Ethical research isn’t just about designing sound studies and obtaining IRB approval—it’s also about ensuring the safety, dignity, and well-being of participants throughout the research process. When participants raise concerns or experience adverse events, how researchers respond can make all the difference.
Let’s start with some definitions:
- Adverse events are any unintended harm or risk experienced by a participant due to their involvement in the study. These can be physical (e.g., injury in a behavioral intervention) or psychological (e.g., distress from sensitive survey questions).
- Participant complaints can range from concerns about consent procedures, discomfort with study procedures, or dissatisfaction with how their data is handled.
In a perfect world, researchers wouldn’t have to deal with either of these scenarios. But in reality, being prepared to address them is critical. As an IRB ourselves, Viable Insights approaches these situations openly.
Our policy is that if there are participant complaints or adverse events, researchers must inform us. From there, we communicate with participants and assess how best to address the issue. These procedures aren’t about punishing or embarrassing researchers but ensuring participant protection and rights.
Researchers should share this goal. It fosters trust between researchers and participants and ensures compliance with ethical research principles and IRB requirements. It also helps prevent legal and reputational risks for research teams and institutions. And when researchers share this goal, it improves the quality of research by identifying unanticipated risks or issues.
Understanding the Role of IRBs
Institutional Review Boards (IRBs) exist to ensure research upholds ethical standards, particularly concerning participant safety, informed consent, and data protection. But their role isn’t limited to just approving studies. IRBs also help researchers navigate unexpected challenges like participant complaints or adverse events.
By engaging with your IRB throughout the research process, you can:
- Receive guidance on ethical dilemmas and how to handle sensitive participant concerns.
- Ensure documentation of adverse events for transparency and continuous improvement.
- Mitigate risks by having a structured approach to addressing participant issues.
Proactive Strategies to Prevent Complaints and Adverse Events
Rather than only reacting to participant concerns, researchers should take proactive steps to minimize risks and improve study experiences. Here’s how:
Set Clear Expectations in the Consent Process
Start by informing participants of their rights and how to raise concerns with the researcher or IRB directly. Provide a direct, responsive point of contact rather than a generic email address. You’ll also want to ensure consent materials are clear, accessible, and free of complex jargon.
Maintain Open Communication Throughout the Study
Regularly check in with participants, especially in long-term studies. You should also create opportunities for participants to share concerns, even if they are hesitant. And work to normalize feedback so participants feel comfortable voicing discomfort.
Implement a Rapid Response Plan
Designate a team member responsible for addressing participant concerns in real-time. It’s also a good idea to ensure research staff understands the protocol for handling complaints and adverse events. Lastly, keep thorough documentation to track issues and responses.If you need help with any of the above, we’d love to chat!
What to Do When an Issue Arises: Responding to Complaints and Adverse Events
Even with strong preventive measures, participant complaints and adverse events can still happen. Here’s how to handle them effectively:
Acknowledge the Concern Immediately
Respond promptly and show empathy. Let participants know their concerns are taken seriously and do your best to avoid defensive or dismissive language.
Assess the Severity of the Issue
Begin by determining whether the complaint is related to discomfort, privacy, or ethical concerns. Then evaluate if an adverse event caused physical, emotional, or psychological harm. Consult your IRB to determine the next steps if needed.
Document the Incident Thoroughly
Record details of the complaint or adverse event and track actions taken and any necessary follow-ups. Maintain confidentiality while ensuring transparency.
Take Corrective Action and Follow Up
Modify study procedures to prevent similar issues in the future and then offer additional support resources, such as counseling services. Keep participants informed about the actions taken to resolve their concerns.
If a participant experiences distress from a survey question, researchers could modify or add a warning before sensitive topics. Offering mental health resources also demonstrates ethical responsibility.
Strengthening Your Research Practices for the Future
The best researchers don’t just react to complaints—they learn from them. Here’s how to continuously improve your research approach:
Conduct Regular Ethical Audits
Periodically review study procedures to ensure ethical alignment and gather feedback from both participants and research staff.
Foster a Culture of Ethical Reflexivity
Train your team on participant-centered research practices and discuss past challenges to refine future studies. Stay informed on evolving ethical research standards.
Build Long-Term Relationships with Your IRB
Engage with your IRB beyond just approval processes and participate in IRB-led discussions on ethical research.
Ethical research isn’t just about compliance—it’s about fostering trust, protecting participants, and strengthening the integrity of your work. A participant-centered approach ensures both ethical responsibility and research excellence.
If you’re looking to enhance your research practices, we offer expert guidance. Let’s work together to ensure research that prioritizes both quality and participant well-being.