Disease relevance of Informed Consent

• Eosinophilia-myalgia syndrome, L-tryptophan, and informed consent [1].
• RESULTS: Fifty patients with Centers for Disease Control HIV infection stages A (10 patients), B (20 patients), and C (20 patients) were included in the study after each gave informed consent [2].
• After informed consent was obtained all patients completed the NIH prostate cancer awareness survey and had a serum sample obtained for PSA before examination [3].
• METHODS: Twenty-one patients within 30% of ideal body weight, who provided institutional review board-approved informed consent and were randomized to receive disulfiram (500 mg oral, n = 11) or nothing (control, n = 10) the night before surgery, were evaluated [4].
• STUDY DESIGN: After obtaining informed consent, we initiated hydroxyurea therapy at a dosage of 10 to 20 mg/kg per day in 15 patients with severe SCD (hemoglobin SS, hemoglobin SS-alpha thalassemia, or hemoglobin S-beta0-thalassemia) [5].

Psychiatry related information on Informed Consent

• Veterans with chronic PTSD (N = 18) were enrolled in an 8-week open trial of citalopram after providing written informed consent [6].
• Thirty obsessive-compulsive patients without comorbid axis I diagnoses except for tic disorder as assessed by DSM-III-R criteria gave informed consent and were recruited consecutively; they underwent a 10-week randomized treatment with fluvoxamine, paroxetine, or citalopram [7].
• Twelve patients who met Research Diagnostic Criteria for a history of bipolar affective disorder gave informed consent for open discontinuation of lithium therapy for 3 weeks [8].
• Federal regulatory, state statutory, and tort-based problems in research involving informed consent with Alzheimer disease and dementia patients [9].

High impact information on Informed Consent

• Informed consent and BRCA1 testing [10].
• BMJ did not describe informed consent in 25 articles (42%) before 1997 vs 15 (25%) after 1997 (P =.05), and JAMA did not describe ethics committee approval in 25 (42%) before 1997 vs 13 (22%) after 1997 (P =.02) [11].
• PARTICIPANTS: The Task Force on Informed Consent is part of the Cancer Genetics Studies Consortium (CGSC), whose members were recipients of National Institutes of Health grants to assess the implications of cancer susceptibility testing [12].
• After the patient gave informed consent, a 2-mL intravenous injection of sterile saline solution or prochlorperazine edisylate (10 mg) was given to each patient at the time of randomization [13].
• Two patients gave their informed consent to receiving infusion of 1-desamino-8-D-arginine vasopressin (DDAVP), a vasopressin analogue known to raise the vWF levels in plasma by two- to fourfold [14].

Chemical compound and disease context of Informed Consent

• DESIGN/METHODS: After obtaining written informed consent, 61 patients presenting to a clinic with acute migraine were infused with 300 mg of intravenous valproate sodium [15].
• Monitoring a clinical trial conducted under the Food and Drug Administration regulations allowing a waiver of prospective informed consent: the diaspirin cross-linked hemoglobin traumatic hemorrhagic shock efficacy trial [16].
• In a multicentre, randomized, open study, 306 patients of either sex, over 18 years of age with stable chronic plaque psoriasis > 100 cm2 in surface area, and who gave informed consent, applied Dovonex (calcipotriol) ointment (50 micrograms/g) twice daily or Dithrocream (short-contact dithranol) 0.1-2% for up to 3 months [17].
• Fourty-four patients with advanced chronic renal failure (mean creatinine clearance 8.9 +/- 9.6 ml/min, range 1.1-63.7 ml/min) were enrolled after they had given their informed consent [18].
• METHODS: After obtaining informed consent, emergency department patients who presented with a chief complaint of chest pain and cocaine use within 24 hours of arrival were prospectively enrolled [19].

Biological context of Informed Consent

• Deoxyribonucleic acid (DNA) was obtained after informed consent; amplification of MYH7 exons 13 (R403Q), 14 (R453C) and 19 (G716R and R719W), and TNNT2 exon 9 (R92W) was performed by polymerase chain reaction [20].
• SUBJECTS AND METHODS: We investigated the CYP11B2 C-344T genotype in 802 subjects, aged 40 and over, in a Japanese community, who gave written informed consent and were monitored for 24 h ambulatory BP [21].
• Percutaneous absorption of hydrocortisone was measured in six healthy adult men from whom informed consent had been obtained [22].
• The Society for Academic Emergency Medicine believes that protection of human subjects is vital in emergency medicine research and that, whenever feasible, informed consent is at the heart of that protection [23].
• A survey of benzodiazepine use among general practice patients was conducted without written informed consent [24].

