Why should I participate in Clinical Research?
People participate in clinical research for a variety of reasons. Some people find it intellectually stimulating to contribute to the discovery of new treatments that are safer and more effective than existing treatments. Others participate because they do not have access to quality medical care for their pulmonary conditions, and as a participant, can receive medications and physician consultations free of charge. All participants benefit from the expert education they receive regarding the management of their condition. In addition, we compensate participants for the time they spend in our studies.
Will I qualify for one of the studies?
Enrollment criteria are variable according to each study and include factors ranging from age to smoking history. The best way to find out if you qualify is to call our recruiter. She will go through a brief medical questionnaire with you and enter your information in a secure database. The coordinators of the different studies will then be able to contact you if you seem like a good match.
I don't have an airway condition; can I still participate?
Oftentimes we need subjects without airway diseases to act as controls for our studies. These "healthy controls" allow us to determine if the findings we make are specific to the disease or not. Give our recruiter a call to get on our list of healthy subjects.
How do I enroll in a study?
You can complete an online survey, which can be found here. We ask you a series of medical questions and enter your information into a secure, password-protected database. The coordinators of the different studies will then be able to contact you if you seem like a good match for a study.
Can I participate in more than one study?
We do not allow subjects to participate in more than one study at a time because we do not want data to be confused. However, it is often possible to participate in a second study after the first one is finished and a period of time has passed. The length of time required between studies varies; let your coordinator know if you would like to continue participating.
Will I be compensated for my time?
Your time is valuable and we appreciate that you spend it contributing to research. We always compensate subjects for the time spent in the clinic and often for at-home procedures. Currently we compensate $35 for the first hour and $25 for each additional half hour. These rates are subject to change and vary based on each study.
Will my insurance be billed for my particpation?
We do not collect your insurance information for any purpose and your insurance will never be billed. Also, you will not be charged for any procedures related to study participation. If you do receive a bill, please let us know immediately so that we can straighten things out.
Is it safe to participate?
Your safety is our number one priority. All technicians and staff go through an extensive training program before they are allowed to conduct study procedures. Physicians are on-call whenever we perform tests that are potentially hazardous to your health. Study coordinators will let you know the risk involved in each procedure, and you will always have the option to end participation at any time.
How will my private health information be shared and remain confidential?
The University of California is a research institution. All research projects conducted by the University must be approved through a special review process to protect patient safety, welfare and confidentiality. Your medical information may be important to further research efforts and the development of new knowledge. We may use and disclose medical information about our patients for research purposes, subject to the confidentiality provisions of state and federal law.
The health information that we collect about you during your participation in a study is stored both electronically and as paper files. Access is limited to the researchers in the Airway Clinical Research Center. De-identified data (data that has had your name, birth date, or other identifiers removed, and is assigned a unique study I.D. number) is made available to the Data Coordinating Centers of the Asthma Clinical Research Network and the COPD Clinical Research Network. Blood tests performed at the UCSF Clinical Lab are filed in your permanent medical record at the University, and are accessible to your primary care physician or other attending medical professional.
We do not share the results of your lung function testing with anyone outside the research group except by your request.
How do I get to my appointment at the Airway Clinical Research Center?
The ACRC is located on the 13th floor of Moffitt Hospital on UCSF's Parnassus campus.
From the East Bay- Napa, Solano, Contra Costa, and Alameda Counties (80)
From the Bay Bridge, stay in the second lane from right and follow signs to Golden Gate Bridge, 101 North. Take the Octavia St./Fell St. exit. Stay in left lane and exit on Fell Street. On Fell Street, stay in the far right lane and drive about two miles (stay in the right lane when Fell Street curves to the left). At the end of Fell Street, turn left onto Stanyan Street. Stay in the left lane, proceed up the hill and turn right onto Parnassus. UCSF is at the top of the hill. For validated parking, please park in the second public parking garage on the right at the first stop light (after 400 bldg.)
From Marin and Sonoma Counties (101 and 1)
From the Golden Gate Bridge, take the 19th Avenue exit (on right 1/4-mile after toll plaza) onto Park Presidio Drive. Stay in the right lanes as you pass through Golden Gate Park onto 19th Avenue, where no left turns are allowed. Go three blocks, turn right on Kirkham, right on 20th Avenue, and right (east) on Judah. Follow Judah up the hill to UCSF. Judah becomes Parnassus at 5th Avenue. The entrance to the public parking garage is on the left.
From the South Bay (101)
Take Highway 101 North (Bayshore Freeway). Stay in the left lane and follow the signs to the Golden Gate Bridge;Take the Octavia St./Fell St. exit. Stay in the left lane and exit on Fell Street. On Fell Street stay in the far right lane and drive about two miles (stay in the right lane when Fell Street curves to the left). After exiting Fell Street, turn left onto Stanyan Street. Proceed up the hill and turn right onto Parnassus. UCSF is at the top of the hill. The entrance to the public parking garage is on the right.
From the Peninsula (280)
Take Highway 280 north; stay in the left lanes and take the Golden Gate Bridge exit onto 19th Avenue (north). Proceed in the right lanes and turn right (east) on Judah Street. Follow Judah up the hill to UCSF. Judah becomes Parnassus at 5th Avenue. The entrance to the public parking garage is on the left.
