An informal audit summary
In response to many concerns raised by PIs across the Health Sciences Center, the Office of Research and Graduate Education has undertaken an informal audit of regulatory requirements associated with basic science laboratories at the HSC. In partnership with the offices of Research Integrity and Compliance (ORIC), Environmental Health and Safety (EH&S) and the HSC Information Technology Services group, we identified reductions in the scope, frequency and length of several requirements, while still ensuring compliance with federal, state and local regulations. The following summarizes outcomes of this audit to date.
I. Office of Research Integrity and Compliance
a. Conflict of Interest. CITI training for Conflict of Interest in Research must be completed every four years, and a brief Disclosure of Interest in Research form is submitted/updated annually. The first two sections ONLY of the CITI Conflict of Interest training modules are now required – Financial Conflicts of Interest: Overview, Investigator Responsibility and COI Rules, and Institutional Responsibilities as they Affect Investigators. The remaining three sections are considered OPTIONAL. This represents a reduction from three required modules to two.
b. Animal Care and Use. Researchers complete a subset of CITI training modules that are directly relevant to their research program and the species employed.
i. The number of required modules for Behavioral Researchers, Biomedical Researchers without Surgery, and Biomedical Researchers with Surgery were reduced by 50%. Refresher versions of these trainings are required every three years.
ii. Note also that in 2015 and 2016 the IACUC implemented multiple changes to the protocol submission and review processes that represent a significant reduction in the burden placed on PIs. For example, routine semi-annual laboratory inspections are only conducted where survival surgeries or terminal procedures are performed, or if the PI works with USDA-regulated species; annual reviews are only required for protocols that involve USDA-regulated species; literature searches for alternatives to painful/distressful procedures are only required if category D or E procedures are performed on USDA-regulated species; more protocol reviews are eligible for review by designated members rather than full committee, reducing the time needed for approval; several sections of the protocol forms were streamlined and appendices shortened or removed.
c. Human Subjects Research. During this audit, ORIC identified numerous IRB training modules that are not required by law. Specifically, Biomedical Research Investigators are now required to complete nine training modules (instead of 14). Refresher trainings for these investigators have also been reduced to six required modules (from 13). For Social and Behavioral Researchers, one module in the original training, and five modules (out of 13) in the refresher training are no longer required.
II. Environmental Health and Safety
d. Three comprehensive laboratory safety training modules previously required on an annual basis are now required upon initial hire, and subsequently ONLY if necessitated by changes to the research program, or identification of deficiencies in the laboratory. These modules are Hazardous Waste (RCRA), Hazard Communication and Laboratory Safety. Annually, PIs are required to read, and confirm their compliance with, a set of key laboratory safety principles. This change is expected to result in a significant time savings for established PIs.
III. HSC Instructional Technology
e. IT security awareness training is still required annually, however the training slide set has been reduced considerably (from 24 to 14 slides). One can also opt out of the training module and proceed directly to the quiz module.
IV. Streamlined workflow for researcher access to Epic electronic health records
f. Mallory Weaver (firstname.lastname@example.org) in the HSC Office of Research and Graduate Education coordinates requests for Epic access for research purposes, and ensures termination of access at project completion. She works with a Review Team and the HSC IT office to verify that requestors hold an active IRB-approved protocol and have completed HIPAA training.
We are committed to identifying additional means to move toward more efficient compliance with regulatory guidelines. As always, we welcome your input.