Research involving human and animal subjects can involve serious risks to the subjects themselves. Failing to conduct research involving human and animal subjects in adherence to laws and guidelines not only places subjects at serious risk, but institutions and investigators as well. Keeping in compliance with ever-changing guidelines requires mountains of paperwork and can lead to a slow review and approval process — if you’re not prepared.
The biggest challenge for an institutional compliance office is protecting the human and animal subjects involved in studies. That entails making sure everyone is following all the rules and regulations from the federal and state governments, as well as any local and institutional policies. All decisions and actions of the compliance review committees and all communications between investigators and the compliance office must be documented, which can create a very taxing process for compliance officers and investigators.
Many institutions still rely on paper systems for applications, approvals and reviews, which means a cumbersome workflow that slows the approval process. The sheer amount of paper involved can be enormous. Some individual studies may require reams of paper, so annual printing and document storage bills can grow exceptionally high.
Investigators rely on their compliance offices to process their materials quickly, so they can get down to the important business of conducting the research. With an electronic system like Cayuse IRB, compliance offices can do that much more effectively.
At the start of the compliance process, electronic systems use form builders for protocol submission, which lets research administrators create forms customized to a given institution’s needs and the nature of the study to be conducted. The forms ask only those questions relevant to their institution’s policies and the study’s requirements, eliminating time wasted on irrelevant questions.
Going electronic also means your compliance processes are suddenly much more transparent—both the compliance office and the investigators can track the progress of studies through the review and approval process. Meeting minutes and agendas can be created right in the system, then formatted properly without having to be copied into a file or a secondary system. Tasks like documenting the review process for protocols can also be done in real-time within the system, so keeping track of communications between the investigators and the compliance committees is easy and efficient.
Board members can review and approve protocols right in the system and see all notes and comments on a proposal in one place. Plus, with a cloud-based eRA system, this can be done anywhere at any time, which is especially helpful when investigators and board members are on the road.
Since approval to conduct research studies needs to be renewed at least annually, electronic systems also keep track of and send notifications about upcoming renewal dates. Catching these deadlines on time eliminates the chance of a study slipping out of compliance and risking harm to the study subjects.
No compliance office can run without good communication. Keeping all the information about a study in one system makes it much easier for research staff and compliance officers to stay on the same page. The transparency of electronic systems means approvals can be processed more quickly and makes the entire process more efficient and streamlined.
Of course, an electronic system alone isn’t a cure for all compliance headaches. But adopting an electronic system will free employees from hours of paperwork shuffling and do the documentation for you, so your team can get on to the important thing: research.
What other tools or practices does your compliance office use for improving efficiency? Tell us in the comments below.