Waiver of Informed Consent Protocol

Use the "Waiver of Informed Consent" Protocol [formerly known as Third-Party Access to Existing Data or 3PA] if you propose to access existing data about individual persons that have been collected by others and which contain personal identifiers, such as names or phone numbers. The protocol still applies even if you do not intend to use or report the personal identifiers.

The protocol outline is designed to elicit the information needed for the CSUB Human Subjects Institutional Review Board [HSIRB] to evaluate requests for waiver of consent by individuals for use/disclosure of information about them for research purposes. The structure reflects the provisions of the federal Health Insurance Portability and Accountability Act [HIPAA] that regulates research access to protected health information. If the data requested contain protected health information, then the waiver documentation provided by the HSIRB will satisfy HIPAA requirements. However, at CSUB the same procedure is used to evaluate requests to waive informed consent for use/disclosure of any information for research purposes, such as scores on standardized tests in the educational setting.

Note: 

  1. Use of this procedure is limited. For a researcher to seek access to existing data collected by another entity, for example, a school or public agency providing services to the individuals whose data are requested. Waiver of informed consent will be granted only if the research participants are placed at no greater than minimal risk.
  2. All protocols submitted will undergo review by the HSIRB.
  3. If the individuals have consented that their data may be used for research purposes, then this request for waiver of informed consent is not needed. However, if individuals have only consented that their data may be used for purposes of program evaluation and/or providing of services, then this request for waiver of informed consent is needed.

The Waiver of Informed Consent request is submitted through the Cayuse HSRB Initial form and is processed by the GRaSP Office.  If you are a student, you will be asked in the form to identify your faculty research supervisor who will automatically receive an e-mail to review and certify the content of the form.

Please contact us if it is inconvenient for you to use these online materials or you have questions:

Isabel Sumaya (Research Ethics Review Coordinator) 661-654-2231 or isumaya@csub.edu

Gwen Parnell (Research Compliance Analyst) 661-654-6712 or gparnell@csub.edu

Marianne Wilson (Research Ethics Reviewer) mwilson52@csub.edu