The Tufts Social, Behavioral and Educational Institutional Review Board (SBER IRB) is a group of faculty, staff, and community members that reviews research studies involving human subjects to ensure the safety and welfare of research participants.

The IRB acts as an advocate for people who are participants in research studies by doing the following:

• Making sure that any risks are as small as possible
• Making sure that all risks and potential benefits of the study are communicated fully and openly
• Deciding whether it is right to ask people whether they want to take part in a research study
• Reviewing each research study while it is going on to make sure participants are protected
• Acting as a point of contact between the research team and the participant, if there is any issue that needs to be resolved

The Tufts Research Participant Advocate can also help you with questions or concerns about participating in research at Tufts University.

A research study is an organized activity to learn more about a problem or to answer scientific questions. There are different types of research studies, including:

• Studies that test the effectiveness of a behavioral intervention
• Studies that find out how students learn
• Studies that determine the best way to prevent or treat different conditions that affect physical, mental or emotional health
• Studies that use surveys or interviews to understand feelings people have about different social topics

It is up to you! If you decide to participate in a research study, you would do so as a volunteer. It is your decision whether or not you will participate. If you decide not to participate in a research study or choose to end your participation in a research study, this will not affect your relationship with Tufts University or lead to any penalty or negative consequences. If you are already participating in a Tufts research study, you may choose to stop participating at any time for any reason.

There are many reasons people decide to participate in a research study at Tufts, such as:

• Help find a treatment for an illness
• Help other people who are sick
• Help find new or improved ways to teach students or train teachers
• Help researchers find out more about different aspects of society
• Help researchers find out more about how people behave or perform in different scenarios.

Informed consent is the process of learning the key facts about a research study to help you decide whether or not to participate.  Informed consent begins when the researcher or research staff explain the research study to you. Researchers will provide information through conversations with you throughout the course of your participation, including through a written informed consent form or information sheet.  The consent should be written so you can understand it. If it is hard to understand, be sure to ask the researcher to explain it. Make sure you understand all the information told to you during the consent process before you decide about participating in the study.

During the informed consent process, you will be informed about the following:

• That you are being asked to participate in research and your participation is voluntary
• The purpose of the research
• How long the study is expected to take, including the length of individual study visits
• What will happen in the study and which parts of the study are experimental
• Possible risks or discomforts
• Possible benefits
• Any appropriate alternative procedures, if any, that may be helpful to you
• The people to contact with questions about the study, about your rights, and about any injuries related to the research study
• Confirmation that being in the study is voluntary and you can quit at any time without penalty
• How your confidentiality will be maintained throughout the study

Depending on the nature of the study, the researcher may provide you with additional information during the consent process, such as:

• Whether information the researcher collects about you may be de-identified and shared with other researchers or used in future research
• Whether you will be paid or compensated if you choose to participate
• Whether any medical treatments are available if you are injured during your participation in the study
• Whether participation may involve risks to you or your embryo or fetus if you are pregnant
• Anticipated circumstances under which the researcher may decide to end your participation in the study
• Whether your participation will cost you any money
• The consequences of your decision to stop participating and what the research team may do with the information they have already collected about you after you decide to stop
• That significant new findings developed during the course of research which may affect your willingness to continue participation will be provided to you
• The approximate number of subjects involved in the study