Text ::   Skip Nav ::

circare logo

Brochure Contact Home Privacy Terms of Use Tools

print Print Page ::     Link to CIRCARE Link To ::

Site Map

About Us Who We Are
About CIRCARE Incorporated Officers & Board of Directors
CIRCARE Vice-President Paul Gelsinger
Gelsinger P. Jesse's Intent. © 2001. Available from http://www.circare.org/submit/jintent.pdf
Information for Journalists
What We Do
CIRCARE's Accomplishments
Index of Public Comments and Testimony Provided by CIRCARE
Supporting CIRCARE How You Can Help
CIRCARE Brochure. © 2002. Available from http://www.circare.org/brochure.pdf
Link to CIRCARE / Graphics and HTML Code
About circare.org Information About This Web Site
How to Contact CIRCARE
Email Message Form
Terms of Use
Privacy Policy
Internet Tools
About Our Web Site: Credits & Acknowledgments


General Information Resources
Index of Information Resources for Human Research Protections
Introduction, Overview, and Basic Information
Ethical Codes and Guidelines For Human Research
Commissions and Committees on Human Subject Protections
Commercial Insitutional Review Boards
Phase I Research Clinics
Resources For Consumers & Research Subjects
Index of Resources for Research Subjects / Brochures on Research Participation
How To Complain About Research
U.S. Food and Drug Administration (FDA) Regulations and Information
Index of FDA Research Regulations and Information
FDA vs. DHHS Regulations: Comparision Chart (Formatted for print in HTML or PDF.)
U.S. Food and Drug Administration (FDA) Documents Alphabetized by Addressee
FDA Warning Letters to Institutional Review Boards (IRBs)
FDA Warning Letters to Clinical Investigators (A – E)
FDA Warning Letters to Clinical Investigators (F – L)
FDA Warning Letters to Clinical Investigators (M – R)
FDA Warning Letters to Clinical Investigators (S – Z)
FDA Warning Letters to Sponsors and Contract Research Organizations (CROs)
FDA Warning Letter Overview by Year and Type
Form FDA 483s Notices of Inspectional Findings
Early Cases of Clinical Investigator Misconduct in FDA-Regulated Research
Consent Forms
NDA 20-823 Novartis Exelon
U.S. Office For Human Research Protections (OHRP)
Office For Human Research Protections
Children in Federally Regulated Research
National Institutes of Health (NIH)
NIH Information / General Information, How to Find Specific Information on Research Sponsored by NIH


Human Research Protections and Bioethics Publications (Free and online for the most part.)
Articles, Human Research Protections and Bioethics Authors A — K
Articles, Human Research Protections and Bioethics Authors L — Z
Bibliographies, PubMed Search, Books, and Projects
Bioethics and Medical Journals
Bioethics and Human Research Protections Reports
Clinical Trials
Clinical Trial Registries
Study Results Databases Suggestions for Use
Medical Care
Medical Treatment, Clinical Practice Guidelines, and Providers of Credible Information
Drugs and Medical Devices
Drug Information Resources (Including dietary supplements.)
Medical Device Information and Regulations
How To Complain About FDA-Regulated Drugs, Medical Devices, and Dietary Supplements
Medicare Coverage of Clinical Trials
Compulsory Research Participation in Return for Medicare Reimbursement
Physician Discipline, Medical Licensure, Physician Training and Education
Index of State Medical and Osteopathic Licensing Boards
State Medical Board Cases: Physician Conduct in Research and Related Cases Physician Last Names A – G
State Medical Board Cases: Physician Conduct in Research and Related Cases Physician Last Names H – Z
Medical Board Orders for Physicians Associated with the Great Lakes College of Clinical Medicine
Bioethics Organizations and Education Providers
Index of Organizations, Academic Programs, and Research Protections Training and Education Resources


