Get the free IRB Authorization Agreement

This document outlines the agreement between two institutions regarding the reliance on the Western Institutional Review Board (WIRB) for review and oversight of human subjects research.

How to fill out irb authorization agreement

How to fill out IRB Authorization Agreement

1. Begin by reviewing the IRB Authorization Agreement template provided by your institution.
2. Fill in the names of the institutions involved at the top of the form.
3. Provide the names and contact information of the principal investigators for each institution.
4. Clearly outline the purpose of the research study.
5. Include a detailed description of the research activities, methodology, and any potential risks involved.
6. Specify the timeline for the research project.
7. Include information about funding sources and any financial disclosures.
8. Attach all necessary supporting documents, including consent forms and study protocols.
9. Ensure that all parties involved in the agreement review and sign the document.
10. Submit the completed agreement to the appropriate IRB for review and approval.

Who needs IRB Authorization Agreement?

1. Researchers conducting studies involving human subjects across collaborating institutions.
2. Institutions that need to share oversight of research activities with other entities.
3. Any organization that requires IRB approval but does not have their own IRB.

People Also Ask about

Is IRB approval a big deal?

Yes. The FDA regulations require IRB review and approval of regulated clinical investigations, whether or not the study involves institutionalized subjects.

What is an IRB agreement?

A Reliance Agreement (also called an IRB Authorization Agreement (IAA), Cooperative Agreement, or Memorandum of Understanding (MoU)) is a document signed by two or more institutions engaged in human subject's research that permit one or more institutions to cede review to or rely on another IRB.

What is the IRB authorization agreement's primary purpose?

An IRB Authorization Agreement (IAA) is a special agreement between two institutions who are engaged in human subjects research to establish the Single IRB reviewing. An IAA allows an institution with a Federalwide Assurance (FWA) to extend the applicability of its FWA to cover another institution.

What is an IRB authorization agreement?

An IRB Authorization Agreement (IAA) is a special agreement between two institutions who are engaged in human subjects research to establish the Single IRB reviewing. An IAA allows an institution with a Federalwide Assurance (FWA) to extend the applicability of its FWA to cover another institution.

What is an IRB approval letter?

The IRB approval letter lists the consent document(s) and other study documents that were approved with the submission. Please note, it does not list the study application. Investigators can obtain a list of these items by following the instructions listed below.

What is an IRB consent?

The IRB reviews the informed consent process to help to make sure that the study details are communicated in language that is readily understandable to the person who may volunteer to be a research subject. The informed consent process includes: Background information about why the study is being done.

What are the requirements for IRB approval?

Specific criteria used by the IRB to determine the approval period (e.g., the nature of the study and risks posed by the study; the degree of uncertainty regarding the risks involved; the vulnerability of the subject population; the experience of the investigator; the IRB's previous experience with the investigator and

What is institutional review board authorization?

The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, exempt, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy.

For pdfFiller’s FAQs

What is IRB Authorization Agreement?

An IRB Authorization Agreement is a formal contract between two or more institutions that outlines the responsibilities of each institution regarding the protection of human subjects in research. It allows one institution's Institutional Review Board (IRB) to rely on another's review and approval of research protocols.

Who is required to file IRB Authorization Agreement?

Institutions engaged in collaborative research involving human subjects, where one institution relies on the other's IRB for review and oversight, are required to file an IRB Authorization Agreement.

How to fill out IRB Authorization Agreement?

To fill out an IRB Authorization Agreement, institutions must include details such as the title of the research project, names of involved institutions, specific responsibilities of each party, and the terms of IRB reliance. Additionally, both parties must review and sign the document to indicate their agreement.

What is the purpose of IRB Authorization Agreement?

The purpose of an IRB Authorization Agreement is to streamline the IRB review process in multi-site research studies and to clearly delineate responsibilities to ensure compliance with ethical standards and regulatory requirements in the protection of human subjects.

What information must be reported on IRB Authorization Agreement?

The information that must be reported on an IRB Authorization Agreement includes details about the research study, the participating institutions, the specific roles and responsibilities of each institution, contact information for IRB officials, and the terms of the reliance agreement.