The CTSA - Clinical Research Unit (CRU), MetroHealth Medical Center (MHMC) is an area within MetroHealth for patient-oriented research, where neonatal, pediatric and adult clinical research is conducted . Many areas of medicine are investigated: new devices, new medications, ways to gain better understanding of a disease, and the impact of nutrition and exercise on health.

Research trained Registered Nurses staff the CRU. Outpatient visits may be as short as 5-10 minutes or last as long as 12 hours. Some studies may require you to stay overnight. A physician responsible for each study is always available.

Me ... participate in a study?

Volunteers have enabled medical research to advance and increase the number of medical discoveries. Medical research might help us understand a disease better and provide you or a family member with improved treatment. In some cases, it may even save lives. Before taking part in a study, the following will be explained:

• The purpose of the study
• What your rights are as a participant, including your right to drop out of a study at any time
• What will be expected of you for the study
• Possible benefits of being in the study
• How long the study will take

If a study involves a new medication, device or clinical procedure (i.e., surgery), the information given will also include:

• Your chances of being treated or not
• How a person is assigned to a group
• Any risks of being in a group
• Other treatment alternatives you might want to consider instead of being in a research study

If you agree to be part of a study, you will read and sign an informed consent disclosure before the study is started. It is important that you understand what is involved. Please ask questions.

Confidentiality and Privacy

If you participate in a research study, you will be treated the same as if you are a patient at MetroHealth Medical Center being seen in one of the clinical offices. Confidentiality and privacy of your records is maintained. Information obtained cannot be communicated (spoken or written) without your permission. A copy of the consent will be added to your hospital medical record unless otherwise stated in the consent form. If you are admitted to the CRU, the admission form, doctor's orders and progress notes will go to your medical record.

Nutrition

Some studies require you to go without food and/or beverage before a visit. This means you should not eat or drink for 8-12 hours before your visit. During your confirmation call (the day prior to your study), you will be given any special instructions that apply to you, including directions about food, beverages, medications, or smoking. A meal will be provided if you spend a long period of time in the CRU that day. Food is provided for the research volunteer only. A nutritionist will meet with you before a study begins if meals are to be provided or if you must be on a special diet.

To aid in your relaxation during a study...

During those studies of an hour or more duration, it is recommended that you bring a quiet activity (i.e., a laptop computer, a craft, reading, puzzle books, etc.) or a favorite movie (a VCR & DVD player are available).

Special Testing on the CRU

Several studies require the use of equipment on our unit for special testing. These include:

• Exercise equipment
• Underwater weight tank for body fat determination
• Heart rate monitors
• RMR hood for estimation of calorie needs
• DEXA machine for bone mineral content and body composition
• BodPod and PeaPod machines to measure body fat