For health research studies that recruit or enroll human participants, the process of consenting individuals can be the most daunting part of launching. Though some research teams cling to traditional paper-based consent processes, many adopt electronic consent (eConsent) to accelerate enrollment and improve participant comprehension. But adopting eConsent can feel daunting to many research teams who don’t understand what/how to communicate to their institutional review boards (IRBs) to obtain their approval.
IRBs play a vital role in ensuring ethical and legal compliance for health research teams. This article explores the various requirements for eConsent that your IRB will likely expect to understand when reviewing your study’s scientific protocol.
The Importance of an IRB Related to Consent
IRBs pay special attention to the consent process for research participants because of their mandate to ensure the ethical conduct of research involving human subjects. This mandate spans a few different objectives:
Protecting participant rights
Informed consent is a fundamental ethical principle in research. This means, at its core, that research participants have control and autonomy over making decisions about whether they participate in research. IRBs seek to ensure your research program will adequately inform participants about your aims, any potential risks and benefits that come with participation, and their rights as it pertains to the study.
Ethical responsibility
The consent process serves as a safeguard against potential abuses or violations of participants’ autonomy, dignity, privacy, and confidentiality. IRBs ensure that researchers obtain valid and voluntary consent, minimizing the potential for exploitation or harm.
Informed decision-making
IRBs stress the importance that participants have a comprehensive understanding of the research in which they are consenting to participate. By reviewing consent documents and processes, IRBs assess that the information provided to participants is accurate, complete, and comprehensible. This enables participants to make informed decisions based on an understanding of the study’s purpose, procedures, potential risks and benefits, and alternatives.
Risk-benefit assessment
IRBs assess the potential risks and benefits associated with research protocols to determine whether the study is ethically justifiable. The consent process allows participants to weigh the potential risks alongside the potential benefits of a study to make an informed decision about their involvement. IRBs review consent forms and processes to ensure that participants are adequately informed about the nature and magnitude of the risks and benefits involved.
Protecting vulnerable populations
Certain groups, such as children, individuals with cognitive impairments, or those with limited decision-making capacity, are considered vulnerable in research settings. IRBs pay particular attention to the consent process for these populations to ensure that their rights and interests are protected. Special considerations, such as obtaining assent from children or utilizing appropriate proxy decision-makers, are taken into account by IRBs when reviewing the consent process. Assent is defined as a willingness to participate in research by persons who are not old enough to express informed consent but are old enough to understand how they will participate in the research, what the research aims to study, and any possible risks or benefits. Informed consent must always be obtained from a participant’s parent or legal guardian in addition to the participant’s assent.
Legal and regulatory compliance
IRBs operate within legal and regulatory frameworks that require the protection of human subjects in research. This includes national and state regulations. Compliance with these regulations is crucial to ensure the integrity and credibility of research findings. By overseeing the consent process, IRBs ensure that research protocols adhere to applicable regional, local, and federal laws and regulations, many of which accord with international ethical guidelines.
Research integrity
IRBs aim to uphold a high standard for integrity in the research programs they oversee. A robust consent process ensures that participants have a clear understanding of their rights, the study’s purpose, and what is expected of them. This fosters trust and cooperation between researchers and participants, maintaining the credibility and reliability of the research endeavor.
What to Submit to an IRB for eConsent
So, what do you need to include in your research protocol to satisfy the IRB’s expectations? Let’s explore some of the most likely components you’ll need to address. And if you’re already feeling a bit overwhelmed, let us help you figure it out.
Overview of the eConsent Process
A research protocol should begin with an overview of its eConsent process. This includes its purpose and its importance for the study. Questions that IRBs often ask for this component are: What are the benefits for the use of digital methods to acquire patient consent? Is there any scientific aim for using eConsent in place of traditional paper consent?
In this section, you should summarize the overall process, explain specific steps in the process, and define expectations of the participant at each step. Some of our collaborators use workflow diagrams or detailed explanations for this portion. Here is an example for an eConsent workflow:
Aims of the Research Program
Any IRB will expect to understand the research study via its specific objectives and aims. Objectives are broad statements that describe the desired outcomes of the study, whereas aims are more detailed, measurable, and focused objectives that serve as milestones within the research process. These objectives and aims should align with the research questions and/or hypotheses.
If you’re concerned about your IRB’s willingness to support the use of electronic consent, be sure to emphasize the benefits of using eConsent to achieve the objectives and aims more specifically.
Special Considerations in eConsent for Your Patient Population
You will already be describing your target participant population, but if there are special considerations for accessibility or multi-language support, you should include that detail.
