TABLE 1—

Design, Statistical Methods, and Ethical Standards

Pesticide, Class, Location of Study	Design	Doses Administered (all orally), Number Dosed, Gender	Sample Interval	Analytical Method	Ethical Standard Claimed	Written Informed Consent Available
Aldicarb, carbamate, Inveresk Clinical Research, Edinburgh, Scotland	Double-blind, placebo- controlled, single dose	Placebo, 16M, 6F 0.01 mg/kg, 8M 0.025 mg/kg, 8M, 4F 0.05 mg/kg, 8M, 4F 0.075 mg/kg, 4M	(Hours) −16, −3, 0 predose	Mean of 3 predose vs postdose	Declaration of Helsinki, 1989	Yes
			1, 2, 4, 6, 8, 21 postdose	ANOVA (treatment, time, treatment-time interaction)
Dichlorvos, organophosphate, Medval Ltd, University of Manchester, UK	Open label, single dose	70 mg, 6M	(Days) 0, 1, 5 or 6, 7, 14	Within group: pre vs each time, paired t test within subject: permutation	Declaration of Helsinki, 1989	No, but protocol states “volunteers completed a consent form.”8
Dichlorvos organophosphate, Medval Ltd, University of Manchester, UK	Single-blind, placebo- controlled, randomized	Placebo, 3M OR 7 mg daily for 21 days, 6M	(Days) 0, 1, 2, 4, 7, 9, 11, 14, 16, 18, 25, 28, 29, or 30	Group means at each time by repeated measures ANOVA; pre vs post at each time by paired t test; within-subject, permutation	Declaration of Helsinki, 1989	No, but protocol states “volunteers completed a consent form.”7
Dichlorvos, organophosphate, Medval Ltd, University of Manchester, UK	2-phase, open label, placebo- controlled		(Days) pre-dose 3 measures in 7 days prior to dose 1	Between-group, pre vs post dose group means by paired t test within-subject, permutation test	Declaration of Helsinki, 1989	No, but protocol states “volunteers completed a consent form.”6
		Phase 1: day 1, 35 mg 4M day 8, placebo, 4M, day 14, 35 mg, 6M	Phase 1: 1, 3, 5, 7 or 8 days after dose or placebo
		Phase 2: 2 week hiatus followed by 21 mg daily up to 15 days, 6M	Phase 2: 3, 5, 8, 10, 12, 15, 17, 19,22, 24, 26, 29, 33, 40, 47, 54 days after initial dose
Azinphos methyl organophosphate, Inveresk Research, Tranent, Scotland	Randomized, double-blind, placebo- controlled, repeat dose	Placebo, 4 M 0.25 mg/kg daily for 28 days, 8M	Pre-dose, 8 determinations over 2 weeks; before dose on each day and 4 hours post dose on days 1, 2, 3, 4, 5, 7, 10, 14, 17, 21, 28	Repeated measures ANOVA (treatment, time, treatment time interaction) pesticide vs placebo, pairwise at each time (error variance from ANOVA)	Declaration of Helsinki, 1996	Yes
	Declaration of Helsinki, 1996
Chlorpyrifos organophosphate, MDS Harris, Lincoln, Nebraska	2-phase, single dose randomized, double-blind, placebo- controlled	Phase 1: placebo, 6M, 6F 0.5 mg/kg, 6M, 6F 1.0 mg/kg, 6M, 6F	(Hours) Phase 1 and 2: −10, 0, pretreatment and 2, 4, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 posttreatment	Truncated at 96 h for phase 1 and 48 h for phase 2 and analyzed separately by univariate repeated measures ANOVA and fixed effects modeling	Declaration of Helsinki, 1996, 21 CFR parts 50, 56, 321 [sic]	Yes
		Phase 2: placebo, 6M, 6F 2.0 mg/kg, 6M, 6F

Note. ANOVA = analysis of variance; M = males; F = females.

In phase 2 of the 2-phase dichlorvos study, boldface numbers in sample interval column denote days on which subjects were dosed.