Introduction
Genetically modified organisms also termed as GMOs have their genes altered by genetic engineering techniques. Over the past 10 years, many organisms have been genetically modified/altered for numerous purposes. Some of the micro-organisms that have been altered are yeast, bacteria, plants, fish, insects and mammals. GMOs form the base of genetically modified food and crops. GMOs have been utilized in scientific research for the betterment of human life. GMOs are known for their potential benefit to mankind in the fields of biotechnology, agriculture, healthcare and scientific research. (Phillips T. 2008)
GMOs are organisms whose genes are modified or altered. Modification of a gene may involve insertion, mutation or deletion of genes. Insertion of genes can be performed using sophisticated genetic engineered techniques. However, insertion of genes involves the transfer of genes from a different species by horizontal gene transfer. Genetic engineering has made gene insertion possible by introducing or attaching the gene of interest to a virus, inserting the gene into the nucleus by means of a syringe, the application of electroporation or by the use of a gene gun to fire small particles. Genetic modification involves crops, plants and animals. There are numerous advantages of genetically modifying crops and plants. Some plants have possess gene inserts, mutations or deletions in order to be pest-resistant or draught resistant. Some of the GM crops are nutrient rich. Common examples are the golden rice (Vitamin A enriched) and vitamin-enriched corn. The use of GM animals helps in the research of human diseases, enhancement in the production and food quality traits, and improvement in animal health. Some of the GM animals have been employed for human therapeutic purposes. GMOs are known to have positive impacts on humans. The need of GMOs s essential for the ever growing population. However, various studies need to be conducted that would provide evidence on the safety and efficacy of GMOs. (Phillips T. 2008)
The purpose of conducting a scientific study on GMOs is to evaluate the safety and efficacy of GMOs. Most clinical trials evaluate the toxicity of GMOs. Non-clinical trials use animal models to evaluate carcinogenicity and toxicity of the desired genetic modification. Most clinical trials include a randomized, placebo and double blinded design. The placebo may involve a non-therapeutic agent to evaluate the psychological impact on patients or animals. Randomization and double-blinded designs prevent bias in recruiting and treatment interventions. Clinical trials for GMOs are also used to evaluate the therapeutic benefits of GMOs on mammals and humans.
A classic example of clinical evaluation of GMO’s is the evaluation of GM plant diets in animal health. The study involved GM plants like potato, maize, soybean and rice. The study covered 12 multigenerational and long-term clinical trials. Most of the studies involved randomization along with placebo or control group. The placebo group consisted of Non-GMO food crops for animals. The interventional or experimental group consisted of GM food crops. However, the researchers carried out a review of 12 clinical studies and compiled the information from these studies. (Snell C et al; 2012 )
Animal Subjects/Participants
The study involved only animals. The review compiled or gathered information from 12 clinical trials that evaluated the effect of GM food crops on animal health. Most of the studies involved a large number of animals. Clinical trials that involve large number of subjects often have less bias or false positive results. Most studies carried out ranges from 90 days to 2 years. However, the duration of the study did not impact the results of the trials. Clinical trials that were conducted for more than 12 months were advantageous over short-term clinical trials. (Snell C et al; 2012)
Variables in the study: Most of the clinical trials reviewed by the researchers contained many variables. All variables (dependent and independent) were examined before, during and after the clinical trials. Some of the variables involved diseases animals, weight and sex, age, and species. Some of the studies included pregnant animals to evaluate the effect of GM diet on the fetus and the mother. Disease animals were avoided in most cases. Inclusion criteria of most studies involved healthy animals and preferably males. Different animals were included in the clinical trials. Cows, buffalos, bullocks, horse, sheep, pigs, and donkeys were included in the clinical trials. Independent variables like climate, ambience and emotions of the animals were taken into consideration. All clinical trials that evaluated the effect of GM food on animals were carried out in accordance to the local and national animal welfare agencies. The researchers carried out clinical tests to evaluate toxicity in the animals. The researchers performed hematological tests to detect the presence of external DNA that might have entered the animal. All methods were employed to avoid bias from confounding variables. However, long-term studies that accounted both, independent and dependent variables and clinical tests were found to be precise and efficient. (Snell C et al; 2012)
Blinded study: Double-blinded clinical trials were conducted in four out of the twelve studies. Double-blinded studies are mainly carried out when human participants are involved. In double-blinded studies, both the researcher and the participant/subject are not given information on the intervention. In the case of GM crop and animal trials, the researcher and the animals were not given information about the diet being received. However, double-blinded studies are not necessary for animal studies since animals have no idea about the diet. Single-blind studies are utilized to avoid bias by the researcher. (Snell C et al; 2012)
References
Phillips, T. (2008). Genetically modified organisms (GMOs): Transgenic crops and recombinant DNA technology. Nature Education 1(1):213
Snell C, Bernheim A, Bergé JB, Kuntz M, Pascal G, Paris A, & Ricroch AE. (2012) Assessment of the health impact of GM plant diets in long-term and multigenerational animal feeding trials: a literature review. Food Chem Toxicol. 2012 Mar; 50(3-4):1134-48. doi: 10.1016/j.fct.2011.11.048. Epub 2011 Dec 3.
