Research starts with a question. Researchers then create a study plan to find an answer to that question. Sometimes, the answer is what they expected, and sometimes it isn’t. Sometimes, they learn something brand new that gives them an idea for a different question!
They do research studies to learn more about humans, disease, or nature. Often, they do studies because they don’t know how to help you feel better, or because they think maybe they can help you in a better way. Some research studies ask your opinion about topics, or study why people behave the way we do.
An Institutional Review Board, or IRB, exists to protect the rights and welfare of volunteers like you. The IRB is a committee of diverse people, some scientific and some non-scientific, with varying knowledge and cultural backgrounds. They read each study plan and decide if the research can go ahead. They may also decide that the research plan must be changed before they will approve it, or that it simply cannot be done.
WATCH: How IRBs Protect Human Research Participants
The most important thing to know is that it is UP TO YOU! Ask questions about the research and get informed before you decide. If you choose not to participate in a medical study, that is okay! You will continue to receive your regular treatment from your doctor.
Here are some helpful questions to get you started:
- What is the purpose of this study?
- Why am I, specifically, being asked to participate?
- Will the research help me personally?
- What exactly will happen to me in the research?
- Will there be medications, procedures, or tests?
- When will I be done with the study?
- What kind of study is this, and will it involve a new or untested intervention that is considered experimental?
- Will I get the new item being tested, or something else, like a placebo (an inactive substance) or my regular medicine?
- Would I be given the results of any study tests or procedures that are done?
- Are there any risks, discomforts, or unpleasant side effects?
- What other options do I have?
- How will my information be kept private?
- Will I be paid for being a part of the study, or have to pay anything?
- What happens if I volunteer to participate now, but decide to quit the study later?
- Who can I contact if I have questions?
WATCH: Questions to Ask Before Volunteering in Clinical Trials
Here is a longer list of questions that you can download and print!
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Being a study volunteer is not the same as being a regular patient. In medical care, your provider has the freedom to adjust your treatment at any time. In medical research, a researcher has rules and schedules described in the approved study plan. This means that the researcher must follow the plan for any tests and medications you will receive, and not do something different from the plan just for you. However, if you or the researcher believe that your participation in the study is not good for you, then you or the researcher can choose to remove you from the study.
WATCH: How is Medical Research Different from Medical Care
Children need safe and effective medical care, just like adults do. However, medicines that work in adults may not work the same way, or at the same dose, as they do in children. Some conditions can affect children differently that they do adults.
If we don’t study treatments and conditions in children, we limit all children’s access to the good medical care that adults enjoy.
Get the facts about the study, and your child’s other options, and make an informed decision. It’s up to you!
Studies are planned well, and done carefully, and can be a great way for eligible participants to:
- Play an active role in their own health care.
- Gain access to new research treatments before they are available to the public.
- Get expert medical attention at a leading health care center during the trial.
- Help others by contributing to medical research.
There may be risks to medical research.
- There may be unpleasant, serious or even life-threatening side effects to a treatment that is being tested.
- A new testing treatment may not work for you.
- A medical study may need more of your time and attention than regular medical care, including trips to the study site, more treatments, hospital stays, or complex dosage requirements.
- For non-medical studies, the risks might include feeling uncomfortable when being asked certain questions.
Every study is different! Some offer a payment for each time you have a study visit, some will only reimburse you if you had travel expenses, and some don’t offer any compensation. Sometimes joining a study gets you access to something else you want, such as counseling, or even a chance to try a new treatment idea when you have no other treatments that work for you.
Informed Consent is the conversation between you and the researcher about the study, plus your final decision of whether or not to participate. If you decide to join a study, you may be asked to sign a paper or electronic document that lists the important study information. Before you decide to participate, you should understand 1) what is being studied and why, (2) any potential risks and benefits of the test treatment, 3) your other options are if you decide not to participate, (4) and the risks and benefits of those other options. The researcher should be sure that you understand, and you have the right to ask questions before consenting, and throughout your participation. You may also decide to leave the study at any time for any reason, even after you have consented.
WATCH: What to Expect about the Informed Consent Process
You do not have to be in any study if you don't want to be.
You have the right to change your mind and leave a study at any time without giving any reason, and without penalty.
Any new information that may make you change your mind about being in a study will be given to you.
Information you enter may be shared with Stony Brook researchers who are hoping to find volunteers for their studies. We do not share your information with pharmaceutical or device companies, the public, or any third party. We only share your information with a Stony Brook researcher if their study might be a good fit for someone with your survey answers, and we will only share information that they need, and no more.
For example, if you have arthritis, a researcher studying patients with arthritis would not necessarily need to know if you are a twin or have ADD/ADHD. We only share the minimum amount of information needed to help the study team decide if the study might be a good fit for you.
If we see that we have a study that might interest you, someone from the study team will contact you, by telephone, email or mail. They will ask you some questions, and you may also ask questions, to see if your participation in the study might be a good idea.
Clinical trial plans must include a way to keep participants safe. This safety action might include removing a participant from a study, reducing or stopping their test treatment, or even stopping the study altogether. A researcher can initiate a safety action, or they may be instructed to take an action by the IRB, FDA, or other safety committee. Researchers must report any safety results to these groups during the study, such as unexpected side effects or other important participant health information, so that any needed action can be taken.
If you have questions about your rights as a research subject or if you would like to obtain information or offer input, contact the Stony Brook University Research Subject Advocate, Ms. Lu-Ann Kozlowski, BSN, RN, (631) 632-9036, OR by e-mail, lu-ann.kozlowski@stonybrook.edu.