University of South Florida
Human Research Protection Program (HRPP)
Guidance for Investigators
New to USF
We extend a warm welcome to investigators and research staff that are new to the University of South Florida (USF) Research Enterprise! USF is a leading public research university and is one of the fastest growing federally-funded institutions. We are glad you have joined the USF research community. Please contact the USF Human Research Protection Program (HRPP) for any questions you have or to discuss your proposed human subjects research. We encourage you to explore this guidance document and the HRPP website to review our policies, procedures and other guidance available http://www.research.usf.edu/cs/irb.htm or call us (813) 974-5638.
The USF Human Research Protection Program (HRPP)
The University of South Florida (USF) Human Research Protection Program (HRPP) supports the university’s dedication to excellence in teaching and research by promoting the ethical principles of respect for persons, beneficence, and justice. The HRPP is authorized by USF System Policy #0-305 to protect human subjects who participate in research. The HRPP has a Federalwide Assurance (FWA00001669) with the U.S. Department of Health and Human Services (DHHS), Office of Human Research Protection (OHRP) which commits the university to comply with the requirements set forth in the federal regulations for the protection of human subjects. The HRPP promotes the highest quality research and is accredited by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP).
The HRPP follows federal regulations which guide the establishment and function of the USF Institutional Review Boards (IRB) in the review and oversight of human subjects research. The IRB functions independently in the protection of human subjects and is structured to minimize undue influence. The HRPP has specific Policies, Standard Operating Procedures (SOPs), Guidance Documents, Tip Sheets, and education programs that direct investigators and the IRB in the ethical conduct of research and in the protection of the rights, safety, and welfare of human subjects. HRPP Policy 102 “Ethical and Regulatory Mandate to Protect Human Subjects” outlines the overarching requirements for the conduct of human subjects research. Additional HRPP policies and guidance documents are available via the website and in hardcopy as requested by members of the research enterprise. We invite investigators to visit the HRPP website for guidance and useful links that may assist you in the development of your research.
This document provides investigators with guidance on the requirements of the USF HRPP and submitting to the USF IRB when conducting research involving human subjects. General information regarding human research protections and relevant federal regulations is incorporated into the required training requirements for all investigators and research staff as outlined below.
The HRPP reviews and oversees both Biomedical and Social Behavioral Human Subjects Research. Definitions are provided below to assist in determining whether your project meets the requirements for IRB review and oversight. If you have specific questions regarding your study and/or the IRB processes, please contact an IRB Research Compliance Administrator (RCA) in the Division of Research Integrity & Compliance (DRIC) at (813) 974-5638 begin_of_the_skype_highlightingend_of_the_skype_highlighting.
Research Requiring IRB Oversight
You are responsible to not conduct Human Subjects Research without prior IRB review and approval. The HRPP defines research that requires IRB oversight and it is outlined specifically in HRPP Policy 301 “Human Subjects Research”. The guidance provided below, serves as an introduction for investigators but keep in mind that the IRB makes the ultimate determination in questionable cases as to whether an activity constitutes human research that is subject to IRB oversight. We encourage you to contact our office if you have questions regarding the need for IRB review.
Department of Health and Human Services (DHHS)
The information in this section is intended to assist Principal Investigators (PI) and research staff in understanding how the IRB determines the need for oversight of a research study. A study requires IRB oversight if it meets both of the following definitions:
1. It is research and
2. It directly involves human subjects or private, identifiable information about or from human subjects (including biological samples, etc.).
Step 1. Is It Research?
According to the Code of Federal Regulations, 45 CFR 46.102 (d), Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. Graduate students planning a thesis or dissertation in a social behavioral field will most likely require IRB review & oversight. Please contact an RCA to discuss your specific proposal.
Systematic investigation means an activity that may include:
· Collection of observational or qualitative data
· Collection of data using surveys, testing or evaluation procedures, interviews, or focus groups
· Collection of data using experimental designs such as clinical trials
· Some demonstration and service activities
A contribution to generalizable knowledge means public presentation of the study data through any of the following:
· Meetings, conferences, seminars, poster presentations, et al
· Publications, including journal articles, papers, dissertations, and master's theses and projects
Step 2. Are Human Subjects Involved?
According to the Code of Federal Regulations, 45 CFR 46.102 (f), a Human Subject is a living individual about whom an investigator (whether professional or student) conducting research obtains data through observation, intervention, or interaction with the individual; or obtains identifiable private information.
Observation includes:
· Counting the frequency or otherwise recording specific behaviors of humans; or
· Audio or video tape recording the subject’s behavior or interactions.
Intervention includes:
· Manipulations of the subject or the subject’s environment
· Applications of procedures or treatments, such as drugs, devices, or biologics; or
· Administration of psychological therapies or counseling to change behavior or promote well-being.
Interaction includes:
· Communication with the subject
· Interpersonal contact between the investigator and the subject
· Physical procedures to collect data, such as taking blood samples
Private information includes:
· Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual where the individual can reasonably expect will not be made public (e.g. a medical record).
· Specific information about the individual must be individually identifiable (e.g. the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
Food and Drug Administration (FDA)
According to the Code of Federal Regulations, 21 CFR 50.3(c) Clinical Investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration (FDA) under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of part 58 of this chapter, regarding nonclinical laboratory studies.
