Institutional Review Board Institutional Review Board (IRB) (IRB)

Human Subject Research Human Subject Research Office (HSRO)Office (HSRO)

University of Miami University of Miami

and Affiliated Institutionsand Affiliated Institutions

Investigator ResponsibilitiesInvestigator Responsibilities

Investigators have the primary responsibility for Investigators have the primary responsibility for protecting the rights and welfare of human research protecting the rights and welfare of human research subjects and are responsible for complying with all subjects and are responsible for complying with all UM Institutional and UM IRB policies & procedures.UM Institutional and UM IRB policies & procedures.

www.hsro.miami.edu 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 305-243-3195hsro “help desk” at 305-243-3195

The University of Miami has a Federalwide Assurance The University of Miami has a Federalwide Assurance (FWA) approved by the Office of Human Research (FWA) approved by the Office of Human Research Protections (OHRP) in the Department of Health and Protections (OHRP) in the Department of Health and Human Services (DHHS).Human Services (DHHS).

Through its FWA, the University has agreed to permit Through its FWA, the University has agreed to permit only human subject research that is appropriately only human subject research that is appropriately reviewed and approved by the IRB in accordance with all reviewed and approved by the IRB in accordance with all regulations including those of Title 45, Part 46 of the regulations including those of Title 45, Part 46 of the Code of Federal Regulations. These requirements and Code of Federal Regulations. These requirements and principles apply to all human subject research conducted principles apply to all human subject research conducted under the auspices of the University of Miami or affiliated under the auspices of the University of Miami or affiliated institutions (for which UM has agreed to take on the institutions (for which UM has agreed to take on the responsibility as the IRB of record), regardless of funding responsibility as the IRB of record), regardless of funding source or support.source or support.

Federalwide Assurance (FWA)Federalwide Assurance (FWA)

(Required for eligibility to receive federal funding for research) (Required for eligibility to receive federal funding for research)

Principal Investigators Principal Investigators and the Study Teamand the Study Team

PI’s hold ultimate responsibility for the administrative, fiscal PI’s hold ultimate responsibility for the administrative, fiscal and and scientific conduct of the research project. scientific conduct of the research project.

All official IRB correspondence shall be addressed to the All official IRB correspondence shall be addressed to the Principal Investigator. Principal Investigator.

PI’s must sign new study applications, continuing reports, PI’s must sign new study applications, continuing reports, amendments, reportable events and the required amendments, reportable events and the required Assurance Statements. This signature commits the PI Assurance Statements. This signature commits the PI

to to having knowledge of, and to his/her compliance with having knowledge of, and to his/her compliance with the the responsibilities of a Principal Investigator. responsibilities of a Principal Investigator.

Signatures have meaningSignatures have meaning. This meaning is strictly . This meaning is strictly interpreted by interpreted by the IRB and the institution. the IRB and the institution.

Study team members have the responsibility to work under Study team members have the responsibility to work under PI PI supervision to conduct the study in strict adherence supervision to conduct the study in strict adherence to, and with to, and with knowledge of, regulations, policies, the knowledge of, regulations, policies, the study protocol and IRB-study protocol and IRB- imposed stipulations. imposed stipulations.

SPECIFIC PI RESPONSIBILITIESSPECIFIC PI RESPONSIBILITIES Proper conduct of the study. Follow the Proper conduct of the study. Follow the

approved approved protocol, maintain appropriate protocol, maintain appropriate oversight of the oversight of the research and appropriately research and appropriately delegate research delegate research responsibilitiesresponsibilities

Submit all required continuing and final study Submit all required continuing and final study reports in a timely mannerreports in a timely manner

Submit any reports, audits, or reviews of studies Submit any reports, audits, or reviews of studies performed by outside agencies or a Data performed by outside agencies or a Data

Safety Safety Monitoring Board (or similar entities) Monitoring Board (or similar entities) to the to the HSRO within ten (10) working days of HSRO within ten (10) working days of receipt receipt by the Principal Investigator. by the Principal Investigator. 

PI Responsibilities - PI Responsibilities - ChangesChangesEnsure that no amendments/changes in Ensure that no amendments/changes in

the approved IRB application, study the approved IRB application, study protocol or informed consent protocol or informed consent

documents are implemented without documents are implemented without prior IRB approval prior IRB approval (except in an emergency, (except in an emergency,

if if necessary to safeguard the well-being of a human necessary to safeguard the well-being of a human participant.  Note- the PI must report emergency participant.  Note- the PI must report emergency

changes to the changes to the IRB within ten [10] working days of such IRB within ten [10] working days of such changechange) )

Ensure no implementation of an Ensure no implementation of an exception to a protocol (even if that exception to a protocol (even if that exception pertains only to one or a few exception pertains only to one or a few participants) without prior IRB participants) without prior IRB approval. approval. 

