Stephens Participant FAQ

About Stephens & Associates

Stephens has been conducting clinical trials since 1989.  Our location in Texas opened in 1989, Japan in 1992 and Colorado in 1994.  For more information on our company, please view the About Us section on our website homepage.

At Stephens we test the safety and effectiveness of a variety of prescription and over the counter drugs and devices, cosmetic and skin care products.  Some examples of the types of products we test are:

For more information on the types of studies we do, please view the Services and Trials sections on our website.

We have research locations in Richardson, Texas; Colorado Springs, CO and Tokyo.

Registering and Applying for Studies:

  1. Go to the Participate in a Study box at the top left hand of the page
  2. Select Login/Register from the dropdown list
  3. Select NEW USERS-Create a New Account and Register in our Database
  4. Select Submit
  5. Go through the questions on the forms
  6. After the form is completed, Select Submit
  7. You will receive a Validation Email with the Subject Line: Activate your Account with Stephens & Associates.  Please note, you must activate your account to complete your registration.
  8. Click the link in the email to activate your account.
  9. You will be directed to a webpage that will give you your account information and tell you that your account is now active.
  10. You will receive a 2nd email with the subject line: You have been registered with Stephens & Associates and a notification will be sent to your recruiter to contact you.
  1. From our home page, at the top left hand side of the page, hover your mouse over “Participate in a Study” and select “Current Studies” from the drop down list.
  2. Select “Learn More” next to the study you would like to apply for.
  3. Select “APPLY for this study” on the right hands side.
  4. You will be required to log in, if you have not already.
  5. Follow the steps to register for the study and we will be in touch!
  1. Email recruiting@stephens-associates.com
  2. State in the subject line “Trouble Registering or Applying”
  3. Detail in the email the specific problem you are having

Due to confidentiality agreements we cannot reveal the names of our sponsors.

 

Being a Study Participant

Informed consent is a process in which Stephens provides potential and enrolled study participants with information about a clinical study. This information is to help you decide whether you want to enroll, or continue to participate, in the study. The informed consent process is intended to protect you and should provide you with enough information for you to understand the purpose, procedures, risks of, potential benefits of, and alternatives to the study. You will have as much time as you need to read it and ask questions.

In general, you must sign an informed consent form before entering a study to show that you were given information on risks, potential benefits, and alternatives and you understand it. Signing the document and providing consent is not a contract. You may withdraw from a study at any time, even if the study is not over.  Before signing the informed consent form, you will have as much time as you need to read it and ask any questions.

Please visit the Center for Information & Study on Clinical Research Participation  for a list of questions to ask and some information on how to prepare to be a participant on a clinical trial.

For Colorado Springs, CO, email Anna Hasler at ahasler@stephens-associates.com

For Richardson, Texas, email recruiting@stephens-associates.com

The age ranges for our studies are 6 months to 80 years old.  The age range will vary with each study.  If you are minor (under 18 years old), you must have a parent or legal guardian come with you to the first visit in order to participate.

The risks for participating will depend on the study.  These risks will be described to you in the Informed Consent Form when you come in for the study. If you do not understand what any of the risks mean or have additional questions, please ask.  We want you to be fully informed before you choose to participate.

Stephens & Associates will try to protect any personal information given during this study. Any records that identify you may be seen by the following people:

Any additional people that may have access to your personal information, will be given to you in the Informed Consent Form, prior to you participating on the study.  Stephens & Associates cannot guarantee complete confidentiality. The results in this study may be presented at meetings or in publications. Your identity will not be used in those presentations.

Due to the nature of our studies and having to screen for certain difficult skin conditions etc., we schedule extra people so that when there are disqualifications, we will still have enough to fill our quotas. There are times when studies end up having less people disqualify, and we end up with a surplus. This unfortunately results in cancellations of the extras.

Please tell the study staff or Investigator immediately.  The Informed Consent Form will have instructions on who to contact and their phone numbers.  If you have a reaction or side effect, medical treatment will be available. You will not have to pay for treatments if they are related to the study. If you choose to see a doctor other than the one provided to you, you will not be repaid. If you need treatment after the study is finished that is not related to the study, you will have to pay for it.

Payment:

Depending upon the type of study, we may be restricted and not be able to list the compensation amount.  Listing the payment amount can be seen as coercing you to participate in the study.  Please do not let this discourage you from participating in any study.  If you have any questions about the compensation, contact your recruiter and they will give you the details and help answer your questions

Stephens does not pay cash to protect the safety of the subjects and employees.

If you are paid $600.00 or more in a calendar year by Stephens & Associates, we are required to report the payments to the Internal Revenue Service (IRS).

Typically you will receive compensation for study participation at your last scheduled study visit. When studies are shorter in length (1 day– 1 week), checks must be mailed due to processing procedures. In these cases, checks may be picked up in person at the clinic if prior arrangements are made with the study leader.

Test Products:

Test products that are considered drugs or devices, must be approved by the FDA before they are sold to the public.  Depending upon the study, the test products being used may be already approved by the FDA and other times they are not.  Before they are approved to be sold, they have to be tested in many clinical trials for safety and effectiveness, like the ones you participate in at Stephens.  The Sponsor will submit the information from the clinical trials to the FDA and the FDA will determine if it can be sold to the public.  Not always but many times, the drug or device has been tested in other clinical trials before it is tested through Stephens.

Test products like cosmetics and skin care and personal care products are considered over-the-counter products.  These do not get approved by the FDA before they are sold to the public, but the FDA regulates what the product is claiming to do (i.e. reduces noticeable fine lines and wrinkles within 4 weeks).  The studies that Stephens conducts, and the ones you would participate on, would provide the sponsor with the data to back up their claims for these labels and test them for safety to see if they cause irritation.  Depending upon the study, the test products being used may already be sold or contain ingredients similar to those already being sold on the market.

Due to confidentiality agreements we cannot reveal the name of the product you are testing.  On rare occasions, the sponsor may allow us to disclose to you the name of the product you are testing if you are not given this information during the study. This information is typically not provided until the end of the study or after the product has been released for sale to the public.  The Investigator or study staff will notify you if the sponsor allows us to give you this information.

Important Information and Resources

Informed consent is a process in which researchers provide potential and enrolled participants with information about a clinical study. This information helps people decide whether they want to enroll, or continue to participate, in the study. The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. In general, a person must sign an informed consent document before entering a study to show that he or she was given information on risks, potential benefits, and alternatives and understands it. Signing the document and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over.

Center for Information & Study on Clinical Research Participation

This website educates study participants, the public, medical and research professionals about clinical research participation and what it means to be an active participant in the process.  The FAQ in the Public or Patient section gives an excellent overview of clinical research trials.

Food and Drug Administration (FDA)

The FDA’s website provides a wide variety of educational tools for consumers, patients, study participants, healthcare professionals, and researchers.   They also provide the laws and guidelines that must be followed by which Stephens and anyone conducting research.