University of South Florida - click to return to home page
Search the USF Web site USF Site map USF home page Links for Prospective Students Links for Our Current Students Links for Visitors Links for Faculty & Staff Links for Alumni & Parents USF Campuses Links for Business & Community

Human Research Protection Program (HRPP)

Policies and Procedures

Table of Contents

100 - USF Human Research Protection Program (HRPP)

200 - Institutional Roles and Responsibilities

300 - Human Research Activities

400 - FDA-Regulated Research

500 - Veterans Administration-Regulated Research

600 - Informed Consent

700 - Investigator Roles and Responsibilities

800 - Institutional Review Board (IRB) Roles and Responsibilities

900 - HRPP Office

1000 - Research Participants


100 - USF Human Research Protections Program (HRPP)

101 - Statement of Principles: USF Human Research Protection Program – New!

102 - Ethical and Regulatory Mandate to Protect Human Research Participants – New!

103 - The Assurance and IRB Registration Process

104 - Florida State Laws and Regulations

[ Go To Top ]

200 - Institutional Roles and Responsibilities

201 - Institutional Responsibilities for IRB Administration – New!

202 - Human Research Protection Program (HRPP) Supporting Programs – New!

203 - Institutional Review Board (IRB) Membership – New!

204 - Expedited Review Process – New!

205 - Managing Conflict of Interest for IRB Reviewers – New!

206 - Non-Compliance in Human Research Activities – New!

207 - Relied-Upon IRBs – New!

208 - Reporting Concerns and Complaints – New!

209 - Scientific, Scholarly, and Departmental Review for Research Involving Human Participants – New!

210 - Statement of Policy Regarding Use of Human Participants in Research (#0-305) – New!

211 - Conflict of Commitment and Conflict of Interest, USF Health Sciences Center Policy on – New!

212 - Unanticipated Problems Involving Risks to Participants or Others – New!

213 - Reporting Events Determined Not to Be Serious or Continuing Non-Compliance or Unanticipated Problems Involving Risks

214 - IRB Reporting Policy: Unanticipated Problems Involving Risks to Participants or Others; Serious or Continuing Noncompliance; or Suspensions or Terminations of IRB Approval – New!

[ Go To Top ]

300 - Human Research Activities

301 - Human Research Activities – New!

303 - Exempt Human Research Activities – New!

304 - International Research – New!

305 - Research Involving Prisoners – New!

306 - Research Involving Childrren – New!

307 - Research Involving Deceased Persons – New!

308 - Research Involving Deception – New!

309 - Research Involving Decisionally Impaired Participants – New!

310 - Research Involving Pregnant Women, Human Fetuses, and Neonates – New!

311 - Single Case Reports

[ Go To Top ]

400 - FDA-Regulated Research

401 - Planned Emergency Research – New!

402 - Emergency Use of a Test Article in Human Research Activities – New!

403 - Use of Devices in Human Research Activities

404 - Use of Investigational Drugs and Biologics

[ Go To Top ]

500 - Veterans Administration-Regulated Research

501 - Veterans Administration (VA)-Regulated Research – New!

[ Go To Top ]

600 - Informed Consent

601 - Required Elements of Informed Consent – New!

602 - Obtaining and Documenting Informed Consent: General Principles – New!

603 - Obtaining and Documenting Informed Consent: Potentially Vulnerable Populations – New!

604 - Waiver or Alteration of Informed Consent – New!

[ Go To Top ]

700 - Investigator Roles and Responsibilities

701 - Investigator Responsibilities – New!

702 - Investigator Responsibilities: Initial Review

703 - Investigator Responsibilities: Continuing / Final Review

704 - Investigator Responsibilities: Information Reports

705 - Investigator Responsibilities: Modification Requests

706 - Investigator Responsibilities: Reporting Serious, Related Adverse or Unanticipated Events or Related Unanticipated Problems Involving Risks to Participants or Others

708 - Recruitment Advertising – New!

709 - Conducting Off-Site Research – New!

710 - Privacy and Confidentiality – New!

711 - Investigator Requirements for Human Research Protection Training – New!

[ Go To Top ]

800 - Institutional Review Board (IRB) Roles and Responsibilities

801 - Institutional Review Board (IRB) Roles and Authority – New!

802 - Ad Hoc and Continuing Consultants – New!

803 - Data and Safety Monitoring – New!

804 - Frequency of IRB Review – New!

805 - Federal Criteria for IRB Approval – New!

806 - Additional Conditions for Approval – New!

807 - IRB Review Responsibilities: Continuing Review – New!

808 - IRB Review Responsibilities: Information Reports

809 - IRB Review Responsibilities: Initial Review – New!

810 - IRB Review Responsibilities: Modification Requests – New!

811 - IRB and IRB Staff Review Responsibilities: Reported Unanticipated Problems Involving Risks to Participants and Others

812 - Legally Authorized Representative – New!

813 - Primary / Secondary Reviewer System – New!

814 - Suspension or Termination of IRB Approval of Research – New!

815 - IRB Review Responsibilities: Review of Non-Reportable Events

[ Go To Top ]

900 - HRPP Office

901 - IRB Administration

902 - Developing Policies and Procedures

903 - All IRB Support – New!

904 - Administrative Closures

905 - IRB Membership Roster – New!

906 - IRB Records Retention and Accessibility – New!

907 - IRB Staff Responsibilities: Continuing / Final Review

908 - IRB Staff Responsibilities: Information Report

909 - IRB Staff Responsibilities: Initial Review

910 - IRB Staff Responsibilities: Modification Requests

911 - IRB Staff Responsibilities: Reported Related, Serious, Unexpected Adverse or Unanticipated Events Involving Risks to Participants and Others

912 - Documentation of Convened IRB Meetings – New!

[ Go To Top ]

1000 - Research Participants

1001 - Participants' Rights and Responsibilities

1002 - Compensation for Injury

1003 - Payment to Research Participants – New!

[ Go To Top ]

Division of Research Integrity & Compliance
Mail: 12901 Bruce B. Downs Blvd, MDC35, Tampa, FL 33612-4799   Phone: (813) 974-5638  Fax: (813) 974-5618

Copyright © 2008, University of South Florida. All rights reserved.

Direct questions or comments about this Web site to jarnaldi@research.usf.edu  Last updated: July 1, 2008