Link To ::
Recently posted documents
Dr. Paolo Macchiarini Trachea Transplants: /info/pm/macchindex.htm
Texas Applied Biomedical Services, aka TABS IRB FDA Proposal to Disqualify Commissioner's Decision 2016-02-29 /fdawls/tabsirb-fdacommissdecis-20160229.pdf
USA ex rel. Edith Shlian v. Abbott Laboratories, Inc., Western Institutional Review Board, Cardiovascular Research Foundation, Midlantic Cardiovascular Associates, P.A., Mark Midei, M.D., St. Joseph Medical Center Civil No. 11CV01920 USDC Northern Dist Maryland /lex/11cv01920-complaint-20110713.pdf
Shaun Bobbi Kelehan, M.D. Texas Medical Board Agreed Order 2015-08-04 [professional disciplinary action arising from death of research subject in hypertension trial] /pd/kelehan-order.pdf
(TACT investigator) Zbigniew Grudzien, M.D. Final Report Attorney General of Washington Medicaid Fraud Control Unit 2012-08-21 /tact/grudzien-finalreport.pdf
Carol Roberts, M.D. Wellness Works FDA Establishment Inspection Report 2010-12-16: /tact/roberts-fdaeir-20101216.pdf
Carol Roberts, M.D. Form FDA 483 2010-12-16: /tact/roberts-fda483-20101216.pdf
CIRCARE Public Comments In re: Docket ID Number HHS-OPHS-2015-0008: Notice of proposed rulemaking, Federal Policy for the Protection of Human Subjects 2015-12-20: /submit/CIRCARE_commonrule_nprm_2015.pdf
Docket ID Number HHS-OPHS-2015-0008: Notice of proposed rulemaking, Federal Policy for the Protection of Human Subjects (read public comments) http://www.regulations.gov/#!docketDetail;D=HHS-OPHS-2015-0008
Trial to Assess Chelation Therapy (TACT) Mount Sinai Medical Center Report to OHRP 2008-11-05: /tact/15-0286-report-20081105.pdf
Dear TACT Participant Letter Gervasio Lamas, M.D. Mount Sinai Medical Center 2009-07-13 : /tact/tact-participantletter-20090713.pdf
Trial to Assess Chelation Therapy (TACT) Consent Form Mount Sinai Medical Center 2008-12-01 : /tact/tact-consentform-20081201.pdf
Beverly H. Scheer v James F. Burke, D.O. et al. No. 1901 EDA 2013 (Memorandum) Appeal from the Judgment Entered June 18, 2013 2015-03-25: /lex/scheer-2015-1901-eda-2013.pdf
University of Minnesota Human Research Protections Program: AAHRPP Final Report and Prefatory Note 2015-02-26: /dw/uminn-aahrppreport-20150226.pdf
University of Minnesota Human Research Protections Program: AAHRPP Final Report, Appendices 2015-02-26: /dw/uminn-aahrppreport-append.pdf
TABS IRB (aka Texas Applied Biomedical Services) FDA Notice of Opportunity for Hearing 2014-09-16: /fdawls/tabs-irb_nooh_20140916.pdf
Jerry Menikoff, M.D., J.D. Director, Office for Human Research Protections. Improving Informed Consent 2014-05-06: /tact/menikoff_20140606.pdf Accessed on 2014-07-03 at: http://www.cincinnatichildrens.org/WorkArea/DownloadAsset.aspx?id=112810 (see pp. 4-11 on TACT consent form)
Before the Texas Medical Board In the Matter of the License of Robert Anthony Weaver, M.D. Agreed Order 2014-05-02: /pd/weaver-2014.pdf (Dr. Weaver worked at the Burzynski Research Institute)
CIRCARE Public Comments In re: U.S. Department of Health and Human Services Request for Comments on Matters Related to the Protection of Human Subjects and Research Studying Standard of Care Interventions Docket HHS-OPHS-2013-0004 78 FR 38343 2013-09-08: /submit/circare_hhs-ophs-201300040001.pdf
Agnesian Healthcare Institutional Review Board 2013-03-25: /fdawls/agnesianhcirb_fdawl_20130325.pdf
Form FDA 483 Inspectional Observations Issued to Rajiv Chandra, M.D. Trial to Assess Chelation Therapy TACT Site Investigator 2010-05-24: /tact/fda483_chandra_tact_20100524.pdf
Rajiv Chandra, M.D., [redacted name] TACT Study Chair (aka Gervasio Lamas, M.D. - duh) 2010-06-14: /tact/tactsite_responsetofdainspection.pdf
FDA Warning Letter to Solta Medical, Inc. 2012-11-28 [ISIS Laser, Serenity Skin Rejuvenation System, Janus Resurfacing Laser]: /fdawls2/solta-medical_fdawl_20121128.pdf
FDA Warning Letter to Celltex Therapeutics Corporation 2012-09-24: /fdawls2/celltex_fdawl_20120924.pdf
FDA Warning Letter to Texas Applied Biomedical Services, aka TABS IRB 2012-09-24: /fdawls/tabsirb_fdawl_20120924.pdf
FDA Warning Letter to Texas Applied Biotechnology Research Review Committee, aka TABS IRB 2000-09-27: /fdawls/tabrrc_20000927.pdf
Celltex Therapeutic Corporation Form FDA 483 2012-04-27: /info/stemcell/celltex483_20120427.pdf
Celltex Therapeutics Corporation's Stem Cell Facility Inspected by FDA Investigators: 483 Inspectional Observations Form Now Available. Leigh Turner, Ph.D. Health in the Global Village 2012-06-25: http://www.healthintheglobalvillage.com/?p=668
