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Frequently Asked Questions

Texas Health Resources conducts clinical trials across the Texas Health Resource system. You or your family members may be able to participate in important research that improves peoples' lives. Texas Health Resources is committed to promoting the rights and welfare of all research subjects who participate in research activities across the system. 

Following are frequently asked questions about research and your rights as a research participant at Texas Health Resources.

Q. What is research?
A. Research is a way to answer a question and to gain knowledge.  We use knowledge gained from research to come up with new treatments.

Q. What is a clinical trial?
A. Clinical trial is the scientific term for a test or study of a drug or medical device in people. These tests are done to see if the product is safe and effective for people to use. Doctors and other health professionals run the tests according to strict rules set by the U.S. Food and Drug Administration (FDA). The FDA sets the rules to ensure that people who agree to be in the studies are treated as safely as possible.

Q. Why volunteer for a clinical trial?
A. By participating in a clinical trial, you can potentially try a new treatment that may or may not be better than those that already exist. You can also help others better understand how the treatment works in people of different races and genders.

Q. What is a protocol?
A. A protocol describes the rules to follow during the research. For example, a protocol states why it is important to study the research question and how the research team will answer the research question. A protocol also states how the research team will protect the health and well being of the research volunteers. A protocol includes information on the study procedures, medications to be used, possible risks and benefits, possible adverse events, and data analysis methods.

Q. Who gets to be in a study?
A. Each research study is different. Each study tries to find answers to a specific question. Researchers must follow strict rules to decide who may take part in research. Not everyone with the disease or problem that is being studied can take part in a research study.Q. Is participation in clinical studies voluntary?
A. Research studies include only people who choose to participate. You should take your time to make your decision and discuss it with your friends, family and/or physician prior to deciding to participate in a research study.

Q. What is informed consent?
A. Informed consent is the process that gives information to people who are thinking about taking part in research. After learning about the research, you should understand:

  • The purpose of the study
  • The procedures involved in the study
  • The possible benefits and risks of taking part in the study
  • The rights of people who take part in research
  • That taking part in research is your choice
  • What you can do instead of taking part in the study
  • How the research team will give you any new information that may be learned after you decide to take part in a study that might cause you to change your mind

Informed consent is a process that helps you learn about the research study. After learning about the study, you will be able to ask the researcher or his/her staff questions. You should only agree to take part after you clearly understand the study and feel comfortable. You should take time to talk over your decision with your doctors, family, and friends. If you agree to take part, you will be asked to sign an "informed consent form." The informed consent process goes on even after you are taking part in the study. If researchers learn new information after you begin the study, they must share this with you.

Q. How are volunteers protected?
A. To help you decide if you want to be in a study, the FDA requires that you be given complete information about the study before you agree to participate. This is known as informed consent. Before you can be in the study, you must sign the informed consent form, showing that you have been given this information and understand it. The informed consent form is not a contract. You can leave the study at any time, for any reason.

Q. Who reviews and approves research at Texas Health?
A. Federal regulations require that a committee called the Institutional Review Board (IRB) review, approve and monitor all research involving human subjects. The IRB's goal is to protect the rights and welfare of human research participants. It monitors human subject research to determine that it is conducted ethically, and in compliance with federal regulations, state law and Texas Health Resources' policies and procedures.

IRB members include physicians, nurses, and community representatives, with Texas Health administration representatives also participating. Studies are submitted electronically at Texas Health, via the electronic Institutional Review Board (eIRB).

Q. Is participation in clinical studies voluntary?
A. Research studies include only people who choose to participate. You should take your time to make your decision and discuss it with your friends, family and/or physician prior to deciding to participate in a research study.

Q. Can participants end their participation in a clinical trial?
A. Participation in a clinical trial is your decision. You may refuse to be in the trial or you may stop participation in a trial at any time. If you decide not to participate, or you withdraw, you will not have any penalty or loss of benefits to which you are entitled and this will not affect your future medical care.

