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IDH1931 Research Guide

Guide for the ID1931 Course.

FIU's Office of Research Integrity

IRB Procedures

IRB TOPAZ Online Protocol Submissions: Instructions on submitting an online IRB application

IRB Investigator Manual: Procedures and policies for investigators

IRB SOP Manual: Standard Operating Procedures for the FIU IRB

IRB Non-Compliance SOP: Process for Allegations of IRB Non-Compliance

IRB SOP on MRI Research: IRB requirements for using the FIU MRI machine

Review Criteria

Determining if IRB Review is Needed: Types of studies that do not need IRB review

Types of IRB Review: Brief Overview of Exempt, Expedited, and Full Board Review

IRB Exempt Review: Explanation of Exempt Review and Categories

IRB Expedited Review: Explanation of Expedited Review and Categories

IRB Full Board Review: Explanation of Full Board Review Process

Human Subjects Decision Charts: Charts for determining the types of IRB review

Informed Consent

Informed Consent Information: Information on obtaining informed consent

Informed Consent Form Templates: Required FIU consent form templates

Data Security

Privacy Practices and HIPAA: Information on using medical records

Data Safety & Monitoring: Information on monitoring and protecting human subjects data

Data Management Security: Tips to help manage and secure human subjects data

Certificates of Confidentiality: Guidance on protecting sensitive information

Use of Social Security Numbers: Notification of Usage of Social Security Numbers

Safety & Monitoring

Adverse Event Reporting: Information on reporting events and incidents to the IRB

Protocol Deviation Reporting: Information on reporting protocol deviations to the IRB

Data Safety & Monitoring: Information on monitoring your research project

Florida Abuse Hotline Information: FAQs on reporting abuse or neglect to the DCF

QA/QI Program: Information on quality assurance and improvement

Clinical Trials

WIRB Submissions: Information on submitting protocols to Western IRB (WIRB)

An Introduction to Clinical Trials: Sponsored by the National Institutes of Health (NIH)

Learning about Clinical Trials: Sponsored by the National Cancer Institute/NIH

Listing of Clinical Trials: Sponsored by the National Institutes of Health (NIH)

FDA Guidance Documents:  Information on using drugs, biologics, and medical devices

Faculty Advisors

Student Agreement: An “optional” agreement template for advisors to use with their students

Other Useful Guidelines

Useful Acronyms: Acronyms on IRB-related subjects

Regulatory Resources: Helpful links to regulatory information

Miami-Dade County School Research: Guidance on submissions to the MDCPS RCC

Oral History Projects: Guidance to clarify the issue of oral history projects and the IRB

Ethnography Projects: Guidance to clarify the issue of ethnographic projects

Non-FIU Researchers: Procedures for external researchers to recruit on the FIU campus

International Research – International Compilation of Human Research Standards

FIU Research Integrity: Research Integrity provides assistance in the following areas of research compliance:

Human Subjects Protection:

Institutional Review Board (IRB) approval is required for research involving human subjects. There are two IRBs: a Social and Behavioral IRB (SB-IRB), chaired by Dr. Mary Jo Trepka, and a Health Sciences IRB (HS-IRB), chaired by Dr. Adriana Campa.

Animal Welfare Protection:

Institutional Animal Care and Use Committee (IACUC) approval is required for research, research training, experimentation, or biological testing (or for related purposes) involving animals. The Chair of the IACUC is Dr. Robert Lickliter.

Biosafety Protection:

Institutional Biosafety Committee (IBC) approval is required for research involving recombinant DNA (rDNA) or synthetic nucleic acid molecules. The Chair of the IBC is Dr. Kathleen Rein.

Dual Use of Research Concern (DURC):

Institutional Review Entity (IRE) approval is required for life sciences research involving one or more of the 15 agents or toxins listed in the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern.

Responsible Conduct of Research:

ORI provides training for the responsible conduct of research utilizing the CITI Online Training website to disseminate information to faculty, staff, and students. Continuing education workshops are also offered throughout the year.

Research Misconduct:

ORI has partnered with Convercent to provide an anonymous and confidential way for faculty, staff, and students to report allegations of research misconduct and other ethical concerns.

Ethical Panther Reporting Line: Convercent

Available Online: www.convercent.com/report

Toll free number: 844-312-5358