Thinking BioSynthEthically

Research involving Synthetic Biologic and the dissemination of its findings stimulate discussions in a context of risks, due to emergence of new genetic circuits and organisms. Thus, a basic question arises in this area: how to deal with new technoscientific processes? Moreover, there is a recurring concern related to the socio economic reach of these scientific discoveries. (PARENS, JOHNSTON and MOSES, 2009).

Such discussions can be analyzed from two different, but complementary perspectives: the academic and the community. The individuals included in the academic field are also part of the community and are responsible to bridge the gap between these two realities by introducing the scientific discoveries. Thus, people in academia are extremely important in the process of scientific construction of Synthetic Biology by being active agents and disseminators of SynBio findings, familiarizing the community with the field. Nevertheless, the effective preparation of researchers to deal with ethical discussions involving Synbio needs to get more attention from college education.

It is possible to apply Bioethics concepts to create panoramas that solve conflicts involving Synthetic Biology (GUTMANN et al, 2010). Intervention Bioethics is the most applicable to the technoscientific innovations produced by Synthetic Biology and its ethical and philosophical dilemmas regarding the need for protection (either of the environment, of animals or of economically disadvantaged populations).

Intervention Bioethics embraces the concept of protecting the basic principles of bioethics described by Beauchamp and Childress, guiding the discussions around situations consistent with the socioeconomic and political reality of underdeveloped countries. (GARRAFA and PORTO, 2003). Therefore, utilizing such approach fits into the political, economic and social situation experienced by Brazil today.

Thus, bioethics presents a decisive role so that the risks and benefits involved in SynBio research can be evaluated, reflected and discussed among academics who may eventually work in the area, so that they are able to lead the community to Synthetic Biology research filled with social and ethical concepts. Therefore, the characterization of individuals in Synbio bioethics concepts allows the detection of discrepancies to be translated in theoretical and practical training to bring a broader approach to this field of knowledge.

Instigating Questions

We sought to characterize the Brazilian academic community through a questionnaire. The form is subdivided into two sections: the first aims to identify how respondents relate to the concept of science (Q.6 , Q.7 , Q.8 , Q.9 , Q.10 , Q.11); while the second aims to evaluate how concepts of Intervention Bioethics are embedded in decision-making of respondents (Q. 13).

Question 13 aims to expose a situation in which the respondents are placed in a decision-making position. Each item of question 13 was elaborated using concepts that are based in aspects of Intervention Bioethics (BOTTLE , 2005). We highlight below what each item sought to privilege : "a" - a precaution ; " B " - equity; " C " - distributive justice ; " D " - protection ; " And " - non- maleficence ; " F " - autonomy; " G " - biosafety ; " H " - charity

The Questionnaire

COnsent Form

This research aims to characterize the academic community view of Synthetic Biology and to analyze how Bioethics influences scientific decision-making process. Then, Bioethics topics for educational purposes will be proposed according to the needs of this population. The first step is to answer the following questionnaire within a two week period. This questionnaire explores your views on how science and bioethics are related and how they influence decision making in Synthetic Biology research. Participants may feel uncomfortable with some of the questions. The benefits expected from this research are theoretical and practical training of the academic community on bioethics educational topics applied to Synthetic Biology, according to this community needs. Therefore, we aim a social approach of Synthetic Biology. You are allowed to ask questions and any further clarification, in addition to asking for new information if needed, simply by contacting any of the researchers in the Brasil-USP iGEM team or any Board of Ethics. You have secured your right to not participate or to withdraw your consent form any time without any prejudice or retaliation. The information from this questionnaire is confidential: there is no identification of volunteers, ensuring the confidentiality of their participation. We emphasize that there won’t be any compensation to participants involved in this research, since the participation is totally voluntary.

Q1. Where are you from? How old are you?

Q2. Which category do you fit in?Undergrad (specify: freshman, sophomore, junior or senior), Grad student, Researcher, Professor, etc)

Q3. What is your field of study?

• Math and Engineering
• Biological Sciences
• Humanities
• Other

Q4. Gender:

• Female
• Male
• Other

Q.5 What is your higher education institution or company?

Q.6 I support the creation of a code of conduct and ethics concerning biotechnology matters.(1 / 2 / 3/ 4 / 5 / No opinion)

Q7. Ethical concerns in research are unnecessary (excluding those from scientist to scientist) because scientists must be autonomous.

Q8. The ethical and moral values of society must interfere in scientific and technological development.(1 / 2 / 3/ 4 / 5 / No opinion)

Q9. Scientists’ work is not influenced by social values. (1 / 2 / 3/ 4 / 5 / No opinion)

Q10. No technology is either good or bad, it depends on its application. (1 / 2 / 3/ 4 / 5 / No opinion)

Q.11. All scientific development leads to social development. (1 / 2 / 3/ 4 / 5 / No opinion)

Q.12 During your time in college, was Synthetic Biology addressed by any of your professors? (Yes / No / Do not remember)

Q.13. Following there is a short fictional history about Synthetic biology and some questions about it.

