Source: MedCity News
Conducting a successful clinical trial depends on well-designed patient recruitment procedures and retaining the research participants until the completion of the study.
The participants must receive information regarding the study and voluntarily agree to participate. This process is known as informed consent, which isn’t as simple as getting verbal or written consent from a participant.
What is informed consent?
According to the FDA, informed consent involves providing a participant with:
- Adequate information to make an informed decision about participating in the clinical research.
- Ensuring that the participant has an understanding of the information provided to them.
- An adequate amount of time to ask questions and discuss the trial and research protocol with the family or friends.
- Voluntarily agreeing to participate in the research trial.
- Information as the trial progresses, or as the situation requires.
The informed consent process must provide sufficient information and opportunity to the participant to consider whether to participate or not. The regulator and participant should exchange information and discuss the contents of the informed consent. It should include the purpose, duration, risks, benefits, costs and additional expenses of the trials along with a description of the trial procedure, volunteer’s rights and alternative care options.
Different types of informed consent
Informed consent may differ across across clinical trials, and it’s not limited to one type of consent. Informed consent can be any of the below three types:
- Implied consent: This refers to the consent when a patient passively cooperates in a process without a specific discussion or formal consent. This kind of consent is not required to be documented in any record. The principle of good communication applies in implied consent.
- Verbal consent: The study participant states their consent to a procedure verbally but doesn’t sign any documents. It is applicable in routine treatments, such as for diagnostic procedures and prophylaxis.
- Written consent: A written informed consent is necessary in case of extensive intervention involving sedation, surgeries, high-risk medications and clinical trials.
Informed consent is not a one-time process, rather it is the start of a relationship based on communication. Research staff should not only obtain consent before trials, but they have to obtain it from the participants throughout the trial process. This is mandatory because there are times when new information arises, and it may change the elements of a trial.
Moreover, there are times when informed consent is not required. Often informed consent is confused with implied consent. But implied consent is a type of informed consent that isn’t explicitly stated or written down. It is suggested or implied by the patient’s actions.
For example, if a patient has fever and visits a medical practitioner, the visit implies that he or she needs routine clinical care. So there’s no requirement to get the patient’s explicit consent. However, if there is a need to deviate from the standard of care (e.g., a research study or clinical trial), sufficient information about the risks involved and the potential discomfort to the patient needs to be communicated in a language preferred by the patient.
To many, the term informed consent is mistakenly viewed as obtaining the participant’s signature on the consent form document. But as per the FDA, that is only a part of the informed consent process that should involve providing adequate information to the participant to make an informed decision about their participation in the clinical investigation.
The stance of regulatory agencies
The primary concern of all regulatory agencies is patient safety and protecting the rights of clinical trial participants to ensure that they have reliable and sufficient information before deciding whether to join the trial process or not. The FDA oversees clinical trials to ensure that these are designed, conducted, analyzed and reported as per the federal laws and GCP (Good Clinical Research Practice) regulations.
For all FDA-regulated clinical investigations, legally effective informed consent must be obtained from the participant or the participant’s legally authorized representative. The informed consent must meet all the guidelines and regulations of 21 CFR 50.20 and must include the basic information required by 21 CFR 50.25 (a). If required, one or more of the additional elements of information at 21 CFR 50.25 (b) and 21 CFR 50.25 (c) must be addressed as well.
An investigator educates the participants on the informed consent process, verifies their understanding, and obtains consent as per FDA guidelines. The Belmont report with updated charts in 2018 serves as a standard guide for institutional review boards (IRBs) or ethics committees to steward all human subjects research at the site level or sometimes at the national level (e.g., central IRBs in the U.S.).
The guidelines that apply to the in-person informed consent process also apply to the remote electronic informed consenting process. The guiding principles along with the 14 decision charts enable IRBs to make sound judgements on requirements or waivers of informed consent. The FDA may audit any clinical trial to verify proper procedures are followed, including the verification that proper informed consent was obtained from study volunteers.
Digital technologies are reinforcing trust among clinical trial participants
John Wilbanks and team at Sage Bionetworks led the development of consent and governance frameworks for population scale programs such as the NIH All of Us Research program and the National Covid Cohort Collaborative (N3C).
Multi-stakeholder consortia such as the TransCelerate Biopharma and the clinical trials transformation initiative provide recommendations for proper implementation of eConsent and other digital health technologies in clinical trials. Those introducing these technologies need to carefully consider how trust can be developed and retained with study volunteers throughout the engagement process including the need to:
- Verify the patient’s comprehension via a questionnaire or quiz.
- Provide convenient means for participants to ask questions or seek clarifications.
- A signed letter of agreement or a document that the patient has understood what they are consenting to.
The best way to deal with the issue of trust in clinical trials is to use bidirectional and multi-modal digital communications between research teams and participants. This should enable participants to ask questions and discuss the trial process with the investigator team during the informed consent process. The trial sponsors can include educational videos in languages that the participants are sufficiently literate to comprehend.
With digital technology, investigators can achieve the following objectives in the trial process and telehealth medicine:
- Engage effectively through omnichannel interactions to foster loyal long-term relationships
- Innovate in telehealth patient care by catalyzing the development of products to deliver value
- Execute effectively by digitizing processes to drive efficiencies and cost savings along with cycle time reductions
The role of advanced platform technology and the acceptance of telehealth in accelerating clinical trials
Advanced human-centric technology platforms are designed by considering that all stakeholder perspectives can help strengthen trust with study volunteers in the clinical trial process, maximize research productivity, and minimize the burden on participants and researchers.
A well-designed platform maps out the patient journey in the researchers’ workflow, showing them how they find, educate, consent, screen and enroll participants that qualify for a specific trial. Greater acceptance of telehealth and video calling capabilities by clinical researchers is driving the acceleration of clinical trials in a range of therapeutic areas including rare diseases and cancer.
A modular, eClinical software-as-a-service (SaaS) platform can allow participants and researchers to access the study from any browser-enabled mobile device in a study-fit design. This minimizes the logistical burden and risks of exposure to infection, and offers the flexibility to ensure continuity and integrity of clinical studies needing to be pandemic-proof.
