FAQs

• Expertly trained professional staff
• Fun, friendly atmosphere
• Focus on patient comfort and safety
• Flexible scheduling

All medical evaluation and treatment related to the research study are provided to you at no charge.

A research-trained physician will oversee your care in the area being studied.

You will have the opportunity to receive and evaluate new treatments for your health concern.

Your participation will help make new devices, treatments, or medications available to the general public.

Our clinical research studies provide you with compensation for your time and travel.

Your first step is to contact Diagnostics Research Group by completing a brief email contact form.

You can access the form by clicking on the Contact Form link here.

Once you have completed and emailed the form, you should expect a member of our research-trained staff to contact you within three business days.

If you prefer, you may call us directly at 210-692-7157.

Please be aware that each clinical research study has a distinct set of guidelines and requirements for participants. Such things as age, condition being researched, medical history, and present medical condition are all considered. You can participate in a clinical research study only if you meet specific criteria for that particular study.

The FDA specifies that you can participate in only one clinical research study at a time.

Clinical Researchers are known as "Investigators" in the research industry.

Our Investigators are a group of highly trained medical professionals who possess a wide range of medical practice and clinical research skills.
 

Charles P. Andrews, MD, CPI

Director of Clinical Research: Diagnostics Research Group

Principal Investigator: Diagnostics Research Group

Certified Principal Investigator (CPI) 

Randall C. Bell, MD

Principal Investigator: Diagnostics Research Group

John R. Holcomb, MD

Principal Investigator: Diagnostics Research Group

Nora L. Walker, MD

Principal Investigator: SleepWalker

Investigator: Diagnostics Research Group

All of our coordinators are nurses with experience in clinical research ranging from two to 18 years. We have seven coordinators who are certified through the Association of Clinical Research Professionals. Our patients have described our coordinators as “friendly, professional, wonderful and punctual.”

A Clinical Trial is a medical clinical research study that is conducted to evaluate the safety and effectiveness of new drugs, treatments and medical devices

Clinical Trials may also evaluate new uses for drugs that are already on the market as well as evaluate and develop new treatments for medical conditions that may currently have no successful treatment available.

Before the FDA (U.S. Food and Drug Administration) will consider approving new treatments and drugs, they must be proven to be safe and effective in treating a disease or illness.

The purpose of clinical research studies is to give the FDA, controlled and accurate information to assist them in their decision-making process.

To evaluate the safety and effectiveness of new drugs, new combinations of drugs, treatments, and medical devices.

They may also evaluate new uses for drugs that are already on the market, as well as evaluate and develop new treatments for medical conditions that may currently have no successful treatment available.

Before the U.S. Food and Drug Administration (FDA) will consider approving new treatments and drugs, they must be proven to be safe and effective in treating a disease or illness.

Each research study is designed as a test for a specific device, treatment, or medication. The length of your participation in a clinical research study can vary from a period of weeks to several years.

• Subjects (you) express interest in becoming study participants.
  
• You are asked to read, and then sign the Informed Consent. The Informed Consent provides you with the full details necessary for you to make an informed decision about becoming a research study participant in that trial.
  

We ask that you not sign the Informed Consent document until all your questions have been answered.

• You will enter a thorough screening process to see if you qualify as a participant. The screening process consists of collecting information about you. This information is collected through screening procedures such as medical and surgical histories, medication histories, physical measurements such as blood pressure, heart rate, weight, blood testing, skin testing, EKG's, X-Rays, pulmonary function testing, etc. Each study determines which particular screening procedures will be performed.
  
• As a participant in one of our studies, you will be made comfortable and treated respectfully by our professional research staff.
  
• As a participant you may be required to complete questionnaires and symptom diaries, and record all medications you take while in the study. Some studies require some of the following procedures to be performed: blood collection, urine and other specimen collection, pulmonary function testing, electrocardiograms and X-Rays.
  
• At the close of the trial, data collected from study participants is presented by the company Sponsor to the FDA. That agency then makes a decision to approve or reject the findings of the study. Only with their approval, will the new device, treatment, or medication be made available to the general public.
  

Clinical research studies are very highly controlled to ensure the utmost safety for the participants and are conducted under the direction of a pharmaceutical company that is responsible to and under the authority of the U.S. Food and Drug Administration (FDA).

