Sei sulla pagina 1di 19

Running head: EFFECTS OF GMOS ON THE HUMAN FETUS

Health effects on the Human Fetus from Maternal Consumption of GMOs:


Research Proposal
Jordan A. Sirtoli, RN
NUR 560
SUNY Institute of Technology
4/25/14

EFFECTS OF GMOS ON THE HUMAN FETUS

Abstract
Currently, no clinical trials have been completed on humans regarding health effects of
genetically modified organisms (GMOs). Animal research demonstrates conflicting results
regarding fetal health effects from maternal consumption of GMOs. However, considering that a
number of studies have demonstrated deleterious effects on fetal development at all should
present concern. On account of this, a research proposal is provided below in an effort to
determine if maternal consumption of GMOs can lead to deleterious fetal development in
humans. The research, consisting of a comparative descriptive design, will be a longitudinal
study that involves annual questionnaire methods to Registered Nurses throughout the country.
After assembling the data and accounting for all variables, a multivariate statistical analysis will
be performed comparing maternal GMO consumption to fetal health outcomes.

EFFECTS OF GMOS ON THE HUMAN FETUS

Background and Significance


It is well recognized that the prenatal period is an extremely vulnerable time for fetal
development. Toxins and infections that can cause harm to the mother can cause equal or more
harm to the fetus. Furthermore, many environmental exposures that may not seemingly be
harmful to the mother could cause serious harm to the fetus. It is well known that the dangers of
smoking cigarettes during pregnancy, for example, have both seriously damaging effects to both
the mother and the fetus. Because of fetal vulnerability, it is vital that any environmental toxins
that can lead to deleterious effects in fetal development are identified and well recognized.
Recent advancements in biotechnology have drastically altered much of the food now
present in the human diet. Genetically modified organisms (GMOs) are one of these recent
advancements in biotechnology. Encyclopaedia Britannica defines a GMO as an organism
whose genome has been engineered in the laboratory in order to favour the expression of desired
physiological traits or the production of desired biological products. (Fridovich-Keil, 2013,
para. 1). For example, genetic modifications to crops have many uses such as increasing crop
yields per area, modifying plants to produce natural insecticides (such as the Bt toxin), or
expressing proteins for herbicide tolerance (Fridovich-Keil, 2013, Carman et al., 2013). In
addition to the term GMO, it will also be necessary to define organic food for the sake of
later discussion. Many people interpret organic as the opposite of genetically modified; in
other words, non-GMO. However, there is more to the term organic than just non-GMO.
According to the National Organic Program (NOP), which is overseen by the Federal Drug
Aministration (FDA), the term organic is defined as a labeling term that indicates that the
food or other agricultural product has been produced through approved methods that integrate
cultural, biological, and mechanical practices that foster cycling of resources, promote ecological
balance, and conserve biodiversity. Synthetic fertilizers, sewage sludge, irradiation, and genetic

EFFECTS OF GMOS ON THE HUMAN FETUS

engineering may not be used. (Agricultural marketing services, 2014, para. 1). The public can
identify an organic product by its unique USDA organic label.
Because biotechnology and genetically modified foods are fairly new to the human diet,
and its chronic effects on human health are not well known despite FDA approval, further
research needs to be completed to ensure these new technologies do not pose any harm to fetal
development. Although there have been a number of animal studies completed regarding GMOs
and reproduction, Smith (2009) points out that there have been absolutely no clinical trials
completed on humans, nor have any been identified by this author as of this date.
Despite the few animal studies published regarding the safety of GMO consumption, its
profound use is extremely common worldwide. After FDA approval for human consumption of
GMOs in 1995, 50 percent of soy beans, cotton, and corn in America were genetically modified
in 2010 (Fridovich-Keil, 2013). In fact, by the end of 2010, 1/10 of the worlds farmland was
covered by genetically modified (GM) crops (Fridovich-Keil, 2013).
Controversy continues to parallel the conflicting results of animal studies on the general
health effects from GMO consumption, including those regarding reproductive health and fetal
development. Besides for variables such as poor research design, there are countless different
types of gene/protein modifications used in the agricultural industry which may account for the
different effects found among various studies. Biotechnological advances have allowed scientists
to insert different kinds of proteins or traits into different kinds of crops based on their desired
effect. Different proteins as a result of different genetic modifications may result in different
health effects, and therefore pin-pointing the specific cause may be an onerous task. In a review
of the literature, Zhang & Shi (2011) identify a large number of animal studies assessing the
general reproductive health effects from GMO consumption in animals. Each study identified
within this article focused on various crops (as well as various animal species), many of which
had different protein insertions or traits. Therefore, it is not surprising that the results of these