Research in Canada
Freedom of Information Act (FOIA) Information
Freedom of Information Act Index
Tips for FOIA Requests and Frequently Used Addresses
How to Find Information Released Under FOIA
Index of Documents Disclosed Under FOIA by UCLA re: Research on Induced Malaria for HIV/AIDS
Index of FOIA Documents Related to Henry Heimlich M.D.
Index of Miscellaneous FOIA Documents
Special Topics SFBC International Inc.
SFBC International Inc. Introduction and Collected Information
Table 1: FDA IND Drug Studies Conducted at SFBC International Inc.
Table 2: FDA IND Drug Studies Approved by the LeeCoast Research Center Institutional Review Board
Table 3: FDA IND Drug Studies Conducted at SFBC International Inc., Miami and Approved by the Southern Institutional Review Board Inc.
Table 4: Combined Data Part 1 — FDA IND Studies Conducted by SFBC International Inc. and Approved by the LeeCoast Research Center Institutional Review Board and Independent IRB Inc.
Table 5: Combined Data Part 2 — FDA IND Studies Conducted by SFBC International Inc. and Approved by the LeeCoast Research Center Institutional Review Board and Independent IRB Inc.
Table 6: FDA IND Studies Approved by First Foundation for the Protection of Human Subjects in Research, Inc. Institutional Review Board
Special Topics Malariotherapy Research
Malariotherapy For HIV Henry Heimlich M.D. and the Heimlich Institute Foundation Inc.
Malariotherapy For HIV Pt. II
Malariotherapy For HIV Pt. III
Malariotherapy For HIV Pt. IV
Malariotherapy For HIV Pt. V
UCLA FOIA Documents, Induced Malaria Research
Induced Malariotherapy for Lyme disease Henry Heimlich M.D. and the Heimlich Institute Foundation Inc.


Special Topics Emergency Research with Waiver of Informed Consent
Clinical Trial Watch I: Emergency Research With Waiver of Informed Consent
The Polyheme® Trial Pt. 1: What's Wrong with This Trial (Under revision, 2006-03-27.)
The Polyheme® Trial Pt. 2: Community Consultation and Public Disclosure Information Submitted to FDA docket 1995s-0158 for Polyheme® Trial Sites
The Polyheme® Trial Pt. 3: Media Articles and Related Publications About the Polyheme® Trial
The Polyheme® Trial Pt. 4: Links to Articles on Polyheme® Published in Medical Journals
Diaspirin CrossLinked Hemoglobin (DCLHb) Clinical Trial
Special Topics EmpowerPlus Research
Index of Empowerplus Research, The Synergy Group of Canada Inc., and Truehope Nutritional Support Ltd.
EmpowerPlus Research Section I: Documents, ATI Disclosures by Alberta Science & Research Authority re: Grant Applications by Bonnie Kaplan Ph.D.; Investigational Drug Product(s) Ingredients, Manufacturers, Distributors, and Trademarks
EmpowerPlus Research Section II: Documents, Disclosures by the University of Calgary; Health Canada Investigational New Drug Application for EmpowerPlus
EmpowerPlus Research Section III: Clinical Trials with EmpowerPlus, Consent Forms, Clinical Trial Approvals, Clinical Trial Funding, Clinical Trial Publications, and Poster Presentations
EmpowerPlus Research Section IV: Documents, Health Canada ATI A-2001-0845/ms
EmpowerPlus Research Section V: Documents, Health Canada ATI File number A-2002-00199/ms
EmpowerPlus Research Section VI: Hearings, Standing Committee on Health (Parliament of Canada)
EmpowerPlus Research Section VII: Health Canada Advisories and Warnings about EmpowerPlus, Health Canada Health Hazard Evaluation of EmpowerPlus, Media Stories, and Press Releases
EmpowerPlus Document Index


Special Topics Index
Andrew Wakefield and Research with Autistic Children
Use of Unapproved Medical Devices at A. I. Dupont Hospital for Children   William I. Norwood M.D. and colleagues and the Cheatham Covered Platinum Stent
TGN1412 Tegenero AG Clinical Trial
Ketek™ Clinical Trials and FDA Approval
In re Cardiac Devices Qui Tam Litigation
Pesticide Research in Human Subjects (U.S. Environmental Protection Agency)
Index of Unethical Human Research; High-Profile Cases
Genetic Research
Genetic Research Information Resources
Paul and Jesse Gelsinger
James Wilson M.D., The Institute for Human Gene Therapy, The University of Pennsylvania, et al., U.S. Department of Justice Settlements, NIH Funding, and More
Special Topics Ephedra Research
Ephedra Index
FDA/HHS Documents
Clinical Trials With Ephedra
Government Hearings and Investigations
Ephedra Lawsuits, Lobbying, and Media Stories


