Healthcare

Clinical Trials Frequently Asked Questions

What is a research study?

A research study is an organized activity to learn more about a problem or answer questions. Many different kinds of studies are conducted. For example studies may be done to:

  • Test if a product, such as a drug or equipment, is safe and effective.
  • Find out what education practices work best.
  • Determine the best way to treat or prevent an illness.
  • Survey or an interview to understand needs, problems, or feelings people have about an important topic.

Why volunteer for a study?

There are many reasons to take part in research. You may want to:

  • Help other people.
  • Help find a cure for an illness.
  • Help scientists find out more about how the human body and mind work.

If you decide to take part in a research study, you do so as a VOLUNTEER. That means YOU decide whether or not you will take part. You can say “no”. If you choose to do so, you have many important rights, including the right to decide that you want to quit the study at any time.

Are there benefits to being in a research study?

There may or may not be a direct benefit to you if you take part in a research study. No one can predict the outcome of a research study or how it might affect you. The study may not help you personally, but your taking part may result in information that helps others in the future.

Are there risks or side effects in a research study?

Sometimes research procedures may cause discomfort and side effects. The risks and side effects of the research may not be known completely when you start the study. The research staff will discuss with you known possible risks so you can decide if you want to volunteer. If you do volunteer, the research staff will tell you about any new risks that they learn about during the study for as long as you take part in the study.

What questions should I ask before I agree to take part in a research study?

Before you decide to volunteer to take part in a research study, you need to know as much as possible about the research study. If there are any issues that concern you, be sure to ask questions. You might want to write your questions down in advance. Remember, if you do not understand the answer to one of your questions, ask the question again and ask the person to explain the answer in a way you can understand it. If you forget the answers to the questions during the study, just ask them again.

What is informed consent?

Informed consent is the process of learning the key facts about a research study before you decide whether or not to volunteer. You should only agree to volunteer in a study if you have a clear understanding of what will take place in the study and how it might affect you. Informed consent begins when the research staff explains the facts to you about the research study.

The research staff will assist you with the “informed consent document” that goes over these facts so you can decide whether or not you want to take part in the study. These facts include details about the study, procedures you may receive, the benefits and risks that could result, and your rights as a research volunteer.

Who will answer my questions about the informed consent form?

You should take your time when you read the consent form. If you have any questions, ask the research staff. If you don’t understand something, ask them to explain it to you so you do understand. If English isn't your native tongue, ask for an interpreter to be present when you are discussing the study with the research staff. You can take information home with you and discuss it with your family, friends, a health care provider, or others before you decide whether or not to take part in the study.

If you decide to take part in the study, you will be asked to sign the informed consent form. However, the informed consent process is more than just signing a piece of paper. It is a process that goes on throughout the study. During the course of the study, you may be told of new findings, benefits or risks. At that time, you can decide whether or not to continue your taking part in the study. You may change your mind and leave the study before it starts or leave at any time during the study or the follow-up period.

Who will see my records?

Like your medical record, the information in your research record will be confidential. The informed consent document will tell you how your information will be kept safe and who will be able to access your information.

What is an IRB?

The Institutional Review Board (IRB) is a group of people such as scientists, non-scientists, and people from the local community who make sure that human research is ethical. If you are invited to take part in research the study should be approved by an IRB. The IRB serves to protect your rights and your welfare before and during the research study. For example, the IRB makes sure that any risks in the research study are as small as possible.

How do I get more information?

How do I get more information?

You can sign up at www.researchmatch.org if you would like to be contacted about research opportunities you may be interested in.

Interested in participating in a particular research trial at Oregon Health and Science University? Visit the research opportunities page at http://www.ohsu.edu/research/rda/so/ to search for available trials or contact:

Clinical Research Navigator
503-346-3540
navigator@ohsu.edu

If you have any questions, concerns, or complaints about research at Oregon Health and Science University, or just want to talk to someone about research in general, please contact:

David Holmgren, IRB Manager
503-346-3528
holmgred@ohsu.edu