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Consent Form, Study Number 91-M-194 The Evaluation of Lithium Treatment in Dementia of the Alzheimer's Type, Major Depression, and Age-Matched Controls. Undated. National Institutes of Mental Health. (Principal investigator Susan Molchan, M.D.) Accessed on 2007-03-31 at: http://www.circare.org/consents/91-m-194_consentform.pdf (6)
Consent Form for Protocol B351: A prospective, randomized multi-center, double-blind, placebo-controlled, parallel-group comparison of the efficacy and safety of three fixed-doses of SDZ ENA 713, 3 mg, 6 mg, and 9 mg per day in patients with probable mild to moderate Alzheimer's Disease. Accessed on 2007-02-08 at: http://www.circare.org/consents/huckeba_sdzena713consent_19950421.pdf (5) [NB: If you see blank pages open the file with Adobe® Reader or other pdf program.]
Consent Form: TIDE Trial Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) Sponsor: GlaxoSmithKline Inc.: http://www.circare.org/consents/Avandia-TIDE-trial_consentform.pdf
Research Ties Diabetes Drug to Heart Woes. Gardiner Harris. New York Times. 2010-02-19
URL: http://www.nytimes.com/2010/02/20/health/policy/20avandia.htmlBaucus, Grassley Release Finance Committee Report of Diabetes Drug Avandia, Express Concern About FDA's Role in Protecting Patients in Ongoing Avandia Study. Committee on Finance Press Release. 2010-02-20: http://finance.senate.gov/press/Gpress/2010/prg022010.pdf
Senator Charles Grassley Letter to FDA Commissioner Hamberg RE: GSK's TIDE Trial. 2010-02-18: http://finance.senate.gov/press/Gpress/2010/prg022010b.pdf
Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) NCT00879970. Clinicaltrials.gov. Updated 2010-02-12: http://www.clinicaltrials.gov/ct2/show/NCT00879970
NCT00879970 History of Changes. Accessed on 2010-02-21 at: http://clinicaltrials.gov/archive/NCT00879970S. Prt. 111-41 Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia. Committee on Finance. January 2010: http://finance.senate.gov/press/Gpress/2010/prg022010a.pdf
Consent for Enrolment (sic) in the Geier Experimental Protocol for the Treatment of Autism. Mark R. Geier, M.D., Genetic Centers of America. Undated [Lupron®, chelation drugs NOS]: http://www.circare.org/consents/geier_consent.pdf
Geier Clinical Study Protocol. Mark R. Geier, M.D., Genetic Centers of America. Undated: http://www.circare.org/consents/geier_clinicalstudy_protocol.pdf
Consent Form, A new syndrome: enteritis and disintegrative disorder following measles and measles/rubella vaccination. 1996-09-16. Royal Free Hospital. (Principal investigator Andrew Wakefield) Accessed on 2007-02-07 at: http://www.circare.org/consents/wakefield_consent_19960916.pdf
Protocol, A new syndrome: enteritis and disintegrative disorder following measles and measles/rubella vaccination. 1996-09-16. Accessed on 2007-02-07 at: http://www.circare.org/consents/wakefield_protocol_19960916.pdf (4)
Follow this link for more information about Andrew Wakefield and research with autistic children
06-M-0238 Parental Permission and Minor Assent Form: An Investigation of the Efficacy of Mercury Chelation as a Treatment for Autism Spectrum Disorder. National Institute of Mental Health. (Principal investigator Susan Swedo, M.D.) Rev. 2006-06-27. Accessed on 2007-01-01 at: http://www.circare.org/consents/06-M-0238_consent.pdf
06-M-0238 Protocol: An Investigation of the Efficacy of Mercury Chelation as a Treatment for Autism Spectrum Disorder. Rev. 2006-06-27. Accessed on 2007-01-01 at: http://www.circare.org/consents/06-M-0238_protocol.pdf
Mercury Chelation to Treat Autism. Clinicaltrials.gov. Accessed on 2007-07-12 at: http://www.clinicaltrials.gov/ct/show/NCT00376194
EDTAChelation Therapy)