CIRCARE InfoMail ®
CIRCARE InfoMail Media Contacts
Subscribe to the CIRCARE InfoMail
CIRCARE InfoMail: Main Index and Information
InfoMail 2005
2005-02-14: Lack of Effective Accountability in Research Deaths (Jesse Gelsinger's Requiem)
2005-04-14: The Lack of Representation by Human Subjects, Their Families, and Advocacy Organizations in Advisory Bodies Entrusted with Ensuring Public Safety in Human Research
2005-05-25: Federal Guideline, if Enacted, Would Coerce Human Subjects into Clinical Trials Without Informed Consent
2005-08-21: CBS News Raises Issue of Research Subject Safety
2005-08-22: CIRCARE Presentation to the Secretary's Advisory Committee for Human Research Protection (SACHRP)
2005-12-02: Research Subjects and the Bloomberg News Report: Disturbing Allegations
Archive: InfoMail 2004
2004-02-02: Testing Ecstasy on Subjects Diagnosed with PTSD and the Use of Internet Recruiting
2004-02-25: Relabeling ECT as a Low Risk Device Without Appropriate Research
2004-04-12: The Creation of a Database For Recording Adverse Events in Genetic Studies
2004-07-15: Neglect of Reporting Adverse Events
2004-08-09: An Ethical AIDS Study? The Use of Non-Standard Care
2004-10-16: Regarding the Failure of the Public Safety System For Drug Testing in the Case of Vioxx ®
InfoMail 2004 Index
Archive: InfoMail 2003
2003-03-01: The Lack of Informed Consent in the Case of Daniella Rogers
2003-03-09: Lack of Reporting of Adverse Events Leading to Duplication of Harm
2003-04-04: Court Ruling re: FDA Testing for Safety and Efficacy of Drug Use on Children
2003-04-30: The Establishing of Independent Oversight over Research at the Veterans Administration
2003-09-06: Concerns RE: Gene Therapy Experiment at NY Presbyterian Hospital
2003-11-10: FDA Advisory on Suicidality and the Use of Anti-depressants with Children
2003-11-24: The NIH Roadmap and the Lack of Training in Ethics
InfoMail 2003 Index
Archive: InfoMail 2002
2002-04-26: Announcement of CIRCARE's Activities
2002-05-09: Pediatric Death in Study at the University of Chicago
2002-05-20: New Maryland Law
2002-05-28: Regarding Death at St. Louis Children's Hospital
2002-06-27: Concerns Regarding a Nutritional Cure
2002-08-13: Johns Hopkins University Determination Letter
2002-09-04: Disbandment of NHRPAC
2002-09-17: California Law
2002-10-18: Research on Gene Transfer Therapy
2002-10-20: New Officer For CIRCARE
InfoMail 2002 Index


Human Research Protections and the Law
Law and legislation Index
Federal Legislation on Human Research Protections
Senate and Congressional Hearings on Human Research Protections
Index of State Research Protections Laws
Legal Information Resources
Legal Cases Involving Human Research
Human Research Protections and Bioethics in the News
Current News
News Archived by Month and Year
Media Outlets
TV, Video, and Audio Archive

Page Layout, Navigation, and Accessibility

Every page on the CIRCARE web site has a Text link in the upper left corner. When you select the Text link the Betsie perl script will serve the web page as a text file. Information about Betsie is available at the Betsie home page

Some material on this web site is in Portable Document Format (PDF). At the bottom of every web page you'll find a link to download the free Adobe® Reader. The Tools page has a form for converting PDF files to ASCII format with Adobe® Access. Links can be pasted into this form to convert files for screen reading programs.

The Tools page also provides a link to download free viewers for Microsoft Access®, Excel®, Powerpoint®, and Word® files.

We've tried to make our web site as accessible as possible given our rather slender resources. If you have difficulty accessing information on this site, please use Contact Web Master link at the bottom of any page or our Contact Page to let us know. We'll do our best to accommodate your needs.

This web site is not enhanced for any particular web browser, rather we've attempted to make it accessible to all standards–compliant web browsers. Unfortunately this doesn't include Netscape 4.

Links to medical dictionaries and glossaries of terms in clinical research are included in our Index of Information Resources. On some pages where the going can get difficult, there is a medical dictionary search form with the Translation and Print Page options at the upper right of the page. You can find an English dictionary on the Tools page. For your convenience, each web page has a drop down translation menu and search box; to format the page for printing, select the Print Page link. You can search the web with Google™ from our Tools page

Links to major sections of this web site are located directly above the page title. At the top of each page and to the right of the CIRCARE image a utilities menu has links to the CIRCARE Home Page, Contact Page, Privacy Policy, Terms of Use, Site Map, and Tools Page.


Last Updated: 2009-03-12

All material on this site © CIRCARE Incorporated (2002- ) or as indicated. Single copies can be downloaded for personal education.  Adobe® Reader ::   ::

Valid HTML 4.01! Valid CSS!  mozilla and circare