Key Investigator Resources

The Investigator Manual manual (in revision) provides researchers with guidance about applicable FSU human research-related policies and procedures, and lists researchers’ responsibilities. Still in effect, a revision is planned for release in 2022. Click on the Investigator Manual link in the left panel to learn more or to access the manual.

The Templates and Required Forms 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. Click on the Templates and Required Forms link in the left panel to learn more or to access these materials.

Before any human research may be approved by the IRB, individuals conducting the research (FSU faculty, staff, students or non-FSU collaborators) are required to complete or be current on (have completed the required initial or refresher within the last 3 years) the Collaborative Institutional Training Initiative (CITI) Human Subjects Research (HSR) training course. Important note: other CITI courses may not satisfy this requirement. Click on the CITI Training Requirements link in the left panel to learn more about what human subjects training requirements apply to FSU researchers, and detailed instructions about how to enroll in the required training.

On this page you will find a detailed explanation of the requirements for obtaining prospective research participants/human subjects’ voluntary agreement to take part in human research. Click on the Consent Process link in the left panel to learn more about the requirements for consent (including parental permission and child assent), including the specific information that must be included, different consent-type forms that may be used depending upon certain circumstances, and the limited conditions under which the legal requirement for consent or documentation (signed) consent may be waived or altered by the IRB.

This OHSP page provides general information about the National Institutes of Health (NIH) policy for promoting the management and sharing of scientific data generated from NIH-funded or conducted research. The policy establishes the requirements of submission of Data Management and Sharing Plans, and applies to FSU research funded or conducted by NIH that results in the generation of scientific data. Click on our NIH Data Management and Sharing link in the left panel to learn more and to access related resources.

On this OHSP web page are provided more detailed descriptions about the process of OHSP and IRB review of human research. Click on the Human Research Review link in the left panel to learn more about the human research review process, including IRB productivity and performance, a description of the different IRB review pathways for study submissions, or types of submissions or other reviews.

If your studies include working external institutions or independent collaborators, then on the Human Research Review page click on the "Other Types of Reviews" panel and scroll down to the "Single IRB (sIRB) and Other non-FSU Reviews" and "Independent Collaborators or Collaborators at External Institutions that lack a Federalwide Assurance" sections respectively, for additional information and instructions.

This OHSP page provides the human research community with an overview of some of the expectations for protecting research participants/human subjects’ privacy and maintaining the confidentiality of their data, including under the U.S. HIPAA Privacy Rule and the General Data Protection Regulation of the European Union. Click on the Confidentiality, Privacy and Information Security link in the left panel to learn more and access relevant policies and standards and related resources.

Because FSU and TMH (and other organizations such as the University of Florida, Capital Hospital, FAMU) are legally separate organizations, each must separately conform to and document their compliance with applicable federal human research protection laws and policies, including IRB review of separate or joint research activities. However, FSU and TMH will carefully work together and seek to avoid duplicate IRB review and take advantage of available regulatory flexibilities whenever possible. The FSU and TMH IRBs have mutually concurred to following certain processes, including administrative or "pre-IRB" review for determining when either FSU or TMH will perform IRB review, and which IRB will do so.

To learn more about FSU and TMH review requirements, including administrative or pre-IRB review, visit our Studies involving TMH web page or use the link on the left.

A researcher's CAMS ("Conflict Administration and Management System") submission (or lack thereof) may affect IRB review of a RAMP IRB submission, including a delay in IRB review if a CAMS status includes the following: Team Member(s) without Certifications, Awaiting Profile Update or Administrative Review. Delay may also result if a conflict of interest is not suitably disclosed to human research participants (human subjects) through the consent process. Refer to our FAQ #9 under Specific Questions for additional, detailed information about the affect upon IRB review of CAMS submissions and conflicts of interest. Visit this CAMS project web site to learn more about CAMS.

Many incidents arising during the course of research--or even long after research has been completed (e.g., protocol deviations; adverse events involving study participants such as hospitalization, injury or other harm; breach of confidential information; loss of biospecimens; awareness of abuse/neglect/misconduct) may require reporting to the IRB within business 5 days from when researchers become aware of the incident. For further information and brief instructions check out our related FAQ #7 under Specific Questions.

This OHSP web page provides resources for FSU students that plan to lead the conduct human research. Click on the Student-led Research link in the left panel to learn more and access a wide range of templates, FAQs, key tips, instructions, guidance and other information specifically tailored to human research activities that may be led by students.