91女神

91女神 investigators are responsible for conducting research in an ethical and professional manner, and in accordance with federal regulations (both the general regulations pertaining to human subjects protection in 45 CFR 46 and 21 CFR 50 and 56, and any specific regulations that may be imposed by the federal agency funding the research), local, state, and federal laws, 91女神 policies, and the IRB-approved protocol.

Any non-compliance must be promptly reported to the IRB.

The principal investigator (PI) is also responsible for the timely and proper administration of the research project.  Beyond the scientific and clinical conduct of the study, responsibilities include:

• Fiscal management of the project
• Training and supervision of research team members
• Compliance with the sponsor鈥檚 terms and conditions (e.g., non-disclosure of sponsor confidential information)
• Submission of study amendments and continuing review applications in a timely manner
• Obtaining approval for protocol changes prior to implementation
• Timely submission of post-approval reporting requirements
• Disclosure of any potential conflicts of interest (for self and research team members)*

* Disclosures of potential conflicts of interest are reviewed and managed by institutional COI committees or designees; however, the IRB has the final authority to decide whether the potential conflict of interest and its management, if any, allows the research to be approved. 

Please be aware of post-IRB approval submission requirements for more information on the types of events, when to submit, and the appropriate form to use.  The following activities require further submission to the IRB. Submissions should be done in eIRB; for paper 91女神 IRB studies, links to paper forms are below. 

Amendments

Modifications to the approved research may not be implemented without prior IRB review and approval, except when necessary to eliminate immediate hazards to research participants.  Modifications include revisions to any protocol, research procedure, recruitment plan, study instrument, research personnel, study site, or related study document. 
For studies not in eIRB: Change-in-Protocol/For Information Form.

Continuing Review

IRB review is required at least annually for all non-exempt research unless a shorter approval period was determined by the IRB. The purpose of continuing review is to monitor the progress of the study and ensure that it continues to meet the requirements for approval.  It is the principal investigator's responsibility to complete the continuing review form in a timely manner or study approval may expire.
For studies not in eIRB: Continuing Review Form/Notice of Study Closure.

Reportable Events

Serious adverse events, unanticipated problems, protocol violations, complaints and other events must be reported as detailed in the IRB Reportable Events Guidelines.
For studies not in eIRB: Change-in-Protocol/For Information Form or Serious Adverse Event (SAE) Report Form.

• Decision Tree for Reporting Protocol Violations (PVs)
• Decision Tree for Reporting Serious Adverse Events (SAEs)
• Decision Tree for Reporting Unanticipated Problems (UPs)

Study Closure

If all research-related interventions or interactions with human subjects have been completed and all data collection and analysis of identifiable private information described in the IRB-approved protocol has been finished, the human subjects research study has been completed and the investigator should close the study. Studies should be closed in accordance with the 91女神 IRB Guidelines for Closure of Human Subjects Research Studies. Please note record retention requirements specified in that guidance.
For studies not in eIRB: Continuing Review Form/Notice of Study Closure.

When faculty leave/are no longer 91女神 employees, they/their department are expected to close their study(ies), transfer the protocol(s) to another 91女神 investigator, or transfer them to their new institution. There have been exceptions made for Emeritus faculty, who can keep their protocols active with Dept Chair approval. Read our  Guidelines for Closure of Human Subjects Research Studies for more information. 

If terminating employment/association with 91女神, PI should do one of the following:

• Close the study at 91女神 and submit a Final Report Form in eIRB; OR
• Transfer the protocol to another 91女神 investigator via an Amendment; OR
• Request transfer of research outside of 91女神.
  Note: Research records must remain at 91女神 unless otherwise authorized in an agreement. See the 91女神 Policy on Research Records and Biological Specimens: Ownership, Retention, Transfer, and Destruction.

Industry-sponsored studies often are run with organizational binders provided by the study鈥檚 sponsor/CRO. For investigator-initiated studies, researchers can refer to the Regulatory Binder Guidance to put an organizational system in place. In addition, 91女神 provides some sample logs, though units are welcome to develop their own.

Sample Forms/Logs

• Delegation of Authority Log
• Eligibility Criteria Checklist
• Screening Enrollment Log
• Site Personnel Signature Log
• Study Specific Training
• Study Startup Checklist
• Subject Visit Tracking Log