Problems That Cause Delays in Research Ethics Approval and How to Solve Them
Securing ethics approval is crucial for any research project involving human participants, sensitive data, or animal research. It protects participants’ rights, safety and well-being while safeguarding the reputation of both the project and its institution. Committees like Human Research Ethics Committees (HRECs) must sign off on the project before work begins.
Delays in ethics approval can cause significant setbacks, including missed deadlines, issues with funding, and challenges in recruiting participants. There is also the potential for non-compliance with institutional or regulatory rules, which may draw extra scrutiny or even put your project on hold.
To avoid these problems, researchers, institutions, and committees should be aware of the common causes of approval delays and find ways to address them. Using OmniStar’s ethics management and compliance software helps to streamline ethics approval processes in numerous ways
Common Problems that Cause Delays in Research Ethics Approval
Obtaining ethics approval is a precursor to most research projects, yet many are affected by delays that impact associated timelines and budgets.
Incomplete or Inaccurate Applications
One major culprit that prevents the timely approval of an ethics application is a submission which contains multiple errors, missing documents, or mismatched information. When forms have inconsistencies or missing attachments, the ethics committee may need extra review cycles, slowing approval.
Non-adherence to Ethical Guidelines
Ethics committees must follow strict guidelines, including consent procedures and data privacy measures. If your proposal does not meet these benchmarks, it may require extensive revisions or even be turned down, delaying the process. OmniStar’s research administration and management software feature content validation and mandatory fields to reduce the chance of submitting forms that do not meet these guidelines.
Inefficient Communication Channels
Poor communication between researchers and the ethics review board or other reviewers can lead to multiple back-and-forth interactions. Unclear feedback or misunderstood questions often draw out the approval timeline.
The Committee-side Constraints that Cause Delays
While the focus is often on the applicant side, committee constraints can still lead to significant delays. Committees come up against challenges such as limited availability and the need to meet quorum requirements, slowing down review timelines. High volumes of submissions relative to committee staffing, manual agenda preparation and scheduling conflicts only add to the burden. Committees also often juggle multiple priorities that all compete for attention, such as new submissions, amendments and renewals.
By flagging capacity and process constraints, institutions are better equipped to manage the expectations of both applicants and committees. Collaboration becomes smoother, and timelines become more realistic.
Delays Caused by Amendments, Renewals, and Ongoing Oversight
After the initial approval, delays arise from amendments, renewals and ongoing monitoring of research. Common challenges include amendments that lack sufficient justification or clarity, which can trigger additional review cycles. Lapsed approvals due to missed renewal deadlines or failure to submit timely reports will also slow operations.
It’s not just larger amendments that create inefficiencies; repeated minor amendments will eventually accumulate and cause a cascading effect on approval timelines.
It’s important to plan for these delays by documenting any amendments and monitoring renewal deadlines. Ongoing oversight - including adverse event reporting and protocol deviations - must be consistently addressed to avoid further unnecessary delays.
Risk-based Review Pathways (Why some Approvals take Longer)
Not all ethics approvals are created equal. Low-risk submissions typically undergo a faster, expedited reviews process, while higher-risk research requires a full committee review, which naturally takes longer due to the additional scrutiny. It’s important to understand the differences between low-risk, expedited and full committee reviews, and most importantly why certain projects may face longer timelines because of risk.
By aligning the quality of submissions with the appropriate review pathway, researchers can create a smoother process that’s free from inappropriate or incomplete submissions.
Strategies to Avoid Ethics Approval Delays and Streamline Research Ethics Approval
Delays can disrupt funding and participant recruitment, but you can adopt practical steps to keep things on track. Below are key strategies to help researchers, committees, and institutions speed up approval times, cut revisions, and boost overall efficiency.
Upfront Planning that Prevents Ethics Delays
The key to avoiding delays is always proactive planning. From the outset of the study design, researchers should fully map out ethics requirements, align protocols and consent materials, and ensure data plans meet ethical standards.
Before submission, all core documents should be aligned and consistent, including protocols, consent forms, participant information sheets and data management plans. Inconsistencies between documents are a common cause of ethics queries and can quickly extend review timelines.
Pre-submission checks and internal reviews also play an important role in catching gaps or missing documentation before formal review. For multi-site or multi-jurisdiction studies, early coordination avoids delays caused by differing governance requirements.
Strong upfront planning reduces revisions, improves submission quality, and leads to faster, more predictable ethics approvals.
Ensure Application Accuracy
Using a modern ethics management system that enables the design and build of dynamic forms configured to allow data validation before submission provides applicants with immediate feedback and enables the correct information to be captured the first time. OmniStar’s SmartForms help ensure applications are complete and consistent by reducing the amount of manual effort required to validate, and showing only the relevant fields applicants are required to complete.
Align with Ethical Standards
Ethics committees rely on regulations like the NHMRC’s National Statement on Ethical Conduct in Human Research (Australia). Applications that deviate from or application forms that do not guide applicants to include these standards make review and approval of applications more challenging, leading to rejections or more review cycles. OmniStar’s SmartForms and audit tracking, combined with the inbuilt HREA (including state-specific modules) form ensure applications align with these requirements, and provide out-of-the-box review templates, automated compliance checks, and guided workflows.
Use Technology to Streamline Processes
Manual approaches, paper submissions and slow workflows can stall ethics approvals. Shifting to digital solutions and automation can cut waiting times and lighten administrative loads. OmniStar shares review tasks among committee members, automates annual report reviews, and eliminates manual intervention from administrators. This reduces errors and helps approvals move faster.
Transparency and Visibility as Delay-reduction Tools
On top of using technology to automate processes, delay reductions also come from greater transparency and visibility throughout the approval process. Real-time tracking of application status enables applicants and administrators to see where the process stands and what actions are required next. Clear ownership of next steps and centralised records of feedback and decisions help to avoid miscommunications, as well as reduce reliance on lengthy email follow-ups.
Improving visibility means smoother workflows, and that means a faster, more efficient ethics approval process.
Distinguishing Avoidable vs. Unavoidable Delays
You can’t avoid every delay, so it’s important to distinguish between the ones you can and the ones you can’t control. Some can be minimised with better planning, whereas some are inherent to the process.
Avoidable delays often stem from issues such as incomplete documentation, poor coordination, or missed deadlines. Unavoidable delays usually come as a result of structural factors, such as committee schedules, the need for risk-based review, or compliance with regulations.
Streamline Research Ethics Approvals with OmniStar
Keeping research projects ethical, on schedule, and within budget should be a goal for every institution. Manual errors and miscommunication can drag out approval timelines and delay research activities. OmniStar automates and simplifies ethics approval so applications stay accurate, compliant and processed efficiently.
SmartForms reduce errors in submitted applications, while streamlined workflows keep applications moving forward by automating review allocations amongst committee members. Notifications inform applicants of a change of status or next action pending on them. This helps your research team cut admin overhead and speed up approvals. Don’t let avoidable delays hold you back. Book a demo or contact us today to see how OmniStar can help you achieve faster, smoother ethics approvals.
In addition, you can learn more about ethics in research to ensure your project adheres to the highest standards.
