Informed Consent for Clinical Trials & Eligibility

Informed Consent for Clinical Trials

Since any new product or drug being developed may not have any known outcomes, whether that be positive benefits or negative risks, people who volunteer are considered subjects of the research being conducted rather than patients. They must understand that all the possible outcomes of the clinical trial may be much different from existing treatments in order to provide their informed consent. It is our goal to help you understand the process, as well as aid with how best to prepare going into it.

Before any individual is allowed to follow through in the participation of a clinical trial, they must have informed consent. According to the FDA, in order for the informed consent process to be effective, it “must provide sufficient opportunity for the participant to consider whether to participate,” which also involves allowing the individual enough time and opportunity to consider all the information and ask questions. This will include, but not be limited to:

• What all exactly will be done/administered to the subject
• The plan for the protocol and how it works
• Any risks or discomforts they will be exposed to or may experience
• A reminder that participation is completely voluntary, and they may leave at any point they decide

Important questions to ask and consider before entering a clinical trial include:

1. What is the goal or purpose of the study? Do researchers believe the approach will be effective?
2. What are any short-term/long-term benefits or possible benefits?
3. What are any short-term/long-term risks or possible risks?
4. What kinds of therapies, drugs, or tests will I have during the trial or will I receive a placebo?
5. Is there any cost to me?
6. Will I encounter any pain or discomfort from the trial?
7. What are the safety protocols and procedures taking place?
8. How are participants being monitored?
9. Will I be able to continue taking my medications/treatments that are prescribed to me for my current condition?
10. Will I have medical care? Who will oversee my care?

While these are all important questions, you still may have more pertaining to your personal circumstances or inquiry. It is important to ask anything that you want to know before signing the agreement papers to join the trial. Volunteering for a clinical trial is not the same as signing a contract, so remember that there is always the option to leave if you ever become uncomfortable.

The FDA does require a signed informed consent document from the participant; it does not “dictate the specific language required for the informed consent document but does require certain basic elements of consent to be included.” This includes a statement explaining the study and what it involves, as well as all the overview information embodying the study prior to joining.

This signed document states that the participant is fully aware of what to expect going into the trial based on the information provided by the research team and any questions that they have asked beforehand. Always make sure to ask questions after reading the informational document if you do not understand something or find it confusing.

Clinical Trial Eligibility

Even though clinical trials are volunteer-based when it comes to the study subjects receiving the new treatment/drug, not all people who want to join a trial may be eligible. Much of the clinical trial eligibility criteria will depend heavily on statistical factors that pertain to the specific clinical trial that you are considering signing up for, and the goal of the study. These are all outlined within the trial protocol.

After consenting to the process, the clinical trial staff will screen the potential participant to evaluate whether they meet the criteria they are seeking for the study. According to the National Institute on Aging: “Inclusion criteria for a trial might include your age, state of disease, sex, genetic profile, family history, and whether or not you have a study partner who can accompany you to future visits.

Exclusion criteria might include factors such as specific health conditions or medications that could interfere with the treatment being tested.” Several volunteers go through this screening process, and even if one individual finds that they do not meet the specific criteria for that trial, there may be another trial available where they do match the criteria.

Above all, finding out if you are eligible begins with finding a trial that relates most closely to your diagnosis and screening appointment. Anyone considering joining a clinical trial should consult with their doctor to get a professional opinion as to whether or not it is a safe idea from the start.

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