Iranian Journal of Medical Ethics and History of Medicine
Year:2012 | Volume:5 | Issue:SUPPLEMENT 1|Papers Count:11

Research ethics, as one of the main issues of modern bioethics, has attracted the interest of scientists and ethicists in various areas of science and technology around the world. Research Ethics Committees (RECs) have been established to improve putting ethics into practice in the field of research. RECs, fortunately, have received a great deal of attention in different countries, and their mission, goals, and tasks have been described in many national and international guidelines. Ethical guidelines for biomedical research and RECs administrative regulations have been developed in Iran too. The need for special training courses for capacitating members has been emphasized in both international guides and our national administrative regulations for RECs. In this brief article, we present suggestions concerning course presentation and contents, which are provided by international assemblies. In view of the fact that many RECs in our country do not have specific plans for their members' primary training and continuing education, there seems to be a need for fundamental changes in the educational prerequisites for membership in this important organization.

The astonishing advances in medical sciences, owing to research in recent decades, have brought about endless advantages for humans, including improved level of health, prevention of communicable disease, and curative treatments. This trend, despite its great benefits, may undermine the principle of respect for human vulnerability and personal integrity, and expose certain risks to target populations or those excluded from investigations. Therefore, the principle of respect for human vulnerability and personal integrity has received attention by policy makers, law makers, human rights activists, and international organizations. It is necessary to cite the important question that arises here, is there any contradiction between international documents' demands such as the Universal Declaration on the Human Genome and Human Rights and the legal actions of some countries on the principle and merits of Islamic teaching? If not, what type of activity should be undertaken by legislators in Islamic countries in general, and the Iranian Parliament in particular? An in-depth discussion of the issue reveals the fact that there is no contradiction between Islamic law and the principle of respect for human vulnerability and personal integrity. Therefore, there is room for the national legislative body to take legal actions in order to achieve the objectives of the principle of respect for human vulnerability and personal integrity in medical research and practice as articulated by international instruments such as the Universal Declaration on Bioethics and Human Rights in particular.

Healthy volunteers are the first group who take part in experimental studies on the efficacy of new drugs. Parallel with expanding the boundaries of medical science, medical research has shown rapid growth which has caused new and critical ethical challenges in medical research. A clinical trial is one of the essential methods in clinical research and a very challenging method from the ethical viewpoint.Recruiting healthy volunteer participants is necessary in clinical trials of drugs, and it requires special and careful ethical considerations. Although recruiting healthy volunteers is not limited to clinical trials, we have focused our discussion on ethical issues of research on healthy volunteers in this kind of study. In this paper, ethical challenges of involving healthy volunteers in clinical trials have been discussed in four domains of risk-benefit assessment, fair subject recruitment, incentives, and informed consent.The authors believe and argue that using the daily life risks standard as the acceptable risk for healthy volunteers is impractical. We suggest defining a reasonable risk that is acceptable to the research ethics committee. The ethical committee, as a jury, can then evaluate the public acceptance of the risks.

In many countries around the world, we find important evidence about violation of ethics in medical research. In the United States, the history of unethical or even inhuman experiments on human subjects dates back to the time of slavery, and unfortunately, most subjects of these experiments were poor or black people, slaves, prisoners and physical/mentally ill patients. For instance, we refer to the Tuskegee study that was done on black people. Other examples are tormenting experiments on American or Nazi prisoners. In this paper, we will review some infamous unethical experiments and researches in terms of neglecting human dignity and the validity of the research. On the other hand, in response to these dreadful events, some ethical codes and guidelines have been established which we shall review. For instance, the Belmont Report and the Nuremberg Code which were developed in response to the Tuskegee study and Nazi experiments on human subjects, respectively. The medical history of our country, Iran, is free of such troubling acts, however, this does not mean that ethical standards in medical research are fully observed. Therefore, in addition to items that have been enacted so far, to prevent such faults, it is necessary to enact professional codes and guidelines or legislated laws and regulations too.

The Declaration of Helsinki, the most creditable ethical guideline for medical research on human subjects, has been updated 8 times since its establishment and the last revision was in 2008. Researchers, medical research subjects, authors, members of ethics committees, and editors of medical journals must be informed of the tenets of the Helsinki declaration in order to improve achievements of medical research and respect the rights of participants in medical research. In this study, the evolution of the Helsinki declaration is examined, and the provisions of the last version are compared with the previous version (2004). Finally, we made a practical interpretation of the last version, and discussed its differences from previous version. There are seven new paragraphs in the last version of the declaration. Four new paragraphs concern informed consent in areas of its being written and voluntary, renewed consent for using human materials, participants' right to revoke the consent, and exceptions from informed consent requirements. The other three new paragraphs focus on the research subjects' right to being informed of the declarations' provisions, vulnerable groups gaining benefit from research, and registration of randomized clinical trials. It is important for researchers to recognize international guidelines such as the Declaration of Helsinki, because it enables them to use correct scientific and ethical standards in medical research. In the last version of the Helsinki Declaration more emphasis was placed on informed consent and vulnerable groups than previous versions.

In medical etiquette and ethics, benefit and harm assessment includes risk evaluation, rational risk, distinction between medical and non medical utilitarian considerations, individual and community benefit ratio, and issues of the like.This article explores philosophical foundations of this issue. In philosophy, benefit/harm reduces to pleasure/pain and good/bad. Pleasure (spiritual and non-spiritual) is considered a subjective criterion for benefit, whereas applied ethics needs an objective criterion. To achieve such a criterion, we need a specific model for casuistry evaluation and a holistic and organic approach. This article advocates the public sphere model and presumes it is the missing link of ethical confusions and the solution to ethics lack of quantifiability. Public sphere sits between public authority and private sphere, and supervises them impartially. Benefit/harm evaluation components in medical research requires such sphere for clarity and distinction.

Although we have diverse methods in laboratory studies, such as cellular and molecular sciences, understanding many issues related to human health requires research on animals. An ethical duty of every researcher is to respect animal rights. In our country, educational and research activities are carried out frequently on animals. Therefore, guidelines for ethical use of animals in Iran were developed in 2004 after a review of international resources and considering the needs of researchers working with animals. This guideline was written in four sections, including animal transportation, facilities, animal care personnel, and research users. However, some studies show that researchers need comprehensive and easy to use instructions on the ethical use of laboratory animals. On the other hand, inadequate knowledge about ethics principles in research on laboratory animals have revealed the need to update guideline to be more practical, applicable, and in line with researchers' requirements. In this study, the above mentioned guideline was revised and completed in five parts, including transportation, facilities, animal care personnel, research users, and the use of animals in experimental procedures. In the first section, points on transport of animals and facilities, including location, cage, ventilation, humidity, light, temperature, noise, water and food are presented. The new revision, contains additional paragraphs, and some previous paragraphs are split. Another part of the findings is presented in terms of fundamental duties and ethical performance of persons who work in laboratory animals' houses and researchers working with animals. The final section of the findings is related to the use of animals in laboratory processes which are not presented in the previous formulation of the guideline, and includes basic ethical issues in regard to categorizing, anesthesia, surgery, and euthanasia. Therefore, the guideline was revised to be much more practical, more applicable, and should lead to some form of researchers' training in this field.