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This document outlines the requirements for research activities involving human subjects under the Common Rule, including the need for Institutional Review Board (IRB) certification and assurance

How to fill out protection of human subjects

How to fill out Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption

1. Start by downloading the Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption form from the official website.
2. Enter the title of your research project at the top of the form.
3. Fill in your institution's information, including the name, address, and relevant contact details.
4. Provide your contact information as the principal investigator, including your name, email, and phone number.
5. Clearly describe the purpose and objectives of your research study in the designated section.
6. Indicate the type of research you are conducting and whether it involves human subjects.
7. Describe the methodologies and procedures you will use to protect the rights and welfare of human subjects.
8. Review the guidelines regarding exemptions and check the applicable exemption category if you believe your study qualifies.
9. Sign and date the form to certify the information provided is accurate and complete.
10. Submit the completed form to your institution’s Institutional Review Board (IRB) and keep a copy for your records.

Who needs Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption?

1. Researchers conducting studies that involve human subjects.
2. Institutions and organizations that facilitate research involving human participants.
3. Graduate and undergraduate students undertaking research projects as part of their academic programs.
4. Any personnel involved in research that may require ethical review and compliance with federal regulations.

People Also Ask about

How do I become IRB certified?

Fill out and submit a complete CIP® Exam Application, including a signed work verification form and a CV/resumé that clearly reflects responsibilities and experience in administering HRPP/IRB functions. Adhere to the Code of Ethics for Certified IRB Professionals in the CIP® Handbook.

What is the common rule for protection of human subjects?

The main elements of the Common Rule include: Requirements for assuring compliance by research institutions. Requirements for researchers' obtaining, waiving, and documenting informed consent. Requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping.

Who regulates institutional review boards?

An IRB must be registered before it can be designated under an OHRP-approved FWA. IRB registration becomes effective when reviewed and accepted by OHRP. The registration is effective for 3 years.

Who is responsible for IRB approval?

IRBs are enacted under federal regulation, specifically 45 CFR 46, and are regulated by the Office for Human Research Protections (OHRP) within the U.S. Department of Health & Human Services (HHS).

What is protection of human subjects exemption 4?

Code X4 — Exemption category 4 — secondary research involves the collection or study of identifiable private information or biospecimens, if the sources are publicly available, the information is recorded so subjects cannot be identified, the information collection and analysis is regulated under HIPAA, or the research is

What is required for the IRB approval of human subjects research?

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.

Who certifies IRBs?

The CIP program is overseen by the Council for Certification of IRB Professionals (CCIP), which is composed of individuals representing diverse IRBs (social science, behavioral, biomedical, institutional, independent, etc.) across the United States.

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What is Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption?

It is a formal declaration required by the U.S. Department of Health and Human Services (HHS) which assures that research involving human subjects is conducted in accordance with ethical standards and regulations. This certification indicates that an Institutional Review Board (IRB) has reviewed the research proposal and deemed it acceptable.

Who is required to file Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption?

Researchers, institutions, or organizations that conduct studies involving human subjects are required to file this assurance. This includes academic institutions, hospitals, and any entities receiving federal funding for research.

How to fill out Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption?

To fill out the declaration, researchers must complete specific forms provided by the IRB, which generally include details about the research project, methodologies, informed consent processes, and any potential risks to subjects.

What is the purpose of Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption?

The purpose is to ensure that all research involving human subjects is conducted ethically, safeguarding the rights and welfare of participants, and complying with federal regulations.

What information must be reported on Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption?

The information typically required includes the title of the study, a description of research methods, details about human subjects, informed consent procedures, potential risks, and how subjects' rights and privacy will be protected.