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Info For Research Subjects

This section contains general information about research for those thinking about entering a research study. The following information will help you understand what a research study is and what it is not, and who conducts research.

For parents thinking about enrolling a child in research:

We suggest that you review the information available on www.bostonchild.vitalconsent.com. It is an excellent website devoted to research with children and the concerns parents have about allowing their children to be in a research study.

What is an IRB and what does it have to do with research?

Before most research studies can start, they must be approved by a committee, usually called an IRB (Institutional Review Board).  IRBs are made up of scientists, doctors, non-scientists and community members. The IRB reviews the research to make sure it is well designed, that the risks are as low as possible, and that these risks are reasonable when compared to the possible benefits of the research. The IRB also reviews the consent form for the research to make sure that it is accurate. If it approves the research, the IRB continues to review the ongoing research after it starts. It is important to understand that IRB approval does not mean that a research project is safe or that it is right for you. When an IRB approves research, it means that the members of the IRB believe that the research is acceptable to present to people like you for your consideration. However, you need to carefully look at the details of the research and decide whether it is right for you.

What is research?

Research is an organized way to learn more about almost anything. Research is done in many areas, such as engineering, basic science, psychology, and medicine. When research involves people as subjects, it is called human subject research. 

A research study is done to try and answer a question. The question varies from study to study. The research protocol (study plan) clearly states the question to be asked and discusses all of the tests and procedures that will be done during the research study. If you decide to enter a research study, be sure you know what question the research is trying to answer.

What is a Principal Investigator (PI)?

The principal investigator is the person responsible for conducting a research project at one or more locations. The principal investigator is usually a college professor conducting research with other investigators who are college students.

What is a protocol?

The protocol is the “blueprint” for how the study will be conducted. All the details of the study are described in the protocol. The principal investigator and other research staff must follow the protocol. If the protocol is not followed, the results of the research study may not be useful enough to answer the questions the research is trying to answer.

Will I be paid to participate in a research study?

Sometimes subjects are paid to participate in a research study. However, in most cases of college research, subjects will not be paid to participate.

What is the consent form?

Before you enter a research study, you will be given a document called a consent form. Read the form carefully. It should tell you what you need to know in order to decide whether or not to enter the study. For example the consent form should tell you:

  • why the study is being done
  • how long your participation will last
  • the potential benefits to you
  • the potential risks to you
  • if there is payment for participation
  • the plans to deal with research related injuries
  • who will receive information about you from the study

Are there risks in research?

Joining a research study will usually not involve risks. However, risks vary from study to study. You should understand what risks are anticipated in the particular study you are considering and remember that there can always be unanticipated risks for research subjects. If there are any risks, they should be clearly explained in the consent form.

Will I benefit if I participate in research?

Sometimes the person (subject) who joins a research study will benefit directly, and their disease or problem will be helped. However, the possibility of receiving benefits varies from study to study, just like the risks.

What do I have to do if I join a research study?

As a participant in a research study you will have responsibilities. For example, you will be expected to show up for any scheduled appointments and follow the study related instructions given to you.

What are my rights as a research subject?

  • You have several rights as a research subject:
  • You have the right to decide not to participate in the research, and there will be no penalty or loss of benefits.
  • If you decide to participate, you have the right to quit at any time without penalty or loss of benefits.
  • You have the right to be informed about the research study, without any coercion, undue influence, or pressure. Your main source of information about the research study is usually the consent form.
  • You have the right to ask questions about the research study.
  • You have the right to receive a copy of the consent form.
  • You do not waive any of your legal rights by joining a research study or signing a consent form.

Deciding to be in a research study is an important decision and requires that you understand what your expectations are. You should talk about your expectations with the study staff before you agree to be in a research study.