Human Research Protection Program

Human Research Protection Program (HRPP) Accreditation

Great news!  UGA is now AAHRPP-accredited

AAHRPP, at its June 2018 Council meeting, granted full accreditation to UGA’s Human Research Protection Program.  With this accreditation, UGA joins an elite group of institutions around the world that are committed to promoting AAHRPP’s high standards for ethical research that prioritizes the safety and welfare of participants.  Read the full story on UGA Today.

HRPP accreditation seal

UGA’s initial AAHRPP accreditation site visit went extraordinarily well! During the two and a half day site visit, the AAHRPP site visitors conducted an extensive review of the IRB records, and interviewed individuals from various components of our Human Research Protection Program (HRPP) to determine how well our written policies and procedures are translated into practice. More than thirty individuals – investigators and research team members, IRB members, HSO staff, and administrators – participated in interviews.
Of the 15 standards and 60 elements that an institution has to satisfy in order to receive accreditation, the site visitors had only one observation or area that needs improvement, which is related to documentation and record-keeping of IRB activities. UGA’s response, as well as actions already undertaken by the IRB Office, to address this observation has now been submitted to AAHRPP. The entire accreditation application including the site visit report and our response is scheduled to be reviewed at the June 2018 AAHRPP Council Meeting. We will keep you posted on the outcome of this review.
Thank you once again to everyone who participated in the interviews, and provided assistance and support during the site visit. You each represented UGA and our HRPP very well, and collectively demonstrated our institution’s strong commitment to protecting the rights and welfare of research participants. We have much to be proud of!
For information on UGA’s pursuit of AAHRPP accreditation, please contact Dr. Benilda P. Pooser at 706.542.9720 or bpooser@uga.edu.
In order to demonstrate our commitment to the highest ethical standards in the protection of human research participants, the University of Georgia has applied for accreditation of its Human Research Protection Program (HRPP) through the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP).

About AAHRPP and Accreditation

AAHRPP (pronounced “a-harp”) is an independent, non-profit organization that accredits high-quality human research protection programs in order to promote excellent, ethically sound research.  To earn accreditation, organizations must provide tangible evidence—through policies, procedures, and practices—of their commitment to scientifically and ethically sound human research and to continuous improvement.
AAHRPP accreditation uses a set of objective standards to evaluate the quality and level of protection that an organization provides to research participants.  The process is based on self-assessment, peer assessment, and continuous quality improvement.
The goals of AAHRPP accreditation are to:

  • Improve and strengthen the systems that protect the rights and welfare of individuals who participate in research
  • Communicate to the public the strength of UGA’s commitment to the protection of human research participants

The benefits of accreditation extend beyond the research subjects and to the research enterprise as a whole.  To find out more about the value of accreditation, visit http://www.aahrpp.org/learn/considering-accreditation/value-of-accreditation.

The Accreditation Process

There are four (4) major steps in the accreditation process.
The first step is a comprehensive self-assessment and submission of the Step 1 application, which also included the development of new or revised policies and procedures.  UGA has already completed this process.
The application is reviewed and a response to the review along with any revised supporting documents is submitted as Step 2 Application.  UGA has already completed this process.
This is then followed by a site visit from AAHRPP to evaluate our human research protections program.
Our site visit will take place from Wednesday, February 28, 2018 – Friday, March 2, 2018.
Site visitors will review documents and conduct interviews.  AAHRPP will select the individuals to be interviewed.  Anyone who has a role in UGA’s HRPP may be selected for an interview; this includes principal investigators and research team members, IRB members and Human Subjects Office staff.
Finally, AAHRPP’s Council of Accreditation reviews the site visit report at its June 2018 meeting where they deliberate on the team’s findings and determine our accreditation status.
For more information on AAHRPP, see http://www.aahrpp.org/.

The UGA Human Research Protection Program

Although the Institutional Review Board (IRB) is a major component in the protection of research participants, it is important to remember that it is the University’s Human Research Protection Program (or HRPP) that will undergo review and accreditation.
The HRPP is not an office, but rather the collective effort by all of the components that participate in the conduct, review, approval, education, quality improvement, and facilitation of human research at UGA to ensure that UGA complies with all applicable federal, state, and local regulations and requirements.
For an overview of UGA’s HRPP, please view this short presentation.
An HRPP Plan provides detailed information about the organization, scope, and its various components and responsibilities.
For additional information on UGA’s HRPP, please visit https://ugaresearch.staging.wpengine.com/hrpp/.

HRPP Policies and Procedures

As a result of the self-assessment, new or revised policies and procedures were developed and implemented.  These policies and procedures are available at https://ugaresearch.staging.wpengine.com/hrpp/policies-and-procedures/.
For a quick overview of AAHRPP, the accreditation process, and your role in the accreditation process, please view this presentation.

Frequently Asked Questions (FAQs)

AAHRPP, the Association for the Accreditation of Human Research Protection Programs, Inc., is an independent, non-profit organization that reviews and accredits institutions engaged in human subjects research to protect the rights and welfare of the research participants.
AAHRPP accreditation bolsters the university’s reputation as a leader in human subjects research. Research sponsors and other research partners increasingly consider AAHRPP accreditation before pursuing collaborations, or providing funding, for research.
For additional information on the value of accreditation, see http://www.aahrpp.org/learn/considering-accreditation/value-of-accreditation.

AAHRPP will select the individuals to be interviewed based on the protocols list and key HRPP personnel submitted with the accreditation application. Investigators will be selected who reflect the ranges of experience, protocol volume, types of ongoing research, and research risk levels at the organization. In addition to investigators, site visitors will interview study coordinators, co-investigators, and other study team members. Key HRPP personnel, IRB Members, and Human Subjects Office/IRB staff will also be interviewed.

AAHRPP will select the individuals to be interviewed based on the protocols list and key HRPP personnel submitted with the accreditation application.  Investigators will be selected who reflect the ranges of experience, protocol volume, types of ongoing research, and research risk levels at the organization.  In addition to investigators, site visitors will interview study coordinators, co-investigators, and other study team members.  Key HRPP personnel, IRB Members, and Human Subjects Office/IRB staff will also be interviewed.

AAHRPP is interested in your awareness of and knowledge about key human research concepts and policies, including, but not limited to:

  • Human subject research regulations such as the Common Rule (45 CFR 46), FDA regulations, the Belmont Report, and Conflict of Interest Policies
  • Human subject protections and the procedures you use to implement them such as elements of informed consent, strategies for minimizing risk, reporting of adverse event and unanticipated problems
  • The strength and effectiveness of the HRPP, including education and training, adequacy of resources for researchers, and HRPP structure

NOTE: The specific questions you will be asked by the AAHRPP site visitors will depend upon your role within the UGA HRPP.

For questions or additional information contact Dr. Benilda Pooser at 706.542.9720 or bpooser@uga.edu.