Ethical Considerations in International Research
Introduction
Ethics or moral philosophy is a branch of philosophy that involves systematizing, defending, and recommending concepts of right and wrong conduct in day to day life. Its applied form in health care is called Bioethics. One of the essential components of medical sciences is research. Scientific advancement is impossible without research.
Research ethics focuses upon the responsibility of researchers, to be honest, and fair. They should also be respectful to all individuals engaged in research as subjects or patients, and unlisted their results ethically and morally, following the guidelines of publication ethics.
Research begins with a thought, theory, and hypothesis in a scientist’s mind. It then goes through several phases of experiments in the lab followed by animal experiments before engaging human volunteers or patients in its final phase. Human experimentation has been conducted even before the 18th century. However, the ethical attitudes of researchers drawn the interest of society only after 1940s because of human exploitation in Nazi Germany.
Nuremberg Code
The Nazi experiments led to the Nuremberg Code (1947) which was the leading code for all subsequent codes made to protect human rights in research. The ten points of the code were given in the section of the verdict entitled “Permissible Medical Experiments”:
1. The voluntary consent of the human subject is essential.
2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
7. Proper preparations should be made, and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
9. During the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill, and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
This code duly focuses on fully informed consent, liberty of withdrawal from research, protection from physical and mental harm, or suffering and death. Following the release of the Nuremberg code, many developments led to the evolution of the doctrine called the ‘Declaration of Helsinki’.
Declaration of Helsinki
Declaration of Helsinki’ was promulgated in 1964, and periodically reviewed and updated since. It was comprised of
• The well-being of the human subject should take precedence over the interest of science and society.
• The consent should be written
• To use caution if the participant is in a dependent relationship with the researcher.
• To limit the use of placebo
• The participants receive benefits from research.
The Belmont Report
The involvement of human beings in research has also led to the development of the Belmont Report. 0n 12, July 1974, a formidable report was published at the command by the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research. Belmont report was named after the location where it was written down as an outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution’s Belmont Conference Center.,
The three fundamental ethical principles for using any human subjects for research are:
1. Respect for human beings, based upon autonomy.
2. Beneficence. To benefit mankind. ‘Do no harm.
3. Justice. Fair distribution of resources based on an equal and equitable share of costs and benefits to the research subjects.
Principles of Research Ethics
Autonomy
Autonomy is the first and foremost principle of research ethics. Able minded persons have a full right to know all about their role in research, and then freely decide whether to engage in a given activity. They are entitled to have full information about risks and benefits which may be direct or indirect, as well as a right to withdraw at any time. Special rules apply to those who are either dependent or unable to decide for themselves, as indeed vulnerable people such as prisoners, school children, etc.
–This principle of respect underpins core practices including informed consent, protection of vulnerable participants’ rights to privacy, anonymity, and confidentiality. The very spine of Autonomy is Informed Consent, which has been discussed elsewhere in this book.
Beneficence
Beneficence is the 2nd guiding principle of Research ethics. It basically means doing some good. Such a good act may affect/ benefit the subject directly or indirectly.
Non-maleficence
The third principle is called Non-maleficence i.e. to do no harm. It is in fact a corollary to the principle of Beneficence. In other words, research should do good while avoiding harm to the subject. Or at least the risk of harm may be minimized.
Justice
The 4th principle is Justice – fairness and equity. It is the most important pillar of research ethics. It’s two main arms are Distributive and Retributive justice. Plenty of literature is available about Justice as without observing it, no research can be called Ethical or morally correct. A balance must. Be established between those who are engaged in research, taking risks, and those who benefit from it.
Then there are other elements that form the outer core of research ethics as research involves other components through collaboration. They are
Fidelity, honesty, integrity, trust & confidence. Each one of these elements forms the basis of ethical research.
Academic Freedom
Another important component of ethical research is called Academic Freedom. It means that a researcher has the right to develop, design, conduct, and disseminate his findings of research free of any coercion, pressure, commercial interest, undue obligation, vested interest, institutional pressure, or economic benefits just to name a few. Obviously, every research scientist is expected to follow and fulfill established norms of research.
