I *Heart* Paper–Technological Advances and Human Subject Research Protection Programs

While attending the 2021 Advancing Ethical Research Virtual Conference (AER21), I had the opportunity to join several breakout sessions that touched on the unavoidable impact of technology on human subjects research—sessions like the Ethics of Artificial Intelligence (AI) Research and conducting Virtual Research, and others highlighting subtopics ranging from electronic IRB records management systems to eConsent.

These topics encouraged attendees to view cutting-edge tools in new ways and promoted real-world suggestions to embrace existing available technology, while preserving the highest standard of regulatory compliance and ethical protections of participants. Moreover, the speakers offered practical ways for researchers and IRBs to evaluate how these elements are appropriately integrated in the design of the virtual or AI tools, or how researchers or participants are intended to access and use them. 

As I sat in these sessions, I thought about how challenging it is to embrace change. 

Years ago, I attended a conference and a vendor handed out a small white button with the NYC-style logo designed by the late Milton Glaser in 1976, co-opted to read “I (heart symbol) Paper.” Nothing resonated more deeply with me at that moment! My previous institution’s animal care and use program had just successfully completed the transition from paper protocol records and IACUC meeting management documents to an electronic, web-based platform. But oh, the piles of paper that still existed. Today, as an IRB Coordinator at a different institution, also utilizing an electronic, web-based platform, I still proudly display my button at my desk as a nod to the place paper has in our “electronic world” of research!

Technology and automation may pose an inherent element of fear and unfamiliarity. The concept of change may be especially challenging to the deep-rooted paper trail practices in the field of research, no matter the phase (human subject, animal, or in vitro). “Document, document, document” is the mantra, right? Often, for seasoned members of the research community, the hard-copy tangible paper-trail records cannot be easily replaced. These days, there is much less reliance on paper, but there is still paper nonetheless. 

The speakers and discussion at the conference picked up on the notable shift for research institutions (and researchers) to be more open to integrating technology as the COVID-19 pandemic hit, triggering most research activities to go remote or be paused entirely. In my own experience, with the technology we already had available or were quickly able to onboard (electronic IRB platform, virtual meetings), our office had the ability to shift “in the moment” with minimal impact on how the IRB staff or members carried out our regulatory and ethical duties, or how we served the researchers at our sites and participants by extension. 

No matter the upheaval in the world, all regulatory, institutional and ethical requirements for reviewing or conducting research remained the same (including, but not limited to, conduct of IRB reviews and determinations, demonstrating ongoing human research protections, consent processes, HIPAA compliance, data safety).

As we embrace these changes, it seems that paper still fights for a place of value. So when (if ever) will a hard-copy paper research tool be considered an entirely outdated practice? Will paper always be a practical fail-safe method (primary or backup) to ensure no technological “hiccup” triggers your program to be out of compliance? I’m excited to continue to participate in the discussion on paper and technology, and thankful for the AER21 sessions facilitating these topics.

Rebecka (Becky) Snyder is the IRB Coordinator for Ascension Healthcare in Wisconsin, one of the leading nonprofit and Catholic health systems in the United States. She has been with Ascension Wisconsin for three years, first as a Regulatory Specialist for industry-funded clinical trials and then as the IRB Coordinator for almost two years. She also served as the IACUC Coordinator at the Medical College of Wisconsin for about eight years, with a brief pause on her professional career in between to enjoy four years as a stay-at-home mom to her wonderful son.

Save the date for the 2022 PRIM&R Annual Conference, taking place November 14-18 in Salt Lake City, UT (with a virtual option). This conference will continue to provide all the benefits of PRIM&R’s IACUC and AER conferences, bringing both the animal care and use and human subjects protections communities together under one roof to better support the field and our constituents in thinking holistically about the research continuum and achieving our shared goal of advancing ethical, responsible, and high-quality research. Information about registration packages and rates is now available online and registration will open this summer.