Human Research Participant

Understanding Your Rights as a Participant in Human Subjects Research

What is Research?
What is a “subject” or “participant”?
Should I take part in a research study?
Why volunteer for a study?
Are there benefits to being in a research study?
Are there risks or side effects in a research study?
What questions should I ask before I agree to take part in a research study?
Who will see my research records?
What is Informed Consent?
Who will answer my questions about the informed consent form?
What is an IRB?
What if I have a concern or problem?
More information

1. What is Research?

A research study is an organized activity to learn more about a problem or answer questions. Researchers at the George Washington University are constantly looking for better or new ways for improving lives and treating or diagnosing illness and disease. Clinical trials are research studies that are designed to determine whether drugs, devices and treatments are effective and safe for people to use. Some clinical trials may test medications or devices that are already approved and available, while others test drugs that are still experimental or not yet approved for use. Other types of research studies use interviews, focus groups, or surveys to gather information about people’s habits, opinions, and beliefs. Some research studies only involve observation of the way people interact with one another or react to certain situations in order for researchers to gain new insights into human behavior. At GW, all types of research are conducted.

2. What is a “subject” or “participant”?

Being a participant in a research study is not the same as getting treatment as a patient – there might be tests, medicines, or devices that you would not get if you were being treated as a patient. People considering being research participants are given information about the study and what to expect if they decide to participate in the research.

By taking part in a research study, you can also contribute to better understanding of how the treatment or intervention works in people of different ethnic backgrounds and genders or how people of different cultures think about a topic.
Participants help researchers in many different ways. Depending on the goals of the research, participants might be asked to do things like:

take part in interviews (sometimes as part of a group)
complete questionnaires, tests or special tasks
allow access to private information (such as medical records or school records)
let researchers observe behavior complete physical, psychological or other kinds of examinations
give samples of blood, saliva, urine or other materials
take experimental drugs or use experimental medical devices

3. Should I take part in a research study?

The George Washington University is committed to responsible research. Research has significantly contributed to improvements for many people from every walk of life.

Many advances in knowledge would not have been possible without individuals willing to take part in research. You may be asked to volunteer for a research study. This page will help you understand your rights as a research volunteer and help you to decide if you should take part. It will also help you understand some of the basic requirements for good research. We urge you to review this information and discuss it with other people you trust.

If anyone asks you to take part in a research study, you have the right to say “no.”

Your decision will not affect your relationship with the organization conducting the research.
You need to weigh both the risks of the study and the benefits.
It may be helpful to talk with family, friends, or other people you trust.
If you decide to take part in a research study, you can change your mind and stop or leave the study at any time without anyone holding it against you.

4. Why volunteer for a study?

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

help scientists find out more about how the human body and/or mind work;
help other people;
help find a cure for an illness.

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 in the research. If you choose to do so, you have many important rights.

5. 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. You may get better as a result of your taking part in the study, you may stay the same, or you may even get worse. 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.

6. Are there risk or side effects in a research study?

Sometimes research procedures may cause discomfort and side effects. The questions being asked could make you uncomfortable. 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.

7. 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 or take the below list of questions with you. Please note this is a sample list of questions; not every question will apply to every study.

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.

Who is doing this study and what question might it answer?
Will this research help in understanding my condition? If so, how?
What tests or procedures will be done?
Will I have to make extra trips?
What could happen to me, good and bad, if I take part in the study?
How long will this study last?
What will happen to any specimens that I give?
Who has reviewed and approved this study?
Could I get worse during the study? What will happen if I do?
What other options or choices do I have if I decide not to take part?
Will I be charged anything or paid anything to be in this study?
If I decide to take part in this study, how will it affect my daily life?
What will happen to me at the end of the study?
Will I be told the results of the study?
Who will find out that I am taking part in this study?
How do I end my taking part in this study if I change my mind?
Whom do I contact for questions and information about the study?

8. Who will see my research records?

Like your medical record, the information in your research record will be confidential. Information will be given only to the researchers who carry out the study or to those who make sure that the study is safe and carried out the way it was planned. The groups of individuals who might look at your records are the research staff, The Institutional Review Board (IRB), the company or group funding the study, and various government oversight agencies. It is important for these groups to be able to look at your records so they can ensure that the study is conducted using acceptable research practices.

9. 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. Your agreement to volunteer should be based upon 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.

To help you decide if you want to be a research participant in a study, IRBs require informed consent, which means you are given information about the study before you agree to take part. Research participants should be informed about:

the purpose of the research;
how long the study is expected to take;
what will go on in the study and which parts of the study are experimental;
possible risks or discomforts;
possible benefits;
the person to contact with questions about the study, your rights, and injuries related to research;
the fact that being in the study is voluntary and you can quit at any time.

This information is generally provided in conversations with the researcher and in a written Consent Form. The Consent Form should be written so you can understand it. If you don't, be sure to ask the researcher to explain it. Make sure you understand all of the information in the consent form before you agree to be in the study.

10. 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 language, ask for an interpreter to be present when you are discussing the study with the research staff. The written and verbal informed consent information should be given to you in a language that you understand. You can take the 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.

11. 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 ensure that human research is ethical.

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. The IRB does not make a decision for you. The IRB decides, when approving research studies, that it is reasonable to ask people whether they want to be involved in it. The IRB also reviews each study while it is going on to make sure volunteers are protected.

12. What if I have a Concern or Problem?

You can contact the GW Office of Human Research at [email protected] for help if:

you want general information or have general questions about research or your rights;
you wish to discuss problems, suggestions or concerns;
you do not feel comfortable communicating with the study team;
you want advice about how to communicate with the study team;
you have communicated with the study team, but they have not been able to help you.

13. More Information

The Office for Human Research Protections has additional information about research participation, including the following pamphlet for you to download:

Becoming a Research Volunteer: It's Your Decision

Contact Us

The George Washington University Office of Human Research (OHR) is available for your questions regarding projects involving human subjects. Please contact us via:

E-mail: [email protected]

Telephone: 202-994-2715

To receive updates from OHR and IRB, please request to be added to our listserv by emailing [email protected].

Location and Mailing Address:
GW Office of Human Research
1922 F Street NW, 4th Floor, Washington, DC 20052

Appointments

OHR staff are available for consultations by WebEx/Zoom/telephone. In-person appointments and office hours have been suspended. Email [email protected] to schedule a meeting.

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