Law and ethics management report: Clinical research analysis

 Law and ethics management report: Clinical research analysis 

Business Ethics: For conducting Clinical Research

Executive Summary:

This report discusses the essential standards and norms which are required for the case study. The deontological, ethical concept which is based on the standards and norms underlined in the case study is also explained. Furthermore, the practical value of different economic concepts which is relevant to the case is also discussed. The RADAR concept which are the factoring ethics is taken into consideration during the decision making process and the different ethical concepts for carrying successful clinical research activity is India is highlighted. Moreover the main aspects for scheduling  meeting with the NGO representative is discussed to facilitate action and achieve the goal for faster and efficient completion of the clinical test and for successful  approval of the drug.

 Contents:

Executive Summary…………………………………………………………………………………………………2

1. Introduction………………………………………………………………………..…………4

2. Overview of essential moral standards and norms………………………………………….4

3.Ethical concept by which the moral standards and norms are based: Deontological ethics………………………………………………………………………………………………………………………….6

4.Practical value of different economic ethics concepts………………………………………7

5.RADAR concept…………………………………………………………..…………………..8

6. Preparing for business activity in India…………………………………………………….9

7.Different culture concept using theoretical approach…………………………………….11

8. Main aspects for preparing for the meeting with the NGO representative……………..12

9. Conclusion……………………………………………………………………………………13

10. Bibliography………………………………………………………………………………..14

• 1.      Introduction:

Culture is a distinct way of knowing the people living in different parts of the world.This includes traditions,art,food,behavior,languages,symbols,greetings,dress codes and other norms,beliefs and values which exist uniquely in every place.Culture is a collective dimension.Undertaking business globally requires the knowledge of different cultures in order to lead a successful business activity and effective communication is the key to carry out international business. Business ethics are the professional ethics which is to be followed carefully to work professionally. It outlines the business philosophy and determines the fundamental purposes of the company.

The case study involves a biotechnology company, BVVB AG which is a research-based company. It has marketed cancer vaccine which had provided good profits for the company. The research done on ‘tick-borne encephlitis’ vaccine and leprosy vaccine is facing criticism due to adverse side-effects shown  and expensive treatment charges to treat the side-effects. These vaccines have a huge potential for benefiting the developing countries. The research costs in conducting clinical tests are high so the base for conducting research is shifted to a research company, CRE Ltd, in Calcutta, India. This shift is due to reduced costs and reduced monitoring requirements by about 50% .However, now the clinical tests carried out in the Calcutta is facing negative reports and criticism.This will hinder the efficient approval process of the drugs.

2. Overview of essential moral standards and norms:

Bacteria and Virus Vaccine Biotechnology company needs to have certain moral norms and standards the organization needs to adhere. The organization needs to stick to the ethical norms for conducting research. The code of conduct needs to be adhered by the employees, customers, shareholders, suppliers and partners. The employees of the organization need to be committed to fairness, honesty and provide a safe and healthy environment. The organizations are committed in providing confidentiality, reliability in the delivery of the product, attention to detail and uncompromising services. The shareholders should be committed in pursuing sound growth and objectives in order to exercise prudence in the use of resources and assets. The partners and suppliers have the responsibility in handling the customers and other teammates. The business needs to be conducted in accordance to the rules and regulations. Employees need a workplace where they are to be respected, appreciated and satisfied. Non-tolerance of discrimination or harassment involving religion, gender, age, nation, origin, disability or sexual orientation otherwise strict action needs to be taken. The management needs to ensure that the employees need to have a workplace and environment supporting respect, integrity, trust, honesty and responsibility. Everyone working in the organization needs to create an environment of honesty, support, trust, responsibility and integrity and fostering a working environment which is free from retributions or deviations from any sort of ethical behavior.

Decisions are taken after the straightforward application of the ethical rules. This includes honesty in all dealings with the granting organization, community and contemporaries from any distorted and fabricated misinterpreted data. Also honesty needs to be displayed in reporting the experimental procedures and for the results of the research which is to be conducted. Examining the results of the research conducted critically and complying with the institutional regulations and rules as well as governmental policies and strategies. Objectivity needs to be maintained. Thiswill influence research and can keep away from dishonesty or unfairness in experimental designs, data analysis and its related outcomes when conducting any research project. Performing with genuineness , authenticity ,conformity, steadiness and reliability in thoughts and deeds. The organization needs to respect the intellectual property such as the patents and copyrights and avoid the use of unpublished data without any legal permission. If any research publications are made it needs to be focused in advance learning .The capability and competence needs to be upholded to improve the scientific profession. If conducting research in human subjects, various aspects such as the privacy needs to be respected, benefits needs toe maximized, risks and harm to be minimized. Also reporting of undesirable events and striving to share the burden and benefits of research. It is imperative that the researchers understand, apply and assessing various regulations and rules in order to take correct ethical decisions and action in various conditions. The unethical related issues in research includes filing patents without the approval from collaborators and associates,adding friend as an author when the friend has not contributed well in the research, modifying the statistical technique, publishing journals in different journal fixing an experiments, fabricating and fixing the experiments and violating the bio-safety regulations and rules^1.

