Institutional Review Board (IRB)

Broward College Institutional Review Board Policy and Procedure

College Policy 6Hx2-4.29
Procedure Manual A6Hx2-4.29

Any violation of the policy and or procedure will be reviewed by th​e IRB Committee and the College Provost and Senior Vice President for Academics and Student Success (or designee). The 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 is associated with unexpected serious harm to subjects (45 CFR 46.113). A suspension or termination of IRB approval of research may occur at any time during the period for which IRB approval had already been granted. At any time during the approval period, if further participation is deemed to not be in the best interest of the College, the College Provost and Senior Vice President for Academics and Student Success (or designee) may suspend or terminate the research and the researcher will be notified immediately. In all cases, the College will take the necessary action(s) to maintain the integrity of all research projects being conducted at and through Broward College to ensure that the rights and welfare of all research subjects, as well as the College, are sufficiently protected.

Studies involving more than minimal risk and/or a vulnerable population [“children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons” (HHS, para 1)].

Researchers wishing to conduct human subject research at Broward College must complete and submit an IRB Protocol Form. When completing the Protocol Form, researchers must select one of the three types of IRB review that they believe their study falls under. After selecting the type of review, researchers must complete Sections I-VI of the Protocol Form.

Protocol Form

The sections are as follows:

Section I General Study Information
Section II Study Summary and Rationale
Section III Study Design
Section IV Participants
Section V Risks and Benefits
Section VI Additional Documents

Once completed, researchers must sign and date the certification at the end of the Protocol Form. All researchers working on the study (primary investigators and co-investigators) must submit a certificate of completion to show they completed a human subject's protection training course. The National Institutes of Health (NIH) offers a free online course on protecting human research participants at http://phrp.nihtraining.com/users/login.php.

Researchers are required to submit a copy of an informed consent form for each study submitted for IRB review, in addition to a copy of their IRB approval letter from their graduate institution, if applicable. The Informed Consent Template below provides instructions and guidelines for creating an informed consent document.

Informed Consent Template

To assist researchers with submitting a complete proposal packet to the IRB, please use the Submission Checklist.

Submission Checklist

Completed IRB Protocol Forms should be submitted electronically with required and supporting documents as attachments to irb@broward.edu, in one communication. Please note the IRB reserves the right to request a hard copy of the Protocol Form and supporting documents, if deemed appropriate.

Federal regulation requires that any adverse events associated with participation in a research study be reported to the IRB. The Department of Health and Human Services (HHS) defines an adverse event as follows:

“Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research (modified from the definition of adverse events in the 1996 International Conference on Harmonization E-6 Guidelines for Good Clinical Practice).”

If an adverse event has occurred while conducting your study, you must submit an Adverse Event Form to the IRB, as soon as feasible at irb@broward.edu.

Adverse Event Report Form

For more information regarding reviewing and reporting unanticipated problems and adverse events see the HHS Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events at http://www.hhs.gov/ohrp/policy/advevntguid.html

Federal regulation requires the IRB to review any proposed changes to research protocols. Researchers wishing to make change s to their approved IRB protocols must first receive permission from the IRB. Researchers should complete and submit an Amendment Form to the IRB at irb@broward.edu prior to implementing any changes to their approved protocols.

Amendment Form

Federal regulation requires the IRB to conduct continuing review of approved research protocols set at a time interval appropriate to the level of risk associated with the research, but no less than annually. One month prior to the IRB approval expiration date, the researcher must submit a Continuing Review Form to the IRB. The IRB will notify the researcher in writing, 60 days prior to the approval expiration date, to inform the researcher that their study is subject to continuing review. If the researcher wishes to continue conducting the approved research, even if only coding or analyzing data, the researcher must complete a Continuing Review Form and submit it electronically to irb@broward.edu.

Continuing Review Form

The Continuing Review Form must be submitted one month prior to the IRB approval expiration date. The timely processing of the form will ensure that there is no lapse in IRB approval. No research may be conducted passed the expiration date unless the study has been reviewed and renewed by the IRB.

The completion or termination of a research protocol is a change in research activity that must be reported to the IRB. The closure of an approved research protocol means that no further research, data collection, follow-up, and coding of data or data analysis will be conducted. Even if a study is no longer enrolling subjects, it remains active until data analysis, write-up of research results, and manuscript preparation that requires the use of personally indefinable information is complete. Upon final completion of a research project, a Research Closure Form must be completed and submitted electronically to irb@broward.edu.

Research Closure Form

Records relating to approved research must be retained for a period of at least three years after the completion of the research project. All research materials, consent forms, questionnaires, data, etc. must be retained for at least three years and may be subject to review by the IRB, if deemed necessary. This information should be included within the IRB Protocol Form and all Informed Consent Forms.

We know there will be some questions and we are here to answer those for you.

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U.S. Department of Health & Human Services, Office for Human Research Protections

Code of Federal Regulations, Protection of Human Subjects (45 CFR 46)

National Institutes of Health (NIH) Protecting Human Research Participants course

The Belmont Report

Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events

Letters of support from Broward College for investigators who wish to obtain data from Broward College and are employed by Broward College (e.g., faculty, staff) while attending an external post-secondary institution, may be provided at the discretion of the IRB. Requests should be submitted electronically through irb@broward.edu using the Letter of Support Template below.

Please download the Letter of Support Template for guidance.