OVPRI Human Subject Research Protection Blog

The VCU Human Research Protection Program is dedicated to facilitating ethically and scientifically sound research through robust review of research projects and through effective education and outreach to the VCU research community.

By Nyssa Towsley, MS, CIP; Education & Outreach Manager, Human Research Protection Program

The VCU HRPP recognizes that the process of undergoing IRB review can be a stressful experience for investigators. It is easy to become overwhelmed or feel defensive during an extensive external review process. Complex and heightened emotions can come with external review processes, including IRB review. Fundamentally, there is often a misunderstanding about the purpose of IRB review. The purpose is not to pass judgment on the merit of the research or the researcher. Rather, the purpose of IRB review is to facilitate the conduct of ethical and compliant research through an independent ethical and regulatory review. The IRB review process often assists investigators in operationalizing their research plans, thus ensuring risks are minimized and managed, thereby protecting participants, while also ensuring the success of the research project and the quality of the data it produces.

However challenging, the IRB review process is crucial, not only because it is an ethical and regulatory requirement, but because the IRB review process presents an opportunity for investigators, IRB members, and HRPP staff to engage in a creative, collaborative, and generative partnership. Together, we can achieve the shared goals of protecting participants and ensuring research studies at VCU are of the highest ethical and scientific quality.

The purpose of this article is to contextualize the feedback provided by the IRB, and hopefully provide a new perspective and framework for collaboration between investigators and the HRPP/IRB.

When the VCU HRPP/IRB interacts with investigators, we strive to:

  • Engage meaningfully with investigators to help build understanding and capacity around regulatory requirements and ethical standards
  • Build understanding around regulatory language and requirements, utilizing different methods of educating and explaining to meet investigators where they are at with their own knowledge and experience
  • Collaborate with investigators to creatively problem-solve when regulatory issues arise with study designs and plans
  • Provide clear and concise instruction regarding change requests and requirements from the IRB; working with investigators to ensure they understand requirements and change requests from the IRB so they can implement changes to the study and/or IRB application appropriately
  • Recognize the challenges faced by investigators during the research protocol and IRB submission development process, and engage with investigators from a place of empathy and good faith to address challenges together
  • Hear and appreciate feedback from investigators on how well we achieve these goals, with an eye towards continuous quality improvement, participant protection, and investigator satisfaction with the process

When investigators interact with the HRPP/IRB, we expect them to strive to:

  • Recognize that feedback from the IRB is not a criticism of the merit of the research or the researcher; rather, understanding that feedback from the IRB represents an investment in the success of a research project – meaning that research studies that are fully operationalized and designed in line with ethical and regulatory standards are more likely to succeed in the long term
  • Engage with HRPP staff and IRB members in a respectful and open-minded manner. HRPP staff and IRB members are your colleagues, and experts in their own fields and disciplines, who should be treated with respect and collegiality
  • Understand that there is no such thing as a perfect IRB submission. Even IRB members who submit research studies receive feedback and change requests on their IRB applications! Research involves many moving parts, and the purpose of external review is to ensure nothing is accidentally overlooked. This means feedback and change requests should not be taken personally, and should be seen as common and expected parts of the process
  • Proactively seek out help and assistance from HRPP staff and/or IRB members when something is not understood, is not clear, or when the process starts to feel frustrating. The HRPP can only assist those who proactively seek guidance and assistance and who come to the conversation in good faith, ready to learn and creatively problem-solve
  • Provide constructive and honest, but respectful, feedback on the process, so that the HRPP can continually improve its processes and investigator interactions, to maximize participant protection, efficiency, and investigator satisfaction

When investigators and the HRPP/IRB engage with each other in generative, collegial partnerships, participants are protected, and the research we conduct at VCU continues to be held to the highest ethical and scientific standards. When investigators, IRB members, and HRPP staff see IRB review as an opportunity to refine research projects through a collaborative process, we can shed our defensiveness and come to mutual understanding. When we do this, we make the IRB review process more transparent, effective, and efficient.

The Education & Outreach unit of the HRPP is dedicated to promoting this framework of collaboration between the HRPP/IRB and investigators, through education and training for the research community as well as for members of the HRPP/IRB. Investigators are welcome to request education and outreach activities and services from the HRPP at irbeducation@vcu.edu

Categories IRB Education and Training
Tagged ,