BVVAG needs to be committed in providing healthy and safe work environmental surroundings and adhere to sound business practices.

3. Ethical concept by which the moral standards and norms are based: Deontological ethics

Deontological ethics are the ethical rules and regulations which judges the morality based on action and adherence of rules and regulations. They are rule-based ethics which are concerned with how people do the right thing and avoiding the wrong thing. They usually refer to ‘the principle of thing’. The deontological ethics helps in teaching the clients, employees and stakeholders to do the acts and have the duty to act accordingly regardless of bad or good consequences. It also focuses in the moral rights which is laid down specifically by the organization and adhering to the rules and regulations. This deontological ethics emphasizes on the value of every human being and they tend to focus on giving equal respect to all human beings. Also this provides a basis for human rights and the ethics giving due regard to the interests of a single person even who are at odds. Kantian ethics say that certain things should not be done however the consequences maybe. This seems to reflect the thinking of humans. This theory provides certainty. The consequentialist ethical theory brings about the degree of uncertainty to the decision-making and the result of consequences from a particular action as the future is considered unpredictable. If the action is considered right then a person should do it and it it’s a wrong action, the employees, stakeholders and scientists should not further pursue it keeping to the moral standards and moral choices when taking decisions. Various acts being carried out with whether they are with bad or good intentions they need to be relevant to the moral judgments.

1. Abbas, F et.al, Why ethics in research are crucial, vol. 6, no. 5, 2012, p.660-663.

The act discusses the case of ‘accident’ if people have unintentionally done a bad act and this seem appropriate with ordinary thinking on ethical issues².The individual’s rights are inviolable and acknowledged.The deontological ethics emphasizes on the value of every human being and focusing on giving equal respect to all human beings.

4. Practical value of different economic ethics concepts:

The practical value of different economic ethical concepts includes the dilemma based on morality and competition. Discussing the modern business ethical approaches and coming to the appropriate solution of rules with a correct legal framework. The business ethic concept includes the corrective business ethics, charitable business ethics, functional business ethics and the integrative business ethics.The economic ethical concept applies to all aspects of the business conduct which is relevant to the entire organization and monitors the conduct of the individuals.  Second concept is the correctivebusiness ethicswhich are the applied ethics, which guards the moral, situative profit waiver and deals with business restriction. H. Steinmann et. al explains this concept of embedding ethics in all the business activities and reasoning by dialogue through argumentative understanding and commitment. Also the implementation of sound ethics for positive business dealings with other organization. Next concept is the charitable business ethics deal with profit allocation for non-business purposes which extend to beyond the business dealings. This specifically deals with the principle of ‘profit maximization’ and the profit to be used for non-economic claims or donations. This helps in gaining the good-will of the organization.

2.BBC, About duty-based ethics, 2012, http://www.bbc.co.uk/ethics/introduction/duty_1.shtml, Viewed 8 November, 2012.

The integrative ethics give the sound-basis for a different valued-based rationality and critique the economic reason. This integrative business ethics give high priority of ethics over the economics. P. Ulrich explains this concept as unconditional priority of ethics over the economics. The concept binds the business principles and defines clearly the rights of the stakeholders which in this case is the core management team of the Bacteria and Virus Vaccine Biotechnology company, the CRE limited and the respective governments involvement.The corporate distribution includes the task distribution being fair with respect to the biotechnology company.The ethics in this concept involve the life-serving governance and embedding the competition and the market.The functional business ethics acts as an instrument for economic rationality. The profits earned by the organization needs to align with the morals though rules which come under the legal framework whereas the game moves are action undertaken by the persons and the corporation. So integration of both economic ethics and corporate ethics are essential to maximize benefits between the stakeholders, employees and the clients.

