New Standards for Accreditation Advance Professionalization of Clinical Research

Stephen A. Sonstein, PhD, Chair of the CAAHEP’s Committee on Accreditation of Academic Programs in Clinical Research

Stephen A. Sonstein, PhD

Clinical research is taking another step toward professionalization with the anticipated approval  of new “Standards and Guidelines for the Accreditation of Academic Programs in Clinical Research” by the Commission on Accreditation of Allied Health Education Programs (CAAHEP), says Stephen A. Sonstein, PhD, professor and director of clinical research administration at Eastern Michigan University. Sonstein is chair of the CAAHEP’s Committee on Accreditation of Academic Programs in Clinical Research, which developed the Standards and Guidelines.

According to the CAAHEP website, programmatic (or specialized) accreditation examines specific schools or programs within an educational institution (e.g., the law school, the medical school, the nursing program). The standards by which these programs are measured have generally been developed by the professionals involved in each discipline, and are intended to reflect what a person needs to know and be able to do to function successfully within that profession.

CAAHEP’s new clinical research–focused standards and guidelines for accreditation are part of a broader effort to recognize that the clinical research enterprise should begin to transition from primarily on-the-job training situations. Instead, those entering the field “require core academic preparation and competencies based on the recognition that clinical research is a standalone profession,” Sonstein says.

Sonstein will present two sessions at the ACRP 2017 Meeting & Expo related to competence in clinical research, including Core Competencies in Clinical Research: An Analysis of International Differences in Perceptions and Relevance, and Forging a New Path to Professionalism: GCP vs. Core Competency-Based Training. Come see where clinical research is heading in Seattle, WA, April 28-May 2. View Program & Schedule

ACRP 2017 Meeting & Expo

“This is a part of an important movement to standardize the education process via accreditation,” agrees Terri Hinkley, RN, BScN, MBA, CCRC, FACRP, the Workforce Innovation Officer for ACRP and a member of the CAAHEP committee.

The CAAHEP board is expected to endorse the new standards and guidelines when it meets next month. The final “Standards and Guidelines” document will be posted on the CAAHEP web page upon board approval. A review copy is available at

The approval will cap a two-and-a-half-year process with open hearings and discussions about the goals and content of academic programs in clinical research. CAAHEP hopes to begin offering accreditation services beginning in September, 2017.

For more information, or if your academic institution is interested in future accreditation, please email

Author: Michael Causey