A researcher may reflect upon his personal views, values, norms, and practices, which may influence the choice of topic for research, data, and its sources, as well as their interpretation, which must conform to ethical principles under all circumstances. Consistency and integrity in the documentation, discussion, unbiased evaluation, assessment and independence, and impartiality, as well as frank and openness, are invaluable components of ethical research.
Freedom of research is another element. It is essential that researchers, as well as institutions involved in research, must remain free and independent during the entire process. It is of paramount importance when the topic may be controversial or when a commercial or vested financial interest wishes to impose any constraints or pressure to gain certain advantages. Responsible research is ethical research.
Developing a hypothesis takes a lot of effort in gathering thoughts, analysis, and synthesis followed by developing a most appropriate questionnaire. Such a questionnaire should expand on the careful and targeted choice of questions, engagement of a statistician from the outset, a methodology for conducting due research in considerable length, precision and clarity, analytical perspectives, quality of recording observations, and careful documentation, comprehensive documentation of results, statistical analysis of results using most suitable tools, discussion on the research completed, acknowledgment of relevant persons, and bibliography.
It is the responsibility of the institutions to oversee the research, in terms of its ethical application, advice and facilitation, and maintenance of good scientific practice. Institutions should also observe, supervise, manage all research activities following the established global guidelines. They must also make clear distribution of roles and responsibilities of each individual involved in research so that each person feels engaged and shares his due responsibility with commitment and dedication.
Human dignity
Nothing is more important than human dignity in reaper he on human beings. It is the job of the researcher as well as the institute to ensure that the dignity of an individual is never compromised, nor indeed of a group of people collectively. The institutions are obliged to safeguard against any undue distress, disrespect, insult, injury, humiliation harm or damage to a person or persons involved in the research.
Privacy
It is vital for a researcher to observe and maintain individual privacy with concurrence to maintain personal autonomy, integrity, honesty, freedom, and right of co-determination. Personal privacy is one of the elements of basic human rights. It transcends all faith or none; all cultures and norms, values, and practices.
Data Protection and storage
It has gained unprecedented importance in these days of internet and electronic media facilities. One wrong click and personal details may end up with an evil person who may exploit, malign, blackmail, rob or destroy a person abusing it. It is therefore vital that all data must be carefully, diligently and confidentially stored in a suitable place. Personal e-mails may not be used to share the data. Institutional and encrypted, official e-mail is used and that too with only an authorized person, with a warning or disclaimer attached to destroy it if it reaches out , by mistake, to un-authorized person.
Data gathered for a specific purpose maybe kept only for the purpose and duration for which it is required. Similarly, data gathered about identifiable persons must be stored carefully, exclusively and with special protective measures.
Observing the code of privacy is of paramount importance when self-respect, individual rights are at stake; or inability to decide oneself, incapacity to protect and safeguard personal interest, or indeed observe, maintain or safeguard personal interests are at stake.
Duty to inform
An essential component of research ethics is the obligation on the part of the researcher to inform all participants about relevant elements of research. They must fully and appropriately inform each participant of the field of research, its aims and objectives, its purpose and underlying reasons, any risks or potential harms as well as expected benefits, the resources and sources of funding, and conflict of interest or indeed vested interest of the funding agency or agencies. What is also important is the factor data protection, it’s sharing, who will gain access to personal details, and who will benefit from the outcome of the research, and any possible consequences of the proposed research.
Consent and obligation to notify
Informed consent is the single invaluable component of research ethics. It does not mean just mentioning the project briefly and obtaining a signature on a piece of paper, as is often the practice in most developing countries where the subjects do not even understand English which is the academic global lingua franca. Informed consent must be written down in the language of the participant who should be fully explained each item as discussed before.
Surrogate consent is a common practice in developing nations, where a clan system continues to flourish. So, a clan chief often gives general consent on behalf of his clan men. It raises many questions as a corrupt chief may compromise the fate of a large population. Similarly, ahead of the family in compromised societies can also give surrogate consent, which may yet be questionable.
