It’s no secret that researchers don’t exactly love to talk about compliance. While a necessary step for any research project to ensure funding is secured and ethical standards are maintained, compliance is often seen as a time-consuming process involving lots of red tape and back-and-forth conversations between PIs and reviewers.
Healthcare research teams in particular face several obstacles to seeking compliance approvals. In this blog, we’ll review some of these challenges and how technology can help ease common headaches.
Time constraints
We know that physicians and clinicians wear many different hats in their daily responsibilities, from caring for patients and keeping up with the latest research and diagnostic care, to mentoring new clinical researchers. Healthcare professionals also often work long or irregular hours with unpredictable disruptions. This leaves little time to manage the administrative side of research projects they may be working on, and can limit access to certain on-site facilities or documents required to keep research moving.
Time constraints can be particularly frustrating when dealing with submissions to the IACUC, IRB, IBC, and other ethics committees. When a PI’s time and access to resources is limited by the requirements of their daily work, the back-and-forth communications involved in preparing, submitting, and amending compliance submissions can drag on much longer than anticipated. Limited time for research administration can also compound the other challenges covered in this blog.
Security concerns
While paper documentation and manual approval processes continue to decrease in popularity in favor of digital communication methods (e.g., email, collaborative messaging apps), many teams still rely on paper files for submitting and managing research compliance documents. However, paper documents — especially those containing sensitive information like confidential review notes, ethics committee meeting minutes, or even intellectual property — present a substantial security risk and can be stolen, lost, or damaged without proper storage and management.
Digital communication methods such as email can eliminate some of these risks but are still vulnerable to security breaches ranging in sophistication from attacks on IT infrastructure to inadvertently sending sensitive information to an incorrect email address or someone without proper viewing authorization. While many digital security concerns are monitored and addressed by an organization’s IT department, individual physicians and clinicians must be cognizant of potential vulnerabilities, especially when submitting sensitive compliance information across email.
Ineffective communication
Email ensures message delivery to the intended recipient, but conversations can easily become disorganized in overloaded inboxes, missed CCs, or multiple branching threads from a single request.
Ineffective communication and version control challenges can be very frustrating when working through compliance submissions, revisions, and approvals. Both researchers and reviewers need to stay on top of all submissions and respond to emails as soon as possible to ensure a project can move forward without delays. However, time constraints in healthcare environments mean that simple back-and-forth communications could take upwards of 24 hours, depending on when a recipient has time to check their messages and appropriately respond.
Training new hires
Everyone is new to their role in research at some point in their career, and gaining familiarity with the processes and nuances involved in managing compliance submissions doesn’t happen overnight.
New researchers take time to onboard, but as we already covered, clinicians and physicians often don’t always have enough time to mentor new team members through compliance submission processes. Because mistakes in submissions can take additional time to correct, it is important to make sure new researchers feel comfortable and confident in their responsibilities through more effective training documentation or forms that can guide them through submission to a successful review and approval.
Similarly, onboarding new research administrators and ethics committee reviewers can be daunting and time-consuming. Having guidance within forms and reviewing documents will empower reviewers to provide thorough, accurate feedback to researchers the first time, thereby reducing delay in approval.
Lapsed approval
Securing compliance approval is just one step in the research process. Once approval is secured from your IACUC, IRB, IBC, or other compliance board or committee, teams have a limited amount of time to complete their research before this approval lapses.
While expired compliance approval doesn’t signal the end of a project, it does mean additional time spent re-securing approvals so the project can continue. With this in mind, researchers need to ensure approvals are renewed as soon as they are in danger of lapsing to keep their projects moving without unnecessary delays.
Modern technology for managing compliance
Fortunately, Cayuse’s compliance solutions like Human Ethics (IRB), Animal Oversight (IACUC), and Hazard Safety (IBC) can help healthcare research teams avoid these common pitfalls and reduce administrative time spent on submissions, approvals, and revisions.
Always available: All Cayuse research solutions utilize a cloud-based digital platform and role-based logins, so PIs and research administrators can access and manage their projects even when working remotely.
Secure access: Role-based dashboards ensure that sensitive information is only available to those who need it, reducing the risk of security breaches. Cayuse is also SOC 2 and ISO 27001 audited and has a GDPR/CCPA-compliant data privacy program.
Better communication: Our dashboards allow for filtering by PI names, submission types, status, title, expiration dates, and more at any point so nothing can get lost, while notifications ensure submissions, revision requests, and approvals are easily visible as soon as they are available. Configurable, digital forms also meet the unique needs of your organization and ensure submission accuracy. Guided forms help researchers provide well-informed and complete responses, while on-screen checklists offer relevant feedback to support the onboarding of new reviewers.
Easy-to-use: Built-in version controls ensure that consent forms, recruitment statements, and documents are the correct versions that need to be processed and approved. Built-in checklists ensure that even new ethics committee members know what to look for in the review process.
Keeping you informed: Automated notifications alert researchers when their approvals are lapsed or nearing expiration, with built-in alerts when studies are 30, 60, or 90 days out from lapsing ethics approval.
