For Research Participants

Research involves an investigation, study, or project involving standardized step(s) or procedure(s), which may be novel or experimental in nature, meant to yield a result, outcome, or information that addresses a question, problem, or hypothesis. Research can involve humans, either through direct interaction or through the use of their identifiable information (e.g., medical records, etc.). There are different types of research projects. For example, a research study may test if a treatment is safe and effective. A research study may be done to find out what healthcare practices work best. A research study may be done to determine the best way to prevent an illness. A research study may use a survey or an interview to understand the feelings people have about their health. One type of research study is a clinical trial. A clinical trial is a research study that will try to decide whether new treatments are safe and effective. In clinical trials, treatments are often compared with placebos to check the effectiveness of that treatment. A placebo is an inactive substance that may resemble an active substance. However, it typically has no value to treat or prevent an illness.

The Institutional Review Board (IRB) is a group of people who review and approve research involving humans. The IRB includes medical people, social behavioral and biomedical/clinical scientists, public health advocates, and people from the local community. They review human research to make sure it is well-planned, scientifically sound, and ethical.

The IRB serves to protect your rights and your welfare before, during, and even potentially after you participate in the research study. For example, the IRB makes sure that any potential risks involved in the research study are as small as possible to reduce the chance of harm (e.g., loss of privacy, physical injury, etc.). The IRB does not decide your participation in research. The choice to participate in research is yours only. Rather, the IRB decides whether it is right to do the research project and how to safely include research volunteers. The IRB also reviews each research study while it is going on to make sure volunteers are protected.

The North Texas Regional Institutional Review Board (or NTR IRB) is the IRB that reviews and oversees human research studies and projects for the University of North Texas Health Science Center (UNTHSC), John Peter Smith Hospital Network (JPS), University of North Texas – Dallas (UNT Dallas) and Tarrant County Public Health (TCPH). We are here to serve you!

Thousands of research studies are being conducted each year. These research studies have contributed to health, social, behavioral, and public health-related improvements for many people from every walk of life.

However, these advances would not be possible without people willing to volunteer to take part in research studies. You may be asked to volunteer for a research study approved by the North Texas Regional IRB. The information presented here aims to help you understand your rights as a research study volunteer. It may help you to decide if you should take part in a research study. Please discuss this information with other people you trust.

Like your medical record, the information in your research study record will be confidential. Information will be given only to the people who need it. This includes the Principal Investigator (person in charge of overseeing all aspects of the research study), researchers and research team who carry out the research study. Other individuals who may access your information includes the Institutional Review Board (IRB), the organization, company or group funding the research study, and various government oversight agencies. It is important for these groups to be able to look at your research records, so they can ensure that the research study is conducted using acceptable research practices and procedures.

The research team will explain the research study to you and provide you a consent document with all the relevant information needed to decide on whether or not to participate in research. You should take your time when you read the consent form.

If you have any questions, ask the research team. If you don’t understand something, ask them to explain it to you so you do understand. The information will be given to you in a language that you know.

You can take the consent document/information home and discuss it with your family, friends, a health care provider, or others before you decide whether or not to take part in the research study. If you decide to take part in the research study, you will be asked to provide verbal consent and, where appropriate, sign the consent form showing you agree to participate

The informed consent process is more than just (signing) a piece of paper. It is a process that goes on throughout the research study. During the research study, you may be told of new findings, information, benefits or risks. At that time, you can decide to either continue or leave the research project. Separately, you may change your mind at any time and leave the research study before it starts, or during the course of the study.

There are many reasons to participate in research study.

You may want to:

· Help find a cure or treatment for an illness, health or mental health condition

· Help find ways to provide better care, services and/or education

· Help other people who are sick

· 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. If you choose to do so, you have many important rights.

Informed consent is the process of learning the facts and information about a research study before you decide whether or not to volunteer. Your agreement to volunteer should be based upon knowing what will take place in the research study and how it might affect you. Informed consent begins when the research team approaches you to participate in research.

The research team will go over these facts, so you can decide whether or not you want to take part in the research study. These facts include details about the research study, tests or procedures you may receive, the benefits and risks that could result, and your rights as a research volunteer. These facts should be provided to you in document, cover letter or sheet, where applicable, you will be asked to sign the document acknowledging your understanding of these facts as well as providing your permission to participate in and follow study procedures.

There may or may not be a direct benefit to you if you take part in a research study. For example, your health or a health condition you have may get better as a result of your participation in the research study. It may stay the same. It may get worse. No one can predict what will happen with a research study or how it might affect you. The research study may not help you personally. The research study may result in information that will help others in the future.

Sometimes research procedures and interventions may cause discomfort and/or unwanted side effects. For example, the questions being asked could make you uncomfortable.

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

Before you decide to volunteer to be 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. It is important to understand what you are being asked to do as part of research.

You might want to write your questions down in advance. The following is a list of sample questions. Please note that not every question will apply to every research study.

· Who is doing this research study?

· What question does this research study answer? What are researchers wanting to learn or know?

· Will this research study help in understanding my condition? If so, how?

· What tests or procedures will be done?

· Is it possible that I will receive a placebo (inactive substance)?

· Will I have to make any extra trips for the study visits?

· What could happen to me, good and bad, if I take part in the research study?

· How long will this research study last?

· What will happen to any specimens that I give?

· What happens to my study information or records during the course of the study?

· Who has reviewed and approved this research study?

· Could my condition get worse during the research study? What will happen if it does?

· What other options or choices do I have if I decide not to take part in this research study?

· Who will be in charge of my care during the course of the study? Will I be able to continue to see my own doctor?

· Will I be charged anything, or be responsible for paying if something happens to me as a result of participating in the study (e.g., injury)?

· Will I be given compensation for participating in this research study?

· If I decide to participate in this research study, how will it affect my daily life?

· What will happen to me and my study information at the end of the research study?

· Will I be told the results of the research study?

· Who will find out that I am taking part in this research study? Who has access to my study information?

· How do I end my participation in this research study if I change my mind?

· Whom do I contact for questions and information about the research study?

Remember, if you do not understand the answer to any of your questions, do not hesitate to ask again. Ask the research team to explain the answer in a way you can understand it. If you forget the answers to the questions during the research study, just ask them again.

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

Remember:

· Your decision should not affect how you are treated. This includes

· You need to weigh both the risks of the research study and the benefits.

· It may be helpful to talk with family members, friends, or your health care providers.

· If you decide to volunteer for a research study, you can change your mind and stop or leave the research study at any time. Your decision will not affect how we treat you.

If you have questions about your rights as a research participant, please contact:

North Texas Regional Institutional Review Board (NTR IRB)

UNTHSC Office of Research Compliance

3500 Camp Bowie Blvd

Fort Worth, TX 76107

NorthTexRegIRB@unthsc.edu

(817) 735-0409

Please call this number if you have concerns or complaints, or just want to talk to someone about research at this organization.