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This document is a certification for research activities involving human subjects, ensuring compliance with the Common Rule and institutional review board (IRB) regulations.

How to fill out protection of human subjects

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

1. Obtain the Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption form.
2. Review the instructions provided with the form for clarity on each section.
3. Provide your institution's name and address in the appropriate section.
4. Fill in the Principal Investigator's name, contact information, and position.
5. Indicate whether the research involves human subjects and briefly describe the research project.
6. Review your institution’s policies on human subjects research and any additional documentation required.
7. Sign and date the form where indicated, indicating your agreement to comply with regulations.
8. Submit the completed form to the appropriate Institutional Review Board (IRB) or relevant authority.

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

1. Researchers conducting studies involving human participants.
2. Students undertaking research projects that engage human subjects.
3. Institutions receiving federal funding that mandates ethical review of studies.
4. Organizations seeking to ensure compliance with federal regulations on human subject research.

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 documentation process that ensures research involving human subjects complies with ethical and regulatory standards, ensuring the protection of participants' rights and welfare.

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

Researchers and institutions conducting studies involving human subjects are required to file this documentation, including universities, hospitals, and other entities engaged in research.

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

To fill out the documentation, one must provide specific details about the research proposal, including objectives, methods, participant recruitment strategies, and measures taken to protect participant confidentiality and safety.

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

The purpose is to ensure that research adheres to ethical principles and federal regulations, thus safeguarding the rights and welfare of human participants used in research activities.

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

Information required includes the researcher's name, study title, purpose, methodology, the number of participants, potential risks, benefits of the research, and plans for informed consent.