Clinical Trials

Congratulations to our incredible CAMC Institute for Academic Medicine Clinical Sciences Research Department for managing the AAHRPP reaccreditation process! The department consists of Corporate Director Dan Lucas, PharmD, HRPP Manager Michael Whitler, BS, Research and Review Specialist April White, BS, and HRPP/IRB Coordinator Emma Huffman, MSc.

 

Who worked on this?

April White, BS, and Michael Whitler, BS, were the leads on the accreditation process. They contributed several hours to submitting applications, analyzing them and submitting supporting documentation to demonstrate how the AAHRPP Standards are met at the Institute for Academic Medicine and across Charleston Area Medical Center. We are proud to acknowledge their hard work in prepping research staff for interviews and providing educational sessions on policy and procedures when needed. This milestone achievement could not have been accomplished without their dedication.

 

The Institute for Academic Medicine would also like to thank all of the Human Research Protections Program's components for their outstanding dedication to meeting the Accreditation Standards. Each component plays an integral part in the function of the HRPP. This includes, but is not limited to, the Institutional Official, Chief Academic Officer, Clinical Trials Center, Cancer Research, Outcomes Research, Clinical Sciences Research, CHERI Administration, General Counsel Office, Institutional Review Board, Institutional Scientific Review Board, Program Chairs and Department Leaders, Investigators, Coordinators, CAMC Pharmacy, Safety Officer, Privacy Officer and the Compliance Department. The dedication to the Human Research Protections Program is immeasurable and deeply appreciated.

 

The Clinical Sciences Department would like to thank everyone who personally participated in the reaccreditation site visit process (interviews, providing the documentation that was needed, etc.). We want to personally thank HRPP/IRB Coordinator Emma Huffman, MSc, who joined our Clinical Sciences Research team in the middle of reaccreditation and did not hesitant to contribute to the workload. We want to extend a thank you to the Institutional Review Board Chair, Christopher Terpening, PharmD, PhD, for his long-standing dedication to the HRPP and human subject participates of our community, and to the Institutional Scientific Review Board Chair, Scott Fields, PhD, for his dedication to the HRPP and scientific merit review contributions, of the investigator-initiated research that is produced from the organization. Finally, we would like to thank our leaders, Sharon Hall, MSM, Dan Lucas, PharmD, and Doug Knutson, MD, for their support and guidance throughout the entire process of reaccreditation. We would also like to acknowledge the efforts of Executive Assistant Bonnie Scott for helping us with administrative tasks to make the site visit go smoothly.

 

What does this mean to patients? What does this mean to our community?

The purpose of AAHRPP accreditation is to strengthen human subjects’ protections for participants in research. Accreditation helps build public trust in patients and the community. It ensures that the research patients participate in is conducted and adhered to in the highest ethical standards and that their safety and rights are top priority to our organization. When patients from our community participate in research at CAMC, they can be confident that their well-being is protected throughout the research process.

 

What does this mean to CAMC?

Achieving AAHRPP Accreditation means demonstrating our commitment to excellence in our human research protection program and the quality of the research conducted. This benefits the participants of research studies and the overall quality of the research that comes from our institution.

 

Why is it important to be accredited?

AAHRPP Accreditation is a global effort for accredited organizations to meet rigorous international standards. There are several reasons why AAHRPP Accreditation is vital to our organization: it reduces the risk of non-compliance, the organization benefits from a common commitment to continuous quality improvement, sponsors and other funders realize that AAHRPP accredited organizations have more efficient operations in human subjects protection processes and often consider accreditation status when choosing investigative sites and accreditation prompts trust among collaborative organizations (currently more than 60% of research universities and 65% of medical schools are accredited nationally).

 

When is the accreditation period?

The reaccreditation period happens every five years after the initial accreditation. We have undergone two reaccreditations to date. Each year, we must submit an annual status report providing metrics allowing global benchmarking of the accredited bodies. The reaccreditation period takes over a year from start to end. We started the Step One application in September of 2023. The Step 2 Application was submitted in April 2024, and we had the site visit in June 2024. We underwent the AAHRPP Council review in September 2024 and were granted Full Reaccreditation. Our next reaccreditation process begins in September 2028 with the submission of Step 1 Application.