Ethics And Biomedical Issues

20th November 2012

Abstract Biomedical engineering is a learned profession that combines expertise and responsibilities in engineering, science, technology, and medicine. Since public health and welfare are paramount considerations in each of these areas, biomedical engineers must uphold those principles of ethical conduct embodied in this Code in professional practice, research, patient care, and training. This Code reflects voluntary standards of professional and personal practice recommended for biomedical engineers .In this paper we shall be enlightening the situation when you juxtapose science with religious issues taking into consideration of Islam. Along with DNA storage and DNA banking for biomedical research and its technical, social ethical issues ;educational and Social ethical issues in the pursuit of molecular medicine and Rationality and religion in the public debate on embryo stem cell are elaborately discussed.

Introduction Medicine is not an exact science in the way that mathematics and physics are. It does have many general principles that are valid most of the time, but every patient is different and what is an effective treatment for 90% of the population may not work for the other 10%. Thus, medicine is inherently experimental. Even the most widely accepted treatments need to be monitored and evaluated to determine whether they are effective for specific patients and, for that matter, for patients in general. This is one of the functions of medical research.Another, perhaps better known, function is the development of new treatments, especially drugs, medical devices and surgical techniques. Great progress has been made in this area over the past 50 years and today there is more medical research underway than ever before. Nevertheless, there are still many unanswered questions about the functioning of the human body, the causes of diseases (both familiar and novel ones) and the best ways to prevent or cure them. Medical research is the only means of answering these questions. All physicians make use of the results of medical research in their clinical practice. To maintain their competence, physicians must keep up with the current research in their area of practice through Continuing Medical Education/ Continuing Professional Development programs, medical journals and interaction with knowledgeable colleagues. Even if they do not engage in research themselves, physicians must know how to interpret the results of research and apply them to their patients. Thus, a basic familiarity with research methods is essential for the competent medical practice. The best way to gain this familiarity is to take part in a research project, either as a medical student or following qualification.

Ethical Requirements With the upraising of the field of biomedical research, one cant be oblivious to the issues related to it. One needs to be eclectic about an experiment whether it can have consequences or unexpected aftermaths. In order to check whether the ethical requirements are adhered to every proposal for medical research on human subjects must be reviewed and approved by an independent ethics committee before it can proceed. In order to obtain approval, researchers must explain the purpose and methodology of the project; demonstrate how research subjects will be recruited, how their consent will be obtained and how their privacy will be protected; specify how the project is being funded; and disclose any potential conflicts of interest on the part of the researchers. The ethics committee may approve the project as presented, require changes before it can start, or refuse approval altogether. Many committees have a further role of monitoring projects that are underway to ensure that the researchers fulfill their obligations and they can if necessary stop a project because of serious unexpected adverse events. The reason why ethics committee approval of a project is requiredis that neither researchers nor research subjects are always knowledgeable and objective enough to determine whether a project is scientifically and ethically appropriate. Researchers need to demonstrate to an impartial expert committee that the project is worthwhile, that they are competent to conduct it, and that potential research subjects will be protected against harm to the greatest extent possible. One of the more controversial requirements of a medical research project is that it contribute to the wellbeing of society in general. It used to be widely agreed that advances in scientific knowledge were valuable in themselves and needed no further justification. However, as resources available for medical research are increasingly inadequate, social value has emerged as an important criterion for judging whether a project should be funded. The social worth of a research project is more difficult to determine than its scientific merit but that is not a good reason for ignoring it. Researchers, and ethics review committees, must ensure that patients are not subjected to tests that are unlikely to serve any useful social purpose. To do otherwise would waste valuable health resources and weaken the reputation of medical research as a major contributing factor to human health and well-being. It should not be necessary to require that research results be reported accurately, but unfortunately there have been numerous recent accounts of dishonest practices in the publication of research results. Problems include plagiarism, data fabrication, duplicate publication and gift authorship. Such practices may benefit the researcher, at least until they are discovered, but they can cause great harm to patients, who may be given incorrect treatments based on inaccurate or false research reports, and to other researchers, who may waste much time and resources trying to follow up the studies.

Religion and Research Bio medical research in some aspects has created rather a clich midst the culture which has engulfed more than 1.1billion people on planet.
[1]In 1963,

