Teaming up with the IRB: The Power of Collaboration

The question kept nagging inside my head, “How can I best help others?” When the pandemic began, I was overwhelmed with a deep desire to serve. I became a physician to help others, and here I was, at the onset of this international health crisis, working on analyzing results from my prior clinical research projects and caring for my patients with headache, but not directly on the frontlines caring for COVID-19 patients. Schools had just been shut down at the state level, and local quarantine orders were advising working from home as much as possible. As I was contemplating my next steps, I went into my office early on Sunday, March 15^th to bring home essential supplies so that I could conduct my research from home. Although the parking lot was nearly deserted, I recognized the familiar cars of several senior administrators. I envisioned them meeting behind closed doors to discuss our hospital’s pandemic strategies. With my degree in public health, I considered searching for the room where they were meeting to charge in and volunteer my services. I imagined being greeted with joy and gratitude at the assistance I was offering. I quickly realized my vision of aiding could be viewed as barging in un-invited on a senior-level meeting, obtrusively interrupting important planning. I opted to defer that option. Rather, I recognized I needed to find concrete opportunities to use my expertise to help in specific ways.

Later that day, I emailed an Italian colleague and friend. As headache physicians and mindfulness researchers, we had bonded at a scientific meeting in 2019. I reached out to check on her given the dire circumstances in Italy, and she explained how she had started offering online mindfulness classes through “Mindfulness for Milan,” to support the public in managing the stress and anxiety during the lockdown. A light bulb went off inside my head. As a trained mindfulness instructor, I could offer mindfulness to my patients. The emotional toll of the pandemic was overwhelming, and I was especially concerned about my patients with migraine, as stress can be a common migraine trigger. Inspired by my Italian friend and colleague, I decided to begin leading my patients in online mindfulness sessions. Further, as a clinician researcher, I also wanted to know if these sessions were of value, and if so, would participants want additional sessions?

I felt an urgent need to provide this help as rapidly as possible. When this pandemic began, it felt like the crisis would only last a few weeks, and I wanted to ensure this service was available promptly. So many were suffering, and this plan was a palpable way I could use my expertise to support others. Although the idea arose in wanting to serve my patients with migraine, I quickly realized that it did not need to be exclusive to migraine and could benefit anyone interested.

I began working on the IRB protocol and the plan of action. Given the need for social distancing, I wanted the entire study to be conducted online and remotely, so patients could feel safe participating in the comfort and safety of their own homes. I had recently conducted a study with an online educational session for patients, and had embedded REDCap surveys before and after the online session to capture pre/post data. Although initially I thought I would lead the mindfulness sessions live-online, I realized that having the session pre-recorded would allow pre- and post-surveys to be completed online, similar to my prior study and ideal for capturing immediate pre- and post-session responses.

As my plan unfolded, a multitude of questions began to emerge on how to conduct the study in the most ethical way possible. For example, without any in-person contact but with an active intervention, what was the best way to obtain informed consent? Further, with the entire study conducted remotely, could I share the information broadly with colleagues at other institutions so that they could share this offering with their patients as well, or would they need an IRB in place as well? Since the study was online, could I advertise nationally, and possibly even internationally? Could anyone interested participate, or did the study have to pertain to a clinical population? I did not even know the active state of our IRB, with everything shutting down in the midst of the quarantine. Moreover, if operational, would they be available for the rapid approval of this study that I was seeking?

The next day, Monday morning, March 16^th, I reached out directly to our IRB director, a reliable and resourceful leader whom I had come to know over the last 8 years at my institution as someone always ready to offer assistance. I wanted to ensure full clarity with these nuanced questions from the onset to ensure a smooth IRB process and rapid approval. I received an immediate response that the IRB office was open, operational, and studies related to COVID-19 were receiving top priority. I received swift responses to all my questions, with specific recommendations and concrete advice. For example, as long as other providers at other institutions were just acting as referral agents, they would not need a separate IRB. The informed consent form would be online prior to the pre-survey, and they helped me draft a full consent with all the appropriate language, but concise enough to be effective in an online environment. I could define eligibility as anyone interested in participating in the mindfulness session, without any exclusion criteria. I could recruit internationally. As I worked through the online IRB submission process, I encountered several additional challenges, and with each issue, I received prompt support. Although no one was working in their hospital offices, our IRB officers communicated rapidly via email and provided home office numbers for availability. As I was finalizing it, I was told they were anticipating my submission. Such efficient responses and anticipation made me feel like we were working on the same team, side-by-side, all of us together versus the sideline clock ticking.

By that Thursday, March 19^th, my initial submission was complete and it was in the hands of those at the IRB. At most institutions, for a full protocol initial IRB review, I would be expecting at least a 2-week turnaround. However, for this study, I received the first round of feedback by Friday, March 20^th. Given the oncoming weekend, I reached out that Friday afternoon and spoke with the IRB director himself over the phone to clarify further issues. One of the challenges was that the study needed to be registered on clinicaltrials.gov prior to IRB approval. Our institution had recently instituted a new program to support investigators with this registration process, and someone had already started this process for our study! I communicated directly with this kind and supportive person, even speaking on the phone over the weekend, to comply with this protocol. By Saturday, March 21^st, our study had received expedited IRB approval.

I was filled with joy and amazement! My research study had moved from a floating idea in my head to IRB approval and study implementation within 7 days—what would be astonishing during normal times, and nearly heroic in the midst of a pandemic. While the world was “shutting down,” our IRB was gearing up. I felt like our research was valued, my goal for rapid turnaround understood, and my voice appreciated. I was able to communicate directly with the IRB team and received speedy responses to all inquiries. Further, the awareness of the need for COVID research and its priority at our institution created an environment that allowed for a multitude of important COVID projects to be initiated and conducted.

The IRB was originally created to protect patients in the midst of horrific unethical research practices. Unfortunately, over the years, many researchers have often felt like IRBs can hinder research. Slow responses, delays in providing feedback, and a multitude of forms and amendments can sometimes feel like dramatic administrative burden to the successful conduct of research. Conducting this research study in the midst of the pandemic gave me a newfound respect for our IRB team. The entire experience made me feel like we were working side-by-side, with the same goals in mind. Our IRB’s approach was to ensure that our study was conducted with the highest ethical rigor in a transparent and seamless fashion, providing support along the way to facilitate its success.

We found very powerful and encouraging results from our study (currently under review for publication). Our goal had been to recruit 200 participants, and we surpassed our goal with 233, including 20 international participants. We were able to target patients with migraine, but also over-worked health care workers and the general public. We found significant improvements in momentary stress, anxiety, and COVID-19 concern from our single mindfulness session, and most participants wanted more sessions. Given the study was inspired by a colleague helping others, we asked participants what they were doing to help others, and were overwhelmed with the positive responses of acts of kindness.

Garnered with this information, I proceeded to lead 13 weekly mindfulness sessions over the summer, and received positive feedback of its value in people’s lives during a time of such uncertainty. The pandemic has been an overwhelmingly stressful time, and we wanted to provide a program to target the emotional well-being during this crisis. In the process, we also discovered that the pandemic has created an enhanced sense of altruism. Having the support of our IRB during this time created a smooth and efficient process that aided the success of our research. Using my skillset and expertise to serve others through clinical research in the midst of this pandemic has been extraordinarily meaningful and allowed me to respond to the question that so many have asked at this time of crisis, “How can I best help others?”