The purpose of an Institutional Review Board (IRB) is to ensure the protection of the rights, safety, and well-being of human subjects involved in research. This is accomplished by reviewing the proposed research protocols – including methods, tests, surveys, and informed consent/assent documents – and the continuing review of protocols once they are approved. Although regulations require IRB review and approval for research involving human subjects if funded or regulated by the federal government, most research institutions, professional organizations, and scholarly journals apply the same requirements to all research involving human subjects.

The IRB of The School Board of Broward County, Florida is registered with the U.S. Department of Health and Human Services' Office of Human Research Protections (OHRP):

• IRB Registration Number:                    IRB00005849
• Federalwide Assurance Number:       FWA00011214

This information may be accessed at http://ohrp.cit.nih.gov/search/irbsearch.aspx?styp=bsc. The Federalwide Assurance (FWA) is the only type of assurance currently accepted and approved by OHRP. Through the FWA, an institution commits to the Department of Health and Human Services that it will comply with the requirements for the protection of human subjects in the Code of Federal Regulations in Title 45 Part 46, also known as the Common Rule. BCPS IRB policies have been drafted in accordance with the Common Rule, which may be accessed at:
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101.

The Common Rule gives an IRB the authority to:

• Approve or deny research
• Modify research
• Conduct continuing reviews
• Observe/verify changes to approved research protocols
• Suspend or terminate research not being conducted in accordance with the IRB approved protocols or that has been associated with unexpected serious harm to subjects
• Observe the consent process and the research procedures

Principal Investigators and research teams that wish to conduct research through The School Board of Broward County, Florida must be familiar with, and abide by, all aspects of the Common Rule.

The Common Rule specifies different levels of review, including categories of research that:

• Are exempt from review
• Are eligible for Expedited Review
• Require Full Board Review

The final determination as to the appropriate level of IRB review for any research protocol is determined by the Chair of the BCPS IRB, and based on the federal criteria for exemption and Expedited Review. For research that may be exempt from review, refer to the Common Rule 46.101(b) at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101.

Expedited Reviews are conducted for research protocols that involve no more than minimal risk to human subjects. For research eligible for Expedited Review, refer to the Common Rule 46.110 at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101.

Research requests subject to Full Board Review are requests that are determined by the IRB Chair and Human Protections Administrator to have more than a minimal risk to participants. An IRB Committee has been established to review and vote on proposals subject to Full Board Review.

In addition to the IRB levels of review, the IRB and Research Review process is also designed to determine, whether the proposed research methods are compatible with a public school setting, if the research questions are of interest to the District, and the impact of the project on staff time and resources. Research Requests that fulfill all IRB requirements may be denied should reviewers find the impact on school operations, staff time and resources, and instructional time to outweigh the potential value of the findings to BCPS.

As stipulated in the Common Rule, the BCPS IRB is responsible for the continuing review of all projects that have been approved through the IRB Review process. As such, it is the responsibility of the Principal Investigator to:

1. Update any changes in the research protocol by submitting a completed Change Request to the IRB/Research Review Chair for review. Absolutely NO changes may be implemented before they have been approved except in the interests of the immediate safety of the subjects as stipulated by the Common Rule.
2. Submit a Renewal Request prior to the annual expiration date. Regardless of whether the approved research project is a single-year or multi-year study, the BCPS IRB and Research Review process only approves research for a period of one year. Research not completed within the timeframe specified in the protocol approved on the original Research Request will require re-approval by participating schools and staff.
3. Immediately notify BCPS IRB staff of any adverse events to subjects that occur as a result of their participation in the BCPS-approved research. Notification must include a completed Adverse Events form.
4. Submit an electronic copy of the final research report to BCPS IRB staff no later than four months after completion of the study.

The Common Rule (46.113) further stipulates that "An IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional official, and the department or agency head."

Failure to comply with the above reporting requirements:

• Will result in BCPS refusal to consider future proposals from the Principal Investigator.
• May result in the Department of Health and Humans Services' Office of Human Research Protection sanctions.

Most submissions to the IRB and Research Review process are subject to an Expedited Review. Research Requests subject to Full Board Review are requests that are determined by the IRB Chair and Human Protections Administrator to have more than a minimal risk to participants. An IRB Committee has been established to review and vote on proposals subject to Full Board Review. The District's IRB Committee members include the voting and alternate members identified below.

Full-Time Voting Members

Alternate Members

IRB Full Board Review meetings are scheduled on an as-needed basis. The Principal Investigator will be notified by email of the date of the meeting at which the protocol will be reviewed. The researcher is urged to be present for the meeting or available by telephone to answer questions that may arise.