Consent Form, Trial to Assess Chelation Therapy (TACT). Version 2. 2003-06-30. National Center for Complementary and Alternative Medicine. (Principal investigator Gervasio Lamas, M.D.) Accessed on 2006-09-30 at: http://www.circare.org/tact/tactconsentform_20030613.pdf
Lamas GA. Clinical Trial Protocol, Trial to Assess Chelation Therapy (TACT). Version 2, pp. 1-53. May 30, 2003. Available from http://www.circare.org/tact/tactprotocolv2_20030530.pdf
Lamas GA. Clinical Trial Protocol, Trial to Assess Chelation Therapy (TACT). Version 2, pp. 54-93. May 30, 2003. Available from http://www.circare.org/tact/tactprotocolv2b_20030530.pdf
Consent Form, Trial to Assess Chelation Therapy (TACT). 2003-01-13. National Center for Complementary and Alternative Medicine. Accessed on 2006-09-30 at: http://www.circare.org/tact/tactconsentform_20030113.pdf
Coronary Artery Risk Factor Reduction Registry. American College for Advancement in Medicine. (Principal investigator L. Terry Chappell, M.D.) Accessed on 2006-09-30 at: http://www.circare.org/tact/acamedtaregistry_consentform.pdf
Informed Consent, Disclosure and Acknowledgement Form for Chelation Therapy Study. American College for Advancement in Medicine. (Principal investigator Eleazar M. Kadile, M.D.) Accessed on 2006-09-30 at: http://www.circare.org/tact/acamirb_sampleprotocol.pdf
Nutraceutical Treatment of Mental Disorders in Adults: An RCT with Bipolar Disorder. 2001-11-07. Alberta Innovation and Science. (Principal investigator Bonnie J. Kaplan, Ph.D.) Accessed on 2006-09-30 at: http://www.circare.org/FOIA/uc_137_139.pdf (3)
Akoury M. Health Canada letter to I. Mitchell with attachment, Information Request to Bonnie J. Kaplan Ph.D., re: studies titled Nutraceutical Treatment of Mental Disorders in Adults: An RCT with Bipolar Disorder and Fibromyalgia Clinical Study. Accessed on 2006-09-30 at: http://www.circare.org/FOIA/hc_cta_20020104.pdf
Open Trials of a Nutraceutical Treatment for Mental Disorders in Adults. Alberta Children's Hospital Foundation, Alberta Science and Research Authority, and Evince International LLC. (Principal investigator Bonnie J. Kaplan, Ph.D.) Accessed on 2006-09-30 at: http://www.circare.org/FOIA/uc_133_134.pdf. (3)
McNeilly PJ. Office for Human Research Protections Determination letter to the University of Utah re: Kaplan BJ, Simpson JS, Ferre RC, Gorman CP, McMullen DM, Crawford SG. Effective mood stabilization with a chelated mineral supplement: An open-label trial in bipolar disorder. Journal of Clinical Psychiatry. 2001;62(12):936-944. 2002-08-19. Accessed on 2006-09-30 at: http://www.hhs.gov/ohrp/detrm_letrs/YR02/aug02e.pdf
Open Trials of Nutritional Supplements for the Treatment of Children with Anxiety/Mood Problems. (Principal investigator Bonnie J. Kaplan, Ph.D.) Accessed on 2006-09-30 at: http://www.circare.org/FOIA/uc_135_136.pdf (3)
A Randomized Controlled Trial of a Nutrient Supplement in the Treatment of Fibromyalgia. Alberta Heritage Medical Research Foundation. (Investigators Bonnie J. Kaplan, Ph.D. and Liam Martin, M.D.) Accessed on 2006-09-30 at: http://www.circare.org/FOIA/uc_131_132.pdf (3)
Follow this link to find more information about research with EmpowerPlus
Study Number 93-DK-31 A Six-Month Course of FIAU for Chronic Hepatitis B. National Institutes of Health Clinical Center. (Principal investigator Jay H. Hoofnagle, M.D.) Accessed on 2006-09-30 at: http://www.circare.org/consents/consent_93dk31fiau.pdf (1)
Study Number 91-DK-AI-213 A Four-Week Course of FIAU for Chronic Hepatitis B. National Institutes of Health Clinical Center. (Principal investigator Jay H. Hoofnagle, M.D.) Accessed on 2006-09-30 at: http://www.circare.org/consents/91-DK-AI-213_consentform.pdf (1)
Study Number R-90 The Tolerance of HIV-Infected Patients with Herpes Group or Hepatitis B Virus Infections to Oral Doses of FIAU. National Institutes of Health Clinical Center. (Principal investigator Stephen E. Straus, M.D.) Accessed on 2006-09-30 at: http://www.circare.org/consents/consent_r90fiau.pdf (1)
