Conducting a successful clinical trial depends on carefully designed patient recruitment procedures and retaining study participants until the study is complete.
Participants must receive information about the study and voluntarily consent to participate. This process, called informed consent, is not as simple as obtaining verbal or written consent from participants.
What is informed consent?
according to Food and Drug Administrationinformed consent involves providing participants with:
- Sufficient information to make informed decisions about participating in clinical research.
- Make sure participants understand the information provided to them.
- Allow enough time to ask questions and discuss trials and research protocols with family or friends.
- Voluntary consent to participate in research trials.
- Information as the trial progresses or the situation requires.
The informed consent process must provide participants with sufficient information and opportunities to consider participation. Regulators and participants should exchange information and discuss the content of informed consent. It should include the trial’s purpose, duration, risks, benefits, costs, and additional costs, as well as a description of trial procedures, volunteer rights, and alternative care options.
Different Types of Informed Consent
Informed consent can vary from clinical trial to clinical trial and is not limited to one type of consent. informed consent Can be any of the following three types:
- acquiescence: This refers to the patient’s consent in the process of passive cooperation without specific discussion or formal consent. This consent need not be recorded in any records. The principles of good communication apply to implied consent.
- Oral consent: Study participants verbally agreed to the procedure but did not sign any documents. It is suitable for routine treatments such as diagnostic procedures and prevention.
- Written consent: Written informed consent is required in the case of extensive interventions involving sedation, surgery, high-risk drugs, and clinical trials.
Informed consent is not a one-time process, but the beginning of a relationship based on communication. Investigators should obtain consent not only before the trial, but must also obtain consent from the participants throughout the trial. This is mandatory as new information sometimes emerges and may change elements of the trial.
Additionally, informed consent is sometimes not required. Informed consent is often confused with implied consent. But implied consent is informed consent that is not explicitly stated or written down. It is implied or implied by the patient’s behavior.
For example, if a patient has a fever and sees a doctor, that visit means he or she needs routine clinical care. Therefore, the explicit consent of the patient is not required. However, if deviations from the standard of care are required (eg, research or clinical trials), adequate information about the risks involved and the patient’s potential discomfort needs to be communicated in the patient’s preferred language.
For many, the term “informed consent” is mistakenly seen as obtaining a participant’s signature on a consent form. But according to FDA rules, this is only part of the informed consent process and should involve providing participants with enough information to make an informed decision about their participation in a clinical investigation.
The position of the regulator
The primary concern of all regulators is patient safety and protecting the rights of clinical trial participants to ensure they have reliable and adequate information before deciding whether to join the trial process. FDA oversees clinical trials to ensure that they are designed, conducted, analyzed and reported in accordance with federal law and GCP (Good Clinical Practice) regulations.
to all FDA-regulated clinical studies, legally binding informed consent must be obtained from the participant or the participant’s legally authorized representative. The informed consent form must comply with all guidelines and regulations of 21 CFR 50.20 and must contain the basic information required by 21 CFR 50.25 (a). If required, one or more of the additional information elements in 21 CFR 50.25 (b) and 21 CFR 50.25 (c) must also be addressed.
Investigators educate participants about the informed consent process, verify their understanding, and obtain consent in accordance with FDA guidelines.This Belmont Report The 2018 updated chart serves as a standard guide for institutional review boards (IRBs) or ethics committees to administer all human subject research at the field level or sometimes at the national level (eg, a central IRB in the United States).
Guidance that applies to on-site consent processes also applies to remote electronic consent processes.guiding principles and 14 Decision Diagrams Enables the IRB to exercise reasonable judgment regarding the requirement or waiver of informed consent. FDA can review any clinical trial to verify that proper procedures were followed, including verifying that appropriate informed consent was obtained from research volunteers.
Digital technologies are strengthening trust among clinical trial participants
John Wilbanks and team at Sage Bionetworks led the development of consent and governance frameworks for population size programs such as NIH Research for All of Us program and National Covid Cohort Collaboration (N3C).
Multi-stakeholder alliances such as TransCelerate Biopharmaceuticals and Clinical Trials Transformation Program Provides advice on the proper implementation of eConsent and other digital health technologies in clinical trials. Those introducing these techniques need to carefully consider how to build and maintain trust with research volunteers throughout the engagement process, including the need to:
- Validate patient understanding through questionnaires or quizzes.
- Provides a convenient means for participants to ask questions or seek clarification.
- A signed agreement or document that the patient has learned that they agree.
The best way to deal with issues of trust in clinical trials is to use two-way and multimodal digital communication between research teams and participants. This should enable participants to ask questions during the informed consent process and discuss the trial process with the investigator team. Trial sponsors may include educational videos in languages that participants have adequate cultural understanding.
With the help of digital technology, researchers can achieve the following goals during the trial process and telemedicine:
- Engage effectively through omni-channel interactions and foster loyal, long-term relationships
- Innovate in telemedicine patient care by promoting product development to create value
- Execute effectively through digitized processes to increase efficiency and cost savings while reducing cycle times
The role of advanced platform technologies and the acceptance of telemedicine in accelerated clinical trials
Advanced human-centered technology platforms designed with the perspectives of all stakeholders in mind can help strengthen trust with research volunteers during clinical trials, maximize research productivity, and minimize participants and researchers burden.
A well-designed platform charts the patient journey in a researcher’s workflow, showing them how they can find, educate, consent, screen and recruit participants eligible for a particular trial. Greater acceptance of telehealth and video calling capabilities among clinical researchers is driving an acceleration of clinical trials across a range of therapeutic areas, including rare diseases and cancer.
A modular e-clinical software-as-a-service (SaaS) platform enables participants and researchers to access studies from any browser-enabled mobile device in a study-appropriate design. This minimizes logistical burdens and exposure to infection, and provides flexibility to ensure the continuity and integrity of clinical research needed for pandemic protection.
Photo: Getty Images, Paul Bradbury
