Research & Economic Development

Office of the Vice Chancellor

Concise Summary – Biomedical (Drug Study)

This consent is being given to you for a research study.  Consenting to take part in this study is voluntary.

The purpose of this research study is to find out if a drug called ABC-123 is safe and to determine the safest, most effective dose of the drug.   If you choose to participate you will be in this study for [insert total length of participation here].

Depending on when you enroll in this study, you will receive higher doses of ABC-123 until the safest and best tolerated dose is reached.  ABC-123 is given via i.v. infusion in the [insert location(s)].  You will have tests, exams and procedures that are part of your standard care and for study purposes. Each clinic visit will last 4-5 hours.  Infusions of study drug will be given during week 1 of each 3-week cycle.  After two cycles, you will be evaluated and you may be able to continue receiving ABC-123 if you have had no bad reactions to the study drug or disease progression.

There are risks to this study drug that are described in this document. Some risks include: nausea, diarrhea, low white & red blood cell count, being tired & weak, fever, muscle pain and radiation risks from CT scans.

If you are interested in learning more about this study, please continue reading below.

Concise Summary – Biomedical (non-drug/device study)

The purpose of this research study is to determine the effectiveness of physical therapy in the treatment of patients with ABC.  Participants will undergo a 2-day screening that includes a blood draw, exercise testing, and completion of quality-of-life surveys.  Once screening is complete, participants will complete a physical therapy program that will require visits three times each week for 16 weeks, for a total of 48 visits.  Each visit will take about 2 hours. Participants will also be asked to complete a pain diary and have blood draws every 4 weeks throughout the study.  Follow-up phone calls from the study team will occur at 4 weeks and 8 weeks after completion of the physical therapy program.  Total study duration is about 6 and one-half months.

The greatest risks of this study include the possibility of injury during the physical therapy program and loss of confidentiality.

If you are interested in learning more about this study, please continue to read below.

Concise Summary – Biomedical (Condition with biopsy)

 The purpose of this study is to compare the gastrointestinal (GI) tract in children with Inflammatory Bowel Disease (IBD) and healthy children.  The information we learn by doing this study may help us to develop some target treatments for GI complications in children with IBD. 

Participants in this study will have a blood sample collected and a small piece of tissue removed from their intestine during their clinically scheduled procedure. The comparison of tissue from IBD and healthy children will be done in the laboratory after collection of the tissue. Parents of participating children will also be asked to complete a questionnaire. Your child’s participation is complete once the medical record and questionnaire have been reviewed, and the tissue and blood sample have been collected.

There is a risk of bleeding after the tissue from the intestine is removed. Risks of taking the blood sample are discomfort and/or bruising; infection, excess bleeding, clotting, or fainting are also possible.

If you are interested in learning more about this study, please continue to read below.

Concise Summary – Social and Behavioral (Depression)

The purpose of this research study is to determine the effect of treating depression on how one’s body responds to stress. People with known depression and who are willing to seek treatment for their depression are being recruited for this study. If you choose to take part, you will be asked a series of questions about your mental health and asked to complete surveys about your mental and physical health. You will also have your height, weight, blood pressure and waist circumference measured.

After the screening is complete and if you qualify to take part in the study, you will return to the study site on another day to complete a mental stress test as well as additional surveys. You will be asked to complete two challenging mental tasks while your heart rate and blood pressure are measured. You will be videotaped performing these tasks. Once this study visit is completed you will receive twelve weeks of cognitive behavioral therapy for your depression. At the end of the twelve weeks you will undergo another mental stress test.

The research study visits will be conducted at [location] and each visit will take anywhere from 1-2 hours. People who are depressed are at a greater risk of hurting or killing themselves. This represents one of the greatest risks of this study. Other risks include strong negative emotions that may arise during therapy and the possibility of loss of confidentiality.

If you are interested in learning more about this study, please continue to read below.