Anatomical context of Informed Consent

• The immunohistochemical distribution of AQP5 was compared in minor salivary gland biopsies obtained from women after informed consent: primary SS (53.2 +/- 14 years old, n = 10), healthy volunteers (46.2 +/- 17 years old, n = 10), patients with sarcoidosis (37 and 48 years old), and patients with non-specific sialoadenitis (54 and 61 years old) [25].
• METHODS: After taking their informed consent, we determined TFPI concentrations in the plasma of healthy subjects (group I) (n = 15) (average age, 45.1 = 11.8 yr), cirrhotics (group II) (n = 16) (average age, 43.6 +/- 9.8 yr), and cirrhotics with portal vein thrombosis (group III) (n = 12) (average age, 42.6 +/- 10.7 yr) [26].
• After institutional approval and written informed consent, patients scheduled to undergo coronary artery bypass grafting or valvular surgery were randomly allocated to receive amiodarone (3.4 g over 5 days or 2.2 g over 24 hours) or placebo before surgery [27].
• Eligibility criteria included measurable disease, performance status 0-2, adequate bone marrow function, creatinine <1.5 mg%, bilirubin <1.5x institutional normal, SGOT/alkaline phosphatase <3x institutional normal, and signed informed consent [28].
• METHODS: After informed consent and ethics committee approval, 64 patients were randomly allocated to four groups for intercostal nerve block (ropivacaine 2, 5, 7.5 or 10 mg ml-1 at the end of surgery) [29].

Associations of Informed Consent with chemical compounds

• PATIENTS AND METHODS: The criteria for the observation program were as follows: disease stage I or II; tumor less than 5 cm in diameter; no invasion to the intraspinal canal or growth to the great vessels; urinary vanillylmandelic acid (VMA) and homovanillic acid (HVA) less than 50 microg/mg creatinine; and informed consent [30].
• The criteria for observation included urinary vanillylmandelic acid (VMA) and homovanillic acid (HVA) levels less than 50 microg/mg creatinine, smaller tumor size (< 5.0 cm), preoperative status, and granted informed consent [31].
• All participants gave informed consent to participate in a double-blind, placebo-controlled study on the effects of DHEA on fatigue and general well-being [32].
• After conventional intravenous antibiotics were administered for 3 days, informed consent was obtained and patients were randomly assigned to either continue parenteral antibiotics (n = 53) or switch to oral ciprofloxacin 750 mg taken twice daily (n = 52) [33].
• METHODS: After providing written informed consent, 373 patients with primary or secondary SS and clinically significant dry mouth and dry eyes were randomized to receive 2.5-mg pilocarpine, 5-mg pilocarpine, or placebo tablets 4 times daily for 12 weeks [34].

Gene context of Informed Consent

• Informed consent documents for BRCA1 and BRCA2 screening: how large is the readability gap [35]?
• Informed consent for BRCA1 and BRCA2 testing: what clinicians should know about the process and content [36].
• METHODS: Subjects (30 to 89 years of age; 1693 women, 1554 men) who gave informed consent were randomly selected from a general population in Suita, Japan. MTHFR genotypes were determined by TaqMan polymerase chain reaction [37].
• METHODS: After informed consent had been obtained, the three exons of the VHL gene were PCR-amplified and sequenced either directly or after subcloning [38].
• METHODS: Patients were interviewed by telephone, and blood tests, including a genetic analysis of MRP2, were performed on the patients and family members who gave informed consent [39].

Analytical, diagnostic and therapeutic context of Informed Consent

• Patients were randomized to receive either a scripted informational intervention simulating an informed consent presentation (intervention group, n = 103) or a single sentence about the PSA (control group, n = 102) [40].
• MATERIALS AND METHODS: Study received approval and waiver of informed consent by institutional review board and was conducted in 16 male and 16 female patients with AVMs who underwent repeat sclerotherapy (142 sessions total) with absolute ethanol from July 1997 to December 2003 [41].
• MATERIALS AND METHODS: After parental informed consent was obtained, 80 children requiring Cohen cross-trigonal reimplantation were considered for inclusion in a double-blind study [42].
• METHODS: Informed consent was obtained from 53 asymptomatic patients with confirmed asymptomatic primary hyperparathyroidism who participated in this randomized trial of parathyroidectomy versus observation [43].
• Reply to invited letter concerning: Informed consent for blood transfusion (J Thorac Cardiovasc Surg 1991;101:563-4) [44].

References