46.116(c)(1), explain why the research could not practicably be carried out without the waiver or alteration:

OR

46.116(d)(1) the research involves no more than minimal risk to the subjects; (2) the waiver will not adversely affect the rights and welfare of the subjects; (3) the research could not practicably be carried out without the waiver; and (4) whenever appropriate, the subjects will be provided with additional pertinent information after participation.

If you checked 46.116(d)(1), explain:

Why you feel the research involves no more than minimal risk to subjects

Why the waiver/alteration will not adversely affect the rights and welfare of subjects

Why is it not practicable (feasible) to conduct this research without the waiver or alteration

What (if any) additional pertinent information will subjects receive after participation

Section 2: Waiver of hipaa authorization

1.	Does this research involve the use of protected health information (PHI)?

Yes

No (skip to 3, below)

The Federal Privacy Rule allows the IRB to waive the authorization requirement for use of PHI (45 CFR 164.512 (i)(2)(ii)), provided that the IRB determines and documents that:

The use of PHI involves no more than minimal risk to privacy.

Describe your plan to protect the identifiers from improper use or disclosure:

b.	Describe your plan to destroy identifiers at the earliest opportunity or justify why you plan to retain identifiers:

The research could not practicably be conducted without the waiver.

Please explain, in detail, why this research could not be conducted without a waiver of the requirement to obtain authorization:

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

Describe the specific PHI to be used:

b.	Why is use of PHI necessary for this research?

Does this research involve the disclosure of protected health information (PHI)?

Yes

No (skip to Signature section, below)

The Federal Privacy Rule allows the IRB to waive authorization requirement for disclosure of PHI (45 CFR 164.512 (i)(2)(ii)) provided that the IRB determines and documents that:

The disclosure of PHI involves no more than minimal risk to privacy.

Describe your plan to protect the identifiers from improper use or disclosure:

b.	Describe your plan to destroy identifiers at the earliest opportunity or justify why you plan to retain identifiers:

B.	The research could not practicably be conducted without the waiver.

a.	Please explain, in detail, why this research could not be conducted without a waiver of the requirement to obtain authorization:

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

Describe the specific PHI to be disclosed.

b.	Why is disclosure of PHI necessary for this research?

Will Marshfield Clinic receive any direct or indirect remuneration, financial or non-financial, from, or on behalf of, the recipient of the PHI in exchange for the PHI?

No. Skip to Signature section, below.

Yes. Select the following that applies:

Remuneration is made pursuant to a grant or contract to perform the research, and the disclosure of PHI is a byproduct of services being performed by Marshfield Clinic for the recipient of the PHI under the grant or contract.

Remuneration does not exceed costs to prepare and transmit the data. Remuneration can include direct and indirect costs such as labor, material and supplies for generating, storing, retrieving and transmitting the PHI, labor and supplies to ensure PHI is disclosed in a permissible manner, and related capital and overhead, but it will include any profit.

Remuneration may exceed the costs to prepare and transmit the data, but the disclosure is being made pursuant to the public health authority exception under the HIPAA Privacy Rule.

I attest that protected health information described above is the minimum necessary and will not be reused or disclosed to any other person except as required by law, for authorized oversight of the research study described, or for other research for which the use or disclosure of protected health information would be permitted by the Privacy Rule.

I also attest that any request to waive authorization to disclose PHI does not constitute a sale of PHI.

SIGNATURE

_______________________________

Signature of Principal Investigator	Date

Printed Name of Principal Investigator	Routing Location

Printed Name of Person Completing Waiver	Routing Location

Submit completed paperwork to: Office of Research Integrity & Protections – 1R4

IRB Waiver – Consent and/or Authorization	Page 4 of 4

Version – April 1, 2013

PHI is Information that relates to the past, present, or future physical or mental health or condition of an individual (including the provision of health care to an individual or payment for the provision of health care) which identifies the individual or to which there is a reasonable basis to believe the information can be used to identify the individual. PHI includes demographic information.

To be considered PHI, information must contain one of the following HIPAA identifiers: name, DOB, dates of specimen collection or treatment, address, phone number, FAX number, MHN, SSN, email addresses, health plan ID numbers, account numbers, device identifiers and serial numbers, certificate or license numbers (including license plates), vehicle identification numbers, URL’s IP addresses, biometric identifiers, full face or comparable images, unique codes created from an individual’s identifiable information.

Dux, Barbara J

2013-03-15

Marshfield Clinic