According to the Code of Federal Regulations, 21 CFR 50.3(e) Human Subject means an individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.
Veterans Affairs (VA)
According to the VA Handbook 1200.05, Section 3(g) expands the definition of Human Subject to include investigators, technicians, and other assisting investigators when they serve a “subject” role by being observed, manipulated, or sampled.
Department of Defense (DOD)
According to DOD Directive, 3216.02, defines an activity, for research purposes, where there is an intervention or interaction with a human being for the primary purpose of obtaining data regarding the effect of the intervention or interaction (32 CFR 219.102(f)). Examples of interventions or interactions include, but are not limited to, a physical procedure, a drug, a manipulation of the subject or subject's environment, the withholding of an intervention that would have been undertaken if not for the research purpose.
For research conducted or funded by the DOD, when there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction the data are considered to be about the living individual.
Department of Justice (DOJ), Bureau of Prisons
The provisions of 28 CFR 512 specify additional requirements for prospective researchers (both employees and non-employees) to obtain approval to conduct research within the Bureau of Prisons as outlined in HRPP Policy 301 “Human Subjects Research”.
Not Human Subjects Research (NHSR)
Certain research does not meet the definition of human subjects research and does not require the review and approval of the USF IRB. This includes research on individuals who are deceased, quality improvement studies, single case reports, and limited case series. However, some research projects may require a determination of NHSR by the USF IRB. While this type of research is not governed by federal regulations for the protection of human subjects (45 CFR Part 46), the IRB will review the proposed research to make the determination of NHSR if applicable. For additional guidance is outlined in USF HRPP Policy 312 “Not Human Subjects Research”. We encourage investigators with questions regarding NHSR and whether or not research should be submitted to the USF IRB for review to contact the IRB office for guidance.
Human Subjects Research Submissions to the USF IRB
Register for an account in eIRB
The USF IRB has an electronic submission system for submitting and processing IRB applications called eIRB. All USF faculty, staff, and students conducting human subjects research (at USF or off-site) must submit new applications through eIRB. To submit applications, you must first register for an account in eIRB at https://eirb.research.usf.edu. Employees of USF Affiliates (e.g. the Moffitt, JAHVH, TGH) should also register for an account in eIRB if you plan to conduct studies involving human subjects. The registration process includes an internal verification process that may take up to 48 hours to complete. You will be notified via email when your registration process is complete. For assistance with registration, please call the eIRB help desk at (813) 974- 2880 or .
Complete USF HRPP Education Requirements
All USF and USF Affiliate faculty, staff, and students who are involved in research projects involving human subjects must complete a USF IRB approved education program for human subjects protection. Investigators and research staff may complete the CITI program to meet this requirement www.citiprogram.org. Research staff can upload a copy of their certificates in eIRB when creating a new study. Effective January 1, 2010, the HRPP Human Subjects Education Certification requirement is valid for two years. Please refer to the HRPP Policy 711 “Mandatory Investigator Education Policy” for additional information regarding the USF HRPP education requirements.
Investigator Responsibilities
1. Investigator Responsibilities.
Investigators have certain responsibilities for the conduct and oversight of research involving human subjects. HRPP Policy 701 “Investigator Responsibilities” outlines these responsibilities. In addition, investigators must review and attest to the conduct and oversight of each study involving human subjects when applications are submitted to the USF IRB. As part of their attestation, investigators must certify that they have read each of the following documents and that they agree to conduct their research in accordance with these documents:
· The Belmont Report. This report is a summary of the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
· Federalwide Assurance - FWA00001669. This contract between USF and the federal Office of Human Research Protection (OHRP) of the Department of Health and Human Services (DHHS) assures that investigators conducting human subject research at USF will follow the federal regulations as outlined in 45 CFR 46 (Common Rule) and ethical principles outlined in the Belmont report.
The official listing of USF IRBs and rosters are located on the eIRB homepage under “General Information” https://eirb.research.usf.edu/Prod.
· The Code of Federal Regulations for the Protection of Human Subjects:
o Title 45, Part 46
o Title 21 CFR Part 50
o Title 21 CFR Part 56
o Title 38 CFR Part 16 - for VA Studies only
· USF HRPP Policies and Procedures
2. Login to eIRB and Complete an Application
Research staff proposing to recruit human subjects are required to submit an application to the IRB for review and approval prior to initiating each project.
Research staff login to eIRB using their secure user name and password. It is important that you do not share your user name and password with anyone. Your login serves as your electronic signature and it is against USF HRPP policies to share this information.
Research staff create a “New Study” and complete the applicable pages of the application and upload all appropriate supporting documentation (e.g., protocol, informed consent form, etc.). For assistance with eIRB, you may contact the eIRB Help Desk (813) 974-2880 or .
For questions regarding your individual research projects, you may contact an IRB Research Compliance Administrator (RCA) at the Division of Research Integrity & Compliance (DRIC) at (813) 974-5638. You may speak with an RCA who specializes in either Biomedical research or Social Behavioral research.
3. Upload a Current Curriculum Vitae (CV) or Resume in eIRB
This is a requirement for all research staff and does not need to be uploaded for each new study; however, a current CV or Resume must be maintained.
4. Research Staff May Begin a Study Only After Approval From the IRB.