For example, you may need to provide consent forms in multiple languages, ensuring comprehension by participants from diverse backgrounds. Additionally, it should be accessible to individuals with disabilities, incorporating features like screen reader compatibility and adjustable font sizes. If you have a population such as elderly patients who may lack access to or comfort with technology, explain how flexible your eConsent process is to help them along the way.
Materials for eConsent
Your IRB will likely require review of the materials, screens, and content that participants will review during the consent process – whether on paper, or through digital methods. For eConsent, you will need to share materials with the IRB that can include:
- An overview of the eConsent module and its purpose.
- The screens that the participants will see during the process.
- The eConsent video, or transcript of the video, that accompanies the process.
- Any evaluation questions used for participant comprehension checks.
- Data collected during consent.
- How you plan to collect signatures (like a digital signature).
Participant Comprehension and Informedness
As explained above, the IRB wants to ensure that patients and participants are fully informed and can maintain decisional autonomy about their participation in research programs.
This could involve comprehension quizzes, knowledge assessments, or interactive elements like AI chatbots embedded within the eConsent platform. Explain how these components will be designed to assess or otherwise increase participants’ understanding of key study information.
Data Security and Privacy for eConsent
Understanding how you will secure and protect participant data is critical to IRBs and research teams alike. Ensure you explain the details about how your eConsent platform addresses things that include:
- Data Protection Measures: Describe the specific measures that will be implemented to ensure the security and privacy of participant data during the eConsent process. This could include encryption of data during transmission and storage, access controls (who on your team can access what data), secure server infrastructure, firewalls, and other technical safeguards.
- Compliance with Data Protection Regulations: Emphasize the commitment to comply with relevant data protection regulations, such as the General Data Protection Regulation (GDPR) or Health Insurance Portability and Accountability Act (HIPAA), depending on the jurisdiction and the nature of the study. Explain how the eConsent process will adhere to the requirements and principles outlined in these regulations.
- Data Storage and Retention: Outline the procedures for storing and retaining participant data collected during the eConsent process. Specify the duration for which the data will be retained and the mechanisms in place to ensure secure storage and prevent unauthorized access or disclosure. You may also want to outline the procedures for securely disposing of participant data once it is no longer needed.
- Anonymization and De-identification: Explain how participant data will be anonymized or de-identified to protect privacy. Describe the techniques or methods that will be used to remove or encrypt personally identifiable information (PII) to ensure that data cannot be linked back to individual participants.
- Data Sharing and Transfer: If there are plans to share or transfer participant data, provide details about the procedures in place to ensure secure data sharing and transfer. This may involve secure data transfer protocols, data sharing agreements, or anonymization processes before sharing the data with external parties.
- Researcher Access and Data Use: Address how researcher access to participant data will be controlled and monitored. Explain the mechanisms in place to ensure that only authorized researchers have access to the data and that access is limited to what is necessary for the purposes of the study.
This part of your protocol can create stress for many researchers. Managing the data and privacy necessary for recruitment in multiple states, for example, can become confusing. We can help you figure it out and provide example material if you plan to collaborate with Vibrent to deliver eConsent.
Technical Infrastructure for the eConsent Platform
If you’re planning to work with Vibrent to deliver eConsent, we have comprehensive language and materials we can share to explain the technical infrastructure that will protect your participants and you in the process.
If you aren’t, you’ll need to make sure you share enough information for the IRB to make a clear decision about whether the platform you’ve chosen is robust enough. This could include:
- Detailed architecture diagrams
- How data is managed and housed
- Privacy protection
- Security credentials
How the Research Study Will Assess Risk Associated with Digital Methods
Conduct a thorough risk assessment specific to the eConsent process and describe any potential risks or challenges associated with using electronic methods for obtaining informed consent from your participants. Discuss the steps taken to mitigate these risks and protect participant rights.
Approach for Supporting Participants through eConsent
To promote participant engagement and address potential concerns or queries, you may need to explain to the IRB how your eConsent experience will provide support during the consent process.
The eConsent platform should provide a way for participants to seek assistance, including email addresses and telephone numbers of your principal investigator or study staff, or online chat support, staffed by trained personnel. Likely, you’ll also want to include FAQs and help sections to address common participant queries and provide additional guidance.
If you plan to provide a way for participants to provide feedback on their eConsent experience, enabling continuous improvement of the process, explain that as well.
Describing eConsent to the IRB Doesn’t Have to Be Stressful
Compiling and submitting this information to an IRB can be stressful. But making sure that patients and participants are protected in your study is truly important.
If you’re concerned about submitting your eConsent process and materials to your IRB, we can help. We have materials that you can use if you’re planning to collaborate with us on your study.
If not, and you’re interested in exploring a collaboration, request a pilot, and we can work together to make eConsent a painless part of your study.
