BCRC

Information for Volunteers

To get onto our list of research volunteers, you can call our recruitment office (716-885-3580 ext. 205) between 8 AM and 2 PM, Monday through Friday to sign-up for an initial screening appointment. This takes approximately 15 minutes. We will ask you to complete a brief medical history form and record your height and weight. Once this information has been reviewed and approved, you will be added to our mailing list. You will then receive letters for upcoming studies that you are likely to qualify for.

Participation in a research study typically involves three stages: screening, the clinical stage and follow-up. Prior to screening you will be contacted by a recruiter who will determine if you are eligible to screen for a study. Eligibility criteria include age, gender, weight, smoking status, medication use and other factors. We will do our best to identify the most likely candidates for a study; however, being asked to screen for a study does not ensure that you will qualify.

Screening

Screening usually involves up to a 3 hour morning visit. A document called an Informed Consent Form will explain the purpose of the study, any study procedures, risks, contact personnel, potential side effects of the study medication, and the study fee. One of the BCRC investigators will go over this document and you will be asked to sign it, if you are still interested in participating. Participation in a study is strictly voluntary. Also, during the visit you will undergo a medical history and physical exam by the Medical Director. Typically, blood and urine samples will be collected and an ECG (electric tracing of the heart) will be performed. Blood and urine samples will be obtained to test for drugs of abuse and alcohol. If you are positive for any drugs of abuse or alcohol you will not be allowed to participate in future studies. This information will be kept confidential. Other procedures may be performed as required by the study.

Also, during screening the study schedule and restrictions will be explained to you. Be sure that you can follow the study schedule and agree to the restrictions before committing to participate in a study. Approximately one week after screening you will be notified if you qualify for the study.

Clinical Stage

Studies vary tremendously in time requirements. Some will be short involving one or two visits and other studies will be very long lasting several weeks and involving numerous visits and overnight stays. Once enrolled in a study you must comply with the study schedule and complete all procedures. You will be assigned a time to come to the BCRC for enrollment. This typically involves more blood and urine collection and another physical exam. Study medication will be administered and blood samples will be collected through an IV catheter placed in an arm vein. An IV catheter is a small plastic tube inserted into a blood vessel (vein) in your arm to obtain multiple blood samples over each 24 to 48 hour period. Other procedures may be performed as required by the study protocol. All of this will be explained to you during screening.

All meals and snacks will be provided during the study confinement periods and clinic visits. During the confinement periods you are not allowed to leave BCRC. All bedrooms are semi-private. Separate male and female bathrooms are available. Volunteers are required to go to bed at a regular hour usually between 11 PM and midnight. On most mornings you will be awakened quite early, often by 6 AM. You will have free time available when study procedures are not being performed. During this time you will be free to nap, watch movies, read or pursue other personal activities within the confines of BCRC. Strenuous activities or exercises are not permitted. You may bring a cellular phone or laptop computer to BCRC for personal use, however BCRC is not responsible for your personal property. Lockers are available for you to store your personal possessions. You may be allowed to have visitors during long confinement studies, but visiting hours vary and are limited.

Once all study procedures have been completed you will be discharged from the BCRC. A staff member will instruct you when to return for future study procedures.

Follow-Up

Approximately 1 to 4 weeks after completing the clinical stage of a study you will be asked to return for a brief follow-up visit. During this visit a physical exam is usually performed and blood and urine will be collected. An ECG will also be collected in most studies.