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  • Writer's pictureXing Brew

Leveraging ODK to Facilitate Ethical Research

Updated: May 27

In the realm of field research and clinical trials, ensuring the ethical treatment of participants is of utmost importance. One of the cornerstones of ethical research is obtaining informed consent—a process that empowers participants with the knowledge they need to make voluntary and informed decisions about their involvement. With the advent of digital data collection tools like Open Data Kit (ODK), researchers now have the means to streamline and enhance this critical process.

In this post, we will explore the importance of participant informed consent, how tools like ODK can facilitate the consent process, and practical strategies for implementing effective consent procedures. By leveraging ODK's features and integrating it into consent workflows, we can make the informed consent process more robust and efficient while upholding the highest ethical standards in research.

What is informed consent?

Informed consent is a fundamental ethical requirement in research involving human participants. It ensures that individuals are fully aware of the nature of the research, including any potential risks and benefits, before agreeing to participate. This process is built on three core principles: voluntariness, information, and understanding.

  1. Voluntariness: Participation in research should always be voluntary, free from any form of coercion or undue influence. Participants must be free to choose whether or not to take part in the study without facing any negative consequences for their decision.

  2. Information: Researchers should provide clear and comprehensive information about the study. This includes explaining the purpose of the research, the procedures involved, potential risks and benefits, and the expected duration of participation. Participants should also be informed about their right to withdraw from the study at any time without any consequences.

  3. Understanding: It is crucial that participants understand the information provided to them. Researchers must ensure that the consent form and explanations are presented in a manner that is accessible and easy to understand. This may involve using simple language, providing translations, or incorporating visual aids to help convey complex concepts.

Informed consent is an ongoing process that involves open communication between researchers and participants. It reflects respect for the autonomy and dignity of participants, allowing them to make informed decisions about their involvement in the research. By adhering to these principles, researchers can foster trust, enhance the ethical integrity of their studies, and protect the rights and well-being of participants.

Paper-based vs Digital Consent Forms

Traditionally, participant informed consent forms (ICFs) were paper-based, similar to questionnaires. However, with the emergence of ODK and other electronic data collection (EDC) tools, some researchers are now opting for digital consent forms. Both paper and digital ICFs have their advantages and disadvantages, and the choice between them largely depends on the specific context and requirements of each research study.

Digital consent forms, especially those created using software like ODK, may be the method of choice for many modern researchers as they offer several benefits. For instance, they enable real-time data collection and monitoring, providing immediate access to consent records and efficient management of participant data. The forms can also incorporate features such as audio recordings and visual aids to enhance participant understanding of the consent information.

However, some researchers may still opt for or are required to use paper ICFs for reasons including local regulations that mandate a tangible record for audit purposes, they feel that participants trust and feel more comfortable with paper forms, connectivity or logistical challenges, resource constraints, and various other reasons.

In the next section, we'll explore how ODK can be utilized to create robust digital consent forms and how it can also be used to streamline the process of collecting, digitizing, and monitoring paper-based ICFs.

Designing ODK-based ICFs

ODK offers a variety of features that are extremely useful for creating intuitive digital ICFs. By utilizing some of the form design elements described below, researchers can enhance participant understanding, make consent forms dynamic based on participant characteristics, and improve the completeness of consents.

Form Design
  • Multilingual capabilities: It's important that participants fully understand the nature of the research and the content of the ICF which they are signing. Developing forms in multiple languages to cater to diverse participant groups within a study and allowing participants to select their preferred language can help ensure that they fully understand the consent form. (See this guide on designing multilingual forms)

  • Form Logic: Using ODK form's conditional logic and having questions appear based on participant characteristics (e.g., age and gender), as well as previous answers can make the consent process more personalized and relevant to each participant.

  • Signature Capture: ODK's signature widget supports capturing digital signatures, allowing participants to sign the consent form electronically. This feature ensures that the consent is properly documented and easily retrievable.

  • Multimedia: Using audio, images, and video files can provide verbal explanations or visual demonstrations that help participants better understand the study or consent information. For instance, a clinical trial requiring participants to take a medication might include an image of the study drug.

  • Data Validation: Including data validation rules can ensure that all required fields are completed and that responses are consistent and logical. Examples include:

    • Mandatory fields: Ensure that critical fields, such as the participant’s name, date of birth, and signature, are not left blank.