PI Responsibilities - PI Responsibilities - PersonnelPersonnel Ensure that all key personnel have completed the Ensure that all key personnel have completed the

UM CITI human subject training program, or an UM CITI human subject training program, or an approved, equivalent program approved, equivalent program

   

Ensure orientation, education and other in-service Ensure orientation, education and other in-service training for non-research personnel involved in training for non-research personnel involved in the research.   Examples of such non-research the research.   Examples of such non-research personnel may be hospital nurses or aides, personnel may be hospital nurses or aides, clinical laboratory technicians, cardiology clinical laboratory technicians, cardiology technicians, respiratory therapists etc. technicians, respiratory therapists etc.

Ensure that the study is conducted by personnel Ensure that the study is conducted by personnel qualified by education, training and experience qualified by education, training and experience and that these personnel are informed of study-and that these personnel are informed of study-related changes as these occurrelated changes as these occur

PI Responsibilities - PI Responsibilities - ReportingReporting

    Report a study violation to the HSRO within Report a study violation to the HSRO within 10 working days of its discovery 10 working days of its discovery

Report to the HSRO, Data Safety and Report to the HSRO, Data Safety and Monitoring Monitoring Boards, sponsors and Boards, sponsors and appropriate federal appropriate federal agencies all agencies all unanticipated problems, unanticipated problems, including including adverse events involving risks to adverse events involving risks to human human subjects or others that occur in the subjects or others that occur in the course course of the research, with ten (10) of the research, with ten (10) working working days of the event becoming known days of the event becoming known to the to the principal investigatorprincipal investigator

PI Responsibilities – PI Responsibilities – informed informed consentconsent

Ensure that legally effective informed consent is Ensure that legally effective informed consent is obtained from human participants or their legally obtained from human participants or their legally responsible representative with documents and process responsible representative with documents and process as approved by the IRB as approved by the IRB

Ensure that consent documents are only those with IRB Ensure that consent documents are only those with IRB approval and identifying stamp   approval and identifying stamp  

Ensure that each subject or their legally responsible Ensure that each subject or their legally responsible representative receives a copy of the signed consent representative receives a copy of the signed consent form form

Ensure that a copy of the signed consent form is inserted Ensure that a copy of the signed consent form is inserted into the research file and/or if the subject is a patient, a into the research file and/or if the subject is a patient, a copy of this form is kept in his/her medical record. copy of this form is kept in his/her medical record. 

PI Responsibilities - PI Responsibilities - filesfiles Maintain research files for the duration(s) required by Maintain research files for the duration(s) required by

regulations and policies 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 Copies of signed consent forms obtained from all subjects

participating in and/or who have participated in the protocol participating in and/or who have participated in the protocol regardless of whether or not the subject completed the study.  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 Maintain any authorization documents to use or disclose private health  information (PHI) for a disclose private health  information (PHI) for a minimum of six years from the date authorization is minimum of six years from the date authorization is obtained obtained

PI Responsibilities – PI Responsibilities – FDA FDA regulated productsregulated products

Ensure that research involving FDA Ensure that research involving FDA regulated products is conducted regulated products is conducted under an IND application or an IDEunder an IND application or an IDE

Comply with all applicable FDA Comply with all applicable FDA regulations and fulfill all investigator regulations and fulfill all investigator responsibilities to the FDA and/or responsibilities to the FDA and/or sponsors as appropriate sponsors as appropriate

PI Responsibilities - PI Responsibilities - complaintscomplaints

Ensure timely responsiveness to complaints Ensure timely responsiveness to complaints or requests for information from research or requests for information from research participantsparticipants

Ensure that complaints or requests from Ensure that complaints or requests from participants that are not satisfactorily participants that are not satisfactorily resolved are reported to the IRB resolved are reported to the IRB

Ensure that IRB-approved, properly informed Ensure that IRB-approved, properly informed key personnel are available to participants key personnel are available to participants by phone or other electronic communication by phone or other electronic communication methods approved by the IRBmethods approved by the IRB

PI Responsibilities – PI Responsibilities – Conflicts of Conflicts of InterestInterest

All investigators (“key personnel”) must disclose to the IRB All investigators (“key personnel”) must disclose to the IRB their personal conflicts of interest as defined by regulations their personal conflicts of interest as defined by regulations and/or by institutional or IRB policy  and/or by institutional or IRB policy 

Principal investigators must disclose conflicts of interest Principal investigators must disclose conflicts of interest that may be related to the University or affiliated that may be related to the University or affiliated institutions institutions

If the conflict exists prior to IRB review of the study, the If the conflict exists prior to IRB review of the study, the conflict must be disclosed prior to the IRB deliberation.  If conflict must be disclosed prior to the IRB deliberation.  If the conflict is initiated after IRB review, the conflict must be the conflict is initiated after IRB review, the conflict must be disclosed to the IRB within 10 days after its onset.  disclosed to the IRB within 10 days after its onset.  

