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Investigator Resources

Information for Research Participants
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Institutional Review Boards
UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
Other Policies
UChart Forms & Guidance
HSRO Forms & Documents
University Fees
Ancillary Committee Information
eProst User Guide
Ethics, Federal Regulations & Guidance
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About the HSRO


Basic Folder Information

3.4 Responsibilities of Principal Investigators


Approval Date

 

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

July 8, 2008

Revised: May 10, 2011; June 8, 2011

 



3.4(a) General Principles

3.4(a) General Principles

At the University of Miami, human subject research is a privilege, not an entitlement.  University policy requires that Principal Investigators and all others involved in University research be aware of the specific responsibilities that they must undertake when conducting research. Principal Investigators and all others engaged in human subject research must comply with these written policies and procedures, all applicable federal state and local laws and regulations, and be guided by the principles of the Belmont report to protect and respect the rights and welfare of individuals who participate in research.     

Unless approved by the Associate Vice Provost for Human Subject Research, only UM faculty may serve as Principal Investigators on studies. Jackson Health System employees who obtain approval from the JHS Clinical Research Review Committee (CRRC) may also serve as Principal Investigators on studies.  Jackson Health System employees who obtain approval from the JHS Clinical Research Review Committee (CRRC) may also serve as Principal Investigators on studies. The IRB shall recognize only one Principal Investigator for each project.  The Principal Investigator has ultimate responsibility for the administrative, fiscal and scientific conduct of his/her research project and all official IRB correspondence shall be addressed to the Principal Investigator.

Principal Investigators must comply with all requirements for the submission of continuing and final reports and for the proper conduct of the research in compliance with the IRB approval.  Failure to comply with IRB requirements for active studies is considered serious non-compliance and may be subject to sanctions including possible termination of approved research.  Serious non-compliance shall be reported to the School/College Dean, the Associate Vice Provost for Human Subject Research, Vice Provost for Research and to the Executive Vice President and Provost of the University.

A key responsibility of Principal Investigators is to submit continuing reports in a timely manner to avoid suspension of a study as the result of expiration in IRB approval. As a courtesy, the HSRO shall be to provide Principal Investigators with prior warning of expiration dates of their active studies.  However, it is the responsibility of the Principal Investigator to know expiration dates, to submit continuing review applications with sufficient time for IRB review, and to make necessary changes per regulations if a study is suspended for lapse in approval.



3.4(B) Additional Responsibilities of a Principal Investigator

3.4(B) Additional Responsibilities of a Principal Investigator

  1. Education: Ensure that he/she, co-investigators, sub-investigators, study coordinators, student investigators and all engaged personnel have completed the UM CITI human subject training program, or an equivalent program per approval by the Associate Vice Provost for Human Subject Research, and hold current certification from that program before they participate in the human subject research 
    1. Ensure that orientation, education and other in-service sessions take place whenever non-research personnel are involved in areas impacted by the research or whenever such personnel will be contributing data.  Examples of such non-research personnel may be hospital nurses or aides, clinical laboratory technicians, cardiology technicians, respiratory therapists etc.
  2. Qualified Personnel:  Ensure that the procedures of the study are conducted by qualified personnel following the approved IRB protocol; maintain a list of appropriately qualified persons to whom significant clinical, trial-related duties have been delegated ("delegation of authority log") 
  3. Amendments:  Ensure that no amendments/changes in the approved IRB application, study protocol or informed consent documents are implemented without prior IRB approval in accordance with UM IRB Policies and Procedures (except in an emergency, if necessary to safeguard the well-being of a human participant.  If a change occurs as the result of an emergency situation, the principal investigator must report to the IRB within ten [10] working days of such change). 
  4. Exceptions:  Obtain IRB approval prior to the implementation of an exception to a protocol even if that exception pertains only to one or a few participants.  If an exception is required in an emergency or life-threatening situation before IRB approval can be obtained, the Principal Investigator must follow the policies defined in these Policies and Procedures for "Emergency Use".  The PI must list all exceptions in the ensuing continuing or final report.  
  5. Non-compliance or Protocol Deviation:  Report non-compliance or a protocol deviation to the HSRO within 10 working days of its discovery
  6. Unanticipated Problems and Adverse Events:  Report to the HSRO, and as applicable, to Data Safety and Monitoring Boards, sponsors and appropriate federal agencies all unanticipated problems, including adverse events that occur in the course of the research and that the level of risk to human subjects or others, with ten (10) working days of the event becoming known to the principal investigator. 
  7. Advertisements:  Obtain initial IRB approval for advertisements for the  recruitment of subjects and prior IRB approval for any changes in  advertisements
  8. Reports, Audits or Reviews:  Ensure that any reports, audits, or reviews of studies performed by outside agencies and sent to the  Principal Investigator are submitted to the HSRO within ten (10) working days of receipt by the Principal Investigator.  Any reports issued by Data Safety Monitoring Boards (or similar entities), whether inside or outside the University, must also be submitted to the IRB within ten (10) working days of receipt by the Principal Investigator.
  9. Research Files: Maintain research files for a minimum of three years (or longer according to the sponsor's requirements if applicable) from the date of study completion including:
    1. All correspondence with the IRB and the sponsor (if applicable)
    2. Documentation of subject eligibility
    3. Copies of signed consent forms obtained from all subjects participating in and/or who have participated in the protocol regardless of whether the subject completed the study. 
    4. Any data derived from the study
    5. In addition, principal investigators must maintain any authorization documents to use or disclose private health  information (PHI) for a minimum of six years from the date authorization is obtained
  10. Informed Consent:  Ensure that the legally effective informed consent is obtained from human participants or their legally responsible representative. If the IRB has required written consent, use only the IRB-approved, date-stamped/watermarked informed consent documents  
    1. Ensure that each subject or their legally responsible representative receives a copy of the signed consent form and 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 should be placed in his/her medical record.  
  11. Compliance: Ensure that all members of the research team always comply with the findings, determinations and requirements of the IRB
  12. Recruitment Locations:   Fully inform the IRB of all locations in which human participants will be recruited for the study and ensure that current IRB approvals/letters of cooperation are obtained and maintained when applicable
  13. Suspension/Termination: Ensure prompt and complete compliance with any IRB or administrative decision to suspend or withdraw approval for the study


3.4(c) Investigator's Responsibility Sheet

3.4(c) Principal Investigator's Assurance Statement

To assist Principal Investigators and remind them of their responsibilities, the HSRO will include a brief review of the principal investigator's responsibilities within the "Principal Investigator's Assurance Statement". This Assurance Statement constitutes the concluding page of the computer-based forms that must be signed and submitted by the Principal Investigator to the IRB for new studies, continuing reports, amendments and reportable events. By signing this Assurance Statement, the Principal Investigator shall affirm that he/she has ultimate responsibility for the conduct of the research described therein, the ethical performance of the project, the protection of the rights and welfare of human participants, strict adherence to the study protocol and for any stipulations imposed by the UM IRB. The PI's signature shall also affirm that the PI is knowledgeable of and agrees to comply with all regulations and institutional policies regarding the protection of human participants in research.



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