'Screening audit' as a quality assurance tool in good clinical practice compliant research environments.

BACKGROUND: With the growing amount of clinical research, regulations and research ethics are becoming more stringent. This trend introduces a need for quality assurance measures for ensuring adherence to research ethics and human research protection beyond Institutional Review Board approval. Audits, one of the most effective tools for assessing quality assurance, are measures used to evaluate Good Clinical Practice (GCP) and protocol compliance in clinical research. However, they are laborious, time consuming, and require expertise. Therefore, we developed a simple auditing process (a screening audit) and evaluated its feasibility and effectiveness. METHODS: The screening audit was developed using a routine audit checklist based on the Severance Hospital's Human Research Protection Program policies and procedures. The measure includes 20 questions, and results are summarized in five categories of audit findings. We analyzed 462 studies that were reviewed by the Severance Hospital Human Research Protection Center between 2013 and 2017. We retrospectively analyzed research characteristics, reply rate, audit findings, associated factors and post-screening audit compliance, etc. RESULTS: Investigator reply rates gradually increased, except for the first year (73% → 26% → 53% → 49% → 55%). The studies were graded as "critical," "major," "minor," and "not a finding" (11.9, 39.0, 42.9, and 6.3%, respectively), based on findings and number of deficiencies. The auditors' decisions showed fair agreement with weighted kappa values of 0.316, 0.339, and 0.373. Low-risk level studies, single center studies, and non-phase clinical research showed more prevalent frequencies of being "major" or "critical" (p = 0.002, < 0.0001, < 0.0001, respectively). Inappropriateness of documents, failure to obtain informed consent, inappropriateness of informed consent process, and failure to protect participants' personal information were associated with higher audit grade (p < 0.0001, p = 0.0001, p < 0.0001, p = 0.003). We were able to observe critical GCP violations in the routine internal audit results of post-screening audit compliance checks in "non-responding" and "critical" studies upon applying the screening audit. CONCLUSIONS: Our screening audit is a simple and effective way to assess overall GCP compliance by institutions and to ensure medical ethics. The tool also provides useful selection criteria for conducting routine audits.

Institutional Board Review for Clinical Investigations on Inflammatory Bowel Diseases: A Single-Center Study.

BACKGROUND/AIMS: The growing volume and the diversity of clinical research has led to related laws and regulations as well as the Institutional Review Board (IRB) approval process becoming more stringent. To conduct clinical research efficiently and while following regulations, information about the IRB approval process and feedback is important for investigators. This has yet to be studied. METHODS: We included 381 gastrointestinal disease research proposals (79 with inflammatory bowel disease [IBD], and 302 with non-IBD) reviewed by the IRB of Severance Hospital between January 2009 and December 2013. We retrospectively analyzed research characteristics including research risk levels, results of initial reviews, frequencies of continuing review, numbers of IRB comments, frequencies of IRB comments, and durations from submission to approval. RESULTS: Investigators' decisions on risk level were higher in the IBD group than in the non-IBD group (P<0.05). Results of initial reviews, frequencies of continuing reviews, the numbers of IRB review comments, and durations from submission to approval were not different between the two groups, but IRB decisions on risk level were higher in the IBD group (P<0.05). In subgroup analysis, the number of IRB comments from initial review on informed consent forms and procedures as well were quest of more information were significantly higher in the IBD group than in the non-IBD group (P<0.001 and 0.01, respectively). CONCLUSIONS: In Korea, rare diseases such as IBD require more information for the IRB process due to their distinct characteristics. IBD researchers should develop research protocols more carefully and make their research as subject-friendly as possible.