Welcome to the SUBJECT INFORMATION section of the WIRB website. The purpose of this section is to provide general information about research to people who are thinking about entering a research study. The following information will help you understand what a research study is and what it is not, who conducts research, and why people may choose to participate in research.

Click on one of the following headings or scroll down to read all the sections

For parents thinking about enrolling a child in research
Information to consider before agreeing to join a research study
Some reasons why people join research studies
Risks and benefits of research
Responsibilities and rights of research subjects
Who can I contact with questions or concerns?


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.

back to top of page

Information to consider before agreeing to join 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 "institutional review board," or "IRB." 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.

This website focuses on medical research involving human subjects. Medical research is done to learn more about a drug, a medical device, a medical procedure, or a particular condition or behavior. Some of the terms used to describe medical research are: Research Study, Clinical Research, Research Trial, Experimental Study, or Protocol. Whatever it is called, the goal of medical research is to find better ways to treat conditions, improve health or cure diseases for future patients who have a particular health problem.

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. The U.S. government requires that, before a drug or a device can be sold in the U.S., it must be studied in research and the results must show that it is relatively safe and effective for its intended use in humans. If you decide to enter a research study, be sure you know what question the research is trying to answer.

More information about research is available on AAHRPP's website: http://www.aahrpp.org/www.aspx?PageID=131. AAHRPP is an organization that accredits high-quality human research protection programs.

What is a sponsor?

Research is planned and initiated by a sponsor. The sponsor may be a government agency like the National Institutes of Health (NIH), a pharmaceutical or device company, a public institution like a University or Medical College, or an individual person.

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 medical doctor. Your own physician may be the principal investigator for a research study or the principal investigator could be a physician who only conducts research studies.

Principal investigators often have other professionals assisting with the research study. The principal investigator's research team may include sub-investigators, research coordinators and research nurses. Even if there are other doctors on the research team, the principal investigator is the person ultimately responsible for ensuring that the research is being done according to the protocol (study plan).

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.

What is the difference between medical care and research participation?

The requirement in research to follow a protocol is what makes a research study different from the medical care patients receive from their personal doctor. When people are in research studies they are subjects. When people see their regular doctor for medical care, they are patients. For a patient, the treating doctor uses his or her clinical judgment to do what is best for each patient. A patient may be started on one course of treatment, then switched to another treatment if the doctor determines that the patient is not improving, or is experiencing side effects. What a doctor does for his or her patient depends on what will be best for the patient.

On the other hand, when a person participates in a research study as a subject, the principal investigator must follow the study protocol and provide only the medical care that is specified in the protocol. Consequently the tests and medicines given to the subject may be different than the doctor would give to his or her patient. There are several things commonly done in research studies that are not done in regular medical care, such as randomization, blinding, and use of placebo. It is important to know and remember that there is a difference between being a patient and being a research subject.

What is randomization?

In many research studies subjects are assigned to different groups. The subjects in the different groups may receive different doses of drugs, or different drugs, or different devices or other medical procedures. Many times the assignment to a group is made randomly (like drawing a number from a hat). This means that neither the subject nor the investigator chooses which group the subject is placed in. Randomly assigning subjects to groups helps ensure that the results from the study are more accurate.

What is blinding?

Research also often uses a technique called "blinding." Blinding means that the subjects and often the investigator do not know what drug or medical procedure they are receiving. There is both single blinding and double blinding. In double blinding, neither the subject nor the investigator knows which drug or procedure the subject will receive. In single blinding, only one person does not know, either the subject or the investigator. Blinding is done to help eliminate the possibility of bias by the investigator and or the subject, and to help the research results be accurate. There are several ways that a study can be blinded. One common way to blind a study is to use a placebo.

What is a placebo?

A placebo looks like a drug but contains no active medicine. In studies that use placebo, all the participants in the research receive drugs that look exactly the same, but do not all have the same ingredients. Researchers compare the information about subjects receiving the active drug to the information about subjects who receive the placebo. Placebos help ensure that research results are accurate.

Placebos are not just pills. Sometimes placebos are used in device studies or studies of medical procedures. In these cases, the placebo may be a device that doesn't work, or a fake surgery where a cut is made, but no surgery is done.

The consent form will describe whether the study involves a placebo, so you will know if there is a chance that you will get a placebo.

What is a conflict of interest?