Muslim students studying in American colleges and universities organized themselves into an association (Muslim Students Association). Four years later, in 1967, American Muslim physicians did the same and formed IMANA. MSA transformed into the Islamic Society of North America (ISNA) and IMANA became a constituent body of ISNA. Since its inception in 1967, IMANA has dedicated itself to serving Muslim physicians, Muslim patients and the community at large on issues related to Islamic Medicine nationally and worldwide. IMANA is also a member of the international Federation of Islamic Medical Associations (FIMA). Islamic Medicine is defined as the art and science of practice of medicine by Muslim physicians and other health care providers in the service of humanity under Islamic guidelines as ordained by the divine book Quran and taught by Prophet Mohammad (peace be upon him). IMANA has headquarters in a Chicago suburb and regional chapters in many cities of USA. It is governed with By-Laws and an executive committee. It has several operational committees including the medical ethics committee. Islamic Medical Ethics Islamic practices and beliefs were reviewed for various age groups for the outpatient and inpatient settings.There are many similarities between Islamic concepts of health,treatment and childrens rights and secular ones.Notable exceptions include a greater emphasis in Islam on the sanctity of life from conception onward,concept of maturity ,premarital sex and contraceptive distribution. Islam considers access to health care a fundamental right of the individual. In medicine, there are sometimes difficult decision making situations for choosing better options for the patients care. Thus, a physician at times has to decide for his /her patient in light of available knowledge, his/her experience, his/her peers and consensus of the community. In addition, a Muslim physician derives his /her conclusion from rules of Islamic laws (Shariah) and Islamic medical ethics. The two main principles of Islamic Medicine are: 1) emphasis of sanctity of human life which derives from Quran 5:32 whosoever saves a human life, saves the life of the whole mankind, 2) emphasis on seeking a cure which derives from saying of Prophet Mohammad (p), seek cure as God has created no disease without creating a cure for it except for old age. The five goals of Islamic Shariah are protection and preservation of life, mind, private ownership, family and freedom of religion. Some of the rules of Islamic medical ethics are 1) Necessity overrides prohibition that is if there are certain items which are islamically prohibited, under dire necessity they can become permissible. 2) Accept the lesser of the two harms if both can not be avoided. 3) Public interest overrides the individual interest. 4) Harm has to be removed at every cost if possible. Islamic Medical Ethics also upholds the four basic principles of biomedical

ethics which are 1) Respect for the autonomy, 2) Beneficence, 3) Non malfeasance, and 4) Distributive Justice[1]. Checklist for treating Moslem Any physician or a research scholar needs to keep the track of the Gregorian as well as the Islamic calendar.For instance Muslims fast during the entire lunar month of Ramadan ,which varies in relation to the months of Gregorian calendar. The fast lasts each day from dusk to dawn,during which time Muslims abstain from food, drink and conjugal relations.However a patient should not fast if they fear that it may harm them or the child s hes carrying in womb.Non-nutritive medications are permissible by all routes except oral when fasting [2].Any nutritive injection or solution, such as dextrose or total parental nutrition solutions, invalidate the fast and any Muslim requiring such treatments should not fast.

Ethics regarding preserving Hierarchy The last few years have witnessed an important expansion of human DNA sampling and data collecting. This activity has strategic importance for genetic research, clinical care and future treatments. Collections should be maintained and their use optimized. Human DNA, tissue or cell collections and the attached databases have been extensively exchanged for scientific purposes. However, the status of such collections and databases is not well defined and most institutions have no written policies or agreements regarding this activity. Collections and databases are expensive to establish and maintain. They are of high interest to scientists, to industrial partners, to health care professionals and ultimately for the community. It is difficult to separate public and private research, as researchers from both sectors are often involved in the same project. While this enables effective technology transfer, it also gives rise to concerns about conflicts of interest. Reasons for DNA banking healthcare depends on research, and modern research requires access to biological samples, including DNA. The potential benefits justify the establishment of DNA banks, but the possibility of misuses imposes a responsibility of proper management and protection of the subjects interests. As far as issues of proper management Concerning postmortem uses of samples, a policy of unrestricted access cannot be justified on the grounds that the risk or harm for the subject are no more an issue. If individuals restrict use of their sample when they are still alive, those restrictions apply after their death. Old collections should be regarded as abandoned and therefore useable for new research purposes as long as ethics committee approval is obtained. The implementation of security mechanisms to ensure the confidentiality and long-term conservation of genetic information are an absolute condition. These mechanisms should be in place before the sampling is done, including standardization of coding, sample tracking, computerization and encryption. The standards adopted should permit sample information sharing for research purpose with minimum risk. Discussions should be encouraged among consortia of bankers to issue standardized bank protocols[4].