EFFECTS OF GMOS ON THE HUMAN FETUS

studies varied. Due to the large variety of foods consumed by humans, it could be assumed that
humans are exposed to a wide range of GMO types.
Statement of Problem and Research Purpose
Between the lack of research in humans, some of the disconcerting effects from GMOs
found in certain animal studies, and proof of GMO-associated pesticides found in human
placental transfer (Aris & Lablanc, 2011), the importance of further research on the health effects
of GMOs on the human fetus remains indisputable. The purpose of the proposed research will be
to identify if there are any deleterious health effects on the human fetus from maternal
consumption of genetically modified organisms (GMOs). If results suggest negative outcomes
from GMO consumption, the public can be informed and better health choices can be suggested
for pregnant women. Another concern for the public is the high cost for certain non-GMO or
organic foods. If no negative outcomes from GMO consumption are realized, then this
research can make contributions on more cost-efficient food choices and peace of mind for
concerned mothers. However, this research cannot be a stand-alone, culminating denouement in
the exploration of GMOs and health; and therefore, more supporting research will be necessary.
Review of Relevant Literature
Research articles from the literature review were obtained by searching the CINAHL and
Medline databases. Key terms that were used included: genetically modified food, fetal
development, pregnancy, fetus, and health. Major restrictions within the search were limited to
research articles, dates published between years 2008 and 2014, and the English language. An
initial search query was attempted using a 5 year limit. However, this search yielded minimal
results on the relevant topics. Therefore, an additional year was conceded within the search. The
search was not limited to humans due to the fact little to no research has been completed on this
subject. Furthermore, background research on animals is highly applicable to humans, and also
suggestive for further research on humans. The search was then refined by the specific focus of

EFFECTS OF GMOS ON THE HUMAN FETUS

the study and relevance of the population. Inclusions were originally made using the titles and
abstracts of the articles. Selected articles were then evaluated based upon background,
organization, objectives, and research methods. Opinionated articles, biased articles, and nonscholarly articles were excluded from the review. Using the above inclusion/exclusion process,
only 6 pertinent articles were obtained for review. The review is categorized by types of inserted
genes used amongst the studies; research demonstrating negative fetal health effects from GMO
consumption; research demonstrating no fetal health effects from GMO consumption; and
studies specifically concerning humans.
Inserted Genes of Concern
As mentioned above, there is a high multitude of different genes inserted into crops in
order to obtain certain desired traits. In a theoretical sense, some could cause toxic effects, and
others may not. Therefore, the genetic modifications used in the studies are worth mentioning.
However, according to Carman et al. (2013), a significant number of genetically modified (GM)
crops have been approved to enter human food and animal feed since 1996, including crops
containing several GM genes 'stacked' into the one plant. (p. 38). Consequently, if there is a
concern with a particular genetic modification, its consumption is almost inevitable due to the
broad exposure of stacked foods consumed by humans.
_______The study by Aris & Leblanc (2011) specifically investigates pesticides associated to
genetically modified foods (PAGMF), including GLYP and its metabolite aminomethyl
phosphoric acid (AMPA), GLUF and its metabolite 3-methylphosphinicopropionic acid (3MPPA) and the Cry1Ab protein (a Bt toxin), and explores whether or not PAGMF can cross the
human placental barrier into fetal blood after maternal consumption of the GMO. In a study
investigating the immunocytochemical and ultrastructural aspects of pre-implantation embryos
from Swiss mice fed a GMO diet versus mice fed a non-GMO diet, the authors did not indicate
which gene insertions were used (Cisterna et al., 2008). In a study investigating the reproductive

