Should I Participate in Research?

Before deciding to participate in research, here are some things you NEED to know...

What is a research study?
A research study is the systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge.

What is a human subject?
A human subject is a living individual about whom an investigator conducting research obtains (a) data through intervention or interaction with the individual, or (b) identifiable private information.

Who can be a subject in a research study?
Most research studies have certain criteria that you must meet in order to participate. These criteria are designed to ensure the safety of the subjects as well as to ensure the usefulness of the research. Some studies have broad criteria; for example, you must be over 18. Other studies have much more strict criteria for participating; for example, you must have a certain disease.

Do I have to participate?
NO! Participating in a research study is strictly voluntary. And remember, you can leave or drop out of a study at any time Furthermore, refusal to participate will not result in any penalty or any loss of benefits that you are otherwise entitled.

Who leads a research study?
The Principal Investigator (PI) leads all research studies. The PI is responsible for the overall management of the research study. The PI is also responsible for assuring the safety of the subjects. PIs are often faculty, physicians, or graduate students.

Who else is involved in research studies?
Principal Investigators often rely on a research team to assist them in the day to day studies. The research team can be made up of research assistants, research nurses, data coordinators, statisticians, and other people with specialized skills needed for the study.

Who reviews a study?
At the University of Southern California, all studies that involve human subjects are reviewed by an Institutional Review Board (IRB) before they are allowed to begin.

What is an IRB?
An IRB is a committee of scientists and non-scientists who review projects submitted by researchers at the University of Southern California. At the University of Southern California there are two IRB offices; one for the University Park campus, and the other for the Health Sciences campus.

What kinds of procedures are involved?
Research studies can involve a wide variety of procedures, ranging from filling out surveys and questionnaires to taking experimental medicines or using experimental devices. Some research studies last only a few minutes, while others last for several years. The research team will describe to you all of the procedures that you will be asked to undergo before you agree to be in the study.

Who will see my 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 the study is safe and carried out the way it was planned.

Are there any special rules to help protect certain subjects?
Children, pregnant women, prisoners, and persons with cognitive impairments can all be participants in research studies, but are considered potentially "vulnerable populations." The U.S. government and The University of Southern California have put in place special rules to protect participants who fall into one of these groups.

Are there risks to being in a research study?
Research studies may involve some degree of risk. A study that asks you to fill out a survey has only minor risks, such as answering questions that make you uneasy. For other studies, such as studies that ask you to take an experimental drug, the risks can be much greater. For example, having a bad reaction to the drug. The research team is required to explain to you the foreseeable risks of being in the study before you decide whether or not to be in the study.

Are there benefits to being in a research study?
Not everyone who participates in a research study will benefit personally. Sometimes, your participation in the research study will be of benefit to humanity by helping researchers to learn more about a certain disease or condition. In some studies, however, you may benefit if the experimental drug or procedure makes your disease stop progressing or lessens its effects on you.

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 form" 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, tests, or procedures you may receive, the benefits and risks that could result, alternatives available should you decided not to participate, and your rights as a research volunteer.

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. The following is a list of sample questions. Not every question will apply to every study.

• 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?
• What alternatives are available if I decide not to participate in the study?
• Is it possible that I will receive a placebo (inactive substance)?
• What could happen to me, good and/or bad, if I take part in the study?
• How long will the study last?
• What will happen to any specimens that I give?
• Who has reviewed and approved this study?
• If I have a condition, could it get worse during the study?
• Will I be charged anything or paid anything to be in this study?
• If I decide to participate 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 participation in this study if I change my mind?
• Whom do I contact for questions and information about the study?
• What risks are involved in this study?

Where do I find out more information about human research protection?
To find out more about human research protection please visit our website - http://www.usc.edu/admin/provost/oprs/ or contact:

Office for the Protection of Research Subjects (OPRS)
Susan Rose, Ph.D., Executive Director
837 Downey Way
Stonier Hall, Room 221
Los Angeles, CA 90089-4019
Tel: (213)-821-1154
Fax: (213)-740-9299
E-mail: oprs@usc.edu

Whom do I contact regarding concerns or complaints?
If you have a concern, complaint, or compliment, please contact the respective IRB office listed below. The IRB takes all complaints seriously and investigates all complaints and concerns. You may contact the IRB office by phone, email, or regular mail. Please visit the websites for additional information.

Health Sciences Campus
Institutional Review Board
Darcy Spicer, M.D., Chair
Diana Shycoff, CIP, IRB Director
IRD Building
2020 Zonal Ave, Room 425
Los Angeles, CA 90033
Tel: (323)-223-2340
Fax: (323)-224-8389
E-mail: irb@usc.edu
http://ccnt.hsc.usc.edu/irb/irb.html

University Park Campus
Institutional Review Board
Wynne Waugaman, Ph.D., Chair
Cindy K. Chui, CIP, IRB Administrator
3601 Watt Way
Grace Ford Salvatori Hall, Room 306
Los Angeles, CA 90089-1695
Tel: (213)-821-5272
Fax: (213)-821-5276
E-mail: upirb@usc.edu
http://www.usc.edu/admin/provost/irb/upc.html

Adapted from the Department of Veterans Affairs' Office of Research Compliance & Assurance "I'm a veteran. Should I participate in research?", and the University of Iowa's Human Subjects Office "So you're thinking about being in a research study (PDF)."