IRB Staff AAHRPP Guidance
Thank you for your participation in our upcoming AAHRPP site visit scheduled for Monday, September 28th and Tuesday, September 29th.
This Institution’s Human Research Protection Program (HRPP) is a comprehensive system to ensure the protection of the rights and welfare of subjects in Human Research. The Human Research Protection Program is based on all individuals in this Institution along with key individuals and committees fulfilling their roles and responsibilities. Your role in our Human Research Protection Program is essential to the successful functioning of our HRPP.
In preparation for the AAHRPP Site Visit, we have extracted key components of our HRPP that are most applicable to your role. Here is what we are asking you to do:
Review the PowerPoint presentation that has been created for your role. In this presentation, there will be various documents that are part of our HRPP “Toolkit” that are most applicable to your role.
IRB Staff PowerPoint Presentation
Review the documents that have been highlighted for your role. These documents are available for you below. Start with HRP-101: Human Research Protection Program Plan as this is the document that sums up how our HRPP works. Then move on to the other documents. Should you have questions when going through these documents, don’t forget to write them down. We will be going through these documents (and any questions) at our upcoming training check-in (see #4).
IRB Staff AAHRPP Guidance Documents
HRP-101 HUA Human Research Protection Program Plan
IRB Study Reviewers Guide
IRB Staff Admin Guide
HRP-012 - SOP - HUA - Observation of Consent Process
HRP-024 - SOP - HUA - New Information
HRP-020 - SOP - HUA - Incoming Items
HRP-021 - SOP - HUA - Pre-Review
HRP-027 - SOP - HUA - Certificate of Confidentiality
HRP-030 - SOP - HUA - Designated Reviewers
HRP-031 - SOP - HUA - Non-Committee Review Preparation
HRP-032 - SOP - HUA - Non-Committee Review Conduct
HRP-040 - SOP - HUA - IRB Meeting Preparation
HRP-043 - SOP - HUA - IRB Meeting Minutes
HRP-045 - SOP - HUA - Use of Fresh Human Fetal Tissue in Researc
HRP-051 - SOP - HUA - Consultation
HRP-052 - SOP - HUA - Post-Review
HRP-055 - SOP - HUA - Financial Conflicts of Interests
HRP-062 - SOP - HUA - Daily Tasks
HRP-063 - SOP - HUA - Expiration of IRB Approval
HRP-085 - SOP - HUA - Cede Review
HRP-095 - SOP - HUA - 118 Determination
HRP-096 - SOP - HUA - clinicaltrials.gov
HRP-098 - SOP - HUA - GDPR
HRP-099 - SOP - HUA - 2018 Requirements
HRP-102 - HUA Flowcharts
HRP-103-HUA Investigator Manual
HRP-301-WORKSHEET-HUA Review Materials
HRP-308-WORKSHEET-Pre-Review
HRP-309 WORKSHEET HUA Harvard Policies
HRP-310-WORKSHEET-Human Research Determination(1)
HRP-311-WORKSHEET-Engagement
HRP-312-WORKSHEET-Exemption
HRP-313-WORKSHEET-Expedited Review
HRP-314-WORKSHEET-Criteria for Approval
HRP-321-WORKSHEET-Review of Information Items
HRP-410-CHECKLIST-Waiver or Alteration of Consent Process
HRP-411-CHECKLIST-Waiver of Written Documentation of Consent
HRP-412-CHECKLIST-Pregnant Women
HRP-415-CHECKLIST-Prisoners
HRP-416-CHECKLIST-Children
HRP-802 - SOP - HUA - Institutional Profile Management
HRP-805 - SOP - HUA - Site Updates
Review the information that is found on our AAHRPP Training Website here - https://cuhs.harvard.edu/welcome-aahrpp-site-visit-training-page
- What is AAHRPP?
- What Can I Expect from the Site Visit?
- Things Everyone Should Know
Attend a brief information session that we have scheduled for you. We will send you a separate Outlook invitation that you can place on your calendar. All information sessions will be held via Zoom. Below is the presentation that we will be going over with you during this information session.
Training Slides -- IRB Members
Ask questions! We’re here to help you. Please let us know if you have any questions or if we may assist you in any way!