Researcher 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.
Researchers 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).
Researchers AAHRPP Guidance Documents
HRP-101 HUA Human Research Protection Program Plan
HRP-Ancillary Review Reference-Faculty Sponsor Review
IRB Study Submission Guide
Principal Investigator Assurance-Reference
HRP-013 - SOP - HUA - Legally Authorized Representatives, Children, Guardians
HRP-090 - SOP - HUA - Informed Consent Process for Research
HRP-091 - SOP - HUA - Written Documentation of Consent
HRP-103-HUA Investigator Manual
HRP-213-FORM-Not Human Subjects Research Request Determination Form
HRP-309 WORKSHEET HUA Harvard Policies
HRP-430 CHECKLIST HUA Investigator Quality Improvement Assessmen
HRP-502 - TEMPLATE - HUA Adult Consent Form
HRP-502a - TEMPLATE - HUA Child Assent Form
HRP-502b - TEMPLATE - HUA Parental or Guardian Permission
HRP-502c - TEMPLATE - HUA Exempt Human Research Consent Script
HRP-503 - TEMPLATE - HUA Protocol
HRP-504 - TEMPLATE - HUA Repository Protocol
HRP-506 - TEMPLATE - HUA 118 Request
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 -- Researchers
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!