FDA Inspectors Pound Celltex. Carl Elliott Brainstorm Blog Chronicle of Higher Education 2012-06-26: http://chronicle.com/blogs/brainstorm/fda-inspectors-pound-celltex/48871
US drug regulator audits Texas stem-cell company. David Cyranowski Nature News Blog 2012-06-26: http://blogs.nature.com/news/2012/06/fda-hammers-texan-stem-cell-company.html
FDA report faults Houston stem-cell company. Todd Ackerman Houston Chronicle 2012-06-26: http://www.chron.com/news/houston-texas/article/FDA-report-faults-Houston-stem-cell-company-3661778.php
Celltex Responds to Media Reporting on FDA Visit. Celltex Therapeutic Corporation Press Release 2012-06-27 : /info/stemcell/celltex_pr_20120727.pdf
International Cellular Medicine Society (ICMS) Institutional Review Board Form FDA 483 2012-06-19: /info/stemcell/icms-irb_fda483_20120619.pdf
ICMS Announces FDA Audit Findings. International Cellular Medicine Society Press Release 2012-06-19: http://www.cellmedicinesociety.org/component/content/article/86-news/415-fda-audit-findings
CIRCARE In re: U.S. Department of Health and Human Services, Office of the Secretary, Presidential Commission for the Study of Bioethical Issues, Request for Comments on Issues of Privacy and Access With Regard to Human Genome Sequence Data, 77 Fed. Reg. 18,247 (2012) 2012-05-11: /submit/circare_pcsbi_20120511.pdf
Trial to Assess Chelation Therapy — Trial Documents, FOIA Records, and More: /tact/tactindex.htm
Trial to Assess Chelation Therapy (TACT) U01AT001156 FCOI Nahin, R. Letter to Paul Katz, M.D., Mount Sinai Medical Center RE: MSMC Financial Conflict of Interest Policies 2004-03-23: /tact/U01AT001156_fcoi_20040323.pdf
Trial to Assess Chelation Therapy (TACT) 7U01HL092607 Audit Response Lamas, G.A. Memo RE: Medicaid Audit of TACT Investigator Dr. Zbigniew Grudzien, M.D. 2011-03-14: /tact/7U01HL092607_audit_response_20110314.pdf
Trial to Assess Chelation Therapy (TACT) AT001156 Financial Status Reports 2003-2009: /tact/at001156_tact_fsrs_2003_2009.pdf
Trial to Assess Chelation Therapy (TACT) U1AT001156A PMS Report 2002-2009 (2011-08-11): /tact/u1at001156a_tactpms_report_2002_2009.pdf
Trial to Assess Chelation Therapy (TACT) U1HL092607A PMS Report 2010 (2011-08-11): /tact/u1hl092607a_tact_pmsreport_2010.pdf
Trial to Assess Chelation Therapy (TACT) U1HL092607B PMS Report 2011 (2011-08-11): /tact/u1hl092607b_tact_pmsreport_2011.pdf
CIRCARE In re: U.S. Department of Homeland Security, Notice and request for comment, Docket No DHS-2011-0074, 76 Fed. Reg. 81,517 (2011) 2012-02-21: /submit/circare_submission-dhs.pdf
Trial to Assess Chelation Therapy (TACT) Grant Number 5 U01 AT001156-02 Progress Reports Part 1 2012-02-19: /tact/tact_progressreports_pt1.pdf
Trial to Assess Chelation Therapy (TACT) Grant Number 5 U01 AT001156-02 Progress Reports Part 2 2012-02-19: /tact/tact_progressreports_pt2.pdf
Trial to Assess Chelation Therapy (TACT) Grant Number 5 U01 AT001156-02 Progress Reports Part 3 2012-02-19: /tact/tact_progressreports_pt3.pdf
Smaller files:
Trial to Assess Chelation Therapy (TACT) Grant Number 5 U01 AT001156-02 Grant Progress Report 2003-07-18: /tact/tact-gpr_20030718.pdf
Trial to Assess Chelation Therapy (TACT) Grant Number 5 U01 AT001156-02 Grant Progress Report 2003-12-01: /tact/tact-gpr-20031201_.pdf
Trial to Assess Chelation Therapy (TACT) Grant Number 5 U01 AT001156-02 Grant Progress Report 2004-12-28: /tact/tact-gpr_20041228.pdf
Trial to Assess Chelation Therapy (TACT) Grant Number 5 U01 AT001156-02 Grant Progress Report 2005-12-28: /tact/tact-gpr_20051228.pdf
Trial to Assess Chelation Therapy (TACT) Grant Number 5 U01 AT001156-02 Grant Progress Report 2008-01-30: /tact/tact-gpr_20080130.pdf
FDA Drug Approval Documents Collection Oregon Health Sciences University Digital Resources Library: http://cdm15412.contentdm.oclc.org/cdm/landingpage/collection/fdadrug
Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. WHO Publications 2011: http://whqlibdoc.who.int/publications/2011/9789241502948_eng.pdf
CIRCARE In re: Office of Science and Technology Policy, Notice, Request for Information: Building A 21st Century Bioeconomy, 76 Fed. Reg. 62,869 (2011) /submit/circare_ostp_rfi_20111204.pdf
Essex Institutional Review Board (CDER) 2011-07-26 [approval of fictitious protocol; additional]: /fdawls/essexirb_fdawl_20110726.pdf
Essex Institutional Review Board Form FDA 483 and Company Response 2011-04-11: /fdawls/essexirb_fdafoia_2011-6068.pdf
Waggoner, WC. Essex Institution Review Board Approval Letter to Bruce Frome, M.D. for study titled
