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The FDA and HHS regulations empower Independent Review Boards to approveor disapprove research and require modifications. They are made up ofphysicians, scientists, nonscientists, community members and associatesaffiliated with the IRB. A clinical trial CANNOT take place without anIndependent Review Board.
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Hundreds of thousands of people participate in clinical trials with thehope of finding relief and or to help others. Research is essential tofinding cures and treatments for conditions and diseases. Being a member of aclinical trial is a big decision. It is essential for people to know theirrights and understand how clinical trials work. They follow a definedprotocol or study plan. It is designed to protect the health of participantsand answer specific research questions.
Participating in clinical trials provides hope, can save lives and helpothers.
"Clinical trials for Cancer were instrumental in extending my life,"states Mercie Madrid. Another participant, Mike Means, says, "I participatedin a clinical trial for Psoriasis and my condition improved dramatically."
ASPIRE IRB's 10 Ways to Protect Participants' Rights and Maximize Resultsfor Clinical Research
About ASPIRE IRB http://www.aspire-irb.com
ASPIRE IRB is a privately owned certified Women's Business Enterpriseheadquartered in San Diego, CA. They oversee clinical research studies. Theyreview and approve any research involving human participants with the aim toprotect their rights and welfare. Their goal is to make sure the protocol iswell-designed and the risks are as minimal as possible. ASPIRE has overseenclinical drug trials for Cancer, Psoriasis, Schizophrenia, Depression,Multiple Sclerosis, Pain, Obesity, Dermatology, Heart Disease, Diabetes,Hyperactivity, Alzheimer's Disease, Sleep Disorders, Garlic, supplements andmore. Clients include: Pfizer, Covance, PPD, Takeda, Sanofi-Aventis, Wyeth,Charles River, MRA and J&J.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.
SOURCE ASPIRE IRB