Principal Investigators may recommend to the IRB how Principal Investigators may recommend to the IRB how potential conflicts of interest should be minimized or potential conflicts of interest should be minimized or resolved. resolved.

““Failure is not an option” Failure is not an option” – – astronaut Jim astronaut Jim LovellLovell

Failure to comply with regulations, policies and/or Failure to comply with regulations, policies and/or IRB requirements for active studies is considered IRB requirements for active studies is considered serious misconduct. serious misconduct.

Serious misconduct shall be reported to Serious misconduct shall be reported to appropriate institutional leaders and may lead to appropriate institutional leaders and may lead to sanctions including possible termination of sanctions including possible termination of approved research and/or disciplinary approved research and/or disciplinary employment action.  employment action.  

The primary responsibility of all investigators is to The primary responsibility of all investigators is to safeguard the rights and welfare of each research safeguard the rights and welfare of each research subject. A subject’s rights and welfare must take subject. A subject’s rights and welfare must take precedence over the goals and requirements of precedence over the goals and requirements of the researchthe research

““Advised” ResponsibilitiesAdvised” Responsibilities

In addition to regulatory and policy In addition to regulatory and policy requirements, investigators are advised to requirements, investigators are advised to respect their responsibilities to:respect their responsibilities to: the studythe study the institutionthe institution sponsors and/or funding agenciessponsors and/or funding agencies the IRB the IRB

These intertwined responsibilities include:These intertwined responsibilities include:

Know the study – be prepared to explain the study to Know the study – be prepared to explain the study to reviewers and auditorsreviewers and auditors

Submit complete applications to the IRBSubmit complete applications to the IRB Respond to eProst questions thoroughly and in a manner Respond to eProst questions thoroughly and in a manner

which facilitates IRB review – do not assume!! which facilitates IRB review – do not assume!!

Respond timely and completely to HSRO or IRB requests. Respond timely and completely to HSRO or IRB requests. Show that the study is sufficiently important to Show that the study is sufficiently important to submit, to submit, to utilize resources of the study team, HSRO utilize resources of the study team, HSRO and IRB and to and IRB and to conductconduct

Be available to interact with the IRB during its meetingsBe available to interact with the IRB during its meetings

Be a good citizen. Volunteer for service on theBe a good citizen. Volunteer for service on theIRB or on IRB-related focus groupsIRB or on IRB-related focus groups

““You’ll never walk aloneYou’ll never walk alone” – ” – Rogers and Rogers and HammersteinHammerstein

Human Subjects Research OfficeHuman Subjects Research Officewww.hsro.miami.eduwww.hsro.miami.edu

Office of Research Compliance Assessment Office of Research Compliance Assessment www.miami.edu/UMH/CDA/UMH_www.miami.edu/UMH/CDA/UMH_

Main/0,1770,2425-1;27691-2,00.htmlMain/0,1770,2425-1;27691-2,00.html

Clinical Research Initiation Services OfficeClinical Research Initiation Services Officewww.cris@med.miami.eduwww.cris@med.miami.edu

UM Ethics ProgramsUM Ethics Programswww.miami.edu/ethics2/www.miami.edu/ethics2/

CITI-Collaborative IRB Training InitiativeCITI-Collaborative IRB Training Initiativewww.miami.edu/citireg/www.miami.edu/citireg/

SummarySummary Permission to conduct human subject research is Permission to conduct human subject research is

a a privilege, not an entitlement.  Those privilege, not an entitlement.  Those permitted to permitted to conduct research (faculty, staff, conduct research (faculty, staff, students, fellows) students, fellows) must acknowledge and must acknowledge and accept responsibilities as a accept responsibilities as a UM investigator. UM investigator.

Principal Investigators and study team members Principal Investigators and study team members must must understand their specific responsibilities understand their specific responsibilities and comply and comply with all applicable federal, state with all applicable federal, state and local regulations and local regulations and with institutional and and with institutional and IRB policies and be guided IRB policies and be guided by Belmont by Belmont principles to protect and respect the principles to protect and respect the rights rights and welfare of individuals who participate in and welfare of individuals who participate in research.    research.    

Principal Investigators and all members of the Principal Investigators and all members of the study must study must abide by all decisions of the IRB  abide by all decisions of the IRB