Get the free IRB COVER SHEET (revised 8/19/05) - irb pitt

This document serves as a cover sheet for submissions to the Institutional Review Board (IRB) including information on the study's purpose, investigators, level of risk, recruitment details, sources

How to fill out irb cover sheet revised

How to fill out IRB COVER SHEET (revised 8/19/05)

1. Gather all necessary information regarding your research study.
2. Download the IRB COVER SHEET (revised 8/19/05) form from the appropriate website.
3. Fill in the title of the research project at the top of the form.
4. Provide the names of all principal investigators and co-investigators.
5. Indicate the department and institution associated with the study.
6. Select the type of review that applies to your study: exempt, expedited, or full board.
7. Complete the section regarding funding sources or sponsorship of the research.
8. Describe the purpose of the research in a concise manner.
9. List the anticipated risks and benefits to participants.
10. Sign and date the cover sheet, ensuring all required signatures are obtained.
11. Submit the completed IRB COVER SHEET along with your research proposal to the IRB office.

Who needs IRB COVER SHEET (revised 8/19/05)?

1. Researchers conducting studies involving human subjects.
2. Academics seeking approval for their research projects.
3. Students engaged in thesis or dissertation research.
4. Anyone requiring ethical review to ensure compliance with institutional guidelines.

People Also Ask about

Can an IRB approved protocol be changed?

A principal investigator may not implement any changes to an approved study (including to the protocol or informed consent document) without prior IRB review and approval, unless the change is necessary to eliminate apparent immediate hazards to the subjects.

Which of the following reviews is required for a research study that may cause minimal risk to study participants?

Expedited Review. Expedited review studies are typically assessed by a small number of IRB reviewers. Expedited review is appropriate for studies that, ing to 45 CFR 46.110 and 21 CFR 56.110: Involve no greater than minimal risk AND.

How often does the IRB review ongoing research studies?

Ongoing research studies must be reviewed by the IRB at least annually, or more often if the IRB finds that the degree of risk to subjects warrants more frequent review.

What documents would an IRB need to approve?

What documents do you need for your IRB application? CITI training. Confidentiality agreements. Consent. Data collection instruments. Data use agreements. Eligibility criteria. Online surveys and questionnaires. Parental permission and minor assent.

What is the continuing IRB review required for?

Continuing review provides the IRB with an opportunity to determine whether there is any new information that should be considered to represent such a significant new finding and therefore be communicated to subjects who have already enrolled in the research (e.g., important new toxicity information or new adverse

How often does IRB-approved research have to be reviewed?

The Approval Period Research that is FDA regulated or greater than minimal risk must be reviewed at least annually. The IRB can require more frequent review based upon the nature of the research and the IRB's experience with the individual investigator.

Do IRBs have to review every study?

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

How long are IRB approvals good for?

Most IRB approvals expire one year from the date of approval (exceptions may occur). However, some research may be considered EXEMPT from continuing IRB review and will not be required to submit a scheduled continuation review (renewal) application on an annual basis.

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What is IRB COVER SHEET (revised 8/19/05)?

The IRB COVER SHEET is a form used by researchers to provide essential information about their research project involving human subjects, allowing the Institutional Review Board (IRB) to assess the ethical implications and ensure compliance with regulations.

Who is required to file IRB COVER SHEET (revised 8/19/05)?

Researchers conducting studies involving human subjects at institutions that require IRB review must file the IRB COVER SHEET.

How to fill out IRB COVER SHEET (revised 8/19/05)?

To fill out the IRB COVER SHEET, researchers must provide project details such as title, principal investigator information, funding sources, and a summary of the research methodology, including any potential risks to participants.

What is the purpose of IRB COVER SHEET (revised 8/19/05)?

The purpose of the IRB COVER SHEET is to streamline the review process by providing the IRB with a comprehensive overview of the research study, ensuring that ethical standards are met before the research begins.

What information must be reported on IRB COVER SHEET (revised 8/19/05)?

The IRB COVER SHEET must report information including the project title, investigator details, study objectives, methodology, participant demographics, consent procedures, and any funding or sponsorship information.