Get the free Application for IRB Waiver of Authorization or Altered Authorization under the HIPAA...

This document facilitates submission and review for requests to use/disclose protected health information (PHI) under an IRB approved waiver or altered authorization.

How to fill out application for irb waiver

How to fill out Application for IRB Waiver of Authorization or Altered Authorization under the HIPAA Privacy Rule

1. Begin by gathering necessary information about your research project, including its objectives, methods, and potential impacts.
2. Identify the relevant IRB (Institutional Review Board) that will review your application.
3. Download the Application for IRB Waiver of Authorization or Altered Authorization form from the IRB's website or request it directly from them.
4. Fill out the application form, ensuring to detail how the research meets the criteria for a waiver or altered authorization under HIPAA.
5. Provide a clear explanation as to why the research cannot be conducted without the waiver or alteration.
6. Include information about data handling and confidentiality measures to protect participants' information.
7. Attach any additional documentation required by the IRB, such as consent forms or study protocols.
8. Review the completed application for accuracy and completeness.
9. Submit the application to the IRB, following any specific submission guidelines provided.
10. Await the IRB's review and respond to any inquiries or requests for additional information.

Who needs Application for IRB Waiver of Authorization or Altered Authorization under the HIPAA Privacy Rule?

1. Researchers conducting studies involving protected health information (PHI) who seek to bypass authorization requirements under HIPAA.
2. Institutional Review Boards (IRBs) responsible for ethical review of research studies involving human subjects.
3. Organizations that handle PHI in research and need to ensure compliance with HIPAA regulations while conducting studies.

People Also Ask about

What is the FDA waiver of documentation of consent?

For research that is FDA-regulated, a waiver of documentation of consent may be granted only: When the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside the research context.

What is a waiver or alteration of the requirements of informed consent an IRB?

This waiver applies in the special circumstances when the IRB determines that it is not necessary to obtain the participant's consent to conduct the research. The IRB may approve research where investigators leave out or alter elements of informed consent, provided the research meets all applicable regulations.

What is the IRB waiver of documentation of informed consent?

For some research projects, the IRB may approve a request to waive the documentation of informed consent. This means that the study team must provide a subject with the required consent information, but the study team is not required to obtain the subject's signature on the informed consent document.

Can the requirement for informed consent be waived?

An IRB may waive the requirement for informed consent under specific conditions. Paramount to this is the minimal risk to the research participants.

What is a waiver of HIPAA authorization?

An IRB can grant a Waiver of HIPAA Authorization to permit use and/or disclosure of PHI for research purposes, without obtaining authorization. An IRB may also approve an alteration of the requirements of written HIPAA Authorization provided the research meets the criteria for waiver or alteration (see info below).

What is the IRB waiver of consent?

For some research projects, the IRB may approve a request to waive the documentation of informed consent. This means that the study team must provide a subject with the required consent information, but the study team is not required to obtain the subject's signature on the informed consent document.

For pdfFiller’s FAQs

What is Application for IRB Waiver of Authorization or Altered Authorization under the HIPAA Privacy Rule?

The Application for IRB Waiver of Authorization or Altered Authorization under the HIPAA Privacy Rule is a request made to an Institutional Review Board (IRB) to waive the requirement for obtaining patient authorization for the use of protected health information (PHI) for research purposes.

Who is required to file Application for IRB Waiver of Authorization or Altered Authorization under the HIPAA Privacy Rule?

Researchers or institutions conducting studies that involve the use of PHI and wish to seek either a waiver or alteration of authorization are required to file this application.

How to fill out Application for IRB Waiver of Authorization or Altered Authorization under the HIPAA Privacy Rule?

To fill out the application, researchers must provide details about the research protocol, justification for the waiver or alteration, risks to privacy, and how the data will be protected, among other required information.

What is the purpose of Application for IRB Waiver of Authorization or Altered Authorization under the HIPAA Privacy Rule?

The purpose is to allow researchers to use PHI without obtaining individual authorizations, when certain conditions are met, in order to facilitate research while protecting participants' privacy.

What information must be reported on Application for IRB Waiver of Authorization or Altered Authorization under the HIPAA Privacy Rule?

Information required typically includes the study title, research objectives, description of the PHI to be used, justification for the waiver or alteration, plans for data protection, and a description of how the research fulfills the criteria set forth in the HIPAA Privacy Rule.