The Role of Informed Consent in Ethical Clinical Trials
There may be nothing more important in clinical research than research teams building and maintaining trust with their participants. It’s essential for recruiting and retaining them throughout a trial, and the informed consent process is the cornerstone for it all. A clear and consistent informed consent process is one of the most effective ways to earn and keep that trust.
What is Informed Consent?
Simply put, informed consent is an ongoing communication process between research staff and participants. While many people may think informed consent is only captured at the beginning of a clinical trial, consent must be obtained continually throughout the trial.
There are key components to informed consent, including:
- Voluntary participation: Enrolling in a clinical trial is completely up to the participant, and they reserve the right to drop out at any time, for any reason.
- Understanding and comprehension: Participants must demonstrate understanding of what the informed consent form (ICF) entails with comprehension checks throughout the process. They must also have a space to ask questions if there’s something they don’t quite understand.
- Documentation: ICFs need to be signed and dated in order to be valid. This is how researchers can prove they had the conversation with participants and they understood what the trial entailed.
Why Does Informed Consent Matter in Clinical Research?
Understanding informed consent’s role in clinical research in the U.S. dates back to 1974, when the Belmont Report was created. This report was created after and in response to the Tuskegee Syphilis Study. An investigation into this study found African Americans who had syphilis were lied to and denied treatments for more than four decades.
Written in response to this study, the Belmont Report states three ethical principles to guide human research: respect for persons, beneficence and justice.
Since the Belmont Report has been established, it has paved the way for why informed consent in clinical research has mattered. The informed consent process demonstrates how a study maintains legal and regulatory compliance, it protects participants from harm and builds trust between the research teams and participants. All three of these elements are critical to a trial’s success.
What Information Must Be Disclosed?
When having the informed consent conversation, there must be full disclosure of relevant information. This is so research teams can accurately and completely explain what the trial will entail, and it gives participants a full picture on what to expect. Information to disclose must include (but is not limited to):
- Purpose of the research
- Procedures involved
- Potential risks and benefits
- Alternatives to participation
- Confidentiality protections
- Right to withdraw at any time
3 ETHICAL PRINCIPLES: Respect for Persons. Beneficence. Justice.
The Informed Consent Process
As mentioned earlier, the informed consent process isn’t just a one-time conversation between the research team and participants, it is ongoing. This is because things change all the time during a study: a new side effect may pop up, or there just may be some new information to share. These instances will necessitate a new ICF in the middle of the study. Additionally, as a study moves through each phase, researchers may need to go through the informed consent process with retained participants, even though they consented in earlier phases.
However, participants aren’t the only party researchers need to connect with as they are forming the ICF. They need to work with their institutional review board (IRB) as well. An IRB’s goal is to protect the participants’ rights, safety and welfare as they are involved in the trial. As they are reviewing the ICF, they are looking to see if the study details are phrased in such a way so participants understand.
Additionally, recruiting participants often includes recruiting from diverse populations. This makes sense because typically in clinical research, there needs to be a wide participant pool to understand how the drug may affect different people. With various populations comes differing language barriers, fluctuating literacy levels and potential cultural considerations. All of these factors may affect how the informed consent process goes – oftentimes, for example, for any given study, there are multiple ICFs in different languages. This gives potential participants the chance to go over the informed consent process in their native language, which can further help them understand the process and what it entails.
How Informed Consent is Evolving
Although the practice of informed consent has been around since before the Belmont Report was established, it’s continually evolving, especially as technology continues to change the research landscape.
The idea of bringing in remote aspects to clinical trials has become more popular in recent years. These approaches focus on showing participants that their time and effort in a clinical trial is valued, which makes it easier and more appealing for patients to take part.
One such approach is electronic consent (eConsent). This is when a participant can complete the consenting process wherever is most convenient to them – they do not have to go into a physical site, because it is done online. This is beneficial because participants can go through the consent process at their own pace, rather than at a timed appointment with research staff. With digital consent platforms, it’s essential to have checkpoints and quizzes throughout the process so participants can ensure they are understanding what the trial entails and the risks associated with it. However, if participants have questions about the study or anything related to it, research staff should still be available to talk about their concerns.
Looking ahead, as technology continues to evolve, so will the informed consent process. However, even as this process evolves, it will still be paramount for sites, sponsors and contract research organizations (CROs) to keep participants at the forefront. They must be given clear, understandable information so they can make the best decision about their participation in clinical trials.
Rely on Sabai to Help You Navigate the Informed Consent Process
Sabai’s mission is to protect the rights, safety and welfare of participants, and we understand that starts at the informed consent process. Rely on us as we work with sites and sponsors to prepare ICFs. It’s of utmost importance to us to ensure participants understand the trial they are a part of and feel protected as they participate.