Protocol H3X-XC-PPPA Fialuridine (FIAU): Pharmacokinetic / pharmacodynamic dosing regimen study in patients with compensated chronic hepatitis B. New England Medical Center Hospital. (Principal Investigator Marshall M. Kaplan, M.D.) Accessed on 2007-01-24 at: http://www.circare.org/consents/H3X-XC-PPPA_consentform.pdf (1)
Protocol H3X-MC-PPPA Fialuridine (FIAU): Pharmacokinetic/Pharmacodynamic Dosing Regimen Study in Patients with Compensated Chronic Hepatitis B. University of Texas Medical Branch at Galveston and Eli Lilly and Company. (Principal Investigator David Pear, M.D.) Accessed on 2006-09-30 at: http://www.circare.org/consents/consent_h3xmcpppafiau.pdf (1)
Protocol H3X-LC-PPPG(a) Fialuridine (LY303256): Bioequivalence of Syrup and Tablet Formulations, and Influence of Timing of Meals on Pharmacokinetic Variables. Lilly Research Laboratories and Eli Lilly and Company. (Principal investigator David L. Hyslop, M.D.) Accessed on 2006-09-30 at: http://www.circare.org/consents/consent_h3xlcpppgafiau.pdf (1)
Bowsher RR, Compton JA, Kirkwood JA, Place GD, Jones CD, Mabry TE, Hyslop DL, Hatcher BL, DeSante KA. Sensitive and specific radioimmunoassay for fialuridine: initial assessment of pharmacokinetics after single oral doses to healthy volunteers. Antimicrob Agents Chemother. 1994;38(9):2134-2142. Accessed on 2006-09-30 at: http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=284697&blobtype=pdf
Consent Form, TG 13G01 A Phase 1/2 Study of Repeat Intra-Articular Administration of tgAAC94, a Recombinant Adeno-Associated Vector Containing the TNFR:Fe Fusion Gene, in Inflammatory Arthritis Subjects with and without Concurrent TNF-alpha Antagonists. Sponsor: Targeted Genetics Corporation. 2006-05-08: http://www.circare.org/consents/consentform_13G01_20060508.pdf
Consent Form, Induced Malaria as Therapy for HIV Infection. The Heimlich Institute Foundation Inc. (Principal investigator Henry J. Heimlich, M.D.) 1993-09-01. Accessed on 2006-09-30 at: http://www.circare.org/foia2/imtconsentform_19931029.pdf
Protocol, A Pilot Study of Induced Malaria Therapy in 30 Human Immunodeficiency Virus Positive Individuals. 1993-09-01. Available from http://www.circare.org/foia2/malarioth_protocol.pdf
Follow this link to find more information about Henry Heimlich's malariotherapy research
Stimulated Autologous Immune Serum and Autologous Tumor Vaccine in the Treatment of Refractory Solid Tumors. George Kindness, Amscot Medical Labs, and The Pathway Healing Center. (Principal investigator Roy Page, M.D.) 1999-02-25. Accessed on 2006-09-30 at: http://www.circare.org/foia2/cv_03_2238_icf.pdf
Informed Consent to Participate in Investigational Study of Enzyme Potentiated Desensitization. American EPD Society. (Principal investigator Welman A. Shrader, M.D.) Accessed on 2006-09-30 at: http://www.circare.org/foia2/epd_consentforms1998.pdf
Follow this link to find more information about the Great Lakes College of Clinical Medicine IRB
Mentor Study of the Safety and Effectiveness of the Mentor Round Low-Bleed Silicone Gel-filled Mammary Prosthesis in Women Undergoing Primary Breast Augementation, Reconstruction or Revision (Core Gel Study) Consent Form. Rev. 2000-11-02: http://www.circare.org/consents/mentorcoregel_consent_20001102.pdf
Consent Form: Open Label, Randomized, Multicenter, Phase I/III Study of Docetaxel in Combination with Cisplatin (CDDP) or Docetaxel in Combination with 5-fluorouracil (5-FU) and CDDP Compared to the Combination of CDDP and 5-FU in Patients with Metastasis or Locally Recurrent Gastric Cancer Previously Untreated with Chemotherapy for Advanced Disease: http://www.sskrplaw.com/gene/steubing/vaconsent.html (Courtesy of Alan Milstein, SSKR & P, Attorneys At Law.)
