Title: “Expedited” Expedited CHR submission and approval for Chart Review Research (Category 5)

Rationale: Clinical researchers often perform retrospective, chart-review studies as a relatively inexpensive and quick way of determining which clinical questions are worth pursuing before engaging in more expensive, time-consuming prospective studies.

Chart-review studies also play a critical role in developing and generating new scientific hypotheses, and their role in the hierarchy of research methodologies is indispensible.  For junior researchers, who often do not have much in the way of funding or protected time to do research, chart-review studies provide an essential way to get early experience doing research. 

Chart review studies qualify for expedited CHR review under federal regulations, 45CFR46.110, Category 5.  Currently, however, the time and effort required to go through the process of expedited approval is substantial and serves as a deterrent to performing this type of research at UCSF.  The current UCSF CHR form for an expedited chart review (Category 5) study is 20 pages long and empirically cumbersome to fill out.  An estimated 80% of the forms have to be returned to the researcher by the CHR for revision, and usually there are multiple iterations between the researcher and the CHR to correct the form before approval is given.  This back-and-forth is time-consuming and frustrating for both researchers and CHR staff, and slows the pace of research at UCSF.  While the CHR makes every effort to perform these reviews in an expedited fashion, the median time-to-approval for (all expedited categories) is 32 days, which is significant for a researcher who may have only a month or two protected to perform research. 

We propose to simplify and truly streamline the process for obtaining “expedited” CHR approval at UCSF for research projects that involve no-subject contact and are confined strictly to chart review (Currently under Category 5 for expedited CHR review).

It is noteworthy that in some jurisdictions, such as the United Kingdom, non-subject contact chart review to conduct an audit to reflect on one’s own practice is encouraged by the physicians licensing authority as an adjunct to continuing practice rights. Reflection on practice is an important part of continuing practice improvement. What is proposed here is, therefore, completely consistent with comparable demands around such activities in other places.

Plan:

In a direct collaborative effort between UCSF clinical researchers from various specialties and the UCSF Human Research Protection Program staff, we plan to develop a highly streamlined online application form for applying for CHR approval for Category 5 chart review studies. With this unique collaboration, this project is “shovel-ready.”

The questions on the form will be clearly written and focus-group tested to ensure they are easily understood even by novice researchers.  This is to ensure that the form can be completed quickly, optimally in less than fifteen minutes, and accurately so that iterations wherein the CHR has to return the proposal to the researcher for corrections are minimized.  The streamlined form will also be easier for the CHR to review, which should allow for a truly expedited review process and approval.  Internally, the CHR plans to have these forms handled by a consistent small group of analysts so that they can build familiarly with the forms, trouble-shoot efficiently, and keep approval times down. The form will also have clear and simple screening questions to ensure that such proposals truly do fall under the Category 5 designation.

 This proposal will satisfy the Federal Common Rule that requires the conduct of human research receive IRB approval prior to the initiation of the research, as well as the HIPAA requirement that a privacy board, in this case the CHR, reviews the study proposal prior to using Protected Health Information for research.

As part of this project we will develop a new reports within iMedRis that can provide the average and median number of iterations (submission rounds) required for approved research, with filters for application type, submission type, type of research, type of funding, time period, investigator, IRB panel, and HRPP analyst.  We will also enhance other reports of time-to-approval, and add a measurement of the time it takes investigators to prepare a CHR submission.  With these reports we will be able to compare data from current Expedited Category 5 approvals, to data from the new form we generate, and measure improvements in several ways.  Note that these reports will be permanent and can be used to provide UCSF better data on the IRB submission process for all research, including clinical trials.

Criteria and metrics for success:

Our proposal will have succeeded if at the end of the one-year implementation period we have:

1. Developed a concise online form that has been focus-group tested on clinical researchers and approved for use by the UCSF CHR for the purpose stated above.

2. Completing the concise form takes no more than fifteen minutes (on average), even for a novice, junior researcher (e.g. resident or fellow) in our focus-group testing.

3. There is a ≥50% reduction in number of iterations required to get CHR approval for these studies compared to current baseline for Category 5 expedited review studies (baseline iteration data to be generated by new reports within iMedRis). This would also have the indirect benefit of freeing up CHR staff time to focus on other categories of applications, hopefully improving approval times overall.

4. There is a ≥50% reduction in time to approval (measured in days) compared to current baseline for Category 5 expedited review studies (baseline iteration data to be generated by new reports within iMedRis). 

5. We have generated a report system that can be used by the UCSF CHR to provide better tracking data on the IRB submission process for all research done at UCSF, including clinical trials. 

Total Budget: $16,574

Salary support for project leader and research coordinator; two stipends for clinical research collaborators ; printing costs and supplies; focus-group participant compensation.

 Collaborators:

Amy Gelfand, MD (PI) : Dr. Gelfand is a child neurologist and a clinical researcher in pediatric headache. She will serve to oversee the project, including coordinating with the HRPP staff and clinical researcher collaborators, running the monthly research team meetings, and submitting study progress reports to CTSI.

John Heldens, HRPP Collaborator: As the director of the Human Resources Protection Program at UCSF, Mr. Heldens will oversee the iMedris and HRPP staff and supervise the form changes.  He will vet the new mechanism of CHR documention with Privacy, Legal, HIMS, and IT security.

Vanessa Jacoby, MD: Dr. Jacoby is a clinical researcher in OB/GYN at UCSF. She will attend monthly team meetings and give feedback on the form questions as they are being written and implemented.  She is familiar with the needs of clinical researchers who work with vulnerable populations (i.e. pregnant women), and who perform surgical procedures as well as outpatient and inpatient clinical care.

Vanja Douglas, MD: Dr. Douglas is an adult neurologist whose clinical research focuses on inpatient neurology.  He will attend monthly team meetings and give feedback on the form questions as they are being written and implemented. He is also a Journal Editor so will ensure that the needs of journal editors to be assured that research studies they are publishing received appropriate CHR approval are being met by the new submission and approval process.