Pandemia

An unexpected illness called “agasguitamento” affected the global population turning into a pandemy. It is caused by a pathogenic organism that evades the immunologic response of individuals, leading to neuronal destruction. Patients with this disease have very low life expectancy since it reaches its chronic stage quickly. A group of brazilian researchers from a private company has been using Synthetic Biology techniques to establish new genes, not found naturally, that promote the ability to attack the pathogen, introducing them in a microorganism, thus creating an genetically modified organism (GMO). According to lab tests in mice, monkeys and clinical trials in humans, this GMO has shown its efficiency in fighting the pathogen. However, it demonstrated huge toxicity specifically to mice, causing their death. Clinical trials were performed in a small african village affected by the disease before it became pandemic. On this trial most part of the people were cured. However, when the disease became pandemic individuals who underwent testing phase were infected again by the pathogen in a much more severe form. Even though the company knew about this occurrence it provided no assistance to the african population. The GMO began to be commercialized worldwide and several individuals were affected by the disease, including Jose Amado and Antonio Gonçalves, both are forty years old. Only Antonio’s family could afford the treatment. While the GMO was being utilized for therapeutic purposes, there was an error in the disposal of used materials and the GMO reached the water source of an ecosystem that includes rodents.

a) It is necessary to implement strategies to control this GMO. (1 / 2 / 3/ 4 / 5 / No opinion)

b) People who are able to afford the treatment should be assisted first. (1 / 2 / 3/ 4 / 5 / No opinion)

c) There must be equal treatment to people affected by the disease. (1 / 2 / 3/ 4 / 5 / No opinion)

d) The african population must be assisted by the company, in terms of treating the disease for an individuals lifetime.(1 / 2 / 3/ 4 / 5 / No opinion)

e) It is morally acceptable that this GMO is used for treating humans, although it causes rodents death. (1 / 2 / 3/ 4 / 5 / No opinion)

f) The patient Jose is under a vulnerable economic situation and should have access to treatment even though he is not able to afford it. (1 / 2 / 3/ 4 / 5 / No opinion)

g) Do you agree with the following statement: The invasion of a water source by a GMO is able to affect the creatures present in the environment. (1 / 2 / 3/ 4 / 5 / No opinion)

h) Even if all downsides, such as toxicity to rodents and environmental contamination, were controlled, do you agree with the use of this GMO to save human lives. (1 / 2 / 3/ 4 / 5 / No opinion)

Q14. Do you think you are able to define Synthetic Biology? (Yes / No)

Q15. Utilizing Synthetic Biology to assemble new genetic constructs:

• conflicts a lot with my religious values.
• conflicts with my religious values.
• does not conflict with my religious values.
• I do not have religious values.

Q16. What is your opinion about Synthetic Biology?

References

1 SILVA, P. R. D.; ARAÚJO, E. S. N. D.; CALDEIRA, A. M. D. A; CARVALHO, G. S. Construção e validação de questionário para análise de concepções bioéticas. Revista Brasileira de Bioética (Impr.); 20 (3): 490-501, 2012.

Questionnaire Validation

The questionnaire went through a process of semantic validation, applied to approximately 20 respondents who made suggestions for its improvement, in order to achieve a clear and concise language for future respondents. We sincerely thank Prof. Roberto Goldim, Prof. Cleslei Fernando Zanelli, Prof. Marco Antonio Del Lama and Prof. Carlos Gustavo Nunes da Silva for their generous contribution.

Another statistical validation was performed with 21 possible respondents. At this step, the Bartlett's sphericity and the Kaiser - Meyer - Olkin ( KMO) tests were performed, which together evaluate the correlation between the questions and also evaluate if data fit into a possible factor analysis, because the final analysis will be multivariate, Principal Component Analysis (PCA) type. We also evaluated the reliability of the questionnaire through the Cronbach alpha test, which aims to ponder various views according to the correlation between questions and between the final score.

The results of the statistical validation indicated that some issues could negatively impact the final results, which made us more careful with of the following questions:

1. I support the creation of a code of conduct and ethics concerning biotechnology matters.
2. Ethical concerns in research are unnecessary (excluding those from scientist to scientist) because scientists must be autonomous.
3. The ethical and moral values of society must interfere in scientific and technological development.
4. Scientists’ work is not influenced by social values.
5. All scientific development leads to social development.
6. The african population must be assisted by the company, in terms of treating the disease for an individuals lifetime.

The reliability obtained on all questions was very low (Cronbach's α = 0.011). However, by excluding the questions above, the reliability was moderate (Cronbach's α = 0.657).

