37 - Navigating Ancillary Compliance Requirements During the IRB Review Process

Background:  Certain human subjects research studies must satisfy ancillary compliance requirements. For instance, an evaluation by the campus Laser Safety Committee is compulsory for studies involving non-ionizing radiation. Navigating through ancillary reviews can be daunting for investigators and holdups can impact the IRB review process and ultimately when research can begin.

Program

Description:  Although investigators are ultimately responsible for complying with applicable compliance programs, our IRB office assists researchers in navigating the process to ensure adherence to the broader regulatory requirements.

In partnership with institutional ancillary departments, our IRB office created the following processes to help researchers avoid overlooking additional compliance requirements:
1. Inform investigators of additional time required for reviews from ancillary committees.
2. Develop SOPs to ensure IRB staff follow consistent steps.
3. During pre-review, notify ancillary committees of the nature of the research. This helps to prompt early discussion among stakeholders.
4. Provide authorized ancillary committee personnel access to the online application system, where they can provide comments on recommendations for approval.
5. Where possible, add pertinent questions to the IRB application form to ensure compliance with other departmental requirements.

Methods involved in assessing whether the processes described above achieved their goals include reviewing turnaround times and evaluating compliance accuracy.

Program

Assessment:  Program assessment highlights:

1. After the new COI review process was created and implemented, it greatly reduced the approval time for IRB protocols involving potential COIs. In addition, it reduced the back and forth previously needed between the IRB Analyst and the COI Coordinator.

2. Following previous confusion between our office and our intellectual property office, the Office of Technology Licensing, we met with OTL representatives to go over the process and to give them guidance on what information they should be asking researchers to provide. Following these discussions, OTL created a detailed process and established a questionnaire to be sure they were gathering the correct information. This process is now streamlined, and confusion is reduced.

3. Other examples include, but are not limited to, our standard operating procedures associated with ancillary health and safety reviews, including use of magnetic imaging equipment and laser use and safety, data safety and monitoring evaluations, and third party contract evaluations.

Data regarding frequency of ancillary reviews will be collected and displayed in table form.

Limitations: Depending on the ancillary compliance process required, IRB staff may need to prompt researchers to take action. While we have developed SOPs and standard statements, this need to remember to alert researchers may lead to human error. Not all ancillary review channels are captured by the online application system, and so there is not a full-proof mechanism to ensure compliance. Additionally, if the responsible party is unable to take timely action, delays may be encountered.

Discussion:  Each institution has their own ancillary compliance requirements, and examples of our processes and SOPs could be helpful to other institutions. Suggestions for implementation at other sites include adding pertinent questions to their IRB application forms, opening lines of communication with other ancillary review departments, creating standard statements to guide researchers, conducting educational outreach, developing SOPs, etc., all with the goal of reducing the chances of additional compliance requirements falling through the cracks.

With these processes in place, we also hope it will create better awareness on PI’s part to be proactive when it comes to the compliance requirements involved.