Anonymity
Personal data must be saved carefully. It must be anonymized, often using coding techniques, thus de-identifying a person involved in research, particularly when publishing the results where personal identity may be kept in confidence and confidentiality. Abuse of personal data by vested parties such as insurance companies may compromise the rights of an individual in either a raise in the premium, for instance or simply refusal to gain one such as travel insurance or health insurance per se. Sometimes, however, research material may have to be shared with the competent authority. It may be balanced with due consideration of maintaining confidentiality, anonymity, and an obligation to notify. Without a doubt, exposure of a person to an unsavory customer must be avoided at all costs. So a delicate balance has to be drawn between commitment to research and due diligence in all relevant matters. Finally, it must be noted that any identifiable data gathered for specific research cannot be automatically used for another research, irrespective of commonality in the underlying concept.
Responsibility for avoiding harm
Beneficence is the guiding rule in research in medicine. The whole objective is to serve mankind and save it from disease and ill health. However, non-maleficence i.e. avoidance of harm during the exercise must be acutely observed. To bring good at the cost of bringing harm is against the ethical principles of research. It has been argued by Utilitarians that harm to a few may be acceptable for the greater good of larger populations. But the Ethicists regularly question that.
3rd Parties
Many times a researcher has access to third parties, who are not directly involved, engaged, or focused upon in a study. Such persons may become vulnerable if a breach of the code of conduct for research takes place. Third parties become accessible to a researcher through archives, literature search, previous interviews, current observations, meetings, interactions, or gatherings. Their rights to remain anonymous or unidentifiable must receive priority. Inadvertent exposure or release of their personal information would make a researcher liable. A researcher must also give due weightage to side effects or unintended consequences third parties might have to sustain as a collateral side effect of a study, which obviously could potentially bring them harm thus making research questionable on ethical grounds. The pursuit of truth through research is only good if it does not bring harm to first, second or indeed the third party.
Children involved in research
Special guidelines have been developed by the relevant authorities in various countries to safeguard the children in research studies, because of the historical abuse in the past. No unauthorized photos, identifiable data, family recognition, or any element which may adversely affect a child or an adolescent. There has been an upsurge of pedophiles in Western countries in recent decades. It is not just worrying but simply unacceptable to any civilized person, irrespective of faith, or nationality. Regrettably, even the Church has not escaped this tragedy.
As a famous pediatrician once rightly said that, children are not young men or women, they are individuals in their own right, who are still growing and developing, with different needs to adults with different tendencies, abilities, needs, and requirements going through different phases of evolution, growth, and development.
Only only those who know all about children, their needs and demands, their physical and emotional requirements must conduct research involving children. They should hence be able to carve out research compatible with the age of children.
Consent for parents or legal wards gives engaging children. Unless research is directed to benefit them, the involvement of children and adolescents is a highly sensitive matter.
Age for consent is different in different countries. Generally speaking minors between 15-18 may consent to be engaged in research. Data Protection obviously deserves even more care and caution.
The dignity of family life
An individual is also a member of a family. So just as the privacy of an individual is essential, so in the privacy of their families. Their norms, values, cultures, and practices must receive full attention, clear understanding, and utmost sensitivity in all matters of research. If any out of the normal, otherwise irrational, or untoward measure is employed it must be clearly explained to the family as to why and to what purpose is it carried out.in other words, justification duly supported with convincing documentation should make part of the record in the research of this manner. Respect for faith, culture, values, and practices not only grants due gravitas to a researcher but avoids many unwanted pitfalls. Ignorance about cultural variants is no excuse for carrying out otherwise disrespectful actions.
Respect for posthumous reputations
Death is the ultimate reality. Any research involving names or identifiable personal details of a person who is no more with us must be handled with the utmost respect for the deceased, and their brewed or breaking next of kin, family, or friends. Anonymity on posthumous research should be a user rather than an exception.
Correction in acknowledgment.
Dr. Maqbool Jafri. Medical ethics in contemporary era 1995, Pub. The Royal Book Co.
References
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