UW Information Technology

The UW’s Human Subjects Division adds eSignatures to a growing collection of administrative tools to help researchers ease their quest for volunteers

Two people sitting at a desk with a computer and smiling at each other.

Electronic signatures are becoming more common as legal barriers to their use are surmounted. At the UW, more than 60 departments or units are using eSignatures, the university’s official electronic signatures service.

By Ignacio Lobos

During a nice spring day earlier this year, Karen Moe’s office at the UW Tower was extra cheerful with the sudden appearance of balloons and flowers — gifts from colleagues who appreciated her efforts to streamline red tape that had been slowing University research efforts.

As director of the UW’s Human Subjects Division (HSD), she was among several leaders who supported a state bill that eliminated duplicative laws governing the release of certain records for research. The bill helped relieve some public institutions from burdensome administrative processes.

Karen Moe

Karen Moe
Director, UW’s Human Subjects Division

This is HSD at its best, always looking for ways to make its operations more efficient, and being more responsive to researchers without ever compromising the safety, rights and welfare of research participants. That is why last year, Moe jumped at the chance to work with UW Information Technology (UW-IT) to introduce electronic signatures to human subject consent forms. UW-IT offers the eSignatures service at no cost to UW departments.

On the surface, bringing electronic signatures to aid the work of researchers and chisel away at inefficiencies might seem uncomplicated. But it is.

The act of giving consent to participate in research is overseen by federal and state laws that rightfully protect individuals. Getting that signature, Moe said, is vital before any research involving human subjects can begin.

The problem is that getting a signature on a paper-based document can take a great deal of valuable time away from research, particularly more so when a study calls for numerous volunteers. By making electronic signatures available for some types of research, Moe’s office was seeking to widen the field of potential candidates, and making it easier for researchers to gain consent.

Researchers see value in electronic signatures

When UW-IT introduced the eSignatures service in 2017, principal investigators from multiple areas at the UW reached out to Cassy Beekman to talk about their research projects and if they could use electronic signatures to gain consent from human subjects.

“They wanted to do their consent forms electronically, but we quickly discovered that giving consent via electronic signatures was quite complex,” said Beekman, director of Enterprise Content Management with UW-IT. “We wanted to support these efforts but we were not experts in the law.”

At about the same time, Moe had been thinking about how electronic signatures could fit in at HSD, which went entirely paperless in 2016.

“We had just started looking at laws governing electronic signatures when Cassy’s team reached out to us. It really was great timing, and we started working together to see how we could bring eSignatures to our researchers.”

Federal and state laws are designed to protect the rights and privacy of human subjects who participate in studies. Typically, this process involves an assistant or principal researcher meeting in person with potential volunteers, explaining the study in detail and finally obtaining consent, in the form of a signature, before they can participate. Because electronic signatures are relatively new, they were not part of the consent protocol at the UW until recently.

With UW-IT’s assistance, HSD introduced an electronic signature proposal to the governance structure of the UW Institutional Review Board (IRB), which reviews and approves human subjects research. The Board approved electronic signatures for certain types of research.

Now, when researchers apply with the IRB to conduct a new study, they will find a new section on electronic signatures in the IRB Protocol application form, along with a detailed guide to help them determine if their studies are eligible for the eSignatures service, and what they need to do to obtain it. In a second step, researchers need to go through an onboarding process with UW-IT before they can use eSignatures. Biomedical studies that fall under the purview of the Food & Drug Administration are not yet eligible for electronic signatures.

“Karen did a great deal of work to get eSignatures approved by the IRB, adding the information to their forms and creating how-to guides for researchers,” Beekman said. “Her division’s contributions have been great, and they have shown the value of electronic signatures at the University.”

“If something as complex as a human subjects consent form can be done with eSignatures,” Beekman said, “we are excited about other ways eSignatures could help UW researchers in the future.”

Drawing of papers flying out of a computer tablet.

As more work is done online and on computers, the need for paper is reduced significantly. At the UW, going paperless and adopting technologies such as eSignatures helps reduce our footprint on the planet.

This year, nearly 60 groups or departments at the UW are using eSignatures, from financial aid forms filled out by parents and students to multiple other uses. The electronic signatures, Beekman said, need to comply with the same requirements as those done on paper, including meeting retention and storage guidelines. However, eSignatures easily allows users to send, receive and manage documents that require an electronic signature, and it supports the University’s initiative to go paperless while increasing administrative efficiencies.

Opening the doors to more research

With eSignatures now approved for human subjects in lower-risk research, such as answering health surveys, it widens the door for critical research, Moe said.

For researchers, finding candidates willing to participate in a study is an arduous process. At the UW, there are more than 6,000 active studies and 2,000 applications for new studies every year.

“It is becoming more difficult to do research and harder to recruit participants,” Moe said. “Being able to choose from a broader base of participants gives you a more balanced perspective in any study. And eSignatures can help broaden that pool.”

Human subjects can give electronic consent, with an electronic signature, from anywhere. That means researchers can widen their potential pool of candidates into much larger areas, even nationally, without having to meet in person when otherwise not necessary or send paper forms and then wait for them to return in the mail.

“Every little step forward that we take to make it easier to do research is important,” Moe said. “With eSignatures, we certainly hope to do that.”

Learn more: The eSignatures service is offered at no cost to UW departments. Learn how your department can use eSignatures.