Ion Magnetic Induction Device (PAP-IMI-300) As An Immunomodulator in Treating Patients with AIDS.1993-04-22: /pd/essexirb_19930422.pdfBefore the Medical Board of California in the Matter of the Second Amended Accusation Against Bruce M. Frome, M.D. Decision 2001-08-24: http://www.bioethicswatch.org/pd/frome_20010824.pdf
CIRCARE's response In re: Docket No. HHS–OPHS–2011–0005, Advance Notice of Proposed Rulemaking, Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, 76 Fed. Reg. 44,512 (2011). 2011-09-21: /submit/circare_anprm_response_201109.pdf
ANPRM for Revision to Common Rule Information Related to Advanced Notice of Proposed Rulemaking (ANPRM) for Revisions to the Common Rule 2011-07-22 [Deadline for submission of comments is 2011-10-26]: http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html
Read the proposed changes to the Common Rule online [HTML]: http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18792.htm [PDF]: http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/pdf/2011-18792.pdf (ca. 88 pp. in MS Word)
How to submit comments on the proposed changes to the Common Rule: http://www.hhs.gov/ohrp/humansubjects/submitanprmcomment.html
Mission Statement:
CIRCARE is a human rights organization dedicated to the protection of human subjects in research and medical treatment.
CIRCARE's mission is to raise the ethical and professional level of human subject research and medical treatment to a level that is compatible with the principles stated in the National Human Research Protections Act (NHRPA). Support for the enactment of the NHRPA is one of the most important missions of CIRCARE advocacy.
CIRCARE is particularly concerned with the protection of vulnerable subjects, i.e. the mentally incapacitated, children, seniors, the homeless, and the poor.
By raising public awareness of human subject vulnerability in research and treatment, CIRCARE works to prevent unethical practices. CIRCARE believes that good science and clinical practice are compatible with sound ethical principles that respect the rights and dignity of human subjects.
To accomplish its mission, CIRCARE works with the public, the Congress, and representatives of research funding agencies to increase overview and accountability of organizations (i.e. research institutions, hospitals, etc.) involved with human subject research. By establishing a dialog with the public and the scientific community, CIRCARE hopes to advance the ethical principles used in human subject research. This is accomplished through public policy statements, testimony at public hearings, a web site, and periodic publications.
Of particular concern to CIRCARE is the fact that federal guidelines do not apply to privately funded research (except for drug and device applications to the Food and Drug Administration (FDA)), thus creating a two-tiered system of human subject research standards and safeguards. The often highly complex and technical nature of biomedical research and medical treatment of human subjects also impedes understanding of the ethical implications of rapidly advancing fields.
Specific Goals Are To:
- Raise public awareness of human rights violations in research via publications and a web site.
- Enlist public support to eliminate unethical research involving human subjects.
- Work with public agencies to ensure that adequate safeguards are provided to human research subjects whether vulnerable or not under existing federal guidelines.
- Work to improve human subject protection where federal guidelines may not be adequate.
- Work to ensure that research organizations, both public and private, are fully accountable for their investigative procedures and treatment of subjects and that unfavorable data are not withheld from public scrutiny.
- Work to ensure that no coercive conditions are established when human subjects are recruited for a study such as:
- Exploiting altruistic motives for participating in the research
- Offers of financial or medical benefits to the subjects
- Persuasion through potential direct medical benefits from the experimental treatment.
- Work to ensure that research organizations provide fully comprehensible and honest representation of their research protocols and potential health effects on their research subjects, and that the subjects (or their proxies) sign a consent form to participate in the research with a full understanding of the protocol.
- Work to ensure that research organizations establish fully and adequately staffed oversight committees (Institutional Review Boards) to safeguard the rights and interests of the research subjects.
© CIRCARE Incorporated (2002 - ). Revised 2005-11-21.
Last Updated: 2016-08-09
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