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APPROVAL REQUEST FORM: RESEARCH WITH HUMAN OR ANIMAL PARTICIPANTS STUDY INFORMATION Title of study: Date research will begin:Expected completion date:If proposal for external funding: Agency: Deadline: Department.

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How to fill out the Cornerstone University IRB Approval Request Form online

Filling out the Cornerstone University IRB Approval Request Form is essential for researchers seeking approval for studies involving human or animal participants. This guide offers clear and supportive steps to help users complete the form accurately and efficiently.

Follow the steps to complete the form successfully.

  1. Press the ‘Get Form’ button to access the Cornerstone University IRB Approval Request Form and open it in your document editor.
  2. Begin by entering the study information. Fill out the title of the study, the date research will commence, and the expected completion date. If applicable, include information about external funding, the agency involved, and the deadline for the funding proposal.
  3. In the Investigator(s) section, provide your name, department, phone number, email, and check the appropriate designation (student, faculty, or other). Include the date of your submission.
  4. For approval information, if you are a student or non-faculty staff, enter the name and contact details of your faculty adviser. If you are an external investigator, disclose whether your research has been approved by an external IRB.
  5. Complete the Research Information section. Indicate the type of research being conducted by marking the appropriate box for human or animal research. Write a project description, detailing each required aspect including purpose, participant recruitment, age range, and any special consideration categories.
  6. Address potential risks by marking whether any risk is involved in your research and describe any possible psychological, social, or physical risks to participants.
  7. Identify the potential benefits of your research to both participants and humankind. Ensure that any risks are outweighed by these benefits.
  8. Explain the consent process and clarify any involvement of deception during the research. Ensure you cover how informed consent will be obtained from participants.
  9. Detail security procedures, ensuring participant data is protected. Describe measures for anonymity and data storage, and specify how data will be destroyed after the study.
  10. If applicable, complete the animal research section by indicating compliance with necessary regulations and conditions for animal welfare.
  11. After completing all sections, remember to save your changes. You can download, print, or share your filled-out IRB Approval Request Form as needed.

Take the next step by completing your Cornerstone University IRB Approval Request Form online today.

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To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

IRB Application Consent documents (Consent Document(s), Assent Document(s), PHI documents (if applicable), Debriefing Statements (if applicable), etc.) Recruiting documents (e.g. advertisements/poster/flyers, scripts, emails, social media posts, letters, etc.)

All study-related documents must be submitted to the IRB for review. Any separate "donation" agreement is regarded to be part of the informed consent documentation, and must be in compliance with 21 CFR 50.

All proposals submitted for either expedited or full review must contain four primary sections: Purpose of investigation and procedures. Anticipated risk and potential benefits to participants. Steps taken to protect the participants.

Research Requiring Comprehensive IRB Review Risks to the subjects are minimal, and are reasonable in relation to anticipated benefits. The subject selection is equitable. Privacy and confidentiality are protected. Informed consent processes meet federal regulatory and U-M requirements.

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.

Apply for IRB Review Step 1: Determine if your project requires IRB approval. ... Step 2: Complete the Mandatory Online Certification for Researchers. ... Step 3: Complete the IRB Research Project Application. ... Step 4: Make adjustments as necessitated by IRB Review until approved.

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