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As the clinical trials industry starts to incorporate mHealth initiatives into their trials, study teams now have to determine the extent of their ICF consent forms during study deployment, and how to cover mHealth activities within these forms.
As the clinical trials industry starts to take on more mHealth initiatives in their clinical trials, study teams are faced with determining the extent of their consent forms (ICFs) during study deployment, and how to cover mHealth activities in ICFs. This article will delve into some elements of an ICF for studies that incorporate mHealth as a supplement to existing study activities (and where a main ICF containing FDA-required ICF elements already exists).
Disclaimer: This article does not provide advice on how to write a consent form for mHealth studies, but, rather references some elements we consider important. Check with your legal and compliance entities for ICF company-specific guidelines.
Follow Federal Guidelines and Determine Extent of mHealth Use in Your Study
It is always a good idea to review FDA guidelines on consent form elements; specifically, refer to 21-CFR 50.25 on Elements of Informed Consent. Another aspect to explore before writing your consent involves the extent of mHealth use in your study. For example, some studies infuse mHealth in study design and require its use, such as Amgen’s Migraine mHealth Study, which collects data from patients and asks patients to complete PRO questionnaires. In such cases, writing an original ICF containing all FDA-required and mHealth elements is necessary. However, many studies leverage mHealth to supplement study operations, such as text message reminders for appointments, medication reminders, or completing patient reported outcomes surveys.
Sections of a Consent if You are Using mHealth to Supplement a Study
If you are taking this approach, you are obviously required to have a main ICF containing the required ICF elements pertaining to the study. Despite the main ICF, it is still advisable to include an additional ICF that describes the details and purpose of mHealth activities. Below are some suggested sections to include in the mHealth ICF.
Header: This section typically includes the Sponsor’s name, address, study title, protocol number, principal investigator name and contact information, and the patient’s name and study ID number.
Purpose of mHealth Activities: This category tends to describe that the mHealth ICF is a supplement to an existing ICF. Additionally, this section includes the purpose of the mHealth initiative; examples include attending appointments, completing PROs, and investigational product adherence.
Process of mHealth Activities: This section elaborates on how the mHealth initiative will be implemented, the process of the activities, and what the patient should experience. For example, if you are rolling out a text messaging campaign, you will need to describe that the patient will need to offer their phone number to study staff, study staff will enter the patient’s phone number into a system, and how many text messages will the patient expect to receive throughout the study’s duration.
Content of mHealth Activities: This part illustrates examples of what the patient will be expecting. For instance, if you are executing an app that contains gamified visualization of study progress, providing an example of what the visualization looks like and a description of it in the ICF would be beneficial for the patient to better understand what to expect.
Financial Impact on the Patient: This section describes what impact the mHealth initiative will have on the patient financially. To elaborate, if the patient is going to be receiving text messages or will be using mobile data via an app, this section will need to elaborate on what the patient will have to pay (if anything), and whether there will be reimbursement for any overages or mobile surcharges.
Privacy and Personal Information: This category usually describes how the patient’s data will be handled on the backend, who will see the patient’s information, and what information will be seen. For instance, if an app is used, the consent will have to describe how the patient’s data is structured (i.e., will their mobile phone/wearable be linked to the patient’s ID), identify all parties who can access the data (including specific third parties), and what data the parties will be accessing (i.e., phone numbers, PRO data, etc).
Use Disclosure of Information: This section goes into what information will be collected, how it will be secured (i.e., in secured databases), how the systems will be monitored, and how the data will be used.
Refusal to Participate and Withdrawal: This part should indicate that refusal to participate in, and withdrawal from the mHealth initiative is voluntary, and will not result in neither penalties, nor loss of benefits to which the patient is otherwise entitled to.
Subject Acknowledgement and Signature: This final category details a statement of agreement (i.e., that the patient voluntarily agrees to the terms of the consent), a repeat of the withdrawal statement (above), and a signature and date portion.
Are there Other Sections that Need to Be Included?
Study teams are not limited to the aforementioned recommendations, nor are they required to include all of them. It is recommended that study teams check with their legal departments and review FDA’s regulation on ICF elements (21-CFR 50.25) when drafting supplemental consent forms.