The federal government requires specific laboratory research and other designated studies to be performed on any devices, treatments, or medications prior to them being tested on human participants.

All clinical research studies are conducted under the close supervision of experienced research physicians. They generally take place in medical offices, hospitals, certain accredited universities and research dedicated centers such as ours.

Another important safety requirement is that all research facilities conducting clinical research studies involving people must, by federal regulation, involve an Institutional Review Board (IRB) that approves and reviews the research to ensure compliance and safety standards.

Each clinical research study has a distinct set of guidelines and requirements for participants. Such things as age, condition being researched, medical history, and present medical condition are all considered. Remember, you can participate in a clinical research study only if you meet the specific criteria required for that study. The FDA also specifies that you can participate in only one clinical research study at a time.

Let us know if you are interested by:

• Contacting us at 210-692-7157
  

OR

• Click here to go to our "Contact Form”
  

One of our research-trained staff will then contact you and perform a preliminary screening over the phone. If you qualify on the basis of this initial screening, we will make an appointment convenient for you for a full screening visit at our research center. If you do not qualify for a specific study, you are welcome to join our database to be called for future studies.

We adhere to a strict privacy policy for all our research participants.

Our duties 

We are required by law to maintain the privacy of your PHI (Protected Health Information). We must abide by the terms of this notice or any update of this notice.

Your rights 

You have the following rights concerning your PHI 

• To request restricted access to all or part of your PHI. To do this, please ask for, complete, and return to this office a privacy restriction form. We are not required to grant your request.
  
• To receive correspondence of confidential information by alternate means or locations. To do this, please ask for, complete, and return to this office a privacy restriction form.
  
• To inspect or receive copies of your protected health information. To inspect your PHI, set up an appointment for the inspection. To receive a copy of your PHI, ask our office to copy and mail your records to you.
  
• To request changes be made to your PHI. To do this, complete a change of protected health information form and return it to this office. We are not required to grant your request.
  
• To receive an accounting of the disclosures by this office of your PHI in the six years prior to your request. To do this, notify this office in writing that you would like a list of all individuals and organizations to which your PHI has been sent.
  
• To get updates or reissue of this notice, at your request.
  
• To complain to this office or the U.S. Department of Health and Human Services if you feel your privacy rights have been violated. To register a complaint with this office, complete a protected health information complaint form and return it to this office. The law forbids this office from taking retaliatory action against you if you complain.
  

Uses and Disclosures 

We will use and disclose elements of your protected health information (PHI) in the following ways

• Treatment - Payment - Health care operations.
  
• When laws, including in judicial settings and to health oversight regulatory agencies and law enforcement, requires release.
  
• In emergency situations or to avert serious health/safety situations.
  
• To medical examiners, coroners or funeral directors to aid in identifying you or to help them in performing their duties.
  
• To organ, tissue and other donations organizations, upon or proximate to your death, if we have no indication on hand about your donation preferences (or a positive indication).
  
• To contact you about appointment reminders, treatment alternatives and other health related benefits and services.
  

All other uses and disclosures by this office will require this office to obtain from you a written authorization in addition to any other permission you will provide this office.

A placebo is a non-active device, treatment, or medication. It is commonly known as a "sugar pill."

Placebos serve as a standard by which researchers test the efficacy of a device, treatment or medication.

Placebos are not utilized in all trials. We will inform you if a placebo is used in a specific trial.

Topics that you should clearly understand before participating in a clinical research study include:

• The purpose of the research being done.
  
• The type or phase of the clinical research study.
  
• Medications or treatments that will be given during the clinical research study.
  
• Evaluations that will be performed during the clinical research study (laboratory, X-Rays, questionnaires, etc).
  
• What you are expected to do during the clinical research study.
  
• How long your participation will last.
  
• The location of the study site and how often you must come to the study center.
  
• Whether an overnight stay at a clinic or hospital is required.
  
• What a placebo is and whether or not one will be used in the clinical research study.
  
• Benefits you might expect from the trial.
  
• Your right to discontinue your participation in the clinical research study.
  
• Any effect on your health insurance.
  
• How the privacy of your health information is protected.
  
• Whether continuing treatment is available after the clinical research study ends.
  
• Who is sponsoring (paying for) the clinical research study.