Regarding the possibility of assessing the final results of the PCA methodology, it was still dubious due to the number of respondents at the time of statistics validation (n = 21), since Bartlett's sphericity test resulted in p = 0.065, when ideally it would be below 0.05. In addition the KMO resulted in approximately 0.5, but ideal results are above that point. Tests for possible PCA analysis were also performed excluding the questions listed above.

Questionnaire Reliability

As stated before, some questions could negatively influence the reliability of the questionnaire. Thus, considering the total of 405 respondents and all questions, the Cronbach value α was low (0.371). Therefore, to improve the reliability of the questionnaire and allow application in other sample spaces and more accurate statistical analyzes, we decided to exclude some questions, achieving a Cronbach's α ( 0.622 ) close to optimal ( < 0.7 ) (Silva et al , 2012).

The questions excluded were: Q7 , Q9 , Q11 and Q13b . These questions showed internal inconsistency due to the range of variation in the responses. This indicates that there was no convergence tendency in establishing responses, which obscured the overall positioning on the topics that each question addresses. Q7 probably did not have a sufficiently clear construction. Regarding Q9 and Q11, possibly the respondents didn’t feel able to define which social values would be in agreement with scientific research. Q13b divided opinions in extreme ways. If we think about the situation posed in the fictional story we would have two sides of the same coin, on one side there is the united vision of the capitalist profit-making private research and on the other side there is the possibility of saving lives that depend substantially of the treatment, but can not afford it.

Who thinks about Bioethics and SynBio?

Around 405 people participated on the survey and the average respondents age was 30.16 years old. The most participating were female participants being 58.35% of the total participants number (Graph 1). Regarding participation on questionnaire, there was particular attention from professors who contributed 22.48% of the responses (Graph 2). The most participative field of study was Biological Sciences, accounting for 71.78 % of the responses (Graph 3). Regarding conflicts related to religious values and new gene constructs promoted by Synbio, most respondents showed that their religious values are not in conflict with the research in the field (Graph 4).

How does our questionnaire detect relationships in decision making involving Synbio?

The questions used to verify, through PCA analysis, the opinion of the respondents to bioethical dilemmas involving Synbio were: Q6 , Q8 , Q10 , Q13a , Q13c , Q13d, Q13e , Q13f , Q13g and Q13h, due to their reliability, as seen previously. Thus, one can obtain such representation (Graph5):

According to PCA, we are able to conclude that the best questions to analyze the respondents opinion regarding environmental bioethics are Q13e (animal) and Q13h (environment) . As for the analysis of Intervention Bioethics concepts, in the context of problems involving Synbio, the best questions would be Q13g, Q13c, Q13f, Q13d and Q13a, as initially proposed.

As for Q8 it does not show effectiveness for analyzing bioethical concepts in decision making, however, the question acts as an indicative of more favorable position of the respondents in the influence of ethical values in scientific activity, as indicated in 2012 by Silva et al . Q6 and Q10 seem to have some effect on the decision making of the respondents under an Intervention Bioethics perspective. They are related to one of the fundamental principles of Intervention Bioethic: prudence.

Thus, from our questionnaire it is possible to identify demands involving Bioethics and Synbio, so that educational goals are outlined to deal with such needs. Therefore, it becomes possible to carry out educational actions focused on specific demands, enabling the formation of individuals more prepared to the social, ethical and environmental considerations involving Synbio.

What do people in academia think about Bioethics and Synbio?

The academic community was receptive to the ideals of Intervention Bioethics, especially in relation to the concepts of protection, caution and prudence, as seen in the graphs below.

This raises an indication that the Brazilian academic community is concerned about the social impact of Synbio discoveries. Thus, the idea of alterity possibly also guided the decision­making process of respondents.

A theme that seems to require further discussion and reflection from part of the population in question is Animal Bioethics and morality. Q13e showed an intermediate position on the idea of moral­related accidental death of animals exposed to GM (Graph 6).This position may be due to difficulties in the conceptual distinction between morality and ethics.

Furthermore, it would be interesting to stimulate, in this population, the improvement of a systemic view of Synbio discoveries and the environment itself, so that risks can be weighed and decisions made more effectively, ensuring not only human rights, but also those belonging to animals and the environment.

References

PARENS E, JOHNSTON J, MOSES J. Ethical Issues in Synthetic Biology: An Overview of the Debates. Synthetic Biology Project, 2009.

GUTMANN, A. et al. NEW DIRECTIONS: Ethics of Synthetic Biology and Emerging Technologies. Presidential Commission for the Study of Bioethical Issues, Dez 2010.

GARRAFA, V.; PORTO, D. Intervention bioethics: a proposal for peripheral countries in a context of power and injustice. Bioethics, 2003, 17(5-6):399-416. ISSN 0269-9702.

SILVA PRD, ARAÚJO ESND, CALDEIRA AMDA, CARVALHO GS. Construção e validação de questionário para análise de concepções bioéticas. Revista Brasileira de Bioética, 2012, 20(3):490-501.