Volunteering for clinical research: what you need to know about the informed consent process

Medical research has led to many important medical discoveries that make our lives better. When medical research studies are completed, researchers can share the information with the medical community around the world at conferences or via peer-reviewed journals; and the results of these studies often help doctors provide better and more improved care to their patients.  

But many of these trials can not occur without subject participation. Subject participation in medical research trials are the heart and soul of a trial. By volunteering for a medical research trial, you can be a part of helping to find new and improved treatments and better ways to provide care.  

Participation should not be taken lightly and you should fully understand the trial’s objectives, treatments, potential risks and the precautions in place to protect you. This post will cover 10 critical questions to ask before you volunteer as well as introduce the informed consent process you will undergo before your participation begins.  

Before You Volunteer

If you have never participated in clinical research before, you may not even know where to begin or what questions to ask. Before you volunteer, here are 10 critical questions to ask:  

1. What phase is the clinical trial?
2. How long will the trial last?
3. What treatments will be used?
4. What is the main purpose of the trial?
5. How will patient safety be monitored?
6. What are the risks?
7. What are the possible benefits?
8. Are alternate treatments available?
9. What happens if I am harmed by the trial?
10. Can I choose to remain on this treatment even after the study ends?

Understanding the Informed Consent Process

If you are considering clinical research take the time to ask questions. Doctors and sites want great research volunteers and they want those volunteers to remain in the study for its entirety. So make sure that you are informed of what participation entails. Before your participation begins, you will be asked to sign an informed consent. It is important to understand that there is a difference between an informed consent for research versus a general informed consent for treatment. The differences and similarities have been discussed in a previous blog.

21 CFR 50.25 lists elements that are found in an informed consent document and the consent document should be in an easy to understand language. You should also be given a copy of the consent.   

Be on the lookout for these things to be included in your informed consent for a clinical research trial:

• An indication that what you are agreeing to is for research
• An explanation of the purpose of the research
• The expected duration of participation
• Procedure descriptions that are to be followed, including invasive procedures
• Any experimental procedures should be identified
• Noted risks or discomforts
• A disclosure of any alternate procedures or courses of treatments offered
• A statement describing the extent to which confidentiality of records identifying you will be maintained and if published, your identity will remain confidential
• If more than minimum risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of or where further information can be obtained
• Who to contact for answers to pertinent questions about the research and subject’s rights , and who to contact in event of a research –related injury
• A statement that participating is voluntary and refusal will not result in  penalization or loss of benefits in which the subject is otherwise entitled
• Any unforeseeable risks, and any possible risks to a pregnancy, embryo, or fetus
• The approximate number of people involved in the study
• A statement that any new significant findings developed during the study that could relate to your willingness to continue in the research study will be provided to you
• Any anticipated payments, if any, to you for participating
• Any additional costs to you that may result from participating in the research study
• Any anticipated circumstances where your participation may be terminated by the investigator without your consent.

Taking the Next Step

Let your doctor know that you are thinking about joining a clinical trial.  

ClinicalTrials.gov is a searchable registry and results database of federally funded and privately supported clinical trials conducted in the United States and around the world. You can go to this website to search for diseases and conditions. This website gives you information about a trial’s purpose, who may participate, locations, and phone numbers for more details. Using this information along with advice from your healthcare professional could assist you with finding a trial you could be interested in volunteering for.  

Once you find a study, you should contact the clinical trial or study coordinator. The next step is a screening appointment to see if you qualify to participate. This appointment will also give you a change to ask your questions. If you choose to volunteer and qualify to participate you can expect that your health will be monitored during and after the clinical research trial.  

Remember medical research cannot move forward and improve care to patients without the help of volunteer participation. This quote from Michael J. Fox sums it up perfectly. “Every clinical study aims, in some way, to fulfill the promise of scientific innovation – but none of these studies can be successful without the participation of committed volunteers. There is no Department or Secretary of Cures. It’s us.”

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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