Summer 2011

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ABOUT VOLUNTEERS FIRST:

Volunteers First is published by the National Institutes of Health Clinical Center Office of Communications, Patient Recruitment, and Public Liaison.

For more information about clinical studies at the NIH Clinical Center or the information in this newsletter, visit us at http://clinicalcenter.nih.gov/recruit

Information on
current studies:

1-866-444-6676
TTY: 1-866-411-1010
Se habla español
prpl@cc.nih.gov

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The best reasons to volunteer are all around you.

Some you love.
Some you miss.
Some you’ll never know.

Healthy volunteers, partners in discovery

Nurse works with a patientThroughout the years there have been manygroundbreaking medical discoveries pioneered at the NIH Clinical Center, including chemotherapy and immunotherapy to treat cancer, treatment of AIDS with AZT, gene therapy, and countless others. We all benefit from the advances made possible through medical research, and the commitment of healthy volunteers who participate in research at the Clinical Center make this progress possible.

What’s a healthy volunteer? It’s someone with no known significant health problems who participates in research to test a new drug, device,or intervention.

Eric Obame of Maryland has been a healthy volunteer participating in research studies since 2004. "I think people worry sometimes about going to the doctor when they don’t technically need to," he said. "But whenever I participate in research, I know it helps further medical knowledge and maybe even save lives."

Rusti Queen, another healthy volunteer from Maryland agrees, "It was so interesting. I recommend that people who are interested in research ask a lot of questions. You get to learn alot and really help science and medicine." Queen has participated in four studies over the past two years and plans to volunteer again.

"I want to help, and this is a great way to do it,"she said.

Healthy volunteers have always played importan troles in research at the NIH Clinical Center, helping researchers diagnose, treat, and prevent disease since the hospital opened in 1953.

About 300 studies under way here are actively seeking healthy volunteers. Many other studies are seeking patient volunteers, individuals with aparticular diagnosis. For more information about becoming a partner in research at the NIH Clinical Center, email prpl@cc.nih.gov or call 1-866-444-6676 (TTY: 1-866-411-1010) www.clinicalcenter.nih.gov

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How institutional review boards protect patients

Health matters: IRBs and patient protection

Group at a conference tableAn institutional review board (IRB) is an independent committee made up of medical specialists, statisticians, nurses, social workers, medical ethicists, and members of the public. At research institutions like the NIH Clinical Center, the IRB is the advocate of the research volunteer.

According to the Clinical Center Department of Bioethics, there is a chance that even the most careful researchers might overlook ways they could improve their research to make it more consistent with ethical principles or other requirements for research. To avoid such problems, a group of people who are not connected to the research are required to give it an independent review. These committees are not only tasked with protecting the rights and welfare of people who participate in research, but also make sure that every study addresses medically important questions in a responsible and scientific manner.

IRBs carefully examine each research study before it begins and make sure that any risks to volunteers are described clearly and completely. They also make sure that any risks associated with the study are outweighed by potential benefits and have the ability to request changes to planned research if they identify ways to better protect patient or healthy volunteers. Federal laws require that IRBs review and regularly monitor every clinical trial in the United States that involves human volunteers.

Learn more about the Clinical Center’s commitment to research ethics and the protection of patient volunteers by visiting these websites:

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Teaching research at the USA Science Festival

News and information from the NIH Clinical Center

A visitor asks questions at the CC boothNIH Clinical Center staff joined thousands of children, teachers, parents, and scientists on the National Mall in Washington DC last fall for the inaugural USA Science and Engineering Festival. The purpose of this event was to teach kids about research and science, especially the clinical research critical to the prevention, treatment, and diagnosis of health-related illnesses.

The Clinical Center’s booth titled, "Pack a Lunch with Punch for Kids in Research," demonstratedthe scientific research process to more than 900 children. Kids who stopped by learned about clinical research, how it works, and how promising discoveries can be translated into better health for all. Visitors participated in a hands-on demonstration that gave them the opportunity to walk through four different phases of research.

