Читать книгу 100 Questions (and Answers) About Research Ethics - Emily E. Anderson - Страница 19

All persons involved in conducting research, whether they are the lead researcher of a study (called the principal investigator, or PI), or a research assistant working for the PI, are obligated to follow all the ethical rules for research. However, the PI has primary responsibility for what happens during the research. Students conducting research for their thesis or dissertation may have a faculty advisor, but the student has primary responsibility for the protection of research participants. No matter who funds the research, who is conducting it, and what specific form of review is required by an institutional review board (IRB), researchers (PIs, research assistants, and student investigators) must adhere to the basic principles of respect for persons, beneficence, and justice.

Federal research regulations are enforced through a system of local review by an IRB. An IRB is a committee that reviews research to ensure the safety and well-being of human research participants. IRB is the name designated for such committees in the United States. Internationally such committees may also be called research ethics boards (REBs) or committees (RECs). IRBs are located at institutions where research is conducted, such as at universities. Large research institutions may have multiple IRBs. The IRB submission and review process is discussed in detail in Part 8.

An IRB’s primary responsibility is to review planned research studies before they are conducted. This review aims to ensure a favorable balance of risk and benefits; minimization of risks to participants; fair recruitment practices that do not exploit particular groups; and adequate plans to secure valid, voluntary, informed consent when necessary. No recruitment, enrollment, or data collection may begin until an IRB reviews the research study.

In the United States, if research is conducted or supported by a federal government agency (such as the National Science Foundation or the Department of Education), or if data collected will be submitted to the Food and Drug Administration (FDA), then IRB review is required by law. However, academic research institutions almost always require that all human research conducted by students, faculty, and staff members undergo some type of IRB review, regardless of funding source or type.

Because federal research regulations and professional codes do not dictate specific requirements for all situations in research, institutions that conduct research also develop and disseminate their own detailed policies. These policies must be consistent with the federal regulations; but they may include additional requirements, some of which are more stringent than the federal regulations. Researchers are expected to follow their institution-specific policies in addition to the federal regulations.

More questions? See #6, #10, and #81.