When it comes to healthcare, all patients and volunteers have rights that are protected by law. While details and subtleties may vary depending on countries or states, key protections and guarantees revolve around respect and dignity for individuals, confidentiality, quality care, autonomy and knowledge of treatment.
Patient rights in clinical trials
In addition to fundamental safety principles apply, patients and volunteers in clinical research have the right to:
- Give their free and informed consent to participate in the clinical trial. No activity described in the study (intervention, assessment, medication) can be performed without it and the process is designed to respect the autonomy of individuals and to protect their freedom of choice. The decision to participate in a research study is individual and should be free of undue influences.
- Receive fair and clear information about the trial before signing up for it, ask any questions and express all concerns about participating. Volunteers should comprehend the benefits and risks of the study, as well as how it is organized: methods, location, time requirements, etc. A full description of all the details and implications of the trial should always be collected in the Protocol, which must comply with necessary national and international guidelines. Potential participants should receive information both verbally and in writing.
- Refuse to take part in the research and to withdraw from the clinical trial at any point, for any reason and without prejudices or changes in standard care and treatment.
- Privacy and confidentiality. The identities of clinical trial participants cannot be disclosed, and medical information collected in the study is kept confidential. Investigators must ensure that data collection, analysis and interpretation processes always protect the privacy of participants.
If you ever want to volunteer in a clinical trial, thoroughly review and make sure the Informed Consent Form (ICF) includes:
- A statement clarifying the trial will be a research study and that participation is voluntary. It should be clear that participants can revoke their consent and stop their participation at any time.
- A summary of the study’s protocol, explaining the purpose of the study, its duration as well as a list of procedures and when they will be carried out.
- Information about the known and potential side effects, risks or discomfort that the patient might experience.
- If the clinical trial is studying more than one medication, the ICF should specify what is the likelihood of receiving each medication.
- A statement explaining that if there are any updates about the clinical trial protocol or the information included in the ICF, participants will be notified.
All these rights are maintained and enforced through Good Clinical Practices (GCPs), an international quality standard for carrying out a clinical trial in humans, and all that it entails. It focuses on ethical and scientific standards, protection of human rights, and patient safety.
Safety in clinical trials: Who approves a clinical trial?
A clinical trial is ethically justified by the expectation of discovering new ways to improve people’s health, but the potential benefits of a study must always outweigh the risks. To assess this, the trial must be submitted, reviewed and approved by ethics committees and regulatory agencies.
Their work includes the evaluating, giving their opinion, and following up on the trial Protocol, assessing if the investigators are suitable, whether the facilities are adequate for the study, and ensure compliance with current legislation and the ethical principles of biomedical research. It also approves the documents that will be used to recruit and inform participants. Approval from an independent Investigation Ethics Committee (IEC) and the Regulatory Authorities (RA) is crucial. Without it, sponsors cannot even begin to recruit subjects.
Participating in a clinical trial
When someone decides to participate in a trial, they can do so for many reasons:
- To contribute to the development of new treatments that may benefit other people.
- To gain access to new treatments for a pathology, that do not follow standard practice, before they are released on the market.
- To try new formulations that can adapt better to their daily life and needs.
How to sign up for a clinical trial
I’m interested in joining a clinical trial, what are my next steps?
- Get in contact with the nearest doctor or specialist related to the study and let them know that you are interested.
- Pre-screening: sometimes, a short interview is done before scheduling an in-person meeting, where you might be asked basic questions about your medical history. This is known as pre-screening and is used to confirm that potential participants meet the basic criteria for the trial (e.g. age).
- Meeting with the research team. During this meeting, you will be provided with the Informed Consent Form (ICF) describing all the details previously mentioned. Usually, investigators meet with the interested person to explain what the study entails, the risks, benefits, and side effects. Any doubts you may have will also be addressed by the study team.
- Time to decide. Once you are given the Informed Consent Form, you will be given enough time to read it, take it home, and even consult it with family and friends. You will also be able to ask your doctor or primary care physician any questions you might have.
- Make it official. If you decide to participate, you will sign the Informed Consent Form. By signing the document, you are confirming that you understand the trial, that you agree to the terms and conditions, and you agree to participate. Always remember your rights, consent is not a contract.
- Screening: Once the ICF has been signed, you will officially be in the trial, and the Screening part of the trial begins, where researchers continue to review your medical history and circumstances to determine if you meet then necessary criteria to take part in the Treatment phase of the trial. Each clinical trial will have inclusion and exclusion criteria that will depend on the type of clinical trial. These may be related to age, previous illnesses, vital signs, or the treatments being received. A participant needs to meet all the inclusion criteria and none of the exclusion criteria to be able to join. If at any point, a participant no longer meets the inclusion criteria, or they develop an exclusion criterion, they will not be able to continue in the study. When the study is designed and these parameters are being decided, patient safety is always taken into consideration.
- Enrollment: if you pass all screen tests and are eligible to participate, the only step remaining is to start the Treatment phase of the trial.
Clinical trial support for participants
When participating in a clinical trial, you will have access to the medical team whenever you need. They will be available to answer any questions you might have. Their role is to support and monitor your progress during the trial.