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HUMAN SUBJECTS RESEARCH REVIEW FORM Application for

HUMAN SUBJECTS RESEARCH REVIEW FORM Application for 2025

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The document is a Human Subjects Research Review Form from Binghamton University's Human Subjects Research Review Office. It outlines the application process for expedited or full board reviews of research involving human subjects, detailing required information such as principal investigator details, project title, funding sources, participant demographics, recruitment techniques, risk assessment, informed consent procedures, and data protection measures. The form emphasizes compliance with ethical standards and federal regulations regarding human subjects research.

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What is the IRB for human subjects?

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.

Who submits an IRB application?

About the Submission Process: The PI must submit the initial application. A Primary Contact can be added at the time of submission. That person can complete many actions and be the main point of contact but cannot submit formal requests.

What is IRB approval for human subjects?

The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, exempt, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy.

What is the purpose of IRB application?

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.

What needs to be submitted to the IRB?

Submit all materials required for IRB review (e.g., intervention materials, investigator brochures for device or drugs, instruments, protocol, informed consent, information sheet, recruitment). Use the appropriate informed consent template (expedited and full board studies only).

What happens if you conduct research without IRB approval?

There are three (3) types of review paths for an IRB application: Full Board, Expedited, and Exempt. The review path is determined by: Level of risk to subjects associated with the project. The type of research being conducted (e.g., an educational intervention, a survey, an ethnographic observation, etc.)

What are the IRB requirements for approval?

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.

HUMAN SUBJECTS RESEARCH REVIEW FORM Application for 2025

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