<< Previous Section | < Previous Page | Next Page > | Next Section >> Institutional Review Board (IRB) Mission IRBs are impaneled to protect the rights and welfare of human subjects and support the institution's research mission. By requiring local review the Federal Government requires local responsibility that is both institutional and individual. Researchers must respect and protect the rights and welfare of individuals recruited for, or participating in, research conducted by or under the auspices of the Institution. By institution is meant any entity that is sanctioned by the Federal Government to conduct research. The IRB is constituted to be the agency within the institution that reviews and approves research involving humans. Research actions are guided by the principles set forth in the Belmont report (see above). IRBs have a full time administrative core to handle the applications, keep abreast of the changing rules, and monitor the approved protocols. IRB members consist of faculty and non-affiliated non-scientists who in the aggregate possess a broad range of expertise and interests corresponding to the research proposed. Research institutions have a contract, called an assurance, with the Federal government outlining their collective obligations and responsibilities to protect human subjects. These multiple project assurances require ethical review of all human research under defined rules. Review by the institutional IRB(s) is required for research on humans when the conduct or recruitment of the research involves institutional resources, property, or facilities, regardless of funding source, when the research is conducted by or under the direction of any employee, student, or agent of the institution: in connection with her/his institutional responsibilities using any property or facility of the institution when the research involves the use of an institution's non-public information to identify or contact potential subjects The Common Rule adopted the principle of local control of research oversight because: It would enhance education of the research community & the public It would provide greater familiarity with the actual conditions surrounding the conduct of the research It would enhance the ability to work closely with scientists to assure the protection of the rights and welfare of the subjects It would assure that the application of policies is fair to investigators Any study involving research on human beings must go through the IRB. However, there are certain exceptions based on the intent of the research or on the characteristics of the study. Hospitals are required to carry out programs of quality assurance that involves research into clinical practices in the institution. These are usually designed to improve the care locally and there is no intent to generate generalizable knowledge. That is not considered research. On the other hand, a program evaluation/quality assurance program becomes research when the intent of the project is to answer a research question or create generalizable knowledge that will be shared outside of the program being assessed, such as journal articles, professional presentations, etc. Frequently the findings precipitate the interest in publishing. In general, a Study is exempt from IRB Review if it is Research in commonly accepted educational settings involving normal educational practice (Think course evaluations) Surveys, Interviews Questionnaires Observation of public behavior, unless subjects can be identified, directly or through identifiers linked to the subjects; and any disclosure of the human subjects' responses outside of the research could reasonably place the subjects at risk of criminal liability or be damaging to the subjects' financial standing, employability, or reputation Collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if: The sources are publicly available, or If the information is recorded in such a manner that subjects cannot be identified directly or through identifiers linked to the subject Due to HIPAA: Medical record reviews are no longer exempt << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 2 Quick Links Research in Humans History of Rules About Research in Humans Definitions Federal Mandate Respect for Persons Beneficence Justice Common Rule IRB Mission Cases Bibliography Chapter 2 Download (PDF)