Investigator Resources

The following materials provide researchers with important information, instructions, and guidance about OHSP and IRB human research review and submission requirements. These materials are provided here for quick access and reference. However, authoritative materials and approved templates reside in RAMP IRB, and should be accessed there in preparation for any research submission.

• Was there an incident associated with your study? Many incidents (e.g., adverse events, breach of confidentiality, protocol deviations) require reporting to the IRB within business 5 days from when researchers become aware of the incident. Refer to page 3 on our HRP-214 - Reportable New Information form to see what incidents require reporting; refer also to the section, "What are my obligations after IRB approval?" in the Investigator Manual.

• Do FSU human subjects policies apply to your research? Click here or on the image for a larger, pdf copy. All activities in the dark grey area are subject to FSU human subjects policies; activities in the light grey area are also subject to the requirement for certification of IRB review and approval.

• Human Research Review Process. On this OHSP web page are provided more detailed descriptions about the process of OHSP and IRB review of human research, including when FSU researchers work with external institutions or independent collaborators.

• Investigator Manual (in revision). This manual provides researchers with guidance about applicable FSU human research-related policies and procedures, and lists researchers’ responsibilities. Still in effect, a revision is anticipated for publication in Summer 2021.
• Student-led Research. This OHSP web page provides instructions and guidance for FSU students that plan to conduct human research.

• Training & Education. A protocol writing workshop and several RAMP IRB training videos are available here.

• Templates & Required Forms. This page provides access to select and frequently used templates and forms, such as for protocols, consent forms and checklists/worksheets that researchers may reference to see what the OHSP and IRB look for when reviewing submitted studies.

• CITI Training Requirements. Use this OHSP web page to find out what human subjects training requirements apply to FSU researchers, and how to enroll in training.

• HRPP Toolkit. A description of collection of materials and documents that are available in RAMP IRB.

• Revised Common Rule. An overview of the changes in federal regulations that apply to human subjects research. Most changes resulted in reducing the IRB review burden upon the research community. Each federal agency that is a signatory to the revised Common Rule has its own specific regulation. The Common Rule is also referred to as the Federal Policy for the Protection of Human Subjects.

• Consent Process. A detailed explanation of the requirements for obtaining prospective subjects’ voluntary agreement to take part in human research.

• Research Data Security. An overview of some of the expectations for maintaining study subjects’ privacy and the confidentiality of their data, including links to relevant policies and standards.