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We fulfill one of the most important parts of our mission by raising public awareness of the vulnerability of human subjects in research. To this end, we:
The information on our web site has important strengths and limitations. We offer information about human research protection to minimize risk to subjects and maximize recognition of the need for improvement. We encourage readers to consult more than one source of quality information.
This information is not medical advice. CIRCARE officers and board members do not offer medical advice. Those CIRCARE officers or board members licensed to practice medicine are not offering you medical advice here. We firmly believe that medical decisions should be made by you and your primary care physician.
Do not make medical decisions based upon what you read here.
We do not provide referrals to physicians or health care providers, although we do offer resources to obtain information about physicians and health care providers, e.g., we provide URLs for state medical and osteopathic licensing boards.
This information is not legal advice. CIRCARE officers and board members do not offer legal advice. Only a licensed attorney whom you have retained can provide you with legal advice. Those CIRCARE officers or board members licensed to practice law are not offering you legal advice here.
We post warning letters to clinical investigators, sponsors, and institutional review boards (IRBs) issued by the United States Food and Drug Administration (FDA) on the CIRCARE web site. Prior to mid-2009 we provided links to these documents on the FDA website. We repeatedly corrected hundreds of links but after the FDA website revision in 2009 we decided to post relevant warning letters on our website to conserve resources while keeping these documents in the public eye. Although we make good faith efforts to monitor FDA warning letters we cannot guarantee matters have not changed. Therefore visitors should consult the FDA website for the most current information. The main FDA warning letter webpage is available at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm
FDA Website Policy is available at: http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm
Special notice to recipients of FDA warning letters: if there has been a substantive change in matters described in FDA warning letters we will gladly update our information. Please use the
Webmaster email link at the bottom of this page to contact us. From time to time FDA reorganizes its website. Before you contact us to say that FDA
rescinded your warning letter please use the Warning Letter search on the FDA website: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm
We post public documents related to state medical and osteopathic board actions. Such documents include but are not limited to cases involving research, informed consent, and FDA regulated products, i.e. drugs, medical devices, and (rarely) food. Readers are reminded not to draw unwarranted conclusions because a board action is or is not posted on the CIRCARE website. These actions speak for themselves. If you need additional information, please contact the relevant state board. For the most current information and authoritative documents (certified or otherwise) readers should contact the relevant state medical or osteopathic board. CIRCARE maintains a list of state medical and osteopathic boards at: http://www.circare.org/boards/statebrds.htm
Special notice to licensed health care providers: if there has been a substantive change in matters described in public documents related to state medical and osteopathic board orders posted on the CIRCARE website we will gladly update our information. Please use the
Webmaster email link at the bottom of this page to contact us.
We post documents and information about legal cases related to research protection and bioethics. Case documents posted on the CIRCARE web site are public documents retrieved from state and federal courts. Documents are clearly identified and sources are cited as necessary. We make no warranties about these documents except for identification. Additional information may be obtained by contacting the appropriate court. Among the documents posted on this web site are civil and criminal complaints. Please remember that persons should be presumed innocent until proven otherwise. We make reasonable efforts to check on the progress of open cases. We welcome updates and corrections related to cases posted on our web site. Please use the
Webmaster contact link at the foot of any web page to communicate with us.
We do not participate in link exchange programs. If you think your web site would be of interest to our readers, use the
Webmaster contact link at the foot of any web page to communicate with us.
We do not participate in arrangements to refer people to attorneys so please don't invite us to consider them. Attorneys seeking information on behalf of clients should feel free to contact us.
Our web site also contains opinion and advice based upon the insight and experience of CIRCARE officers and board members as non-professional advocates for the protection of human subjects in research. We believe our opinions are reasoned and responsible in the context in which we offer them. To the extent possible, we explain the basis of our opinions. Our opinions are not facts, and other people may or may not agree with them. For this reason we discourage you from making decisions based only upon what you read here. We make every attempt to distinguish opinion from information.
You should not decide whether or not to enroll in research based only on this or any other single source of information.
CIRCARE strives for accuracy on this web site. Original third-party material is reproduced with citation. Sources of information are appropriately cited although the citation style may change from time to time. While we try very hard to ensure our information is accurate, we cannot guarantee it. If you're concerned about the accuracy of information on our web site, please let us know. Use the
Webmaster contact link at the foot of any web page to bring it to our attention.
We encourage people to link to the CIRCARE web site. We offer small graphics with HTML code to make linking to our web pages even easier. Follow this URL to Link To CIRCARE. If you use material from the CIRCARE web site, please credit it appropriately. Copyright and dissemination information can be found at the foot of each page on our web site. Follow this URL for Acknowledgments and Information About Products and Services Used on the CIRCARE Web Site
1. FDA Warning Letters: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm; FDA Warning Letters and Notice of Violation Letters to Pharmaceutical Companies: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/default.htm; FDA FOIA Page: http://www.fda.gov/RegulatoryInformation/FOI/default.htm
If you find the information on this page helpful please support CIRCARE with a tax-deductible contribution today. Because CIRCARE doesn't accept funds from pharmaceutical or medical device manufacturers, we depend on contributions from individuals like you to help us advocate for meaningful protection of human subjects in research. Donating online with PayPal is quick and easy. Find out more on our Support page
All material on this site © CIRCARE Incorporated (2002- ) or as indicated. Single copies can be downloaded for personal education. Adobe® Reader :: ::