Maintaining compliance can be a time-consuming task for research teams, but it’s an essential part of any research project. From IACUC to IBC and IRB, the boards, committees, and protocols in place to support compliance ensure research is conducted safely and ethically, increasing its impact and protecting organizations from legal and reputational damage.
With researchers increasingly identifying inefficient processes and time constraints as major obstacles to effective operations, it’s more important than ever to consider how teams can reduce the time and effort spent on compliance-related tasks without sacrificing accuracy.
In this blog, we examine six key factors research teams should consider to promote better compliance and reduce administrative burden.
1. Improved Transparency
Too often, research teams inadvertently delay compliance and approvals through ambiguous, or overly complicated processes. When stakeholders don’t have easy access to the status of their submissions, researchers can’t determine how to plan and prepare for the procedures or request study space. For example, knowing that a protocol has been sent for full committee review sets the expectation that approval may take a few more weeks rather than a few more days.
A modern, electronic management solution can help increase transparency by centralizing documentation, submissions, and communications. While transparency is key, teams also need assurance that only the right eyes are on the right information at the right time. Role-based dashboards provide appropriate permissions to protect the privacy of a submission (or review) while maintaining transparency into the review process.
2. Proactive protocol management
An expiring protocol can halt your research, necessitating renewals to keep a project in compliance with ethics approval. Protocol review is, therefore, an essential part of research administration, even if it can feel redundant or time-consuming.
To help reduce the administrative strain from continuous protocol reviews, teams should establish reminders to help set a regular cadence for proactive reviews. Additionally, research administration software can flag expiring protocols and send expiration reminders weeks or months in advance to avoid last-minute emergencies.
3. Clear communication
It sounds simple, but clear communication can make the difference between smooth compliance management and arduous discussions that can delay research and feedback on semantics rather than compliance. When a protocol submission arrives missing essential information, it’s important that the request for revisions can get to the research team as soon as possible and that they, in turn, can revise and re-submit just as quickly.
To help avoid unnecessary delays, teams should make sure that everyone understands what they need to do to keep a submission moving forward, establish clear and effective communication expectations, and use frequent reminders to ensure nothing slips through the cracks. Research administration software can help support these strategies by automating notifications and providing digital infrastructure to keep your team organized.
4. Careful protocol submission
Nobody wants to find out their protocol submission was delayed or that revisions are required to keep it moving forward. That’s why it’s important to double-check all protocol submissions for accuracy and completeness before sending them out.
While an additional layer of review can be time-consuming, it can save significant time by avoiding revision requests or, in a worst-case scenario, non-compliant research. Specialized research software can reduce the workload involved in protocol reviews by automatically flagging missing information that may not be caught during a manual review.
5. Checklists, checklists, checklists
Sometimes the simplest solutions are the most effective. Something as straightforward as a physical checklist can help to mentally keep track of tasks and requirements during protocol submissions and reviews.
Even if you would prefer not to keep individual checklists for each submission, it’s still a good practice to develop checklists for essential tasks to reference as needed and keep administrators and reviewers aware of the most important steps for approvals. Just having a visual reference with these requirements laid out can help your team stay on-task. Research Administrative SaaS solutions can provide you tools to enable reviewers to provide thorough, accurate reviews. The checklists are also a tool to help guide new committee reviewers on what to look for during a review.
6. Verified staff training
All research staff must complete training on HIPAA, bloodborne pathogens, radiation, chemical waste, and other areas based on their position before starting work. This training must also be renewed annually to ensure continued best practices and compliance.
Tracking staff training and reminding them when renewals are required will help keep your team up-to-date and protected from audits and fines. While ideally, individuals should be aware of necessary annual certification deadlines, training software designed for researchers can help automatically track training statuses and send notifications when action is required for recertification.
