FAQ

Please note: The information on this page is about medical research studies. There are other types of research studies that do not involve drugs or treatment for health problems. Because all research is conducted in a certain way (according to strict rules and regulations), many of the answers on this page can be used for research studies in general.

  1. What is the purpose of a research study?
  2. Why do people participate in research? Should I participate?
  3. Is there anything that I should know before I join a study?
  4. Who pays for research studies?
  5. What kind of treatment will I receive if I join a research study?
  6. What is informed consent?
  7. Will joining a research study take up a lot of my time?
  8. Are there risks involved?
  9. Will I have to pay for anything? Will I be paid for participating?
  10. Will participating in a research study affect my medical care?
  11. What are my rights if I join a research study?
  12. What are my responsibilities if I join a research study?
  13. What does an IRB do?
  14. What if I have other questions, concerns, or comments, or would like to offer input?

1. What is the purpose of a research study?

The main reason for any type of study is to answer questions. The purpose of a research study (or "clinical trial") is to answer research questions. Research studies are usually performed for one or more of the following reasons:

    • To test new drugs or techniques to see if they may treat or prevent a health problem.
    • To improve current methods of treating health problems.
    • To learn how to prevent health problems from happening in the first place.

A research study is not medical care. Medical care is always available to you outside of joining a research study. If you are a volunteer in a research study, you are not a patient; you are a participant (or subject).

2. Why do people participate in research? Should I participate?

People participate in research studies for many reasons, including:

    • The opportunity to help solve health problems for future generations.
    • The possibility of receiving experimental (or "investigational") drugs and treatments that are not currently approved for use outside of research studies.
    • The opportunity to contribute to the study of groups of people who, in the past, were not usually asked to participate in research studies (e.g., women, African Americans, Hispanic Americans, Asian Americans, American Indians, etc.).

If someone has asked you to join a study, or you are thinking about joining a study, or you have already joined a research study, please read our Participant Rights page for a list of your rights as a research participant.

The most important thing to remember is that the decision to participate in a research study is entirely up to you; it is a personal choice.

3. Is there anything that I should know before I join a study?

Before you decide to join a research study, at the very least you should know:

    • What will happen throughout the study.
    • What type of health care you will receive.
    • What specific study procedures will take place.
    • All of the risks and possible benefits of the study.
    • Any costs to you.
    • What will happen to your medical information and study results.

You should also seek advice from a trusted doctor or health care professional and be sure that all of your questions are answered to your satisfaction.

4. Who pays for research studies?

Research studies are paid for by a "sponsor." Sponsors may be drug companies, hospitals, individuals, or government agencies. Oftentimes, the sponsor is the one who is making the drug or treatment that is being studied.

5. What kind of treatment will I receive if I join a research study?

If you are participating in a medical research study, the type of treatment that you receive may be different than what your regular doctor would prescribe. In fact, as a medical research participant, you may not receive treatment at all. Furthermore, there is no guarantee that any treatment that you may receive will help you. Before volunteering to participate in a medical research study, you should be aware of your alternatives because there may be better options for you.

6. What is informed consent?

An important part of any research study is the "informed consent" process. This process involves the various discussions that take place as a study is being fully explained to you (and your questions are being answered to your satisfaction). It also involves the reading and signing of a document called the "informed consent document (ICD)."

An informed consent document is a written document that clearly explains everything that will take place during a study and all of the details involved with your participation. By signing this form, you are stating that you have given your informed consent to participate; you are verifying that you have volunteered to participate after being told everything that the study involves.

Your informed consent is always confirmed before your participation in a study begins (before study procedures are performed). The informed consent process continues throughout the entire study because your "informed consent" is only genuine if you are truly aware of everything involved with participating in the study.

7. Will joining a research study take up a lot of my time?

If you choose to join a research study, there will be specific study procedures involved. Study procedures may include attending scheduled study visits, having certain medical tests performed, completing forms at home, and other tasks (all of which will be explained to you before joining). Some studies will have more procedures than others. Going to study visits and completing the study requirements may take up a lot of your time. However, each research study is different, and things that participants are required to do will depend on the study.

8. Are there risks involved?

Many research studies use drugs or treatments that may have unpleasant side effects (sometimes called "adverse events" or "adverse effects"). Some side effects can be minor, some can be serious, and some can actually be life-threatening.

While some side effects do not last very long, some can be permanent. There is even a possibility that side effects will happen after you are finished with a study. The risks involved with volunteering for a study depend on the type of research being performed. Because of this, you should know all of the risks involved in a study before you join. You should also ask if there are any unknown side effects.

Some studies use a "placebo" which is something that looks like a drug/treatment but does not contain any active medicine or offer possible treatment. In this case, your symptoms might get worse since you are not receiving any possible treatment for your condition.

Even if a study does not use a placebo, the study drug/treatment that you receive may not help you. This is true both for drugs and treatments that are approved by the FDA and also for those that are experimental.

9. Will I have to pay for anything? Will I be paid for participating?

Usually, participants do not have to pay for any procedures or research in which they take part. However, a study might require that you cover certain expenses out-of-pocket or with your health insurance coverage.

Many research studies will pay you money for your time and effort. Some will give you items such as gift certificates, and some will not pay you anything at all.

Before joining a study, you should know if and how you will be paid, as well as what costs, if any, the research study will require you to cover. All of this information should be clearly outlined in the informed consent document.

10. Will participating in a research study affect my medical care?

Joining a research study (or quitting a research study) will not affect your medical care. You always have the right to receive medical care, whether you participate in a research study or not.

11. What are my rights if I join a research study?

Please review our Participant Rights page for a list of your rights as a participant.

12. What are my responsibilities if I join a research study?

If you decide to participate in a research study, it is important that you be completely honest during the screening process and throughout the entire study. The screening process takes place when the study doctor and the study staff ask questions and perform tests to check and see if you can participate in the research study.

Because some drugs and treatments are harmful to people who take certain medications, or people who have a history of certain diseases, it could be very risky to your health if you join a study without being fully honest with the study doctor and study staff. It will also be your responsibility to report any side effects that happen to you (no matter how minor) to the study doctor or study staff as soon as possible.

If you give false medical information by lying to the study doctor or study staff at any time, you may be putting yourself in danger.

Throughout the course of the study, you will be expected to follow all instructions and come to all scheduled study visits. The study doctor and his/her study staff will tell you what your specific responsibilities will be as a study participant.

13. What does an IRB do?

"IRB" stands for "Institutional Review Board." An IRB is a group of doctors, scientists, and other people from the community who help to make sure that your rights and your safety are being protected as a research participant. The IRB is particularly interested in the risks that are involved in studies under its review and how well those risks are being explained to potential and current participants. If a study is not being conducted properly, the IRB has the authority to stop a research study from continuing (or put it temporarily on hold).

14. What if I have other questions, concerns, or comments, or would like to offer input?

If you did not find the answer to your question about medical research studies here, please email the This email address is being protected from spambots. You need JavaScript enabled to view it. with your inquiry; you may also call us at 888-636-1062, and ask for a member of the Regulatory Department.

why-sterling-2

WHY CHOOSE STERLING?

Innovation. Passion. Commitment. We believe these are the essential components of strong teamwork.

review-board-2

REVIEW BOARD

A diverse group of scientific and non-scientific members with nearly a century of collective IRB experience.

research-canada-mexico-2

RESEARCH IN CANADA

Sterling IRB has formed a strategic partnership with Veritas IRB.

©2014 Sterling IRB. All rights reserved.