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

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

Post on 24-Dec-2015

214 views

Category:

Documents

0 download

Embed Size (px)

TRANSCRIPT

  • Slide 1
  • Institutional Review Board (IRB) Human Subject Research Office (HSRO) University of Miami and Affiliated Institutions
  • Slide 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 a) click Policies and Procedures b) click specific topic in Table of Contents b) click specific topic in Table of Contents hsro help desk at 305-243-3195
  • Slide 3
  • 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). 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. 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. Federalwide Assurance (FWA) (Required for eligibility to receive federal funding for research)
  • Slide 4
  • Principal Investigators and the Study Team PIs hold ultimate responsibility for the administrative, fiscal and scientific conduct of the research project. PIs 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. All official IRB correspondence shall be addressed to the Principal Investigator. PIs 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. PIs 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. 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. 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.
  • Slide 5
  • SPECIFIC PI RESPONSIBILITIES Proper conduct of the study. Follow the approved protocol, maintain appropriate oversight of the research and appropriately delegate research 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 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. 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.
  • Slide 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 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. 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.
  • Slide 7
  • PI Responsibilities - Personnel Ensure that all key personnel have completed the UM CITI human subject training program, or an approved, equivalent program 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 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 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
  • Slide 8
  • PI Responsibilities - Reporting Report a study violation to the HSRO within 10 working days of its discovery 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
  • Slide 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 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 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 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. 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.
  • Slide 10
  • PI Responsibilities - files Maintain research files for the duration(s) required by regulations and policies Maintain research files for the duration(s) required by regulations and policies Files shall include: Files shall include: All correspondence with the IRB and the sponsor (if applicable) All correspondence with the IRB and the sponsor (if applicable) Documentation of subject eligibility 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. 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 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 Maintain any authorization documents to use or disclose private health information (PHI) for a minimum of six years from the date authorization is obtained
  • Slide 11

Recommended

View more >