The Juvenile Justice Professional's Guide to
Human Subjects Protection and the IRB Process
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Federalwide Assurance
Federalwide Assurance
IRB Membership
IRB Meetings
IRB Voting
IRB Research Review Process
Types of IRB Review
Issues Relevant to the IRB Review Process
Modificationof Amendment of the Research Project
Project Suspension or Termination
Re-certification of Research Project
Non-compliance with Human Subjects Regulations
Assurance and Educational Training


All Institutional Review Boards must be established and operated in accordance with the requirements of Federal regulations.

Juvenile justice professionals are responsible for complying with all IRB decisions, conditions, and requirements.

Institutional Review Boards are administered at the Federal level by the Office for Human Research Protections (OHRP), a division of the Department of Health and Human Services (HHS). The Common Rule requires that each institution engaged in human subjects research provide OHRP with a written assurance of its intention to comply with Common Rule policies. An OHRP Federalwide Assurance of Protection for Human Subjects includes the written policies and procedures established by the organization that ensure human subjects protections. IRBs are required to register with HHS.

A Federalwide Assurance (FWA) is effective for five years and must be renewed every 5 years, even if no changes have occurred. Any changes to the legal name of the institution, the IRB Research Administrator, or the Signatory Official require the institution to update its FWA within 90 days after the change occurs. Failure to update the information can result in restriction, suspension, or termination of the institution’s FWA for the protection of human subjects. Many institutions extend human subject protection regulations to non-Federally funded research projects. These organizations require IRB review of all research projects, regardless of the source of funding.

Most organizations that carry out research with human subjects have their own IRB to monitor internal research efforts. Some institutions have more than one IRB, either because of the structure of the institution or the kinds of human subjects research performed at the institution. However, an individual or an institution with no registered IRB (e.g. a juvenile court) may have human subjects research reviewed by an “outside” IRB. Federal regulations do not require any IRB to review research proposals beyond the auspices of the institution. When an IRB does conduct an “outside” review, the IRB written policies and procedures should authorize and describe the process. Written arrangements that individuals or non-IRB institutions have with the IRB must describe the IRB responsibilities for both initial and continuing review of human subjects research.

Each institution must appoint a qualified individual to have overall responsibility for the agency’s research and IRB oversight activities. This person, the Authorized Institutional Official, must have the legal authority to make decisions for the institution and to ensure that research oversight is effectively implemented. In many organizations, the Authorized Institutional Official has the responsibility of selecting the IRB Chair.

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