Get the free Institutional Review Board Application Packet - clevelandclinic

This document serves as an application for the review of research involving human subjects, including necessary forms such as the Human Subjects Review Application and additional reporting forms.

How to fill out institutional review board application

How to fill out Institutional Review Board Application Packet

1. Begin by downloading the Institutional Review Board (IRB) Application Packet from the designated institution's website.
2. Review the guidelines and instructions provided in the packet to understand the requirements.
3. Fill in the cover page with the project title, principal investigator's name, and contact information.
4. Provide a detailed description of the research project, including objectives, methods, and potential risks to participants.
5. Indicate the type of research (e.g., biomedical, behavioral, educational) and the target population.
6. Outline the recruitment process for participants and how informed consent will be obtained.
7. Include any supporting documents, such as surveys, interviews, or consent forms, as appendices.
8. Review the completed application for accuracy and completeness.
9. Submit the application packet to the appropriate IRB office for review.

Who needs Institutional Review Board Application Packet?

1. Researchers conducting studies that involve human participants.
2. Students completing thesis or dissertation research that requires data collection from individuals.
3. Organizations or institutions seeking to ensure ethical standards in research activities.
4. Healthcare professionals conducting clinical trials or other patient-related research.

People Also Ask about

What is the IRB checklist?

Checklists are used by the IRB staff and reviewers to document required IRB determinations. Investigators may consult the checklists to understand the regulatory requirements related to research, however, Investigators are not required to complete the checklists: HRP-410 - Waiver or Alteration of the Consent Process.

Is IRB approval hard to get?

If your study is more than minimal risk, it will be harder for you to get IRB approval. You will need to justify why you are running the study. Less common types of risk for psychology studies are social, physical, and financial.

How long does it take to get an IRB approval?

Under 45 CFR 46.103, the IRB must review and approve all non-exempt human subject research. Failure to obtain IRB approval before conducting research could result in the researcher being unable to use data and other information collected through the research process.

What 5 types of people must be present at an institutional review board?

Under the Common Rule, IRBs must have at least five members and include at least one scientist, one non-scientist, and “one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution”(§ 46.107(d)).

Is it difficult to get IRB approval?

If your study is more than minimal risk, it will be harder for you to get IRB approval. You will need to justify why you are running the study. Less common types of risk for psychology studies are social, physical, and financial.

For pdfFiller’s FAQs

What is Institutional Review Board Application Packet?

The Institutional Review Board Application Packet is a collection of documents and forms that researchers must complete to seek approval for research studies involving human subjects, ensuring that the study adheres to ethical standards and regulatory requirements.

Who is required to file Institutional Review Board Application Packet?

Researchers, faculty, or students planning to conduct studies involving human subjects within an institution are required to file the Institutional Review Board Application Packet.

How to fill out Institutional Review Board Application Packet?

To fill out the Institutional Review Board Application Packet, researchers must provide detailed information about the study design, methodology, potential risks to participants, informed consent processes, and safety measures to protect participant welfare.

What is the purpose of Institutional Review Board Application Packet?

The purpose of the Institutional Review Board Application Packet is to ensure the protection of human subjects in research by evaluating the ethical considerations, risk versus benefit analysis, and adherence to regulations before the research can commence.

What information must be reported on Institutional Review Board Application Packet?

The information that must be reported in the Institutional Review Board Application Packet includes the study title, objectives, methodology, participant recruitment processes, potential risks, informed consent details, and data protection measures.