AAHRPP Boot Camp Presentations

UMMS  has applied for re-accreditation of our Human Research Protection Program (HRPP) from the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP).  Accreditation signals our commitment to protection of our research subjects and the highest quality in human subject research, and is increasingly required to participate in multi-center clinical studies.  An AAHRP site visit is an important part of the re-accreditation process.  

Our accreditation site visit is scheduled for August 13 & 14, 2018.

Status:

 Step 1

 Application Complete  

 Step 2

 Application Complete  

 Site Visit Participant Selection   

 90% Complete

 Site Visit Preparation

  • Bootcamps
  • Consultant Preparation Sessions  

 Ongoing

 Site Visit

 August 13 & 14, 2018  

 AAHRPP Council Meeting   

 December 2018

Key:

Completed  
Current  
Future  

  

  • What Is the Human Research Protection Program?

The UMMS HRPP is a comprehensive system that supports the protection of the rights and welfare of subjects in Human Research. Components of this system include the IRB, Research Integrity and Conflict of Interest programs, the Office of Clinical Research, UMMS senior leadership, Radiation Safety and Biosafety committees, as well as every investigator and study team member involved in human research.

  • Who Will Be Involved In And Impacted By the AAHRPP Site Visit

 AAHRPP selects individuals from the UMMS Human Research Protection Program (including IRB Members, IRB Staff, Researchers, Study Team and key Administrative personnel for interview during the site visit.  If you are selected, you are the one required to attend.  For Investigators, you will participate in an interview session with other investigators.  Your study team does not attend with you.  For selected study team members, you will participate in a session with study team members for other Investigators.  Your Investigator does not attend with you.

All site visit interviews take place in the UMCCTS suite on the 7th floor of the ACC building or by telephone for those unable to attend in person.  The selected participants meet with two site visitors, often in groups of three or more.  The site visit discussion is focused on the Human Research Protection Program overall and are not necessarily focused on the specifics of any one research project or program.  Selected investigators and study team members will receive a tip sheet to guide review and preparation (below).

  • What will the AAHRP SIte Visit be like?

The site visitors are respected, experienced HRPP professionals from accredited institutions.  The site visit process is meant to be collaborative, informative and is not intended to be adversarial in any way.

  • Your Role in Preparing For the AAHRPP Site Visit

If selected, there are resources and training opportunities available:

Resource Materials:

A summary of key concepts for Investigators/study teams for the site visit is available here: 

Preparation activities:

  • Consultant Preparation Sessions: Consultants from Huron will be onsite July 23-25, 2018 to conduct preparation sessions with individuals selected for interview by Site Visitors.  These sessions will cover 1) what to expect and 2) how best to respond to site visit inquiries.  If you are a selected site visit participant, the HRPP Compliance Administrator will contact you to schedule and finalize your consultant preparation session. 
  • Bootcamp Sessions: UMCCTS will once again be conducting HRPP “Bootcamp” sessions to review key HRPP topics: Human Research, Resources and Feasibility, Conflict of Interest in Human Research, Informed Consent and PI Responsibilities, Oversight & Reportable New Information. 

These bootcamps will occur on select Mondays and Wednesdays in July.  These sessions are open to everyone in the human research community. 

If you wish to attend but are unable to do so in person, please contact meg.johnson@umassmed.edu for a zoom link to the meeting.  

Date Time Speaker Location Materials
7/11/2018 1:00pm - 2:00pm

HRPP Bootcamp:  Human Research Determination, Feasibility & Resources

Allison Blodgett & Ann Han

S2-102 (Amp 1)

 

Session I Slides

 

Session I Recordings 

 

(Zoom) Session 1

 

7/16/2018 11:00 AM - 12:00 PM

HRPP Bootcamp: Financial Conflicts and Interest

 Stuart Levitz & Laurie Richard

S2-351 & 352

 

 

7/18/2018 1:00-2:00 PM

 HRPP Bootcamp: Financial Conflicts and Interest

 Stuart Levitz & Laurie Richard

(Repeat of the 1/16/18 session)

S4-102 (Amp 2)  
7/23/2018 11:00 AM - 12:00 PM

 HRPP Bootcamp: PI Responsibility & Oversight

 Allison Blodgett & Anne Roussell

S1-608 Hiatt Auditorium   
7/25/2018 1:00-2:00 PM

 HRPP Bootcamp: Informed Consent

 Allison Blodgett & Anne Roussell

S1-608 Hiatt Auditorium  

If you have questions about the UMMS AAHRPP accreditation process, please contact Meg Johnson at Meg.Johnson@umassmed.edu or at (508) 856-5152.

To learn more about AAHRPP, AAHRPP accreditation or to view a list of accredited institutions, visit: http://www.aahrpp.org/

For more information about the HRPP at UMMS, please visit:  http://www.umassmed.edu/ccts/human-research/