Many organizations recognize the value in having an external entity conduct a comprehensive and thorough review of the human research protection program to ensure that it is operating in compliance with federal regulations and policies and procedures. These reviews can serve to identify and understand weaknesses in a program that leave the HRPP vulnerable to regulatory findings and legal risks.
The problem is that there just aren’t many groups who are able to conduct compliance reviews at an affordable rate and in a way that won’t drain staff resources in the process.
While HRP Consulting Group recognizes AAHRPP accreditation as one of the best ways to improve the quality of an HRPP, we also recognize that there are many organizations who are either not ready to seek accreditation, do not have the funding to do so, or are not interested in the AAHRPP accreditation process altogether.
And so, who do you turn to if you want the benefits of an external review, but aren’t ready for accreditation or simply can’t afford it?
HRP Consulting Group’s Program Evaluations are one way to get you “accreditation ready” without obligating you to go through the accreditation process until you are ready to.
Our standard evaluation process works in three easy steps, but can be customized to the areas of your program that you think are deserving of additional attention.
STEP ONE—Documentation Review
Review includes the following:
- IRB minutes from the past 3 months.
- Written policies and procedures and SOPs.
- Application forms.
- IRB reviewer forms.
- Outreach materials such as participant brochures or website materials
STEP TWO—On Site Review
Review includes the following:
- Review of selected protocols and study files.
- Meetings with IRB staff, members, chairs, and officials.
- Analysis of IRB Office and review operations.
STEP THREE—Written Report
- Following the on site visit, HRP Consulting Group will issue a written report identifying any findings.
- You are not required to respond to the findings, but you may do so if you would like additional feedback from our team.
- As an optional service, we can work with you to improve upon any areas that were identified in the findings
Whether you are considering accreditation or just want a comprehensive review of your HRPP to understand your program’s strengths and weaknesses, HRP Consulting Group can help.
If you would like more information about our Program Evaluation services, please contact us at (347) 862-9321 or by email at services@thehrpconsultinggroup.com.