Q. Will it cost me anything to take part in a research study?
A. Clinical trials test new drugs, devices, or treatments. In some cases, taking part will not cost you or your insurance company anything. In other studies, the research team may bill your insurance company for drugs, devices, and services they provide. It is possible that your insurance company will not pay for some or all of the charges and you may receive a bill for those costs. The study informed consent form will describe any costs to you in detail. If the information in the consent form is not clear, you should ask the research team to explain any costs before you sign the consent form.

Q. Do research participants get paid?
A. Some studies compensate participants for the time they spent participating in a trial; generally this amount is given to cover expenses for parking, transportation, meals, and possibly for lost work time; however, payment may not be substantial enough to constitute inducement to participate for monetary gain.

Q. What is a registry?
A. A registry is a database comprised of information and/or tissues obtained from individuals. This information is collected in a standardized way so that it can be used in research; in this way, it is different from information collected typically by the patient's doctor. These registries are also called "banks." Registries are established for the purpose of collecting as much information as possible about a particular illness or a group of people. Some registries are very large and may include family members of people with specific illnesses. Agreeing to participate in a registry could be as simple as allowing a research study to collect tissues that would normally be thrown away after surgery; or a registry could be designed to collect blood, tissue specimens, and information from your medical records for many years. A registry could have information on 100 people or it could have information on 10,000 people. It is from registries and banks that many researchers develop new ideas for new research studies.

Q. What is a randomized trial?
A. Randomized is used to describe a research study that hopes to compare two or more different treatments or procedures. Randomized means that you will be assigned to a study group by chance, like flipping a coin.

Q. What is HIPAA?
A. As part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), which was originally passed as a means of maintaining healthcare coverage, Congress included Administrative Simplification provisions in HIPAA directed at standardizing how health care information and claims are processed and used. The privacy provisions (as well as the security provisions) were then added to HIPAA's Administrative Simplification provisions to protect how patient health information or "Protected Health Information" (PHI) is stored, transmitted and used.

"The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule establishes the conditions under which protected health information (PHI) may be used or disclosed by covered entities for research purposes. The Privacy Rule also defines the means by which individuals will be informed of uses and disclosures of their medical information for research purposes, and their rights to access information about them held by covered entities."

For more information on clinical trials, visit these websites:

National Institutes of Health: Understanding Clinical Trials

Office for Human Research Protections: Becoming a Research Volunteer

Coming Soon

The Texas Health system welcomes clinical study inquiries and participation from qualified medical professionals.

But where to begin?

To start, please review the frequently asked questions and answers, below, to gain a better understanding about operations surpervised by the Texas Health Research & Education Institute and the organization's Institutional Review Board (IRB).

Interested parties can also use the convenient form below to contact a Texas Health IRB advocate for more information.

Q. Where do I get help?
A. A wide range of support services for clinical studies and product research and development are available through the Texas Health Research & Education Institute.

Q. How do I enter the process?
A. If you are interested in being a Principal Investigator for a clinical trial, your first step will be to set up an eIRB account. The eIRB is the software system that our Institutional Review Board (IRB) utilizes for all study submissions. This may be initiated by going to the eIRB webpage and selecting Request an Account. After you have an account set up, you may start the IRB study submission process.

Q. What about forms, templates and related materials?
A. A complete selection of forms, templates, meeting dates, regulations, fees and other IRB information are always available.

Q. What about research billing and compliance issues?
A. Texas Health has a centralized department that oversees research billing compliance, evaluates proposed study budgets and assists the Legal review of Clinical Trial Agreements. Study agreements and budgets may be sent directly to the Research Administration Department's manager of Contracts and Budgets, JessicaDerr@TexasHealth.org, or by uploading it through the eIRB. An electronic version of the contract and budget are required for review. It is the policy of Texas Health Resources to consistently and fully comply with all laws and regulations pertaining to the billing of research-related charges for our patients. To ensure that patients are properly identified as participating in a research trial, a special admissions form is required to be presented at each time a hospital service is rendered. The Research Administration Department will supply you with this form. Contract and budgets are reviewed and negotiated simultaneously with the IRB review process.

Q. How do I request an IRB advocate?
A. Simply complete and submit the form below to request an IRB advocate or ask any questions related to research opportunities in the Texas Health system.

Contact a Texas Health IRB Advocate