Rules of Procedure of a Research Ethics Committee – An Instrument of Importance to Subjects, Researchers and Committees

Abstract

The development of modern civilization depends on scientific research, often involving human subjects. However, venturing into uncharted territory carries the risk of exposing participants to harm or infringing upon their rights. Therefore, it is desirable that before the experiment is carried out, its design be verified by a competent body that will assess its theoretical assumptions, justification, methodology, feasibility, and the mechanisms put in place to protect the rights and interests of the research participants. With regard to medical experiments, this role is assumed by bioethics committees. However, in the case of research in the humanities and social sciences, general regulations do not require establishing such bodies or issuing opinions on the aforementioned projects. Nevertheless, committees for research ethics may be established on the basis of an internal organizational act, in universities – by order of the rector. Given that general regulations do not specify their mode of operation, the key document governing these issues is the committee's own rules of procedure. It performs a number of functions in relation to potential subjects, researchers and committee members. However, in order to perform these functions, it must contain appropriate provisions. The article presents the key structural elements of the rules of procedure concerning the committee's structure, guidelines for reviewing applications and protocols to be followed. It also indicates possible templates for attachments to applications submitted by persons seeking an opinion, in particular the structure of the application itself and information for potential research participants. The article may therefore be helpful both for those who develop and who apply committee regulations.