17
Aug2017

PRIM&R invited members of our Emerging Professionals Working Group (EPWG) to write about topics of relevance to their work and to the research ethics community. We hope these posts open conversations among research ethics oversight professionals at all points in their careers.

“You are in the center of seeing the knowledge change. All of the flow of how we learn, how we experiment, and then how we implement what we’ve discovered ends up coming in some way through you...”

Dr. Atul Gawande,
2014 Advancing Ethical Research Conference keynote address on the
unique vantage point of IRBs.

The research enterprise is fueled by discovery, creativity, and innovation. IRBs are an integral part of this process. But when the privilege of conducting research meets the responsibility of ethical constraints, we face inherent challenges. Within the complexity and diversity of research across the disciplines, IRBs strive to construct infrastructure, standardize practice, and set goals for efficiency and effectiveness. Central among these challenges is the question of how best to train new IRB administrators for work that spans a vast and ever-changing multiplicity of research.

As a manager in IRB Administration, I’ve collected various tools and resources for my training toolkit, including OHRP’s decision trees, PRIM&R resources, conference slides, professional development resources, and scrawls and drawings in notebooks from meetings attended. While all of these materials are important, a pedagogical tool I have found particularly helpful for training new administrators has been the Socratic Method of instruction.

The spirit of the Socratic Method is interactive dialogue and questioning. Rather than giving the trainee direct answers, the trainer asks questions about the regulations and the protocol at hand. In this way the trainer guides the trainee to discover answers on their own. Through this dialogue, it can be particularly helpful to use analogies to hypothetical situations where details of the research protocols are different but applicable. Trainees are then asked to think through these issues for themselves and to consider the complex contours of how the regulations apply to different research projects.

This method helps new administrators test their assumptions and biases, while building strategies to navigate complexity. Here is a sample of types of questions that could be asked:

  • Background
    • What is the research hypothesis?
    • What are the methods?
    • Are there any risks?
  • Justification
    • What is the regulation?
  • Hypothetical
    • How would this look different if x was…?
  • Clarification
    • What do we know about x?
  • Assumption
    • What are our assumptions?
  • Reason and evidence
    • What would be an example?
  • Perspective
    • What would be an alternative?
  • Implication and consequence
    • How does x affect y?
    • Why is x important?
  • Question about the question
    • Does this make sense?
      • If yes, how?
      • If no, why?

Given the inherent dynamism of research, the unofficial slogan of IRBs is “It depends.” The Socratic approach helps develop an ability to recognize how and why “it depends.” Engaging new administrators with inquiry provides them with both time and space to build deeper understandings of their role in the research process. In its best form, this method fosters experiential learning, collaborative engagement, and critical thinking.

Through eliciting responses, whether it be answers or questions, the new administrator’s understanding and thought processes are revealed. This gives the trainer opportunities to address gaps in knowledge and comprehension. Moreover, respectfulness is critical to this type participatory communication. Modeling collegial and collaborative dialogue can reverberate throughout an office climate. The most rewarding experience I have found from engaging in this form of training has been when the pieces of knowledge align for the trainee. The trainee can then move forward with confidence in their ability to navigate the flux of “it depends.”

Tonya Ferraro is a Senior IRB Administrator at Harvard University.

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