Public Transportation
From the East Bay
Take BART to the Civic Center station and take the N-Judah Muni Metro, or exit to Market Street and take the No. 6-Parnassus bus to the campus. The Muni bus line operates along Market Street with a stop in front of the campus on Parnassus Avenue.
What is the time commitment?
Each study has a different time commitment. Participation can range from 3 hours to 12 months. When you speak to a study coordinator, be sure to ask what the time commitment of the specific study is.
When are study visits conducted?
Our clinic is open Monday thru Friday and we generally run visits from 7am to 5pm. We are closed on holidays and weekends.
Will parking expenses be covered?
Yes. We will validate your parking if you use the UCSF parking lot. Please be sure to bring your parking ticket with you to the clinic.
Will I be able to know the results of the study?
Generally, clinical trials run for months or years. After enrollment has finished and all participants in the study have completed all study requirements, the data are locked and analyzed. After results are obtained, the principal investigator and colleagues write their findings and conclusions, and once this has been published, we can share the results with the study participants, usually by letter.
You can also find a list and links to our study here: https://acrc.ucsf.edu/publications
Who funds airway research at UCSF?
Many of our studies are funded by the National Institutes of Health (NIH), a division of the US Department of Health and Human Services. Other studies are funded by private foundations, pharmaceutical companies or other industry sponsors.
What kind of procedures will I undergo?
Again, the procedures will depend on the study, but you can expect to do some of the following:
Allergy skin testing: A skin-prick test is performed on your forearm to determine whether you are allergic to various allergens. There will be 12 to 16 allergens total. This testing involves introducing a small amount of allergen solution under the surface of the skin and observing for redness and swelling 20 minutes later at the skin prick site.
Questionnaires: Answering questionnaires about your health will help us monitor your condition and how it affects your life.
Blood draw: Many of our studies involve taking blood samples by putting a needle into your vein. This is the standard method used to obtain blood for tests. We will be using these samples to test for such markers as IgE levels, complete blood count, liver function, and genes associated with asthma.
Bronchoscopy: Bronchoscopy is the passage of a thin flexible tube through the mouth, into the windpipe and then into the bronchial tubes. Your throat and vocal cords are sprayed with lidocaine (a numbing medicine) so you do not feel the tube and do not cough as much. You may be given sedatives such as Versed and Fentanyl, which help you relax and reduce cough or discomfort. After this, the bronchoscope is passed into your windpipe. The tube is small enough that you can breathe around it, and is designed so that the study doctor can look through it into your lungs. While the bronchoscope is in your airway, the doctor collects samples such as brushings and small biopsies of the lining of the bronchial tubes.
Electrocardiogram (ECG): An ECG measures the electricity produced by the heart. After removing your shirt, electrode stickers are placed on your chest, arms and legs and attached to the machine. After lying still for a moment, the ECG machine will print a tracing of your heart rhythms.
Exhaled breath condensate collection: You breathe normally in and out of a tube for 10 minutes. The tube collects the moisture from your breath.
Exhaled nitric oxide collection: After taking a big breath in, you steadily blow air out into a mouthpiece attached to a machine that measures nitric oxide. The amount of nitric oxide in the air coming from the lungs is thought to increase when the lungs are irritated or inflamed. This test measures the amount of nitric oxide in your lungs.
Maximal Bronchodilator Response: You perform spirometry and then inhale 4 puffs of albuterol. 15 minutes later, you perform spirometry again and inhale two more puffs of albuterol. After another 15 minutes, you perform another spirometry maneuver. This test measures the maximum degree that albuterol can open your airways.
Methacholine challenge: This procedure consists of inhaling increasing doses of a mist of methacholine, a chemical that causes smooth muscle to contract. After each dose of methacholine, subjects perform spirometry to measure changes in lung function. The procedure will be stopped either after you have a significant change in your pulmonary function or there is no response to the highest dose of methacholine.
If you are a female of childbearing age, a pregnancy test will be conducted before any research methacholine challenge will be done.
Nasal and Throat Swab: A Dacron swab (similar to a Q-Tip) will be used to swab the back of your throat, and the tip of a thin plastic probe (Rhinoprobe) will be gently inserted into each nostril of the nose to collect a sample of your cells for analysis.
Physical examination: We will listen to your lungs and heart, examine your ears, nose and throat and measure your blood pressure and heart rate. The extent of evaluation done each time will depend on the study visit, with a comprehensive evaluation being performed at the beginning of the study to ensure that it is safe and appropriate for you to participate.
Pregnancy test: Women must not be pregnant or plan to become pregnant during any of our studies. If you are a woman and can become pregnant you will give a urine sample for a pregnancy test. You will know the pregnancy test results within minutes.
Spirometry: Spirometry is a breathing test that measures the amount of air you have in your lungs and how well you can move that air in and out. After inhaling a big breath, you forcefully blow the air out into a spirometer (lung function machine). This maneuver is repeated several times.
Sputum induction: Prior to the induced sputum procedure, you will be given 4 puffs of an inhaled bronchodilator (albuterol) to open the airways. You will then be asked to inhale a mist of concentrated saltwater solution for up to 20 minutes. Every 2 minutes you will be asked to cough and spit into a cup. Your lung function will also be monitored every 2 minutes to be sure your breathing has not worsened because of the procedure.
Click here to find videos on common research procedures we perform: https://acrc.ucsf.edu/blog/what-will-happen-acrc