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ASPIRE Independent Review Board Announces 10 Ways to Protect Participants' Rights in Clinical Drug Trials and Optimize Results From Research
Date:6/9/2008

ASPIRE IRB Is Exhibiting at Bio International Convention in San Diego June

17-20 Currently, over 54,255 Trials with Locations in 154 Countries Are Taking

Place

SAN DIEGO, June 9 /PRNewswire/ -- ASPIRE IRB (http://www.aspire-irb.com), an Independent Review Board (IRB), is responsible for overseeing research and protecting the rights and welfare of people participating in clinical trials. ASPIRE IRB partners with drug manufacturers and research companies to get the best results from clinical drug trials and protect the rights and welfare of participants. "Making sure research is being implemented correctly is critical to the success of the study. Each study is unique. For instance people with Schizophrenia can tolerate a higher dose of particular drugs than people without the disorder. Races, because of genetics, react differently as well," explains Alycia Huston, COO of ASPIRE IRB.

The FDA and HHS regulations empower Independent Review Boards to approve or disapprove research and require modifications. They are made up of physicians, scientists, nonscientists, community members and associates affiliated with the IRB. A clinical trial CANNOT take place without an Independent Review Board.

Hundreds of thousands of people participate in clinical trials with the hope of finding relief and or to help others. Research is essential to finding cures and treatments for conditions and diseases. Being a member of a clinical trial is a big decision. It is essential for people to know their rights and understand how clinical trials work. They follow a defined protocol or study plan. It is designed to protect the health of participants and answer specific research questions.

Participating in clinical trials provides hope, can save lives and help others.

"Clinical trials for Cancer were instrumental in extending my life," states Mercie Madrid. Another participant, Mike Means, says, "I participated in a clinical trial for Psoriasis and my condition improved dramatically."

ASPIRE IRB's 10 Ways to Protect Participants' Rights and Maximize Results for Clinical Research
1) Participants can decide not to participate in the research study with

NO penalty or loss of benefits any time.

2) Participants can ask any questions that occur before, during or after

the study.

3) Be Informed. Get a copy of the consent form, the main source of

information for the study.

4) Ask the principal investigator as many questions as needed to

understand the trial.

5) No legal rights are waived by signing a consent form.

6) Ethical and legal codes governing medical practices apply to clinical

trials.

7) Be prompt to all scheduled appointments.

8) Call the research facility if there is a reaction to a drug or device

immediately.

9) Follow the study related instructions that are given to you.

10) Certain studies may expect more visits than regular care. This may

affect employment.

About ASPIRE IRB http://www.aspire-irb.com

ASPIRE IRB is a privately owned certified Women's Business Enterprise headquartered in San Diego, CA. They oversee clinical research studies. They review and approve any research involving human participants with the aim to protect their rights and welfare. Their goal is to make sure the protocol is well-designed and the risks are as minimal as possible. ASPIRE has overseen clinical drug trials for Cancer, Psoriasis, Schizophrenia, Depression, Multiple Sclerosis, Pain, Obesity, Dermatology, Heart Disease, Diabetes, Hyperactivity, Alzheimer's Disease, Sleep Disorders, Garlic, supplements and more. Clients include: Pfizer, Covance, PPD, Takeda, Sanofi-Aventis, Wyeth, Charles River, MRA and J&J.


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