By Blake Adams, VP of Marketing at Florence
75% of research sites either already use electronic informed consent or plan to use it in the future. Sites without this technology will quickly fall behind when competing for sponsors and patients.
But as efficient and popular as eConsent is, it also introduces land mines for any research organization. The Florence team spoke to one NCI Cancer Center administrator who said, “No cancer center administrator wants to be on the front page of a local newspaper due to a data error.”
When Florence designed eConsent, identifying and avoiding privacy hazards was our first priority. Because eConsent gives many stakeholders access to patient data, the software must balance innovation and risk aversion.
To de-risk the move to eConsent, we asked our research partners: “What must eConsent do to work for you?” Here’s what they said:
1) Offer strong access control
Since patients, sponsors, IRB members, site personnel, and monitors can all use an eConsent platform, it’s critical to make sure no one sees data they shouldn’t. eConsent programs must offer granular access controls for documents and data.
Florence created a patented permission control infrastructure for our eBinders product to reduce the risk of the wrong person accessing information. We use this same infrastructure to keep our eConsent safe. Each person has a login that comes with a specific role and permissions. These permissions safely limit what information the person can view and update.
2) Provide insight into what is going on across all studies
Most of the organizations we work with run dozens, if not hundreds, of studies across their enterprise. Teams need a single place to quickly understand what’s happening with informed consent in each of their studies.
Florence eConsent features a central command center that gives visibility into all of the studies taking place across an organization. Research staff can see how many potential participants have joined each site or study as well as how many of those people have already completed their informed consent forms.
3) Make sure staff, and the patient, always have the latest version of the consent form
Informed consent documents receive frequent updates. One research center we talked to while building eConsent told us they had over 800 changes to consent forms in a single year.
Our eConsent software offers audit trails and version control to help sites keep track of their informed consent documents. Version control ensures patients always receive the correct form. Audit trails let site staff and monitors see who has uploaded a new form and when, so research staff have accurate records for inspections. And version control is only one of the many benefits of eConsent.
4) Don’t pressure research staff to create interactive media right away
Many research professionals we spoke to would like to feature videos, quizzes, and interactive content as part of eConsent. But they don’t have the resources or time to create the content and update it on a regular basis.
We built Florence eConsent to mimic the paper consent process. This lets sites and patients use eConsent with minimal training. It also ensures that sites don’t have to worry about updating multimedia content every time they update a consent form.
5) Make it easy for participants to manage their consent
Our site partners often speak of “techquity”—the idea that every patient has different access to and experience with technology. A patient’s age, their income level, and even where they live can affect whether they have WiFi and whether they’re comfortable using a smartphone or tablet.
We designed our eConsent to be easy-to-use and compliant in any setting. If participants need help from research staff or don’t have an electronic device, they can fill out the eConsent form on a tablet at the clinic. Perhaps they have a computer at home, and they would like time to sit down and review documents with their loved ones. eConsent can provide that option too.
6) Keep eSignatures compliant
With eConsent, patients can sign their consent form anywhere. This means the clinic staff need to verify that the person signing the document is the actual participant. They also need to make sure eSignatures follow the regulations of FDA 21 CFR Part 11.
With Florence eConsent, each participant has a unique login and password tied to their email address or phone number. These unique identifiers comply with Part 11 regulations and help verify that the participant or their authorized representative is the one signing.
Florence eConsent also asks users to re-enter their password and provide their purpose for signing when those extra steps are required by Part 11. Sites should only use eConsent vendors that understand FDA 21 CFR Part 11 fully and can help their users remain compliant.
Take the Risk Out of Switching to eConsent
We designed Florence eConsent to make it easy for teams to switch from paper to electronic consent without putting a huge burden on staff, confusing participants, or causing compliance errors. With the right software and help from their vendor, sites can move to a patient-centered eConsent platform with minimal risk.
Want to learn more about the features of our eConsent solution? Take a look at our on-demand product tour.