New Guidance Documents & Webpages Available
The IRB Office has new guidance for the following activities. These guidance documents can be found under Resources, within the Guidance Documents page:
- Notification of Study Participants:
- HRP- 1907: This guidance provides assistance in determining when study participants need to be informed of new information and/or re-consented.
- Evaluating Reports of Data Incidents:
- HRP-1908: This guidance can be used to distinguish between the different types of data, the difference between privacy and confidentiality, and provide guidance on preparing Reportable New Information (RNI) submissions involving data.
- Research that Involves Use of Protected Mental Health and/or Developmental Disabilities Information:
- HRP-1909: This guidance highlights considerations for use of protected health information, covered by the Illinois Mental Health & Developmental Disabilities Confidentiality Act (MHDDCA), for research-related purposes.
The IRB Office has new page for PI Transfers. This page can be found under Compliance, within the Principal Investigator Transfer of Responsibility Guidelines page.:
- Principal Investigator (PI) Transfer of Responsibility Guidelines
- This new page provides resources when a PI would like to or is required to relinquish PI responsibility for a research project.
- HRP-1408 Principal Investigator (PI) Transfer of Responsibilities Checklist provides a comprehensive list of study record considerations and can be completed when transitioning a study to a new PI. This document does not have to be submitted to the IRB but can be retained in the regulatory binder/research record.
The IRB Office has new guidance for FDA Site Inspections. These documents can be found under Compliance, within the new FDA Site Inspection Guidance section of the IRB website.
- FDA Guidance Documents:
- For investigators whose FDA-regulated clinical trials are inspected or audited by the FDA. The following resources are now available:
- HRP-1910 – FDA Site Inspection Guidance: This document is a comprehensive and detailed guidance for a successful FDA site inspection. It includes recommendations, best practices, and what to expect for receipt of an inspection notification, preparing for an inspection, and during and after an inspection.
- HRP-2020 – FDA Site Inspection Preparation Checklist: This template condenses the inspection preparation information found in the FDA Site Inspection Guidance into a general checklist of recommended steps to prepare for an upcoming FDA inspection.
- HRP-2021 – Inspection Request Tracking Log Template: This is a template that study teams may use, customize, or reference to track requests made by an FDA inspector.
The IRB Office has new guidance for the Just-in-Time process. This page can be found under the Submissions tab, within Submission Information.
- Just-in-Time Process:
- This new page provides guidance on the NIH “just-in-time” (JIT) process for certain programs and award mechanisms.
Thank you,
The Northwestern University IRB Office
ear Research Community,
The IRB Office has new guidance for the following activities. These guidance documents can be found under Resources, within the Guidance Documents page:
- Notification of Study Participants:
- HRP- 1907: This guidance provides assistance in determining when study participants need to be informed of new information and/or re-consented.
- Evaluating Reports of Data Incidents:
- HRP-1908: This guidance can be used to distinguish between the different types of data, the difference between privacy and confidentiality, and provide guidance on preparing Reportable New Information (RNI) submissions involving data.
- Research that Involves Use of Protected Mental Health and/or Developmental Disabilities Information:
- HRP-1909: This guidance highlights considerations for use of protected health information, covered by the Illinois Mental Health & Developmental Disabilities Confidentiality Act (MHDDCA), for research-related purposes.
The IRB Office has new page for PI Transfers. This page can be found under Compliance, within the Principal Investigator Transfer of Responsibility Guidelines page.:
- Principal Investigator (PI) Transfer of Responsibility Guidelines
- This new page provides resources when a PI would like to or is required to relinquish PI responsibility for a research project.
- HRP-1408 Principal Investigator (PI) Transfer of Responsibilities Checklist provides a comprehensive list of study record considerations and can be completed when transitioning a study to a new PI. This document does not have to be submitted to the IRB but can be retained in the regulatory binder/research record.
The IRB Office has new guidance for FDA Site Inspections. These documents can be found under Compliance, within the new FDA Site Inspection Guidance section of the IRB website.
- FDA Guidance Documents:
- For investigators whose FDA-regulated clinical trials are inspected or audited by the FDA. The following resources are now available:
- HRP-1910 – FDA Site Inspection Guidance: This document is a comprehensive and detailed guidance for a successful FDA site inspection. It includes recommendations, best practices, and what to expect for receipt of an inspection notification, preparing for an inspection, and during and after an inspection.
- HRP-2020 – FDA Site Inspection Preparation Checklist: This template condenses the inspection preparation information found in the FDA Site Inspection Guidance into a general checklist of recommended steps to prepare for an upcoming FDA inspection.
- HRP-2021 – Inspection Request Tracking Log Template: This is a template that study teams may use, customize, or reference to track requests made by an FDA inspector.
The IRB Office has new guidance for the Just-in-Time process. This page can be found under the Submissions tab, within Submission Information.
- Just-in-Time Process:
- This new page provides guidance on the NIH “just-in-time” (JIT) process for certain programs and award mechanisms.
Thank you,
The Northwestern University IRB Office