When performing studies at TOXCON that involve the participation of human subjects, all relevant international guidelines, recommendations and requirements are taken into account as comprehensively as possible, for the protection of the subjects, TOXCON and the Client.

The following page lists the applicable Guidelines and Requirements

Medical Ethics Committee

All study Protocols and Written Informed Consent Forms would be reviewed and approved by an independent Institutional Review Board (IRB) prior to subject eligibility screening. The composition of this IRB will be in accordance with the recommendations of the World Health Organization and those of the Food and Drug Administration concerning Institutional Review Boards, as published in the Federal Register, 21 CFR, Part 56.

TOXCON’S investigators will keep the IRB informed about the progress of the study as needed. All changes in research activities and all unanticipated problems involving risks to human subjects will be immediately reported to the IRB, except when required to eliminate apparent immediate hazards to human subjects.

TOXCON routinely uses an independent Ethics Review Board in Ontario, Canada. This board has extensive experience with pharmaceutical clinical trials and has been working closely with TOXCON on its consumer products clinical trials.

Non-Occupational Human Exposure Studies

For studies requiring human subjects to be exposed to simulated residential exposure conditions, TOXCON has a database of almost 1000 adult individuals who have participated in various exposure studies. These individuals range from non-asthmatics to moderate asthmatics, and non-allergics to allergics. The cohort is drawn at random from the general population in the greater Edmonton, Alberta, Canada area (pop. > 800,000). Thus, the client has the choice of the type of subject on which to collect exposure data.

The following link gives details of  Recent Studies

Should the client have special subject recruitment needs, TOXCON has a comprehensive subject recruitment system in place.

Occupational Human Exposure Studies

For studies requiring occupational worker exposure data, under simulated exposure conditions, TOXCON can recruit specific occupations for either on-site or off-site studies.

Biological Monitoring

TOXCON is equipped to undertake short-term “cold” biological monitoring studies that do not require the administration of radioisotope – labeled compound. In this case, TOXCON can collect blood and urine samples of volunteer subjects during or after exposure to determine the metabolic fate of a given chemical of interest.

Oral Dosing

If the metabolic pathway of a chemical is not known and needs to be determined through the oral administration of radio labeled compound, TOXCON would sub-contract these services to a laboratory equipped to do so.