5. RADAR concept:

RADAR are the factoring ethics which are taken into consideration during the decision making process. The components of RADAR include recognize, act, decide, assess and resolve. This concept brings about sense with the company-employee population. Recognize in the RADAR case is recognizing the ethical component or ethical values such as the company’s values, individual values and global business standard codex values to any proposed actions.The next step is assessing the ethical standards such as the duties and rights of all people of the organization. The proposed actionof the consequences and its negative and positive impactis evaluated whilekeeping inmind the duty of the stakeholders which include employees and shareholders and also ensuring the likelihood of reducing the negative impacts. Decisions made regarding the organization needs to fit into the moral framework.The visibility and the universalityneed to be ensured and implementing effective decisions through conviction and courage.The last step is resolving and determining different changes which can extend beyond the individual level, developing methods for enforcement and timely monitoring.

6.Preparing for business activity in India:

Conducting a business activity such as research to be done in India as mentioned in this case study requires basic information on the economic environment and the present activities or business in India. The representative of BVV AG needs to comply with the acts such as compliance with Indian company’s act of 1956 and compliance with reserve bank of India. The core elements to consider while undertaking business activity in India includes business ethics of India, corporate governance and corporate social responsibility.

The business culture of India is a reflection of various rules and regulations followed by the people. The ethics, customs and culture needs to be understood. Some examples include that in India, the guests are treated with courtesy and respect. Indians have difficulty in saying ‘no’, this can be a barrier for negotiation. The punctuality and time management in India is still anathema. Laid-back approach followed in government circles can bring about delays, overload of paperwork. Thus a lot of patience is essential in carrying out business activity in India.The business culture in India puts more emphasis on friendship and favors. The ethical business in India regarding the corporate social responsibility is different from the western culture. This includes differences in decision-making, where the decisions are made only by the top management and not involve a participatory approach. This is due to caste system which exists in India.The corporate social responsibility varies according to the type of organization in India.A research based organization in India operates globally,nationally and locally. The organization ensures that they lend a helping hand to the society through provision of products and contribute positively to the society and the employees. This will bring about sustainable improvements to the society. India has a strong belief on corporate social responsibility^3. The materials and supplies areto be used in an ethical way according to the market rates. There is appreciation for protection of human rights in India with regards to the long working hours and other benefits provided to the employees. People develop strong relationships with the local suppliers and customers and correct salary is paid to the employees of the organization in India.

3. Pledging for Change, Ethical Business in India, 2012, http://pledgingforchange.com/business/ethical-business-in-india.php , Viewed 8 November,2012.

Strong ethical governance exists in India and undertaking business activity requires a tedious and a long process of registration with many bureaucratic agencies.Moreover, due to higher chances of profit potential in India, can positively contribute to a developing country like India. India gives high importance to ethical values and integrity within an organization.Indian government has given greater power to the shareholders where self-regulation,approvals and more transparent disclosures are vital⁴.

7.  Different culture concept using theoretical approach:

Cultural concepts are the parameters for the measurement of the cultural phenomenon.Cultural concepts by Hofstede include the power dimensions, individualism, masculinity, uncertainty avoidance and long-term orientation. The power distance index is the measure of the extent where the employees expect the power is unequally distributed. Inequality and power are fundamental for the society. The two power distance approaches are large and small power distance. The small power distance focuses on minimizing the inequality of the people and reducing the interdependence between the more and less powerful people. Parent’s treatment toward their children is equal and vice versa.In the classroom background the teachers are considered experts and take initiatives from the students. Students treat the teachers with respect. The educated people hold less authority and values compared with the people who are less educated. Hierarchy in the organization means inequality of roles performed in the organization, where decentralization is popular. The power in the organization is based on expertise,formal position and the ability to give rewards whereas the large power distance focuses on expecting inequality between less and more influential people. The less powerful people are expected to be dependent on the more powerful people in practice and polarized between counter dependence and dependence. The parents treat their children with the obedience and the children treat the parents with respect. The less and the more educated people depict equal authoritarian values and the centralization is popular. Also wide salary range exists from the bottom and top of the organization and the ideal boss is a benevolent autocrat. The collectivism and the individualism focus on the societies of the world.

4. Business .Gov. In, Corporate Governance, 2012, http://www.iimahd.ernet.in/~jrvarma/papers/iimbr9-4.pdf, Viewed 8 November, 2012.

