You, a friend, or a family member may have been asked to join a research study involving an investigational drug or other medical treatment. Clinical research that involves people requires an IRB like Advarra to protect the rights of those study participants. IRBs ensure that a study is ethical; we review any study protocol with a participant’s safety in mind. We help ensure that participants understand the risks of a study, know they are volunteers, and that the study will be conducted with respect toward the participant.
In a research study, you are a participant, not a patient. This means that the clinical investigator must conduct the study in a way that minimizes risks to you and maximizes any benefits, but the requirements of the study might limit the treatment options the investigator can provide.
If you volunteer to participate in a research study, you also should maintain contact with your regular doctor and other specialists before, during, and after your participation in the study. You should have the best information available about your health care decisions.
A clinical research study is a study that seeks to answer a specific scientific or health question. The study may test an unproven drug, an investigational medical device, a diagnostic tool, a food or drink, or an existing therapy used in a new way. The study also may involve an existing product used in a way that was previously found to be safe and effective in order to learn more about the product’s safety. Or the study may involve only the collection of health information in order to study a health issue in the general population.
People who volunteer to participate in a study may be called human subjects, research participants, or another term that identifies their role as volunteers in a clinical research study.
The doctor or health care professional who conducts the clinical research study may be called a clinical investigator, principal investigator, or study doctor.
It is important to remember that the role of a clinical investigator is very different from the role of a health care provider. Either one may be a medical practitioner or nurse, but your health care provider is responsible for making health care decisions for you based upon your medical condition. A clinical investigator is responsible for conducting a research study according to that study’s protocol.
The people who assist the clinical investigator are part of the research team or study staff and generally include other doctors, nurses, study coordinators, and other health care professionals.
Studies involving a product are generally paid for and supported by the company that developed the product. This company is called a sponsor. Some government agencies, such as the National Institutes of Health, also act as sponsors in funding clinical research.
What is a clinical trial? Why are studies done?
Before a new treatment is approved and put on the market, it must undergo rigorous testing to ensure it is safe and effective. This testing is conducted as part of a clinical study, during which volunteers are given the prospective treatment — under strict guidelines and regulations that the researchers must follow. Besides safety and efficacy, clinical studies help researchers determine how much improvement the treatment offers participants, the proper dose and dosage form, how long the treatment takes to cause an improvement, and much more.
Without clinical research, there can be no new treatments. Clinical studies are essential to advance health care.
How are study participants protected?
Clinical studies and the study doctors who work in them are regulated by the US government. The law requires that every study be reviewed by an independent group of scientists and community members, whose job is to make sure that the study is as safe for the volunteers as possible. This group is called an institutional review board or IRB.
You might consider volunteering for an IRB — these boards need community members and always need help to review studies. The IRB looks at the plan for the study (called the research protocol) before anyone can join the study. They may ask for changes in the study to make it safer for the people who participate. The IRB also looks at the participants’ confidentiality and privacy. If you join a study, measures must be in place to protect your private health information as well as your name and contact information. Your information will not be in any of the reports about the study. If new information that may be important to you and your decision about the study — especially information about safety — is discovered during the research, you will be informed.
Who serves on an IRB?
US regulations require IRBs to have at least five members “with varying backgrounds to promote complete and adequate review of the research activities” (21 CFR 56.107, 45 CFR 46.107). Additionally, every IRB must include at least one member:
- Primarily focused in scientific areas
- Primarily focused in nonscientific areas
- Who is not affiliated with the IRB and/or its parent institution
IRB members may not vote on any project for which they have a conflict of interest. Depending on the study, an IRB may enlist outside experts to provide additional insights.
How are IRB activities monitored and regulated?
Why join a study?
People have many reasons for joining a study. Some people like the feeling that, by joining, they are helping make new treatments available for all. They may feel that they are helping to improve medical care for the next generation. Many studies include health education and medical tests, which some people like to have and join a study for this reason. Some studies need participants who are suffering from a disease or condition. In these cases, these people often participate in hopes of finding a better treatment.
What are the risks?
A study medicine is an untested or limited tested medicine. Clinical studies are done to test the study medicine or treatment. It is important to talk to your doctor and the study doctor about the study. Ask them what is known and what risks they see. And, when you have asked them all your questions, ask them what else you should ask.
All medicines have unpleasant side effects. Some people may experience the side effects, and others may not. Ask the study doctor about the kinds of side effects that may happen in the study.
The study likely will require appointments with the study doctor. Make sure that the schedule is convenient for you. If it isn’t convenient, ask the study doctor if it can be more flexible. These appointments are important for checking the effects of the study medicine on your health. Additionally, some studies may require overnight stays. Rest assured, researchers are required by law to tell what is required before you agree to participate.
What are placebos?
