Institutional Review Board (IRB) Human Subject Research Office (HSRO) University of Miami

1. Institutional Review Board (IRB) Human Subject Research Office (HSRO) University of Miami and Affiliated Institutions

2. Investigator Responsibilities Investigators have the primary responsibility for protecting the rights and welfare of human research subjects and are responsible for complying with all UM Institutional and UM IRB policies & procedures. www.hsro.miami.edu a) click “Policies and Procedures” b) click specific topic in “Table of Contents” hsro “help desk” at 305-243-3195

3. Federalwide Assurance (FWA)(Required for eligibility to receive federal funding for research) • The University of Miami has a Federalwide Assurance (FWA) approved by the Office of Human Research Protections (OHRP) in the Department of Health and Human Services (DHHS). • Through its FWA, the University has agreed to permit only human subject research that is appropriately reviewed and approved by the IRB in accordance with all regulations including those of Title 45, Part 46 of the Code of Federal Regulations. These requirements and principles apply to all human subject research conducted under the auspices of the University of Miami or affiliated institutions (for which UM has agreed to take on the responsibility as the IRB of record), regardless of funding source or support.

4. Principal Investigators and the Study Team • PI’s hold ultimate responsibility for the administrative, fiscal and scientific conduct of the research project. • All official IRB correspondence shall be addressed to the Principal Investigator. • PI’s must sign new study applications, continuing reports, amendments, reportable events and the required Assurance Statements. This signature commits the PI to having knowledge of, and to his/her compliance with the responsibilities of a Principal Investigator. • Signatures have meaning. This meaning is strictly interpreted by the IRB and the institution. • Study team members have the responsibility to work under PI supervision to conduct the study in strict adherence to, and with knowledge of, regulations, policies, the study protocol and IRB- imposed stipulations.

5. SPECIFIC PI RESPONSIBILITIES • Proper conduct of the study. Follow the approved protocol, maintain appropriate oversight of the research and appropriately delegate research responsibilities • Submit all required continuing and final study reports in a timely manner • Submit any reports, audits, or reviews of studies performed by outside agencies or a Data Safety Monitoring Board (or similar entities) to the HSRO within ten (10) working days of receipt by the Principal Investigator. 

6. PI Responsibilities - Changes • Ensure that no amendments/changes in the approved IRB application, study protocol or informed consent documents are implemented without prior IRB approval (except in an emergency, if necessary to safeguard the well-being of a human participant.  Note- the PI must report emergency changes to the IRB within ten [10] working days of such change) • Ensure no implementation of an exception to a protocol (even if that exception pertains only to one or a few participants) without prior IRB approval. 

7. PI Responsibilities - Personnel • Ensure that all key personnel have completed the UM CITI human subject training program, or an approved, equivalent program • Ensure orientation, education and other in-service training for non-research personnel involved in the research.   Examples of such non-research personnel may be hospital nurses or aides, clinical laboratory technicians, cardiology technicians, respiratory therapists etc. • Ensure that the study is conducted by personnel qualified by education, training and experience and that these personnel are informed of study-related changes as these occur

8. PI Responsibilities - Reporting   Report a study violation to the HSRO within 10 working days of its discovery Report to the HSRO, Data Safety and Monitoring Boards, sponsors and appropriate federal agencies all unanticipated problems, including adverse events involving risks to human subjects or others that occur in the course of the research, with ten (10) working days of the event becoming known to the principal investigator

9. PI Responsibilities – informed consent • Ensure that legally effective informed consent is obtained from human participants or their legally responsible representative with documents and process as approved by the IRB • Ensure that consent documents are only those with IRB approval and identifying stamp   • Ensure that each subject or their legally responsible representative receives a copy of the signed consent form • Ensure that a copy of the signed consent form is inserted into the research file and/or if the subject is a patient, a copy of this form is kept in his/her medical record. 

10. PI Responsibilities - files • Maintain research files for the duration(s) required by regulations and policies • Files shall include: • All correspondence with the IRB and the sponsor (if applicable) • Documentation of subject eligibility • Copies of signed consent forms obtained from all subjects participating in and/or who have participated in the protocol regardless of whether or not the subject completed the study.  • Any data derived from the study • Maintain any authorization documents to use or disclose private health  information (PHI) for a minimum of six years from the date authorization is obtained

11. PI Responsibilities – FDA regulated products • Ensure that research involving FDA regulated products is conducted under an IND application or an IDE • Comply with all applicable FDA regulations and fulfill all investigator responsibilities to the FDA and/or sponsors as appropriate

12. PI Responsibilities - complaints • Ensure timely responsiveness to complaints or requests for information from research participants • Ensure that complaints or requests from participants that are not satisfactorily resolved are reported to the IRB • Ensure that IRB-approved, properly informed key personnel are available to participants by phone or other electronic communication methods approved by the IRB

13. PI Responsibilities – Conflicts of Interest • All investigators (“key personnel”) must disclose to the IRB their personal conflicts of interest as defined by regulations and/or by institutional or IRB policy  • Principal investigators must disclose conflicts of interest that may be related to the University or affiliated institutions • If the conflict exists prior to IRB review of the study, the conflict must be disclosed prior to the IRB deliberation.  If the conflict is initiated after IRB review, the conflict must be disclosed to the IRB within 10 days after its onset.   • Principal Investigators may recommend to the IRB how potential conflicts of interest should be minimized or resolved.

14. “Failure is not an option” – astronaut Jim Lovell • Failure to comply with regulations, policies and/or IRB requirements for active studies is considered serious misconduct. • Serious misconduct shall be reported to appropriate institutional leaders and may lead to sanctions including possible termination of approved research and/or disciplinary employment action.   • The primary responsibility of all investigators is to safeguard the rights and welfare of each research subject. A subject’s rights and welfare must take precedence over the goals and requirements of the research

15. “Advised” Responsibilities • In addition to regulatory and policy requirements, investigators are advised to respect their responsibilities to: • the study • the institution • sponsors and/or funding agencies • the IRB These intertwined responsibilities include:

16. Know the study – be prepared to explain the study to reviewers and auditors • Submit complete applications to the IRB • Respond to eProst questions thoroughly and in a manner which facilitates IRB review – do not assume!! • Respond timely and completely to HSRO or IRB requests. Show that the study is sufficiently important to submit, to utilize resources of the study team, HSRO and IRB and to conduct • Be available to interact with the IRB during its meetings • Be a good citizen. Volunteer for service on the IRB or on IRB-related focus groups

17. “You’ll never walk alone” – Rogers and Hammerstein Human Subjects Research Office www.hsro.miami.edu Office of Research Compliance Assessment www.miami.edu/UMH/CDA/UMH_ Main/0,1770,2425-1;27691-2,00.html Clinical Research Initiation Services Office www.cris@med.miami.edu UM Ethics Programs www.miami.edu/ethics2/ CITI-Collaborative IRB Training Initiative www.miami.edu/citireg/

18. Summary • Permission to conduct human subject research is a privilege, not an entitlement.  Those permitted to conduct research (faculty, staff, students, fellows) must acknowledge and accept responsibilities as a UM investigator. • Principal Investigators and study team members must understand their specific responsibilities and comply with all applicable federal, state and local regulations and with institutional and IRB policies and be guided by Belmont principles to protect and respect the rights and welfare of individuals who participate in research.     • Principal Investigators and all members of the study must abide by all decisions of the IRB