Information for Research Subjects

Research studies are done to discover new information or to answer a question about how we learn, behave, and function. Some studies might involve simple tasks like completing a survey, being observed among a group of people, or participating in a group discussion. Other studies, sometimes called clinical trials, involve more risky procedures like testing a new drug or medical device.

Each research study has its own set of criteria to determine who can participate. This depends on the research question being asked and may include restrictions based on age, behaviors, health status, or other traits.

Research is designed to benefit society. This might include learning how to live healthier lives, how to better treat conditions or diseases, why we do the things we do, or how we learn and develop. And while there are several reasons why people choose to participate in research, most people participate based on the possibility of helping themselves or others.

It’s important to understand that you may not directly benefit from participating in research. In fact, with a lot of research, you will not receive any benefit. For some types of research however, there may be a possibility that you could receive benefit, but there is no guarantee.

Most studies involve some risk, though the risks can range from very small to very serious. Some examples of risks include:

• side effects or reactions to experimental drugs, treatments, or procedures
• feeling anxious or uncomfortable
• breach in confidentiality or invasion of privacy.

Side effects or other risks you might experience may be temporary or go away with treatment, but in rare cases they may be permanent, cause disability, or be life threatening. There may also be risks in participating that we don’t know about.

To start, you will be given information about the study so that you can make an informed decision about whether or not to participate. You will also be given an opportunity to ask questions about the study. This process is called informed consent. Before you can start the study, you need to agree to participate (i.e., consent). Participation is always voluntary.

Once you provide consent, the specific procedures or activities you’ll be asked to complete can vary widely and depend on what is being studied. Regardless, all the activities you will be asked to complete will be described during the consent process.

Before you agree to be in the study, make sure you have a solid understanding of the following:

• the voluntary nature of the study
• why the study is being done
• who is doing the study
• the procedures, activities, tests, or treatments involved (including how long they will take, how often they have to be completed, and whether there are any other treatment options available rather than being in the study)
• potential risks, discomforts, or side effects
• potential benefits to participating, if any
• how your privacy will be protected
• how long your participation will last
• what will happen if you are injured while participating
• the costs to you, if any
• what to do if you change your mind about participating
• whom to contact with questions, concerns, or problems

Each study is different, so time requirements will vary. Some may require very little of your time, perhaps only 5–10 minutes, while others may require multiple visits over an extended period of time, sometimes up to several years. Your time commitment for a particular study will be described during the consent process.

Informed consent is the process of telling interested individuals what is involved in taking part in a specific research study. Typically, this includes:

• reviewing written information
• giving the potential volunteer time to review this information while considering participation (taking it home to review with friends or family, if desired)
• discussing the information verbally
• answering any questions

Once all of the information is provided to you and your questions are answered, you will then be asked to decide whether or not to take part in the study.

All decisions are voluntary, and you must provide your agreement (i.e., consent) before any study activities can begin. Usually, this involves signing a consent form. Although, for some studies, verbally agreeing to participate may be sufficient.

Once you provide consent to be in the study, you will continue to receive important information about your participation throughout the study.

It’s important to understand what is involved in taking part in a research study and to carefully consider what that means for you. Research can pose risks to your health, safety, and welfare, so it’s important to understand exactly what those risks are.

It’s also important to understand that taking part in research is voluntary. You make the decision about whether or not to participate, and if you agree to take part, you can always change your mind later.

State law determines who can provide consent. In New York State, only individuals 18 years of age and older can provide consent. Minors, based on their age and ability, are usually asked for their agreement to participate in research, but their parent or legal guardian must also provide their permission to participate. Other special considerations are also made when a minor is a ward of the state or adults are unable to make decisions for themselves.

If you have questions about who can or cannot provide consent, be sure to ask the study team.

The following key points are most important about informed consent:

• Being in a study is voluntary—it is your choice.
• If you join a study, you can change your mind and stop at any time.
• If you have questions about anything that is not clear to you, you can ask them at any point of time before, during, or after the study.
• If you feel you need more time or information to make an informed decision about whether or not to take part in the study, do not hesitate to ask for it.

Research studies involving humans must be approved and monitored by an Institutional Review Board (IRB). An IRB is a committee of individuals responsible for reviewing research to ensure adequate protections are in place to protect the people who take part.

For each study reviewed, the IRB checks to see that:

• there is a good reason to conduct the study
• the risks related to participating are the least possible
• the risks related to participating are reasonable given the knowledge that will be gained from conducting the study
• the plan for selecting subjects to participate is fair
• subjects will be provided enough information about the study

Protecting the information you provide to researchers is a high priority, particularly if you provide health-related or sensitive information.

As part of the IRB approval process described above, all researchers must provide a plan to adequately protect the information they plan to collect in order for the study to be approved. This might include assigning a code to the information collected instead of using your name or other identifiable information and storing the information in a secure manner.

You are free to withdraw from a research study at any time, for any reason. Your relationship with the hospital, clinic, academic institution, or employer will not be affected and you will not lose any benefits to which you are entitled.

Note that in some cases, a researcher may decide to end your participation in the study early. This may happen if the study is no longer in your best interest, if you can no longer complete study activities, or if the study ends early for some other reason.