About Clinical Research Trials- Frequently Asked Questions

If I choose to participate in a clinical research trial, how do I know my rights and responsibilities?

Each clinical research participant is required to understand and sign an Informed Consent Form that describes the study in detail. This form includes the objectives of the study, timelines, benefits, potential safety issues, required visits and procedures, patient rights and responsibilities and emergency contact information.

As the study is updated, or if important information is learned, the Informed Consent Form is revised and each participant is required to sign the new form. A copy of the signed Informed Consent Form is given to each participant for his/her files.

How is safety monitored during a trial?

Each new drug must undergo phases of strict testing before it is considered for release to the general public. In some instances, a drug that has previously been approved for use by the general public will be studied for new indications or uses.

Each research study is conducted according to a detailed study protocol, or set of rules. This protocol has been approved by the FDA, an Institutional Review Board (IRB) and the pharmaceutical company or sponsor of the drug. The protocol requires that extensive safety data be collected at each participant’s study visits.

In addition, Laureate Research maintains strict safety standards. Each patient is assigned a study coordinator who has received education regarding the research protocol and study design. Patient information is carefully monitored by the sponsor, the IRB and the FDA.

How much time is needed to participate?

Each research protocol describes the length of the study, the number of visits required, the procedures required at each visit and the amount of time between each visit. Studies may last anywhere from several days to several years. Laureate Research staff is aware that your time is valuable and schedules patient visits in order to complete them in a timely fashion.

How do I participate?

You may call the research office directly at (918) 491-3770.

How is confidentiality maintained during a trial?

Patient confidentiality is maintained as required by law. All study participants are identified by a study number. The study sponsor, the IRB and the FDA all have access to study records.

What if I have a medical problem related to the study?

If you are injured or become ill from taking part in a study, treatment will be available but will be provided at the usual charge. You and your insurance provider will be charged for continuing medical care and/or hospitalization.

What if I am unable to complete the study?

Participants who are unable to complete research trials are asked to complete termination visits in order to ensure patient safety. Your individual relationship with your physician will in no way be jeopardized and your care will continue as your physician advises.

Who do I call for more information?

If you have any questions or would like additional information, please feel free to call Laureate Research at (918) 491-3770.