Generally, informed consent (IC) is a process that educates a participant about all the aspects of a given procedure or trial, such as risks, benefits, and alternatives, so that the participant is competent to make a voluntary decision about whether to participate in the procedure or trial. The IC is an ethical and legal requirement for research involving human participants. Moreover, a well-coordinated IC must highlight the significance of research for the advancement of medical knowledge and social welfare, which might increase the participant’s willingness to participate in a particular clinical procedure or trial. In clinical trials, the IC process is not only the number one step but also the most important step.

What are the common issues associated with IC?

The obligations of an investigator, sponsor, and Institutional Review Board (IRB) to protect the rights and welfare of human research subjects are significant when it comes to the IC. There are five essential elements of an IC:

1. Description of the research and the role of the participant, including an explanation of all procedures relevant to the participant
2. Description of reasonably foreseeable risks
3. Description of expected benefits
4. Alternatives to participation, such as other studies or services in the area
5. Explanation of confidentiality.

Furthermore, the process followed while obtaining an IC for a research purpose is also significant. It includes awareness and consultation with national and/or regional health research bodies, discussions with community leadership, recruiting and informing research participants, knowing and respecting community practices, accepting oral consent, obtaining consent and assent in research involving children, and obtaining consent from vulnerable populations. However, there are a few circumstances under which IC can be waived, and ethical challenges faced by physicians while obtaining IC from the participants.

Since study protocol versions change daily, mostly it requires a new informed consent form (ICF). Once the IRB approves the new ICF, they send an email notification to the sites. So, it takes time to realize that there is a newly approved ICF for a particular study. Not only that, after receiving and downloading the new ICF, it is required to find out all the active subjects that need to go through the re-consenting process. Therefore, it is very time-consuming and tiring for both the site team and volunteers.

Especially during the Covid-19 pandemic, most volunteers refused to come to the sites, and the site teams were reluctant to do the onsite visits. So, to satisfy both parties and comply with the protocol, eConsent is the ideal solution that addresses these issues while complying with the study guidelines. Sites without this technology will quickly fall behind when competing for sponsors and patients.

COSMOS eConsent

After dealing with these issues and carrying out a lot of research, the COSMOS team designed a next-gen eConsent platform, which helps identify and avoid privacy hazards using system-level roles and dual authentication. With the experience we had over the past ten plus years, the COSMOS team came up with five things that are important in any eConsent Platform:

1. Security: Data privacy is critical for an eConsent, and there should be limited access, especially for authorized personnel only. Therefore, the eConsent program team at the COSMOS created a fine-grain access control infrastructure for the eDocs products to reduce the risk of unauthorized persons accessing the information.
2. Management: Since many studies are being carried out in an organization, there should be a single place for the teams to quickly understand what is going on with IC in each study. Accordingly, COSMOS features a central e-consent management center that gives visibility into all the studies across an organization or site. In the real-time study, the team can see how many potential participants have joined each study, what version of ICF they have signed, and also see the audit trails.
3. Accountability: The eConsent software at COSMOS offers audit trails and version control to help the sites to keep track of their IC documents and provides a real-time reporting capability by study. While version control ensures patients always receive the correct form, audit trails let site staff and monitors see when and who has uploaded a new ICF. It gives the research staff accurate records for inspections.
4. Ease of Use: The eConsent designed at COSMOS is easy-to-use while complying with any setting that makes this platform independent. Moreover, using the award-winning integrated video conference feature in the platform, the study team can complete the consenting or re-consenting of the participants independent of their physical location.
5. Compliance: Another great feature of the COSMOS eConsent is that the patients can sign their consent form anywhere and independent of the type of device. But the clinic staff needs to verify that the person signing the document is the actual participant. With the Televisit and eSignature feature in the COSMOS eConsent, the sites can use a single platform to take care of the ICF process and meet the regulatory requirement without any threats to the security. Each participant has a unique login. These unique identifiers comply with Part 11 regulations and help to verify that the participant or their authorized representative is the one signing.

Furthermore, COSMOS eConsent uses the dual-authentication method for their password and provides their purpose for signing when those extra steps are required by Part 11. Moreover, the sites should only use eConsent vendors who completely understand FDA 21 CFR Part 11, which helps their users to remain compliant. 

The primary purpose of COSMOS eConsent was to facilitate the site teams to convert from paper to electronic consent without having to endure a heavy burden on staff, confusing participants, or causing compliance errors.