The Clinical Center’s Executive Chef Robert Hedetniemi headlined a cooking demonstration with Pete Thomas from the second season of NBC's "The Biggest Loser." Hedetniemi demonstrated how to prepare healthy and affordable meals, including a pomegranate and fig breakfast parfait, an apple-encrusted autumn lunch salad, and a vegetable pasta dinner dish.The USA Science and Engineering Festival aims to invigorate the interest of the nation's youth in science, technology, engineering, and math. More information about the results of the day’s research demonstration and Hedetniemi's recipes, is available at:www.clinicalcenter.nih.gov/scienceexpo.

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Information for patient volunteers Information for healthy volunteers

Asthma and Bronchiectasis Study
Study number: 10-I-0085

Adults 18 to 65 with asthma and bronchiectasis may be eligible to participate in a clinical research study with the drug DAS 181. The investigational drug is being studied as a potential treatment for the flu. The study will last between 6-12 weeks and 12 visits are required. To participate, you must have had well-controlled asthma orbronchiectasis for at least the past three months, not be allergic to milk or milk products, and not be taking oralcorticosteroids.

Plaque Regression Study
Study number: 10-CC-0214

If you have narrowing of the arteries and are taking statin medication you may be eligible to participate in a study to investigate if using magnetic resonance imaging (MRI) is an effective method in comparison to other methods available to estimate your risk of heart disease and stroke.The study will last approximately 24 months. Participants must be 55 or older, currently taking statin or other atherosclerotic medications, and be willing to lower and/or increase their dose.

Autism Study
Study number: 09-CH-0203

This study is designed to help learn more about the role cholesterol plays in autism spectrum disorders. Children four to 11 years of age with a diagnosis of autistic disorder, asperger disorder, or pervasive developmental disorder-not otherwise specified may qualify to participate in this study.

Refractory Asthma
Study number: 09-H-0244

Adults 18 to 75 diagnosed with severe asthma may be eligible to participate in a clinical research study with the medication ACTOS®. The goal of the study is to determine if ACTOS® is effective for treating severe asthma. The study will last 48 weeks and involves 15 outpatient visits. In order to participate, you must have not smoked cigarettes within the past year or have a history ofemphysema or sarcoidosis.

 

Hepatitis B Immunity
Study number: 10-DK- 0187

Did you receive the hepatitis B vaccine (HBV) or did you recover from acute hepatitis B more than ten years ago? Would you like to know if you still have protective antibody levels? This study consists of one outpatient clinic visit for a blood draw and a brief research questionnaire. Participants must have been between 18 and 59 when the hepatitis B vaccine was administered. The HBV vaccine must have been given prior to the year 2000. Individuals who have a history of chronic HBV infection or those who did not receive all three doses of HBV vaccine are not eligible for participation.

Noninvasive Imaging Study
Study number: 10-CC-0153

If you have not been diagnosed with heart failure, you may be eligible to participate in a study that will evaluate the accuracy of non-invasive imaging testing in assessing how the heart functions. Study participants will undergo an MRI or CT scan with iodine contrast. This study lasts about 24 months.

Tai Chi Study
Study number: 11-NR-0030

The goal of this study is to test the effect of Mindful Tai Chi on weight loss and on improving the lifestyle of sedentary obese and overweight individuals. You may be eligible to participate if you are 18 years of age or older and overweight. Participants will be randomly assigned to one of four groups including Mindful Tai Chi, mindfulness meditation, mall-walking, or a discussion group. Each session will be for two hours, once a week for 12 weeks.

Lung Disease Study
Study number: 96-H-0100

This study is evaluating the genetics involved in the development of lung disease. This study requires one or more out-patient visits involving one or more blood draws and possible urine collection. Participants must be 35-70 years of age and healthy.

 

All studies are conducted at the NIH Clinical Center in Bethesda, Maryland.
There is no charge for study-related tests, medications, or treatments.
Some studies listed in this newsletter may be closed to enrollment at later dates.

Contact PRPL for more information at prpl@cc.nih.gov.
Compensation may be provided for healthy volunteers.

For more information about any
of the studies listed above, please call:
1-866-444-6676
TTY: 1-866-411-1010
Se habla español

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Dr. John I. Gallin accpets the award.
The West Drive patient entrance off Cedar Lane is a special NIH entrance for Clinical Center patient and healthy volunteers.

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