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An Institutional Review Board: Research Ethics

The central concept of scientific ethics is the concept of responsibility. The goal of developing scientific ethics in research organizations should be to raise the awareness of scientists about all aspects of responsibility. Moreover, one should take into account the criteria for the proper conduct of the scientific activity, which is based on such values as honesty and impartiality, that can only be properly monitored on an institutional basis.

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The approach to scientific ethics that has the most obvious practical application relates to the proliferation of codes of conduct and other types of the so-called soft law. It is assumed that these standards are consistent with the integrity and good practice of the researcher (Resnik, 2018). The advantages of this deontological approach are the measurability and objectivity of ethical judgment based on pre-established principles.

Thus, scientific ethics implies compliance with the norms and requirements for the conduct of scientific research. This applies to projects related to experiments with tissues and cells of humans and animals, as well as experiments on humans and laboratory animals, collection of personal information, potentially harmful effects on the environment, dual-use research, etc. Compliance with these rules is overseen by ethics committees that review and evaluate specific research projects, depending on their context. Along with commissions, there are also ethics committees with more general functions. Their activity is to consider common ethical issues and analyze the global aspects of the impact of certain technologies on humans and society as a whole (Resnik, 2018). One such institutional entity is Research Institutional Review Board (IRB) — these are independent bodies created to protect the rights of human research participants.

An IRB is characterized with particular authority about researching frames of its jurisdiction. It is not allowed to begin any clinical study with enrolling human participants before obtaining approval from IRB. These boards are granted the right to approve, disapprove, or terminate processes of research, require to make modifications in protocols, even in previously approved research. Moreover, they require that participants should be provided with any additional information helping them to make an informed decision about participation in research. Every organization conducting research studies is obliged to address IRB which will review those studies and make a decision about their approvement (Klitzman, 2015). If the research sites are under the jurisdiction of not one IRB, the bodies can carry out joint or separate reviews; moreover, an option is possible when one IRB recognizes the decision of the other as legitimate.

The IRB should ensure consistency of the procedures applied in the proposed research with declared research design; it should be taken into account that no unnecessary risk to participants is allowed. At the same time, the IRB should analyze the only potential and expected risks and benefits resulting from the research, and not consider possible long-term effects of further application of the knowledge obtained in the research.

The investigator is prohibited to admit any participants before obtaining approval of the study from IRB in written form, and no changes to the study protocol are allowed without prior written IRB approval, except when those are crucially necessary to eliminate immediate hazards to participants (Whitney, 2016). At the same time, variation and diversity of reporting requirements are possible, and the investigator is responsible to know the specific reporting requirements of each IRB involved.

It is often believed that the task of ethics is to identify facts of unfair scientific activity and to ensure that deontological norms are observed in the course of research. However, the institutional implementation of the reflective attitude about the innovative, creative, and transformative power of science also belongs to the sphere of ethics. Researchers should strive to understand the possible social consequences of their work, as well as have the necessary skills to comprehensively reflect on the changes in the world that their work may bring about. In turn, research institutions like the IRBs must assess the ethical acceptability of their proposed innovations in light of gradually changing norms and values.

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Klitzman, R. (2015). The ethics police? The struggle to make human research safe. Oxford University Press.

Resnik, D. B. (2018). The ethics of research with human subjects: Protecting people, advancing science, promoting trust. Springer.

Whitney, S. N. (2016). Balanced ethics review: A guide for institutional review board members. Springer.

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