A placebo is an inactive substance. Studies use placebos to compare against a drug or treatment to check the effectiveness of that drug or treatment.
What are combination products?
If a proposed treatment has both a drug (or biologic) and device component, the FDA may consider it a combination product.
Examples of possible combination products are asthma inhalers, drug delivery patches, collagen implants, and drug-eluting stents. The FDA may decide to treat a combination product as a drug or as a device, and that determination will affect the IRB review.
How do I decide?
Talk with the study doctor and with your own doctor. Ask the study doctor to explain the study — including any details you would like to know. Be certain you ask all your questions. The study staff want you to feel comfortable with the study. Here are some questions you may want to ask:
- What will I have to do in the study?
- How long will it last?
- How many times will I have to come for study appointments?
- How long will the study appointments last?
- Who will be watching out for my health?
- What are the risks in the study?
- Will my transportation and parking be reimbursed?
Again, once you have asked every question you have, ask the study doctor what else you should ask.
What is informed consent?
The US government oversees medical studies that include people. One law ensures that no person can be forced to be in a clinical study or join against their will. Another law requires researchers to make sure that the people who join understand what to expect. Any person who joins a research study must consent to join, and that consent must be “informed.”
The study staff or doctor will give you an informed consent form to explain the study. Please take your time to read and understand it and be sure to ask about anything you don’t understand. If you like, you may take it home and have a family member or your doctor look at the form. If you decide to join the study, the study staff or doctor will ask you to sign the form to show that you understand what has been explained about the study. You will also be given a copy of the informed consent form to take home and keep.
Everyone who joins a clinical study has responsibilities to the study. These are some of the important responsibilities that study volunteers have:
- Come to the study appointments on time. If you have a conflict, please call and reschedule.
- You may be asked to take a medication or fill out forms at home. Please try to do this on schedule and follow the study doctor’s instructions.
- Always try to be honest when answering questions. If you had a headache, it is important for the study staff to know. If you don’t feel better, tell them. They want to know the truth. Ask the study staff what other responsibilities you may have in the study.
Everyone who joins a clinical study has rights. Ask the study staff about your rights in the study. The informed consent form will also tell you about your rights. Some important rights are:
- You do not have to join a study.
- If you join, you can change your mind. You may leave a study at any time.
- You have a right to ask questions and have them answered to your satisfaction.
- Some studies reimburse volunteers for their time and transportation costs.
- You have a right to confidentiality and privacy. Your name and contact information will not be on any study report.
You may have questions about a specific study, an injury that you think might be related to research, the instructions you received, or a payment. Ask the study doctor or staff all your questions. If you have questions about your rights, or if you have complaints, you can also contact the IRB listed on your copy of the informed consent form.
What should I do if someone asks me to consider a study for my child?
Talk to your child’s doctor. No one knows your child’s health better than their doctor. If your child’s doctor is not the study doctor, they may want to consult with the study doctor. Get all the information you need to help you decide whether the study may be a good idea for your child.
Where do I go if I am looking for a study for my child?
Ask your doctor. Search the internet. If your child has a chronic or serious disease, you may be able to find information from a support group for that disease.
Will my child be safe in a study?
Government regulations require that studies including children receive special scrutiny. The IRB will carefully evaluate a study of children to assess the risks compared to potential benefits.
What else should I consider about potentially enrolling my child in a study?
Ask your child. Explain the reasons for the study and what they will have to do. If you have questions, ask the study doctor, and ask them to speak with both you and your child. If your child doesn’t want to be in the study, don’t try to persuade them. No one should ever feel forced to join a study — including your child.
How do I learn more about clinical research?
Visit the links below for more information:
- The Center for Information and Study on Clinical Research Participation is a nonprofit organization that works to help the public understand clinical research. ciscrp.org
To find lists of US clinical research studies:
- Clinical studies are listed on a website run by the US government. You can use this site to find a study. clinicaltrials.gov
- The National Cancer Institute lists cancer studies on its site. cancer.gov/clinicaltrials
- The US Department of Veterans Affairs also works to educate veterans about clinical studies. research.va.gov/default.cfm
- The National Health Council is a group that works to improve health across the country. Its membership represents a breadth of disease-specific participant advocacy groups. nationalhealthcouncil.org
To find lists of Canadian clinical research studies:
- Health Canada’s Clinical Trial Database provides a public listing of Phase I, II, and III clinical trials. health-products.canada.ca/ctdb-bdec/index-eng.jsp
- Health Canada encourages sponsors to register studies on ClinicalTrials.gov (run by US NIH). clinicaltrials.gov
- The Canadian Institute for Military and Veteran Health Research (CIMVHR) works to educate veterans about clinical studies and research. cimvhr.ca
Most medical schools offer information on clinical studies. You can also find information about research studies by searching the web for the participant support groups that meet your specific needs.