Molecular Medicine Boon or Taboo Molecular Medicine is a broad field, where physical, chemical, biological and medical techniques are used to describe molecular structures and mechanisms, identify fundamental molecular and genetic errors of disease, and to develop molecular interventions to correct them. The molecular medicine perspective emphasizes cellular and molecular phenomena and interventions rather than the previous conceptual and observational focus on patients and their organs[5].In order to compendium effect among the society it has become the need of the hour to discuss the educational and social-ethical issues raised by the advances of biomedical research as related to medical practice; outline the implications of molecular medicine for patients, physicians, and researchers; and underline the responsibilities of academia and the pharmaceutical industry to translate the scientific knowledge to a meaningful improvement of the quality of life across all members of society. Molecular medicine marks a bright future for the pharmaceutical and biotechnology sector, providing that these organizations remain committed to their corporate social responsibilities to sustainable socioeconomic development and improve the quality of life across all members of the society. The translation of the advances of molecular medicine into clinical practice is not without technical, educational, as well as social-ethical, challenges. Although the application of genomic technologies into discovery of new disease classifications on the basis of novel genetic and epigenetic alterations has been highly successful, application of technologies targeting the transcriptome has yet to contribute much to the day-to-day care of patients. While a large body of literature has described multi-gene expression profiles potentially useful for disease classification, diagnosis, and prognosis[5] ,only a few of these discoveries have been validated independently and fewer are in the process of further development for potential routine clinical use (as exemplified by use of Oncotype assay in breast cancer therapy)[6]. Molecular medicine has revolutionized our understanding and management of several previously incurable diseases. Whether this will translate into optimal handling of patients and global relief of human suffering will probably depend on society as a whole and not solely on the fruits of biomedical research. However, with sound prioritization of goals, a special focus on education and rational allocation of resources. Decision makers in the political field need to be alerted continuously about the need to prioritize molecular medicine research, with a special focus on collaborative efforts between basic, population, as well as clinical research scientists. The outcome of these interdisciplinary collaborations is a bidirectional approach to molecular medicine research, moving clinical observations to the laboratory environment as well as laboratory discoveries to clinical settings. Funding of these types of collaborations is perhaps best exemplified by the Specialized Programs of Research Excellence (SPOREs) and the Cancer Centers program of the National Cancer Institute (NCI)[6].In these models, investigators from different disciplines work collaboratively to foster research programs that target cancer prevention, diagnosis, and treatment with the ultimate goals of reducing cancer incidence and mortality, and improving

survival and quality of life.

Embryo Stem Cells Embryonic stem cells, as their name suggests, are derived from embryos. Most embryonic stem cells are derived from embryos that develop from eggs that have been fertilized in vitro in an in vitro fertilization clinicand then donated for research purposes with informed consent of the donors. They are not derived from eggs fertilized in a woman's body [7]
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In recent years we have witnessed heated discussions concerning the political regulation of embryo stem cell research and the use of new genetic technologies in biomedicine. Religious views have played a crucial role in some of these discussions, not least those concerning reproductive technologies. President of the USA being widely criticised for allegedly letting religion restrict research aiming for the common good when vetoing federal funding for research on new stem cell lines. Distinction between religious citizens and secular citizens[8]. Religious citizens are understood as those who believe in some supernatural power or reality that may influence the way we do or should lead our lives. For believers, religion is a fundamental source of energy and of normative judgements also in the political sphere, and these judgements cannot easily be secularised without losing content and force.

Protocols A practitioner shall not accept the case or research work readily , a few protocols are to be adhered to. He/She should first find out more about the project and ensure that it meets all the requirements for ethical research. In particular she/he should ask to see the protocol that was submitted to the ethics review committee .He/she should only participate in projects in his/her area of practice , and she should satisfy herself about the scientific merit and social value of the project . If He/she is not confident in her ability to evaluate the project, he/she should seek the advice of collegues in larger centres. She/he should ensure that he/she act in the best interest of the research work or the subjects.

Unresolved Issues Not all aspects of research ethics enjoy general agreement. As medical science continues to advance, in areas such as genetics, the neurosciences and organ and tissue transplantation, new questions arise regarding the ethical acceptability of techniques, procedures and treatments for which there are no ready-made answers. Moreover, some older issues are still subjects of continuing ethical controversy, for example, under what conditions should a placebo arm be included in a clinical trial and what continuing care should be provided to participants in medical research. At a global level, the 10/90 gap in medical research (only 10% of global research funding is spent on health problems that affect 90% of the worlds population) is clearly an unresolved ethical issue. And when researchers do address problems in resource-poor areas of the world, they often encounter problems due to conflicts between their ethical outlook and that of the communities where they are working. All these issues will require much further analysis and discussion before general agreement is achieved. Despite all these potential problems, medical research is a valuable and rewarding activity for physicians and medical students as well as for the research subjects themselves. Indeed, physicians and medical students should consider serving as research subjects so that they can appreciate the other side of the researcher-research subject relationship.

References [1]IMANA ethics committee ,Islamic Habitat Centre ,New Delhi. [2]Issues in Islamic Biomedical Ethics:A Primer for the Pediatrician by Kamyar M. Hedayat and Roya Pirzadeh,MD [3] Data storage and DNA banking for biomedical research: technical, social and ethical issues published in European Journal of genetic Studies. [4]News Medical ,Annual Journal of American Medical Association. [5]Massoud TF, Gambhir SS integrating non -invasive molecular imaging to molecular medicine [6]American Medical Association , Reuters California , Pasadena. [7]Stem Cell Information,National Institues Of Health Resources for stem cell research. [8] Rationality and religion in the public debate on embryo stem cell research and prenatal diagnostics ,Bjrn K. Myskja, published in Med Health Care and Philosophy.