Get the free IRB Expedited Review Application - phila

Complete this form if requesting expedited review for minor revisions, continuing review or other actions eligible for expedited review. The IRB reserves the right to refer requests for review by

How to fill out irb expedited review application

How to fill out IRB Expedited Review Application

1. Review the guidelines for expedited review to ensure eligibility.
2. Complete the cover page with your project's title and principal investigator information.
3. Provide a concise summary of the research project, including objectives and methodology.
4. Describe the population and recruitment methods, ensuring to highlight any vulnerable groups if applicable.
5. Detail the procedures for obtaining informed consent from participants.
6. Outline potential risks to participants and how these will be minimized.
7. Include information about data confidentiality and security measures.
8. Attach any relevant documents, such as consent forms and recruitment materials.
9. Submit the application along with any supplementary materials to the IRB by the specified deadline.

Who needs IRB Expedited Review Application?

1. Researchers conducting studies that involve minimal risk to participants.
2. Projects that fall under specific categories eligible for expedited review per federal regulations.
3. Organizations and institutions that require ethical review for research involving human subjects.

People Also Ask about

Who is responsible for submitting IRB protocols for review?

Investigators are responsible for submitting sufficient materials and information for the IRB to meet its regulatory obligations, and should follow the institutional policies and procedures for continuing IRB review of research that are required by HHS regulations at 45 CFR 46.103(b)(4) and referenced in the

When may a protocol be eligible for expedited review by the IRB?

In general, research may be considered for Expedited review if it involves no more than minimal risk*, does not include intentional deception, does not employ sensitive populations or topics, and includes appropriate consent procedures.

Who completes an expedited IRB review?

Research can be approved as “expedited” if it is no more than “minimal risk” and fits in one of the federally designated expedited review categories. Expedited reviews are conducted by a member of the IRB committee. They do not require a convened committee meeting.

Which study may qualify for an expedited institutional review board review?

If the proposed research presents no more than minimal risk, does not involve any vulnerable populations (i.e., children, prisoners, individuals with impaired decision-making capacity, and/or economically or educationally disadvantaged persons), and involves any of the following, it may qualify for Expedited Review.

What qualifies for an expedited IRB review?

Eligibility for Expedited Review a. Research that involves no more than minimal risk and which appears on the following list of expedited review categories authorized by 45 CFR 46.110 and 21 CFR 56.110. b. Minor changes in previously approved research during the period for which approval is authorized.

What are the requirements for expedited review?

In order to qualify for review via expedited procedures, the research must not be greater than minimal risk and fall into at least one of the expedited categories defined by the federal regulations.

What is an expedited review of the Institutional Review Board?

While the name of this review type implies a quick review, the term “expedited” has nothing to do with the speed of the review. Federal regulations allow certain types of applications to be reviewed by a single reviewer instead of a full committee, and the term for this type of review is “expedited”.

What is an example of an expedited review?

The following types of research are commonly processed under expedited review: Studies involving collection of hair or saliva samples. Studies of blood samples from healthy volunteers. Studies involving noninvasive and minimal risk FDA-approved medical devices (e.g., MRI, electrocardiography, ultrasound, etc.)

What is the difference between exempt and expedited IRB reviews?

Unlike exempt review, expedited review falls under the full protection of regulations and are reviewed administratively by the IRB Exempt/Expedited Team.

Who submits IRB application?

About the Submission Process: The PI must submit the initial application. A Primary Contact can be added at the time of submission. That person can complete many actions and be the main point of contact but cannot submit formal requests.

For pdfFiller’s FAQs

What is IRB Expedited Review Application?

The IRB Expedited Review Application is a simplified process for the Institutional Review Board (IRB) to review research studies that involve minimal risk to participants. This type of review allows certain types of research proposals to be approved without a full board meeting.

Who is required to file IRB Expedited Review Application?

Researchers conducting studies that qualify for expedited review due to minimal risk to participants are required to file the IRB Expedited Review Application.

How to fill out IRB Expedited Review Application?

To fill out the IRB Expedited Review Application, you should provide detailed information about your research study, including the study's purpose, methodology, participant criteria, procedures, and any potential risks or benefits to participants.

What is the purpose of IRB Expedited Review Application?

The purpose of the IRB Expedited Review Application is to facilitate a quicker approval process for studies that involve no more than minimal risk, ensuring that ethical standards are maintained while expediting research approval.

What information must be reported on IRB Expedited Review Application?

The IRB Expedited Review Application must report information such as the research study title, principal investigator details, study objectives, participant demographics, recruitment strategies, data collection methods, informed consent process, and a risk assessment.