Clinical trial participants are a vital part of cancer research and there are federal rules in place to help ensure the safety and ethics of clinical trials
If you are thinking about taking part in a clinical trial,
you may have questions such as:
- Are there risks to taking part in the trial?
- Who is watching out for any problems?
- Who is making sure that people who take part are safe?
- Is the trial trying to answer an important research question?
In fact, there are federal rules in place to help ensure the safety and ethics of clinical trials. You will be protected through:
- The informed consent process
- Careful review and approval of the clinical trial protocol by:
- Scientific experts
- An institutional review board (IRB)
- Ongoing monitoring of the trial by:
- The IRB
- Data and Safety Monitoring Boards (DSMBs) for phase 3 trials
- The organization sponsoring the trial
- The research team
Informed Consent
Informed consent is a process through which you learn details about the trial before deciding whether to take part. This process includes learning about the trial’s purpose and possible risks and benefits. It is a critical part of ensuring patient safety in research.
During the informed consent process, the research team, which is made up of doctors and nurses, first explains the trial to you. The team explains the trial's:
- Purpose
- Procedures
- Risks and benefits
They will also discuss your rights, including your right to:
- Make a decision about taking part
- Leave the study at any time
Before agreeing to take part in a trial, you have the right to:
- Learn about all your treatment options
- Learn all that is involved in the trial, including all details about treatment, tests, and possible risks and benefits
- Discuss the trial with the principal investigator and other members of the research team
- Both hear and read the information in language you can understand
After discussing the study with you, the research team will give you an informed consent form to read. The form includes written details about the information that was discussed with you and describes the privacy of your medical records. If you agree to take part in the study, you sign the form. But, even after you sign the consent form, you can leave the study at any time. You can always ask questions. And, as new information becomes available, the research team will inform you.
Children's Assent
Legally, children are not able to give true informed consent until they turn 18. So, before taking part in a clinical trial, they are asked for their assent. Assent means that they agree to take part. They may also dissent, which means they do not agree. Unlike informed consent, assent is not always required by law, though IRBs may require it.
To take part in the assent process, your child must be mature enough to understand the trial and what they are required to do. Some children as young as 7 years old may be able to take part. But this age varies depending on the child and the group running the trial.
As with the informed consent process, the assent process is meant to be an ongoing conversation between your child, your family, and the research team. This team may include doctors, nurses, social workers, and other health care providers.
During the assent process:
- You give informed permission for your child to join the clinical trial.
- The research team explains the trial to your child in language they can understand, including what it means to take part and what they can expect.
- The research team may use written forms, videos, graphics, and other visual aids to help explain the trial.
- Your child is encouraged to talk with your family and ask questions of the research team.
It may take several sessions before the research team feels that your child has a clear understanding of what the trial involves. At that point, your child is asked to show assent or dissent.
Both Parents Need to Give Permission
Usually, both parents will need to give permission for your child to take part in the trial, unless one parent:
- Has died
- Is unknown
- Is incompetent
- Is not reasonably available
- Has sole legal custody of the child
When Assent Is Not Required
Assent must be obtained from children unless:
- Your child is not capable of assenting.
- Your child might benefit from the treatment or procedure being studied in the trial.
- The treatment or procedure that may benefit your child is only available in clinical trials.
Even if assent is not required, your child will still benefit from going through the assent process. Doing so can help them feel more in control and engaged in the trial. It shows that they have a say in what happens to them and that their questions and input are valued.
Scientific Review
Each clinical trial that is funded by the federal government must be reviewed by scientists from relevant fields before people can enroll. This expert review ensures that the trial is based on sound science. Though not required, many other clinical trial sponsors, such as drug companies, also seek expert advice on the scientific merit of their trials before opening them.
Institutional Review Boards (IRBs)
IRBs also review clinical trial protocols before they can accept patients. The board members make sure that the risk of harms in a trial is low and that any harms are reasonable when compared to the possible benefits. They also closely watch the ongoing progress of the trial from beginning to end and must review them at least once a year. IRBs can require changes to the protocol—or even stop the trial—if necessary to ensure the safety of people enrolled.
Federal rules require that each IRB include at least five people. It must include:
- one scientist
- one person who is not a scientist
- one person who is not connected to or not related to someone who is connected to the site where the trial is taking place
IRBs can also include doctors, nurses, social workers, chaplains, patient advocates, and other health care or community professionals. All members of an IRB are required to understand the IRB’s purpose, functions, and responsibilities, as outlined in federal regulations.
In most cases IRBs are located at the site where the trial is to take place. Many sites that carry out clinical trials have their own IRBs. A clinical trial that is taking place at more than one site often undergoes review by a single IRB, also called a central IRB. The central IRB conducts reviews for all the sites taking part in the trial and works in agreement with each site's local IRB.
Data and Safety Monitoring Boards (DSMBs)
Some clinical trials - especially phase 3 clinical trials, which often involve many sites - use a Data and Safety Monitoring Board (DSMB). Like IRBs, these boards review the progress of a clinical trial and monitor the safety of those taking part in the trial. They also review data on the effectiveness of the trial interventions. Each trial has only one DSMB.
A DSMB is a group of doctors, statisticians, and others who are independent of the people, organizations, and institutions that are sponsoring, organizing, and conducting the clinical trial. Board members are experts in clinical research and clinical trials. They ensure that trial data are complete. They can stop a trial early if safety concerns come up or if the main research question is answered earlier than expected. Stopping a trial early because the main research question has been answered may make it possible for people who are not in the trial to access an effective intervention sooner.
Office for Human Research Protections (OHRP)
OHRP protects people who take part in research and provides leadership for many federal agencies that carry out research involving people.
OHRP enforces important regulations for patient protection in clinical trials, called the Common Rule. These regulations set standards regarding:
- The informed consent process
- IRB formation and function
- The involvement of prisoners, children, and other vulnerable groups in research
Food and Drug Administration (FDA)
FDA plays a role in protecting people who take part in research and ensuring the integrity of data from trials. FDA can remove researchers from conducting clinical trials when they repeatedly or purposely do not follow the rules intended to protect patients or when they have not ensured data integrity.
FDA approves new drugs before they can be sold which helps:
- Prevent fraud
- Ensure that drugs work as they should
- Make sure the drug’s health benefits outweigh their risks
Ending Cancer Clinical Trials Early
Most clinical trials run as planned from beginning to end. But sometimes trials are stopped early. For example, the IRB and DSMB may stop a trial if the people taking part are having unexpected and severe side effects. Or they may stop a trial if there is clear evidence that the harms are greater than the benefits.
In some cases, a trial might be stopped because:
- It is going very well. If there is clear evidence early-on that a new treatment or intervention is effective, then the trial may be stopped so that the new treatment can be made available to others as soon as possible.
- Enough people cannot be recruited to take part
- The results of other trials are published that answer the research question or make it irrelevant
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