Participating in a Research Study

What is a research study?
Who conducts research studies?
Who reviews a study?
What is an IRB?
Where can I find out more about the IRB?
Who can participate in a research study?
What can I expect if I choose to participate in a research study?
Are there any risks to being in a research study?
Are there any benefits to being in a research study?
Are there any special rules to protect certain participants?
Where can I find out more about being in a research study?

What is a research study?

A research study is designed to answer specific questions that will enhance knowledge and benefit members of society.

Who conducts research studies?

The person who is responsible for the study is called the Principal Investigator (PI). The PI may be a Penn State faculty member, staff person, or student. The PI often works with a team of research associates who help carry out study procedures. Members of the research team, depending on the type of study, might include a research nurse, data coordinators, statisticians, or other people who can carry out specific study-related tasks.

Who reviews a study?

All research with human participants conducted at Penn State is reviewed and approved by an Institutional Review Board (IRB). Penn State has two IRBs at University Park that review all social science and biomedical research conducted at all of the campuses except the College of Medicine. The College of Medicine has four IRBs that review research conducted at the College and at the Penn State Hershey Medical Center.

What is an IRB?

An IRB is a committee of individuals with scientific and non-scientific expertise. The committees are comprised mostly of Penn State faculty or staff, but each committee also includes one or more individuals from outside Penn State who can bring a unique community perspective to the review of research. The diversity of IRB membership is designed to enable an understanding of the concerns and needs of the Penn State community where research occurs.

The IRB is responsible for the initial and continuing review of research studies to ensure that research is conducted ethically and in compliance with all applicable regulations. The IRB reviews research to determine, among other things:

• that the research will benefit the research participants and/or society
• that risks to research participants are minimized
• that participants are given the opportunity to provide their informed consent, and
• that participants' privacy is adequately protected.

Where can I find out more about the IRB?

The websites of the research offices at both the University Park campus and the College of Medicine are good sources of information for learning about the research process and the IRBs' responsibilities.

If you have questions, concerns or complaints related to human participant research conducted the The Pennsylvania State University, please contact:

Who can participate in a research study?

All research studies target specific groups of individuals. This helps ensure the safety of research participants and makes it possible to more easily answer the research question. You must meet the criteria for a study in order to participate. The criteria for some research studies are very broad (e.g., women over the age of 18). Others are much more specific such as those that look at a specific disease.

What can I expect if I choose to participate in a research study?

What a research study asks a participant to do varies greatly depending on the type of study. Your participation in a research study could involve any of the following: completing a survey, eating a special diet, engaging in an exercise program, or taking an experimental medication. The length of your participation can also vary significantly from a one-time encounter to several years. Before you agree to participate in a study, the researcher will describe exactly what you will be asked to do. The researcher will provide you with a consent form that includes a written explanation of the research. You will be asked to sign the consent form verifying you understand what will be required of you.

Are there any risks to being in a research study?

The amount of risk varies greatly depending on the type of study. Studies asking you to complete a survey may involve minimal risk such as some uneasiness when answering the questions. Studies that ask you to participate in an exercise regimen may involve some muscular discomfort. Studies using an experimental medical procedure or drug can involve more risks, as you could experience a bad reaction. The researcher will clearly explain to you what the possible risks of the study are before you agree to participate. The risks will also be identified in the consent form that you will be asked to sign.

Are there any benefits to being in a research study?

Some research studies directly benefit the individuals who participate. For example, a diet and exercise study may offer certain health benefits. Other studies are designed to offer greater benefit to society. If you join a study that compares treatments, you may or may not benefit directly.

Are there any special rules to protect certain participants?

The U.S. Government and Penn State University have rules in place that protect children, pregnant women, prisoners, and mentally challenged persons who participate in research studies. These individuals are classified as "vulnerable populations."

Where can I find out more about being in a research study?

Penn State research studies are frequently advertised in local publications and on local radio stations. Some research studies are also listed on the Office for Research Protections' website or on medical department sites, or on GetResearchSmart.org. Additionally, if you are interested in participating in a research study for a specific disease or condition, you can talk to your physician about studies for which you might qualify.