EFFECTS OF GMOS ON THE HUMAN FETUS

and fetal effects on pigs from consumption of GMO maize, researchers were specifically
concerned with the common GM trait, Bt MON810, which is used as a natural pesticide
(Buzoianu et al., 2012). Sanden et. al (2013) studied the effects on offspring of zebrafish using
the same GMO with Bt- maize. The genetically modified trait Cry1Ab and CP4-EPSPS
(5-enolpyruvlshimimate-3-phosphate synthase), also commonly found in the herbicide
Roundup, was investigated by Austrian researchers on its health effects on the offspring of
mice (Velimirov et al., 2008). In another study researching the effects of GM-maize on pigs, the
authors state, The corn used in this study contained 90% DK 42-88 RR YG PL (a triple stack of
NK603, MON863 and MON810 genes) with the remainder being equal quantities of Pannar 5E900RR (containing NK603), Pannar 4E-705RR/Bt (a double stack of NK603 and MON810) and
Producers 5152 RR (containing NK603) (Carman et al., 2013, p. 40). With the large variety of
inserted GM traits in this corn, it is without surprise that the results of the study showed negative
effects on both the gastro-intestinal and reproductive systems among the GM-fed group.
Research Demonstrating Negative Fetal Health Effects from GMO Consumption
Three of the six research articles demonstrated certain deleterious health effects on fetal
development. Throughout a series of experiments incorporated in a multigenerational study on
mice, GM diets consisting of Cry1Ab and CP4-EPSPS in maize were compared to non-GMO
maize diets (Velimirov et al., 2008). The mice fed the GM diet not only had fewer offspring, but
the offspring that were born were considerably smaller than the non-GMO group (Velimirov et
al., 2008). The differences found between the two groups were also statistically significant with
(p=0.011) and (p=0.010) for the 3rd and 4th litters, respectively. Overall, between all deliveries,
the GM0-fed group only delivered 844 pups, compared to 1035 pups from the non-GM group.
Furthermore, in an analysis of metabolic pathways, their research demonstrated that the GM
group differed in concern of cholesterol biosynthesis, interleukin signaling, and protein
metabolism (Velimirov et al., 2008).

______

EFFECTS OF GMOS ON THE HUMAN FETUS

In a separate study by Cisterna et al., (2008), immunocytochemical observations of


embryonic development in mice on a GM diet versus a non-GMO diet revealed that the GM-fed
group had a decrease in pre-mRNA transcription and splicing in two-cell embryos. Furthermore,
in comparison to controls, they found that pre-mRNA maturation was not as efficient in two-,
four-, and eight-cell embryos in the GM fed group (Cisterna et al., 2008). However, the general
morphological embryonic features were similar in both groups (Cisterna et al., 2008).
______Carman et al. (2013) performed a long-term toxicology study on pigs, comparing pigs fed
a GM diet vs. a non-GM diet. As mentioned above, the GM diet consisted of several GM genes
combined in a mixture of GM soy and GM corn. The non-GM diet consisted of a mixture of nonGM soy and corn. Although there were no differences identified in weight gain, feed intake,
mortality, and blood biochemistry between the two groups, the GM-fed pigs had uteri that were
25% heavier than the non-GM group (p=0.025) (Carman et al., 2013). Although not applicable to
this study, the GM-fed pigs also experienced severe stomach inflammation at a rate of 32%
versus 12% on the non-GM group with p=0.004 (Carman et al., 2013). No data regarding fetal
development was provided. However, uterine changes and GI complications could indicate
potential difficulties with pregnancy.
Research Demonstrating No Negative Fetal Health Effects from GMO Consumption
Two of the six research articles that were located demonstrated no negative health effects
on the fetus from a maternal GM-fed diet. Buzoianu et al. (2012) completed research aimed to
determine the effect of feeding transgenic maize to sows during gestation and lactation on
maternal and offspring immunity and to assess the fate of transgenic material. (p. 873). Over
143 days during gestation and lactation, sows were separated into two groups, either a BtMON810 maize diet, or a non-GM diet (Buzoianu et al., 2012). Laboratory values were assessed
throughout gestation, such as leukocyte phenotyping, hematology and Cry1Ab-specific antibody