The collectivist explains about the people who are born into extended families and continue to protect the people in exchange of loyalty. The children are made to think as ‘we’ and the identity is based in the social work. The harmony needs to be maintained and the direct confrontations need to be avoided. The collective interests prevail over individual interests. The economy is based on the collective interests and the political power is exercised by different interests groups. The ideology of harmony and equality prevail over the individual freedom.  The individualist concept focuses on the identity of the individual and the right in maintaining privacy. The ideology of individual freedom prevails over equality. The ultimate goal is self-realization of every individual.The next culture concept is on masculinity and feminity. Feminity focuses on those values of caring and preservation in the society. Modesty and concernfor relationship is expected. In family setting both the parents deal with feeling and resolve all the issues. The managers in this context need to seek for consensus and use their intuition. The major focus is on solidarity, equality and quality of life.The conflicts needs to be resolved by negotiation and conflicts. The masculinity deals with values of progress and material success where money is considered as most important. In family settings, the women are tender and take care of relationships and feelings whereas the fathers deal with facts. The managers need to be assertive and decisive. The major focus is on competition, equality and performance. The Uncertainty Avoidance concept deals with tolerance for ambiguity and uncertainty. It focuses on the extent the culture prepares the society to feel comfortable or uncomfortable in different situations. This minimizes these situations by rules, laws and security measures. The weak uncertainty avoidance is focused on low stress and feelings of well-being. The feelings of emotions and aggression are not to be shown. Students should be more involved in open-ended learning and group discussions. Time management is crucial and precision and punctuality is vital. Moreover,people need to be constantly motivated through self-esteem and achievement. The strong uncertainty avoidance is constantly facing high stress and anxiety. The major focusis on money, tight rules and regulation with constanthard work . Punctuality and precision has to be maintained and people needs to be motivated by self-esteem and security. The next culture concept is the short and long-term orientation. The long term-oriented society are aimed at building of practical virtues oriented toward future rewards, persistence to the dynamic environment and the short-term orientation  focuses on the virtues related to the present and the past such as respect for tradition, preservation and fulfillment of social obligations⁵.

The case study on the BVVB AG Company in carrying out research in CRE limited in India indicates the shift in culture and cultural differences as both organizations are located in different countries. The various cultural concepts discussed gives the understanding of various cultural differences exists in different countries. In the context of this case study, the cultural dimension includes thefollowing the large power distance concept which should be followed as it gives a clear indication of work-power partition within the organization. The collectivist cultural dimension is ideal than individualism because the employees, stakeholders and the client’s need to work together in order to efficiently carry out the clinical research tests within time.The feminist perspective needs to be followed in the organization to prevent any gender discrimination.This will bring about healthy work environment, effective cooperation and collaboration to carry out clinical tests.Next cultural concept which is ideal for the case study is following the strong uncertainty avoidance where scientists carrying out the research for development of tick-born encephalitis and leprosy are constantly provided with motivation. This gives the environment for the scientists to constantly work hard and follow punctuality and precision. Also the long-term orientation concept helps in building virtues oriented towards persistence, saving and adapt accordingly to the changing situation. Adapting the appropriate cultural concept helps the organization to work efficiently and effectively. This helps in improving the strategic thinking, limiting the liability of the top position management,maintain confidentiality with the foreign and the domestic investors and improve capital costs risks^5.

8. Main aspects for preparing for the meeting and discussion with the NGO representative:

The main purpose when scheduling the meeting with the NGO representative is to facilitate action and achieve the goal of making effective decisions. The meeting needs to be conducted with control in order to fully express opinions from both the parties. The agenda of the meeting needs to be clearly outlined. The agenda is to convince and fully ensure the NGO representative about changes made in the procedure of drug-testing and  safety ensured to the society.

5. Business .Gov. In, Corporate Governance, 2012, http://www.iimahd.ernet.in/~jrvarma/papers/iimbr9-4.pdf, Viewed 8 November, 2012.

Reports from the NGO, Panjaa about the negative criticism regarding the clinical tests conducted for the development of the tick-bone encephalitis vaccine and leprosy needs to be addressed for the successful drug approval. The importance of this vaccine development needs to be highlighted during the meeting and how it would bring about  huge benefit for the future of the community’s well-being and how the successful approval of the vaccine will improve the quality of life needs to be emphasized. The minutes of the meeting can be recorded by the secretary and this legal signed document should follow as per the agenda outlined⁶. A healthy discuss needs to be conducted with the sole purpose of carrying out the clinical test on time and not prevent any further delay in successful approval of the vaccines.

9. Conclusion:

Undertaking business globally requires the knowledge of different cultures to lead a successful business activity and effective communication is the key to carry out international business. Business ethics which are the professional ethics needs to be followed carefully to work professionally. It outlines the business philosophy and determines the fundamental purposes of the company. Thus, having a knowing of different cultures, ethics and morals, social corporate governance of country where the business activity is undertaken brings about efficient and successful business dealings and profit gains.

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