Sometimes a principal investigator or sub investigator may have a conflict of interest. Conflicts of interest can take many forms. The most common conflict of interest arises when a doctor who provides you with medical care is also acting as the researcher overseeing your participation in the research study. In this case, there can be a conflict in his or her duty to make medical decisions in your best interest and his or her duty to follow the research protocol.

Another common type of conflict of interest is financial. For example, the principal investigator might own stock in the sponsoring company, be a paid consultant for the sponsoring company, receive speaking fees from the sponsoring company, or be paid by the sponsoring company to conduct the research. The investigator may hold a patent on the drug or device being studied and stand to benefit if the drug or device is approved for general use. You should feel free to ask if either the principal investigator or research staff has a conflict of interest. If the principal investigator or any of the research staff do have a conflict of interest, discuss how they intend to manage that conflict. Only enter the study if you are satisfied with the safeguards that have been put in place to deal with the potential conflict.

Do I have to pay for any of the drugs or procedures in a research study?

You may be expected to pay for some or all of the tests and procedures that will be done during the study. It is different in each study. Sometimes everything is paid for in a research study, and sometimes you or your insurance will be responsible for all of the costs. Also, be aware that sometimes insurance companies will not pay for medical care that is given as part of a research study, so you may be responsible for those costs. Insurance companies may also not pay for complications or injuries arising from your participation in research. Find out what you or your insurance will be billed before you agree to be in a research study. You may also want to contact your insurance company, although it is sometimes difficult to get them to tell you what they will pay for.

Will I be paid to participate in a research study?

Sometimes subjects are paid to participate in a research study. For studies involving individuals with medical problems, the amount of payment is usually based on how inconvenient it is for subjects to come in for the extra visits and to have additional procedures performed. Therefore, the payment will often cover costs like parking and babysitting.

Research studies for healthy people generally pay more, as these subjects have no medical problem and may have little other reason to join the study.

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,
• the standard medical options for your condition
• if there is payment for participation
• the plans to deal with a research related injuries
• who will receive information about you from the study

• Some healthy people decide to join a study because they want to help in developing a cure for a particular disease.

• Some people decide to join a research study because they have a disease or condition and they want to help find a cure.

• Some people decide to join because they have a disease or condition that has not responded to any of the medications available to treat the condition.

• Some people decide to join because they have a very advanced stage of disease and no treatment option is available.

• Some people decide to join because they have a disease or condition and they have had bad reactions to the available treatments and they are looking for something with fewer side effects.

• Some people decide to join a study because they want the money that is paid to subjects.

Whatever your reason, you need to know that there can never be any guarantee given to you that the research drug, device or procedure will work for you or will ever work well enough to be approved for general use. A doctor may tell you about a research study because he or she thinks you may meet the requirements for enrolling. Just because a research study is suggested to you does not mean that you have to join it.

More information about deciding whether to participate in a reseach study is available on AAHRPP's website: http://www.aahrpp.org/www.aspx?PageID=218. AAHRPP is an organization that accredits high-quality human research protection programs.

back to top of page

Risks and benefits of research

Are there risks in research?

Joining a research study will usually involve risks. Those 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. The risks 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 benefit varies from study to study, just like the risks. It is important to remember that the main goal of research is to collect information that may help future patients, not the subject participating in the research study. You should always ask questions and keep asking until you understand how the research study is different from the treatment you would get outside of the research study.

back to top of page

Responsibilities and Rights of research subjects

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

As a participant in a research study you will have responsibilities too. For example, you will be expected to show up for all scheduled appointments, call the study personnel if you have a bad reaction, and follow the study related instructions given to you. You may also be expected to go in for many more visits than you would have with regular care. Therefore, you may have extra costs, such as parking, babysitting and time off work.

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. Again, there will be no 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 get 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.

If you are looking for more resources to learn about research in general, here is a link to AAHRPP's website: http://www.aahrpp.org/www.aspx?PageID=175. AAHRPP is an organization that accredits high-quality human research protection programs.

back to top of page

Who can I contact with questions or concerns?

• If you are in a research study reviewed by the Western IRB (WIRB), the consent form includes information about who you can contact.
• If you have a medical emergency, please call your local emergency number, such as 911.
• For specific questions about the study or to make appointments, please call the study staff listed in the consent form.
• You can call a subject representative at WIRB if you have concerns or complaints you would like to talk about with someone who is not working on the study. If you have a study consent form, please have it available during the call. Click here for the WIRB contact page.
• You can also call a subject representative at WIRB if you have general questions, concerns, or comments about being in studies, or if you have questions about the rights of people in studies. Click here for the WIRB contact page.

back to top of page