EFFECTS OF GMOS ON THE HUMAN FETUS

presence, and other immunologic tests. Hematologic values were also obtained from offspring at
birth and compared. The research showed that sows fed Bt maize had no significant difference in
the control groups, nor signs of inflammation or allergy. Furthermore, no antibodies to the
Cry1Ab protein from oral exposure to Bt MON810 maize were identified, indicating an unlikely
risk to pig health. In the study by Carman et al. (2013) which noted deleterious effects on GI and
uterine health of pigs, the same Bt toxin was also utilized with the GM-fed group. However,
several other gene modifications were also used in that specific GM diet. Also, these two studies
were investigating different health indicators. Therefore, these two studies cannot be compared.
Sanden et al. (2013) performed a study partly concerned with growth and reproductive
performance of zebrafish being fed a genetically modified diet. Over a period of two generations,
two groups of zebrafish fed either a GM maize diet (Involving Bt) or a non-GM diet were
compared (Sanden et al., 2013). Offspring of parents fed a Bt diet demonstrated higher body
mass increase, feed utilization, and specific growth rate than the offspring of the non-Bt fed
parents. Therefore, no negative health effects were revealed from the Bt toxin GM group.
GMO Research Specifically Concerning Humans and Reproductive Health
Aris & Lablanc (2011) performed quantitative research regarding the potential transfer of
GMO related pesticide levels from maternal to fetal blood, which could potentially indicate
adverse health effects on the fetus. The study was aimed to assess if pesticide-associated
genetically modified foods (PAGMF) crossed the placental barrier (Aris & Lablanc, 2011). The
study was designed by gathering blood samples from 39 healthy non-pregnant women, and 30
healthy pregnant women and their fetuses (Aris & Lablanc, 2011). Participants were also chosen
based on characteristics such as age, BMI, and gestational age (Aris & Lablanc, 2011). Results
from all subjects were then compared. Major findings showed that certain GMO related
pesticides were detected in both maternal and fetal blood, and others were not (Aris & Lablanc,
2011). This knowledge of the potential for PAGMF placental transfer is enlightening,

EFFECTS OF GMOS ON THE HUMAN FETUS

10

considering the fragility of the fetus and the potential toxicity of the pollutants. Therefore, this
study provides implications for greater research on humans.
Conclusion of Literature
______It is with certainty that further research on this subject is needed involving both animals
and humans. The most obvious reason is due to the fact that so little research has ever been
completed in the first place, especially on humans. GM foods with the Bt-MON810 genetic trait
do not appear to have any negative reproductive effects on animals based on the two studies
identified. However, this statement only applies to the animals researched in these two studies,
which include sows and zebrafish. Two of the studies showing negative health effects on
embryonic or fetal development either did not identify the specific gene insertions used on the
GM food, or the study used a mixture of GM foods. Therefore, the particular GM toxin of
concern could not be identified. In the study by Velimirov et al. (2008), it was clear that either
the Cry1Ab or CP4-EPSPS genes in maize lead to statistically significant negative outcomes in
reproduction, specifically in the number of deliveries and size of the pups. Further research
should be completed in this area, as these toxins could potentially be related to infertility or poor
fetal health in humans. Furthermore, as Aris and Lablanc (2011) identified, the fact that PAGMF
was demonstrated to cross the placental barrier in humans lays a solid foundation for further
research, especially considering the fragility of the fetus.
Research Question to Guide Proposal
The guiding research question for this proposal is: Does maternal consumption of
GMOs during pregnancy negatively affect the health of the human fetus?
Statement of Applicable Theory

______Florence Nightingales environmental theory can provide a strong framework for this
research. Nightingales belief was that nursing is achieved through altering the environment
(Theory of florence, 2012). According to her theory, poor or unfavorable environments lead to

EFFECTS OF GMOS ON THE HUMAN FETUS

11

disease and poor health (Theory of florence, 2012). Nightingale held the notion that holistic
care requires environmental adaptation (Theory of florence, 2012). Among Nightingales many
contributions in the nursing profession, she also placed a great concern upon proper nutrition
(Calkins, 1989). Calkins (1989) states that Nightingale is not regarded as a nutritionist, although
her contribution to dietetics is considerable because of the systematic and scientific way she
addressed the subject. (p. 1260). The value that she placed in nutrition drove her to read
extensively regarding chemistry, foods, and other related subjects; as well as consult with
specialists in the field (Calkins, 1989). As the premise of this research is involved in the health
effects from environmental adaptation, particularly in food, Nightingales theory will provide a
good driving foundation for the study.
Description of Research Design
The research process for this proposal is inspired by the Harvard Nurses Health Study,
which is among the longest and largest pursuing investigations of variables that influence
womens health (The nurses health, n.d.). The website for this study states that, Every two
years cohort members receive a follow-up questionnaire with questions about diseases and
health-related topics including smoking, hormone use and menopausal status. (The nurses
health, n.d., para. 4). It continues, saying Registered nurses were selected to be followed
prospectively. We anticipated because of their nursing education, they would be able to respond
with a high degree of accuracy to brief, technically-worded questionnaires and would be
motivated to participate in a long term study. (The nurses health, n.d., para. 4). The idea of
the proposed research would be to conduct a similar study as this through an annually detailed
questionnaire; looking at prospective cohorts, as well as assessing data retrospectively. In fact, it
would likely be possible to link this comparative-design study to an already existing study such
as the one provided by Harvard, mentioned above. In other words, a detailed questionnaire