    • Data validation: Check that the consent date is within a valid range and ensure numeric fields such as age or number of dependents fall within a specified range.

    • Calculations: Automatically calculate the participant’s age based on their date of birth and ensure it falls within the study’s required age range.

    • Format validation: Validate that the input follows a specific format, such as email addresses, phone numbers, or study ID numbers.

    • Duplicate entry check: Prevent duplicate entries by checking that identifiers like participant IDs have not already been entered into the system.

Data Processing

Once the ICFs have been digitized and are used for data collection, some features of using ODK that are useful in ensuring a secure, robust, and ethical ICF process include:

  • Instant Data Upload: Data collected through ODK can be uploaded in real-time to a central server, enabling immediate access to consent records and facilitating efficient data management.

  • Encryption: Data collected through ODK can be encrypted, ensuring that participant information is protected and confidentiality is maintained.

  • Monitoring Tools: Researchers can monitor the consent process in real-time, ensuring compliance and addressing any issues promptly.

  • Access Control: Researchers can control who has access to the data, enhancing security and privacy.

Leveraging ODK to streamline the process of validating and monitoring paper-based ICFs

In situations where paper ICFs are needed or preferred to digital forms, ODK can still be a powerful tool in helping to improve the efficiency and robustness of the ICF process, as well as enable research monitors and regulatory bodies to ensure the quality of the ICFs.

One of Databrew's responsibilities as the data management team for the BOHEMIA Project clinical trial was processing over 30,000 paper ICFs collected in rural Kenya. Having used ODK for data collection throughout the multiyear clinical trial, we decided to leverage its abilities in helping to verify, monitor, and enhance the ICF process as well.

Within the BOHEMIA project was a team of Archivists who reviewed all the paper ICFs collected in the field and completed an ODK questionnaire form called the "ICF Verification Tool", which came preloaded with data about participants (including age, status within the study, the fieldworker who visited them, etc. and the type of ICF form(s) they and/or their parents/guardian should have signed) in an attached .csv file. The form then asked about the availability of the ICF and posed a list of questions related to the validity of the form (e.g., did the parent sign, did the witness sign, is the ICF dated, is the handwriting legible).

Data collected about each individual ICF through the verification form allowed data managers to closely track the status of 30,000+ ICF forms—those that were completed properly, those that were missing, and those that needed to be corrected and resubmitted.

This system also allowed for:

  • Real-time Updating: Instant updates and corrections, ensuring that everyone had access to and was working with the most current and accurate information.

  • Data Integrity: The ICF database had built-in validation checks and audit trails between the fieldworkers, supervisors, archivists, and the data management team, which helped ensure the accuracy and completeness of the informed consent process, a critical component of Good Clinical Practice (GCP) compliance.

  • Accessibility/Remote Monitoring: Stakeholders, including researchers, project sponsors, and regulatory authorities, could access ICF information remotely through a data dashboard developed in Google Looker. The system enabled remote monitoring of the informed consent process, allowing sponsors and monitors to assess compliance in real-time without the need for physical presence.

By leveraging ODK, the BOHEMIA Project was able to enhance the efficiency, accuracy, and compliance of the informed consent process, even when relying on paper-based ICFs. (If you are interested in learning more about Databrew's ICF Verification Tool ConsentCheck, download the file below for additional information, and feel free to get in touch to talk about how we can help streamline your research project's ICF process!)

ICF Toolkit Brochure
Download PDF • 123KB

Harnessing ODK for Enhanced Informed Consent Processes

Whether using paper-based or digital informed consent forms, the goal remains the same: to ensure that participants are fully informed and their consent is obtained ethically and efficiently. ODK offers several features for enhancing the digital informed consent process, providing tools that improve clarity, accessibility, and data integrity. It can also be used to enhance paper-based ICF processes to ensure more accurately-filled and complete forms, improve data integrity, and even allow for remote monitoring.

By leveraging these capabilities, researchers can uphold the highest ethical standards, streamline their workflows, and ensure regulatory compliance. As we continue to navigate the evolving landscape of field research, integrating technology like ODK into consent procedures not only enhances the quality and reliability of data but also reinforces our commitment to respecting and protecting the rights of research participants.

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