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Indian Journal of Medical Microbiology, Vol. 29, No. 4, October-December, 2011, pp. 327-330 Review Article Ethical issues in microbiology P Desikan1, A Chakrabarti2, V Muthuswamy3 1 Department of Microbiology, Bhopal Memorial Hospital and Research Centre, Raisen Bypass Road, Karond, Bhopal 462 038, Madhya Pradesh, India Date of Submission: 16-May-2011 Code Number: mb11083 PMID: 22120789 Abstract Ethical issues facing microbiologists could be considered in two parts. The first relates to the way the ethical issues during their laboratory work. The second pertains to ethical issues on the data/reports they generate for the patients or in research. In both segments, there is pressure to perform, which is exerted by both, the community, as well as peers. It has therefore become increasingly necessary to recognize the facts that unethical actions might be a frequent reality. Since some of these activities generate serious ethical concerns, both in practice and research, it is necessary for microbiologists to be aware and equipped to meet these issues in a prepared and measured way.. In an attempt to highlight this requirement, this article outlines the important ethical issues and guidelines relevant to the field of Microbiology. Keywords: Ethics, guidelines, microbiology Introduction Bioethics has emerged as a new discipline over the past couple of decades and is poised to become a multidisciplinary specialty. Although it has been a part of medical jurisprudence till now, advances in medical sciences and the resultant ramifications have created a special identity for this subject. Hospital ethics committees and institutional review boards have evolved as conscience keepers of professionals with the view to safeguard the welfare of society. Bioethical discussions and debates provide perspectives on the relevance of new and existing processes to human values, enabling appropriate decisions. When bioethics was initially recognised as an entity, the important attributes of infectious disease management like rapid diagnosis, significance of acute onset, risk of transmissibility in community, and surveillance were overlooked. Bioethics was individual centric rather than community centric. At that time, it was felt that improvements in sanitation, immunisation, and availability of antibiotics would lead to eradication of infectious diseases. However, with the emergence of AIDS, ethical issues involving communicability of the disease were highlighted. The concept of a patient as victim and vector was emphasised. Since then, bioethics has recognised the relevance of distinctive features of infectious diseases that influence their course and outcome. These features include invasiveness; acuity; communicability; capacity to spread across borders; preventability/treatability; host, community, and global susceptibility; morbidity and/or mortality rates and subsequent socio-economic impact. In microbial research, certain pertinent bioethical issues related to human experiments need to be kept in mind. These are issues of potential harm, informed individual/community consent, self-experimentation, rights of pregnant women with vertically transmissible diseases and matters of consent in mandatory screening tests, control of pandemics, and immunisation. Laboratory services are an integral part of infectious disease diagnosis, treatment, response monitoring, surveillance programmes, and research. Advances in laboratory technologies have created new and complex ethical dilemmas in their wake. Therefore, personnel working in clinical and/or research laboratories should be aware of their ethical responsibilities. It is necessary to comply with the ethical code of conduct prescribed by national and international organisations and address the emerging ethical, legal, and social concerns in the field of biological and biomedical sciences. The basic principles enshrined in the codes and guidelines followed by different countries are as follows: [1]
Microbiology is a key speciality involved in clinical services and biomedical/biological research. The field involves human beings as patients or participants for which clinical ethics and research ethics are applicable and are to be followed by professionals. Hence, the questions "what has ethics to do with microbiology?" or "why should microbiologists bother with ethics?" are of vital importance. Microbiology, as a discipline, has a commitment to society, and the community it serves. On one hand, there are issues of financial accountability to justify the funding that the discipline receives. On the other hand, there are equally important issues of ethical accountability to justify the appropriateness of behaviour of microbiologists in a given situation. Guidance for ethical accountability can either be derived from "descriptive ethics" which denotes the way different cultures respond to ethical questions or it can be obtained by reference to a compilation of "normative ethics" assembled from statements about what is "right behaviour" or what is morally or legally accepted as "correct." Ethical issues facing microbiologists could be considered in two parts. The first relates to the way in which microbiologists work-the process, or means, of doing microbiology work. The second pertains to the practical and theoretical objectives towards which the work is directed, or, in other words, the products, or ends, of microbiology work and the community they serve. In both segments, there is pressure to perform, which is exerted by both the community and peers. It has therefore become increasingly necessary to recognise the fact that unacceptable behaviour might be an infrequent reality. Because some of these activities generate serious ethical concerns, both in practice and research, it would be salutary if microbiologists are equipped to meet these issues in a prepared and measured way. This would require awareness about the existing guidelines for ethics in India and around the world. Of these, some important guidelines are outlined below. Guidelines/codes of ethics