EFFECTS OF GMOS ON THE HUMAN FETUS

12

regarding this subject of GMO consumption during pregnancy and the health of each subjects
fetus or newborn could be tapped into an already existing longitudinal study. This way, baseline
data such as age, demographics, medical history, other features of diet, etc., would already be
contributed into the study. However, for the sake of this assignment, this proposal will be
propositioned as an independent study in order to illustrate the details of the research design.
______After baseline data is obtained, subjects could then be divided into different cohorts (such
as by age) and a comparative analysis could be performed on those who satisfied an organic
only diet during their pregnancy, and those who did not. By obtaining baseline data such as
age, current health, and medical history, other variables that may contribute to the health of the
fetus can be considered or ruled out in the analysis.
The research will consist of a comparative descriptive design, examining and describing
differences in variables of different groups occurring naturally within their setting. It will be a
longitudinal study, not because it is interested in certain subjects over a long period of their lifetime, but because the questionnaires will be completed by a large number of different subjects
(only concerning their pregnancies) over many years. The questionnaires will have a
retrospective component to it as well, because subjects will have to recall on information when
filling out the surveys. The research will be a mixed methods study in terms of qualitative or
quantitative data. This is because the questionnaire will not only be asking qualitative questions,
but also gathering numerical data such as the number of miscarriages within a cohort, the number
of specific fetal complications within a cohort, weights of newborns, etc. Many of the questions
would be considered qualitative because information such as medical history does not really
have a numerical component.
Sampling of the Population
_______Subjects will only include female registered nurses (RNs). This population is chosen

EFFECTS OF GMOS ON THE HUMAN FETUS

13

because RNs would be able to proficiently provide answers to technically worded medical
questions regarding their health, diet, and the health of the fetus or newborn. This would also
likely increase compliance throughout the study due to nurses natural interest in health. As
mentioned above, an optimal way to initiate a study such as this is to tap into an already existing
longitudinal study (such as the one mentioned). This way, immediate access to a large number of
participants would be available. Otherwise, a great amount of effort would need to be taken to
get large samples of people to participate. If the research remained independent, this would have
to be achieved by mailing out letters to a sample population requesting participation in the study.
Addresses could be acquired through collaborating with the NCLEX organization. The sampling
plan would involve mailing letters to nurses based on a stratified random sampling according to
geographical location throughout the country.
Setting
Because the questionnaires will be sent out to the subjects themselves, the subjects will
be able to complete them right at their own homes and send their answers back using a return
address.
Data Gathering
The detailed questionnaire will be sent out to subjects annually. Subjects will be asked to
respond about their pregnancy either retrospectively or based on their current pregnancy. If there
were no past or present pregnancies, the participant can opt out on the questionnaire for that year.
Throughout the questionnaire, nominal, ordinal, and interval/ratio types of data will all be
obtained. The initial part of the questionnaire will involve questions regarding baseline data. The
baseline data will include: age; sex (female); residence (urban or rural); past and present
occupations; type of nursing field (radiation and oncology nursing can be causative factors);
marital status; activities of daily living (amount of exercise, etc.); past and current medical
history; surgical history; weight and height; social habits (drinking, smoking, etc.); recreational
drug use; allergies; and general dietary habits (other than aspects of GMOs). All questions

