Alvita Nathaniel, Ph.D., FNP-BC, FAANP Introduction In the U.S., all research must be approved by an Institutional Review Board (IRB) that evaluates research protocols for the purpose of protecting human subjects. This paper includes a brief history of the development of public policy that guides institutional review boards in the U.S. and commentary on the responsibilities of a grounded theory researcher interested in applying for approval for a research study. An institutional review board (IRB) is a formally constituted committee that approves and monitors biomedical and behavioural research with the purpose of protecting the rights and welfare of research participants. An IRB performs scientific, ethical, and regulatory oversight functions. In the U.S., it is common for grounded theorists to experience frustration with the IRB protocol submission process. Facets of the application process may seem rigid, redundant, and non-applicable. Review board members may not seem to understand or appreciate qualitative methods and delays are common. In addition, a conglomeration of disparate policies and procedures coupled with a variety of types of review boards creates a system that defies description. Nevertheless, a researcher who understands public policy and the responsibilities of institutional review boards can learn to develop research applications that are quickly approved. Created to protect the rights of human subjects, institutional review boards’ policies and procedures flow from ethical principles and two critical 20th century documents. The ethical considerations of harm versus benefit, privacy, confidentiality, respect for persons, truthfulness, and autonomy undergird the protection of human research participants. These principles began to be codified during the Nuremberg trials in response to atrocities committed by Nazi era German physicians in the name of medical research (October 1946 – April 1949). Developed by the panel of international judges overseeing the Nuremberg Military Tribunals and with the assistance of physician consultants (Shuster, 1997), the code served as a set of principles against which the experiments in the concentration camps could be judged (Burkhardt & Nathaniel, 2008). Subsequently, the Nuremberg Code became a blueprint for the Declaration of Helsinki. Addressed primarily to physicians in 1964, the World Medical Assembly developed this declaration as a “statement of ethical principles for medical research involving human subjects….” (World Medical Association, 1964). In the years that followed, governments began to develop regulations based upon ethical principles, the Nuremberg Code, and the Declaration of Helsinki. In 1962, the Kefauver-Harris Bill expanded the principles from the Nuremberg Code by ensuring greater drug safety in the United States. Enacted after thalidomide was found to have caused severe birth defects, the Kefauver-Harris Bill 1) empowered the Food and Drug Administration (FDA) to ban drug experiments on humans until safety tests have been completed on animals, 2) required drug manufacturers and researchers to submit adverse reaction reports to the FDA, 3) required drug advertising to include complete information about risks and benefits, and 4) required informed consent from clinical study participants (First Clinical Research, 2010). In 1966, the U.S. Surgeon General issued a policy statement entitled Clinical Research and Investigation Involving Human Beings in the form of a memorandum to the heads of the institutions conducting research with public health service grants (Sparks, 2002). The policy, which stipulated that all human subject research must be preceded by independent review, was the origin of IRBs in the U.S. (Sparks, 2002). Other public policies followed the Surgeon General’s memorandum. An important longitudinal study began before the Surgeon General’s policy statement and continued for many years afterwards. Every country has profound stories about violations of...