Ovimmune Informed Consent: use of egg yolk containing natural antibodies against candida albicans/tropicalis. Undated: http://www.circare.org/FOIA/ovimmune_consent.pdf
FDA Warning Letter to Marilyn A. Coleman and Ovimmune. 2001-07-19: http://www.circare.org/fdawls2/ovimmune_20010719.pdf
Consent Form Patient Information Sheet A Phase-I, Single-Centre, Double-Blind, Randomised, Placebo-Controlled, Single Escalating-Dose Study to Assess The Safety, Pharmacokinetics, Pharmacodynamics And Immunogenicity Of TGN1412 Administered Intravenously To Healthy Volunteers. Protocol Number: TGN1412. Parexel Project Number: 68419. Version: 02 Final. 2006-02-09. Tegenero AG. (Principal investigator Daniel Bradford MBBS.) Accessed on 2006-09-30 at: http://www.circare.org/foia5/tgn1412_consentform.pdf (2)
Follow this link to find more information about Tegenero AG, Parexel International Ltd., and the TGN1412 trial
Consent Form: Protocol No. 072-01 A Phase III Study of the Effect of MK-0966 in the Treatment of Post Orthopedic Surgical Pain. 1997-11-10: http://www.circare.org/consents/dida_oxx08u10.pdf (7)
Patient Information and Consent Form: A Double-Blind, Randomized, Stratified, Parallel-Group Study to Assess the Incidence of PUBs During Chronic Treatment with MK-0966 or Naproxen in Patients with Rheumatoid Arthritis; U.S. Cohort. 1999-03-03: http://www.circare.org/consents/dida_oxx03z10.pdf
Consent Form: 051 A Randomized, Placebo and Active Comparator-Controlled Dose-Ranging Trial of the Effect of a 12.5% Formulation of MK-0966 in the Treatment of Postoperative Dental Pain. 1997-01-27: http://www.circare.org/consents/dida_oxx07t10.pdf
Atritech, Inc. Watchman Left Atrial Appendage Filter System Pilot Study Investigation Version IV (2003-09-29) Consent Form: http://www.circare.org/consents/watchman_consent_20030929.pdf
University of Pennsylvania Health System Bavarian Nordic POX-MVA-011 Amendment No. 5 10-Sept-2007 A Multicenter, Open-Label, Controlled Phase II Study to Evaluate Safety and Immunogenicity of MVA-BN® (IMVAMUNE®) Smallpox Vaccine in 18-55 Year Old Naive and Previously Vaccinated HIV Infected Subjects with CD4 Counts ≥ 200-750/µL (2008-01-24): http://www.circare.org/consents/pox_mva_011_consentform.pdf
Johns Hopkins Medical Institutions Kennedy Krieger Institute Lead Paint-Abatement and Repair & Maintenance Study 1993-05-20: http://www.circare.org/consents/jhu_consentform_19930520.pdf
Lorcaserin Consent form: A 104-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Obese Patients. Rev. 206-11-15: http://www.circare.org/consents/bloom_consent111506.pdf (8)
BLOOM DM Consent: Behavioral modifications and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus — A 52-Week, Double-Blind, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients with Type 2 Diabetes Mellitus Managed with Oral Hypoglycemic Agent(s). Rev. 2007-12-11: http://www.circare.org/consents/bloomdm_consent121107.pdf (9)
Informed Consent for Participation in Genetic Research Involving Coded Tissue and/or Data, The Genetics of Prostate Cancer. William Catalona Civil No. 03CV01065 USDC MO Doc.# 18-2 2003-10-21: http://www.circare.org/consents/03cv01065_18-2_consentform.pdf
Informed Consent: Boehringer Ingelheim Pharmaceuticals, Inc., A randomised, active-controlled, double-blind, double-dummy, parallel group design, multi-center trial to compare the efficacy and safety of 2.5 μg and 5 μg Tiotropium Inhalation Solution delivered by the Respimat® Inhaler with Tiotropium inhalation capsules 18 μg delivered by the HandiHaler®.
BIPI Protocol No. 205.452 Rev. 2010-10-11: http://www.circare.org/consents/consentform_bipiprotocol205-452_20101011.pdf
Notes
1. Appendix D Informed Consent Documents. In: Manning FJ, Swartz M, editors. Committee to Review the Fialuridine (FIAU/FIAC) Clinical Trials. 1995. Institute of Medicine, National Academies of Science. Accessed on 2009-12-04 at: http://www.nap.edu/catalog.php?record_id=4887
2. Consent form accessed on 2006-04-18 at: http://myweb.dal.ca/mgoodyea/TGNConsent.doc. Minor revisions by CIRCARE include correction of typos and reformatting.
3. Munn Gafuik J-A. University of Calgary Response to Access Request 01-010. 2001-11-07. Accessed on 2006-09-30 at: http://www.circare.org/FOIA/ucati_01-010.pdf
4. Brian Deer. Briandeer.com web site. Accessed on 2007-02-07 at: http://briandeer.com/wakefield/protocol-1996.htm
5. Janice M. Huckeba et al. Civil No. 01CV00032. USDC Southern GA, Augusta Division.
6. Serial Number 109-119 Human Tissue Samples: NIH Research Policies and Practices. Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce. 109th Congress Second Session. 2006-06-13 and 14, pp. 186-195. Accessed on 2007-03-31 at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_house_hearings&docid=f:30412.pdf
7. Consent forms for MK-0966 Vioxx: Drug Industry Document Archive. University of California, San Francisco. Accessed on 2009-03-18 at: http://dida.library.ucsf.edu/queryform.jsp
8. Accessed on 2011-06-20 at: http://www.weightcenter.org/images/BLOOMConsent111506.pdf
9. Accessed on 2011-06-20 at: http://liveweb.archive.org/http://www.weightcenter.org/images/BLOOMDMConsent121107.pdf
Last Updated: 2012-02-29
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