EFFECTS OF GMOS ON THE HUMAN FETUS

14

regarding this baseline data will be answered by circling provided choices (such as by checking
off a list of medical history). However, each question will also have an other section for
participants to write a free-response answer if necessary. Nurses will be asked an estimate on
how much radiation they were exposed to during pregnancy (with choices provided). Oncology
nurses will also be asked the frequency per week they dealt with chemotherapy. Subjects will be
asked these questions not only based on history, but also their status during pregnancy. For
example, it will be important to differentiate if a mother had a history of smoking versus
smoking during her pregnancy. By gathering this baseline data, factors such as age or medical
history can be later analyzed to determine if they were contributing factors to the results of fetal
health or illness.
After baseline data is obtained, there will be focused questions regarding whether or not
the subjects completely abstained (or are abstaining) from GMO foods during pregnancy.
Definitions of GMO foods and organic foods will be explicitly defined on the questionnaire.
Example choices for answering these questions will be based upon a defined numeric scale,
between strictly avoiding GMO foods OR strictly consuming USDA organic foods to usually
consuming GM, or non-organic foods. A defined numeric scale from 1-5 will be provided
within this section for participants to gauge the amount GM foods that they restrict in their diet.
The last part of the questionnaire will include questions regarding the health of the fetus
during pregnancy and the health of the newborn. Nominal and interval/ratio data will be
obtained. The questions will focus on pregnancy complications, fetal health, miscarriages, premature births, weight and height of the newborn, any medical diagnosis of the fetus/newborn,
and sex of the newborn. As presented in the baseline data, participants will be shown a list of
answers/choices for each category in which to be selected. If a certain medical diagnosis is not
provided, subjects will have the opportunity to fill in the other section as free-response.

EFFECTS OF GMOS ON THE HUMAN FETUS

15

Analysis
_______The population of interest should meet certain inclusion criteria. To benefit the research
and maximize data, subjects will be compared by age categories rather than filtering out
participants based upon age. For example, women greater than 40 may put their child at higher
risk for certain congenital defects. Therefore, women of this age group will not be compared to
women of other age groups. The comparative analysis of participants will therefore only occur
between other participants among their own inclusion criteria. Age groups will be <20, 20-25,
26-30, 31-35, and so on. These categories could be created not only based on age, but also on
other features of baseline data such as medical history. Because there are so many natural factors
in healthy fetal development, thorough review of baseline data will be necessary for each
participant. For example, a mother who dealt with severe issues of pre-eclampsia or gestational
diabetes may have to be considered for exclusion. Therefore, some of the inclusion criteria
may have to be decided after the fact due to the infinite number of medical factors. Mothers
who smoked, drank alcohol, or used recreational drugs during pregnancy will be completely
excluded from the study. Oncology nurses will also be put in a separate category, and only
compared to each other. Nurses may be considered for exclusion based upon estimates of
radiation exposure.
Once all data is gathered, the inclusion/exclusion process is completed, all variables are
accounted for, and subjects are placed within the appropriate cohort, a statistical, multivariate
analysis will be performed to determine associations between GMO foods and fetal outcomes.
By using this process, the questionnaires can be completed by an extremely large population over
many years.
Measurement and Instrumentation
_______Majority of the data gathered is nominal data. Therefore, there is no true measurement
for much of the data. Nominal data is simply measured through methods of classification. A

EFFECTS OF GMOS ON THE HUMAN FETUS

16

fair amount of the data is also ordinal, which involves classification and order. This will be
measured through use of scales. For example, in order to gauge the amount of GM foods subjects
restrict in their diet, a numerical scale with classifications will be used for measurement. Some
interval/ratio data will be obtained as well. This will include reported age, weight, and height
(mother and newborn). The interval/ratio data measurements are both reliable and valid. The
ordinal data on the other hand has low reliability and validity. After gathering the nominal data,
counting methods will be used to determine frequencies of occurrence, which is
mathematically reliable and valid.
Ethical Considerations and Limitations
Although an experimental study design would be of stronger validity and reliability,
certain ethical issues would come into play. For example, completely restricting a group of
pregnant women to genetically modified food in order to compare findings to a non-GMO group
would pose an ethical dilemma, especially if the hypothesis is that GMOs may cause potential
harm to fetal development based on previous animal studies. Furthermore, a controlled
experimental study would be unrealistic because aspects such as environment, intake, and
movement of pregnant women would be impossible to control.
One of the major ethical considerations is the protection of confidentiality of participants
information. Extreme measures would be taken to maintain HIPPA regulations and
confidentiality. Participants would also be notified of this. Based on federal and state regulations,
this research would require review by an institutional review board because it involves human
subjects. Approval could be acquired through the American Universitys Institutional Review
Board (Human subjects research, n.d.). Because there are an infinite number of factors that can
influence fetal health, making associations between maternal consumption of GMO foods and
fetal health would require an enormous amount of years to make any reasonable conclusions or
have any statistical validity. This concept and the lack of controls within the study are major
limitations of the study. Compliance of filling out the surveys may also be an issue.

