Rationale: There is currently an unacceptably long delay in the time required to obtain study approval by the UCSF Committee on Human Research (CHR). The CHR must review and approve all studies involving human subjects performed by UCSF faculty, staff, or students. Studies with more than minimal risk to participants, such as trials of diagnostic tests or treatments, require in-depth review by a faculty-led committee, a process referred to as Full Committee Review. Currently, the average time from submission to approval of these studies is 84 days. This long wait time can be a major obstacle to implementing a new study by compromising grant funding, industry contracts, research staff support, and the general progress of science by UCSF Investigators.

The major source of delay in approval of Full Committee Review applications is the process of “returns”, wherein the CHR requests that the investigator make a change or modification to the proposal. Among initial CHR submissions, 75% are returned for modification by a CHR analyst because they are unacceptable for review by the Full Committee. On average, the investigator response to this initial return takes 16 days. When applications are returned to the investigator after a Full Committee Review, the average time for the investigator to respond is 21 days. Many applications have multiple returns that collectively increase the time required for CHR approval.

The aim of this project is to significantly decrease the duration of CHR approval time for Full Committee Review studies by reducing the number of applications returned to the investigator for revision. UCSF approval time for Full Committee Review is significantly slower than the national average; the national target is <42 days for the duration of the approval process. An intervention to minimize or eliminate returns could meet this national goal for CHR excellence.

Plan: We will work in collaboration with John Heldens, Director of the CHR, and CHR staff to develop effective strategies that decrease the number of Full Committee Review application returns. In 2011, the CHR conducted a review of 700 applications and identified several broad categories of common investigator errors. Using these data, we will focus on improving 2 areas that require frequent returns:

1. Administrative Errors: 50% of initial applications are either incomplete or missing required attachments. These returned applications result in significant delays because an incomplete application cannot be submitted to for Full Committee Review.

Improvement Plan: We will review 100 randomly selected applications returned for missing or incomplete components to identify the most common errors (e.g. missing consent form or incomplete investigator descriptions). We will then work closely with CHR staff and the iMedRIS administrator to develop interventions that minimize these administrative errors, such as programmed iMedRIS alerts that prompt the investigator to complete required sections and attach required documents. We will then use logistic regression models to evaluate the proportion of returned applications among 100 that use the new interventions compared with 100 applications submitted with the current iMedRIS format.

2. Content Errors: The second most common cause of returns is significant deficits in the content of the application such as an inadequate description of study procedures or the data safety and monitoring plan, or an incomplete explanation of the study population or recruitment procedures.

Improvement Plan: In collaboration with CHR staff, we will create a “Content Score”, a summary score that reflects the overall quality of the application in terms of key content areas that when insufficiently addressed put the application at a high risk for return. To validate the use of the Content Score, we will use linear regression models to determine if a poor Content Score is associated with slower time to CHR approval among 100 randomly selected applications. We will track these applications for the number of returns, length of time for investigators to resubmit after each return, and the total number of days before CHR approval.

If the Content Score proves to be predictive of time to CHR approval, we will use the Content Score to develop targeted interventions to minimize returns. Possible strategies might include notifying investigators with poor Content Scores that there is a 90% likelihood of a return and recommending further review of specific sections prior to Full Committee review, or incentivizing investigators to provide high quality applications by allowing those with favorable Content Scores to be prioritized for review.

The Content Score will also highlight commonly misunderstood sections or questions of the CHR application. This will facilitate the development of targeted changes in the iMedRIS application to improve investigator responses and subsequently reduce return rates. Possible iMedRIS changes include questions being re-phrased or re-formatted, showing quick links to examples of high quality responses, or including links to other sources of information and help. 

Criteria and Metrics for Success: We will evaluate the success of our project based on significant changes in the time for CHR approval of Full Committee Review applications. In the first 3 months after completing the interventions developed in this project, we will calculate the proportion of applications with administrative errors, the mean number of returns per application, and the total time for CHR approval of all Full Committee Review applications. We will then compare these outcomes to all Full Committee Review applications submitted in the 3 months prior to initiating the new interventions. Metrics of success will be:

1. A decrease in the proportion of applications with administrative errors to <20%
2. A 20% decrease in the proportion of applications returned for content errors
3. A decrease in the total time for CHR approval to <43 days

Budget: We request $50,000 to complete this project. The project involves significant data collection and analysis and iMedRIS programming and testing. Funds will be used to support a programmer/analyst to store, clean, manage and analyze data. Additional funds will support 5% effort for the clinical investigators, 2 CHR analysts, the iMedRIS adminstrator, and the CHR Director. These key personnel will work together to develop and test effective interventions to decrease CHR approval time.

Collaborators: Vanessa Jacoby, MD, MAS will be the principal investigator for this project. Dr. Jacoby is an Assistant Professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences with a clinical research program focused on surgical treatments of common gynecologic conditions, such as uterine fibroids. She has advanced training in clinical research methods and has conducted multiple studies requiring Full Committee Review. Dr. Amy Gelfand, MD is a Clinical Instructor in the Department of Pediatric Neurology with clinical and research expertise in the care of children with chronic headaches. Dr. Gelfand is currently leading a project to simplify the CHR application process for low risk chart review studies. She will apply her expertise and experience from this project to assist Dr. Jacoby in completing the current proposal. John Heldens is the Director of the CHR with a focus on decreasing the number of returns among CHR Full Committee Applications. Dr. Jacoby and Dr. Gelfand have collaborated with John Heldens, the director of the CHR, on previous projects and they will work closely with Mr. Heldens on the proposed project as well.