Message to All Deans, Faculty, and Instructors

RE: Human Subjects Research

Recently, some misperceptions have come to my attention about what constitutes human subjects research. I would like to clarify for all deans. faculty, and instructors what circumstances compel our faculty and instructors to obtain the approval of the USF system's Institutional Review Board (IRB). I ask each of you to inform your staff and students as its appropriate.

General information about the compliance process can be found on this USF St. Petersburg web site or on the USF system's Division of Research Integrity & compliance web site.

with respect to the IRB and human subjects research, I call your attention to the very helpful Quick Start Guide that Research Integrity & Compliance provides. According to this guide:

A study requires IRB oversight if it meets both of the following definitions: A. It is research and; B. It directly involves human subjects or private, identifiable information about or from human subjects (including biological samples, etc.).

Please refer to the Quick Start Guide for more information. In addition, the document Policies and Procedures on the Human Research protection Program (HRPP) is on the web. Please note that the human subjects research compliance pertains to all research. classroom activities such as interviews, surveys, etc., may be considered as human subjects research that is subject to IRB review and approval. Moreover, honors and graduate students planning a thesis in a social science, behavioral science, or educational fields should be aware that heir projects will likely require IRB oversight, and it is the responsibility of the student's thesis advisor and committee to ensure awareness of and compliance with the policies and procedures referred to above.

If you have questions about a proposed project, please contact either Various Menzel, Research Compliance Administrator, vmenzel@research.usf.edu, (813) 974-6433, or Anna Davis, Research Compliance Administrator, annadavis@research.usf.edu, (813) 974-5642.

This is an extremely important topic. Failure of our institution to comply with human subjects research policies could result in debarment of USF St. Petersburg and loss of all federal funding. Each of us has a responsibility to ensure compliance.

Christopher F. D'Elia, Ph.D.

Associate Vice Chancellor for Research and Graduate Studies

 

Research Compliance Programs

Research compliance is an essential element of the USF St. Petersburg research program.  USFSP provides direct support to principal investigators through staff in academic and administrative support offices.  Overall responsibilities for compliance falls to the USF Office of Research, Division of Research Compliance (DRC) located on the USF Tampa campus.

The following is a list of programs with a brief overview, the appropriate link to DSC, forms and templates and education and training opportunities. The links provide direct access to compliance support functions.

BioSafetyProgram

The program was established to reduce the risk of potential occupational exposure to bio hazardous materials (infectious agents, rDNA, biological toxins, and Select Agents/Toxins) in research and/or teaching environment and to prevent the release of bio hazardous materials into the environment. The Biosafety Program also provides administrative support for the Instructional Biosafety Committee (IBC). The IBC is responsible for overseeing the use of all infectious biological agents and recombinant DNA used in research and teaching activities on the USF campuses.

Forms and Template

Education and Training

 

Diving Safety Program

The purpose of this program is to ensure safe, effective diving practices; to educate researchers in new technological advances; and to provide support for the underwater researcher.

Forms and Templates

HIPAA Program

Ramifications of the Health Insurance Portability and Accountability Act of 1996. The HIPAA Privacy Rule sets forth the requirements for the use, disclosure, and security of protected health information (PHI) in research. Access this link, if you are not sure how to proceed. Information is provided on:

Recommended HIPAA Privacy Practices

Overview of USF Procedures for HIPAA in Research

Does HIPAA Apply to Social/Behavioral Research?

Forms and Templates

Education and Training

 

IACUC Comparative Medicine

The University affirms that respect for all forms of the life is an inherent characteristic of scientists who conduct research involving animals, that the respectful treatment, care and use of animals involved in research is an ethical and scientific necessity, and that the use of animals in research and teaching contributes to the advancement of knowledge and the acquisition of understanding.

Forms and Templates

Institutional Review Board

If new to human subject research and USF or are unsure about what to do next, this guide will help you to find your way through the IRB system.

Effective July 1, 2007, studies that are funded through grants or sponsors will be charged a fee for IRB review. For more information check out the IRB Fee Schedule online on this web page.

Forms and Templates:

IRB-01 Medical

IRB-02 Social/Behavioral

IRB Veterans Administration

Education and Training

Important: New IRB Forms

USF Radiation Safety Office

Use, handling, and disposal of radioisotopes.

Forms and Templates

Education and Training