EFFECTS OF GMOS ON THE HUMAN FETUS

17

Another limitation to this study obtaining ordinal data on how much participants
restricted GM food from their diet. This is of low reliability and validity.
Dissemination of Findings
As this is a longitudinal study, findings will not be conclusive for many years. When that
time arrives, findings may be initially disseminated by publishing the work through scholarly
journals such as the Journal of Reproductive Toxicology. Findings will also be forwarded to all
participants. In addition, results can also be discussed at local events, conferences, seminars, and
community meetings. As more exposure to the research is achieved, greater opportunities could
present such as media coverage. Options for peer review would also be made available.

References
Agricultural Marketing Service - National Organic Program. (2014, January 15).
Retrieved April 24, 2014, from http://www.ams.usda.gov/AMSv1.0/nop
Aris, A., & Lablanc, S. (2011). Maternal and fetal exposure to pesticides associated to
Genetically modified foods in Eastern Townships of Quebec, Canada. Reproductive

EFFECTS OF GMOS ON THE HUMAN FETUS

18

Toxicology, 31(4), 528-533. doi: 10.1016/j.reprotox.2011.02.004


Buzoianu, S.G., Walsh, M.C., Rea, M.C., ODonovan, O., Gelencser, E., Ujhelyi, G., Szabo, E.,
Nagy, A., Ross, R.P., Gardiner, G.E., & Lawlor, P.G. (2012). Effects of feeding Bt maize
to sows during gestation and lactation on maternal and offspring immunity and fate of
transgenic material. The British Journal of Nutrition, 109(5), 873-881.
doi: 10.1017/S0007114512002607
Calkins, B. (1989). Florence Nightingale: on feeding an army. The American Journal of Clinical
Nutrition, 50, 1260-1265. Retrieved from:
http://ajcn.nutrition.org/content/50/6/1260.full.pdf
Carman, J., Vlieger, H., Ver Steeg, L., Sneller, V., Robinson, G., Clinch-Jones, C., Haynes, J., &
Edwards, J. (2013). A long-term toxicology study on pigs fed a combined genetically
modified (GM) soy and GM maize diet. Journal of Organic Systems, 8(1), 38-54.
Retrieved from: http://farmandranchfreedom.org/wp-content/uploads/2013/06/carmanvlieger-2013-gm-toxicology-study-pigs.pdf
Cisterna, B., Flach, F., Vecchio, L., Barabino, S.M.L., Battistelli, S., Martin, T.E., Malatesta, M.,
& Biggiogera, M. (2008). Can a genetically-modified organism-containing diet influence
embryo development? A preliminary study on pre-implantation mouse embryos.
European Journal of Histochemistry, 52(4). Retrieved from:
http://ejh.pagepress.org/index.php/ejh/article/view/1226/1335
Fridovich-Keil, J. (2013, December 25). Genetically modified organism (GMO). Encyclopedia
Britannica Online. Retrieved April 22, 2014, from
http://www.britannica.com/EBchecked/topic/897705/genetically-modified-organismGMO
Human Subjects Research - IRB. (n.d.). IRB. Retrieved April 26, 2014, from
http://www.american.edu/irb/
Sanden, M., Ornsrud, R., Sissener, N., Jorgensen, S., Gu, J., Bakke, A., & Hemre, G. (2013).
Cross-generational feeding of Bt (Bacillus thuringiensis)-maize to zebrash (Danio rerio)
showed no adverse effects on the parental or offspring generations. British Journal of

EFFECTS OF GMOS ON THE HUMAN FETUS

19

Nutrition, 110, 2222-2233. doi:10.1017/S0007114513001748


Smith, J. (2009). Doctors warn: Avoid genetically modified food. Retrieved from
http://www.responsibletechnology.org/gmo-dangers/health-risks/articles-about-risks-byjeffrey-smith/Doctors-Warn-Avoid-Genetically-Modified-Food-May-2009
The nurses' health study. (n.d.). Retrieved from
http://www.channing.harvard.edu/nhs/
Theory of florence nightingale. (2012). Retrieved from
http://currentnursing.com/nursing_theory/Florence_Nightingale_theory.html
Velimirov, A., Binter, C., & Zentek, J. (2008). Biological effects of transgenic maize
NK603xMON810 fed in long term reproduction studies in mice. Retrieved from:
http://www.biosicherheit.de/pdf/aktuell/zentek_studie_2008.pdf
Zhang, W., & Shi, F. (2011). Do genetically modied crops affect animal reproduction?
A review of the ongoing debate. Nutrition Reviews, 67(1), 1-16.
doi: 10.1111/j.1753-4887.2008.00130.x

Potrebbero piacerti anche