Code of ethics (American Society for Microbiology) The American Society for Microbiology (ASM) has defined a code of ethics for its members. The document has detailed standards for ethics, rules of conduct, and has a provision for extensive ethical review of any breach of ethical conduct, with provisions for appeal as well. The vision statement of the code of ethics emphasises the promotion of human welfare, accumulation of knowledge, and honesty and truthfulness in all activities endorsed by the society. The jurisdiction of this code of ethics extends to all members of the ASM. [2] Nuffield Council on Bioethics (infectious disease) The Nuffield Council for Bioethics [3] provides some guidelines for the public heath interface with microbiology. It categorically states that it is acceptable for anonymised data to be collected and used without consent, in order to assess and predict trends in infectious disease. It also states that it may be ethically justified to collect non-anonymised data about individuals without consent if this means that significant harm to others will be avoided. However, highly intrusive measures to control infectious diseases, such as quarantine and isolation, would only be justified where there is a real risk of harm to others that could be significantly reduced. Regarding vaccination issues, these guidelines clarify that mandatory vaccination, as opposed to voluntary vaccination, may be ethically justified if they help reduce harm to others and protect children and other vulnerable people. This would, of course, need to take account the risks associated with vaccination and the disease itself, in addition to the seriousness of the threat of spreading that disease to others. The jurisdiction of the Nuffield Council for Bioethics is within the United Kingdom. Who operational guidelines for ethics committees that review biomedical research These WHO guidelines are intended to facilitate and support ethical review in all countries around the world. They are based on a close examination of the requirements for ethical review as established in international guidelines, as well as on an evaluation of existing practices of ethical review in countries around the world. They do not, however, purport to replace the need for national and local guidelines, nor do they intend to supersede national laws and regulations. [4] ICMR Ethical Guidelines for Biomedical Research on human participants ICMR Ethical Guidelines for Biomedical Research on human participants are binding on all medical research conducted in India. They provide guidance for ethical review procedures and general ethical issues. In addition, they specify principles for clinical trials, epidemiological research and genomics research, assisted reproductive technologies, stem cell technologies, transplant research, and so on. [5] ICMR Guidelines for Good Clinical Laboratory practices The ICMR Guidelines for Good Clinical Laboratory Practices [6] (GCLP) outline the principles and procedures to be followed by medical laboratories involved in clinical research and/or patient care so as to provide quality data that can be used for health research and patient treatment. Ethical considerations in these guidelines, which would be binding on all laboratory scientists including microbiologists in India, include the following principles:
WHO handbook for good laboratory practice In this handbook, the WHO and TDR have put together guidelines for good laboratory practices, [7] which cover every aspect of laboratory work. Although it does not mention ethical issues, the fact that it endorses certain laboratory practices automatically presupposes that these practices are scientifically and ethically sound and acceptable worldwide. These guidelines also include the Organization for Economic Co-operation and Development series on good laboratory practice and compliance monitoring. Coming to the ethical issues involved in the process of doing microbiology work, the following broad areas need to be looked into: Ethical issues in the definition of test design and parameters It is important for us to have a set of standard operating procedures that we follow to a T. Any deviation from these procedures would require ethical and scientific justification. Next, our choice of the test system should be based on valid scientific procedures. If an alternative, cheaper test, with the same performance indicators, is available, we are ethically mandated to provide information about that test as well to both the clinician and the patient. In other words, profit should not be the main motivating factor in choice of tests. Coming to procurement of equipment and consumables, dealings with suppliers necessarily need to be transparent. Ethical issues in documentation of test and environmental variables Ethical issues in the documentation of test and environmental variables include a definition of what test is carried out, when, how, and by whom. For example, we are ethically mandated to inform a clinician about the lack of a diagnostic utility of a single widal test in the first week of fever. In addition, it is ethically wrong to allow unqualified personnel to carry out tests without supervision. Raw and derived data from tests need to be documented carefully, and any tampering with this data is unethical. Ethical issues with quality assurance Similarly, internal and external audits need to be diligently documented and carefully archived. Any tampering is, obviously, ethically unacceptable. Ethical issues with evaluation and reporting of results It is ethically mandated to provide information about interpretation and limitations of the test. Confidentiality of every result needs to be maintained. All are familiar with issues of confidentiality with HIV test results, but it must be remembered that every test result is confidential. Once again, tampering with archives of results constitutes a breach of ethics. Ethical issues related to making results part of accepted scientific knowledge To publish, or not to publish, is obviously a personal choice. However, denying access to results of scientific experiments, when it can benefit the community at large, is a matter of debate. In any case, once the decision has been made to publish, publication ethics-details of which would constitute the content of an entire chapter-need to be followed. Ethical issues with use of stored of biological material Once the requested diagnostic tests are carried out, many of us store serum and other biological material. Carrying out other tests on this material would require informed reconsent from the patient/individual for which different options are available. Wherever the patients/individuals are not available for reconsent, the research protocol needs to be cleared by an authorised ethics committee for waiver of consent. These emerging new concepts should be brought to the attention of all microbiologists. Research ethics Research ethics is an important part of microbiology. This involves ethical review of protocols, documentation, and informed consent from individuals reporting of adverse events and any deviation from protocols. Regular reviews are mandatory, and ethics in publication has to be followed. Conclusions
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