Institutional Review Boards: Perspectives from the United States...

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...

International Perspectives of Ethical Approval: The New Zealand scene...

Antoinette McCallin Ph.D. Introduction The paper “Navigating the process of ethical approval” (Carey, 2010) raises many issues about the influence Institutional Ethics Committees have on research methodology and what can or cannot take place in research. Carey draws attention to the ethical challenges classic grounded theory researchers face when an ethical proposal that follows the principles of the methodology is presented to an Ethics Committee, whose main responsibility is the protection of participants. Ethics committees not only guide researchers on acceptable ethical practice, but are charged with monitoring ethical standards and ensuring researchers act in accordance with professional expectations for researchers within the jurisdiction. These committees aim to ensure consistency of ethical practice in research. While there is generally some flexibility in the review process researchers often find ethical requirements constraining, as guidelines are primarily prescriptive and are designed to ensure consistency in the application of universal ethical principles in research. In New Zealand, consistency includes paying attention to broader socio-cultural responsibilities to society that includes promoting awareness of the Code of Health and Disability Services Consumer Rights 1996, the Health Information Privacy Code 1994, and promoting ethical practices which involve Maori (the local indigenous people) in research proposals as much as possible (Ministry of Health, 2006). So while researchers in training assume that their prime interest concerns the management of a research topic and methodology, they quickly find out that ethical guidelines influence research design. Even though there is an international code of ethics (Universal Declaration of Human Rights, 2005) that defines ethical standards for researchers around the world, each country has its own specific requirements depending on the context. In this paper, ethical drivers in the New Zealand context are outlined and considered in relation to Irish issues. This is followed by a consideration of methodological rules and managing the practical realities that emerge when working with a specialist methodology such as grounded theory. Ethical drivers: New Zealand and Ireland There are two major drivers that have influenced ethics and research in New Zealand. The first was a public inquiry into medical research conducted on women who had major cervical abnormalities (Cartwright Report, 1988). The Cartwright Inquiry found that women with cervical abnormality were entered into a randomised control trial without informed consent. Some were treated while others were not. Many subjects developed cervical cancer. Some women died. This inquiry, which was known as “the unfortunate experiment,” raised critical issues about consumer rights and informed consent in research. The Cartwright Report recommended the establishment of the Office of the Health and Disability Commissioner that developed the Code of Health and Disability Services Consumer Rights (1996) and established the Health Information Privacy Code (1994) mentioned previously. Cartwright also recommended that Ethics Committees improve their systems and review processes. Much progress has been made since in that Ethics Committees operate independently from researchers. There is though some tension in balancing individual rights and safety with the increasing pressure for research development in New Zealand (Women’s Health Action Trust, 2010). The Women’s Health Action Trust for example, questions researcher compliance in relation to consumer protection. Nonetheless, the primary purpose of Ethics Committees in New Zealand is to protect and safeguard research participants, and to respect the dignity of persons (Ministry of Health, 2006). The second critical factor influencing research in New Zealand is the Treaty of Waitangi, a document determining the relationship between the indigenous people (Maori) and the Crown. The central focus of this Treaty is the individual rights...

The Future of Grounded Theory1

Barney G. Glaser, Ph.D., Hon. Ph.D. [This keynote address does not detail a “wish list”; it is not an ideology. Rather, it is a grounded analysis of data from the author’s travels that indicates what the future of grounded theory is likely to be. The author discusses in whose hands the future of grounded theory appears to be as well as what accounts for its spread, its use, and its misuse. This paper was first written in 1998. I will try to update it, though most still applies.] I would like to speak about what I consider the future of grounded theory. I will discuss in whose hands the future of grounded theory appears to be and what accounts for its spread, its use and misuse, and where the majority of grounded theory studies are occurring. I will then briefly review poor grounded theory, qualitative grounded theory, social fictions, and theory bits. Finally, I will touch on the future structures in which grounded theory will be taught and centered. First, a few guidelines are necessary. Grounded theory refers to a specific methodology on how to get from systematically collecting data to producing a multivariate conceptual theory. It is a total methodological package. It provides a series of systematic, exact methods that start with collecting data and take the researcher to a theoretical piece that is publishable. Now, all research is grounded in data in some way. It is implicit in the definition of research. Thus, research is grounded by definition, but research grounded in data is not grounded theory, although many jargonizers would have their work designated that way. It is grounded theory only when it follows the grounded theory methodological package. Second, grounded theory is just a small piece of the action in social psychological research. Research methods go in many directions, using many methodological approaches, both quantitative and qualitative and mixes thereof. Grounded theory is a specific general methodology. It is no better or worse than other methods. It is just another option for researchers. Grounded theory is used in part or in whole by researchers. When used in part, it is “adopt and adapt,” with other research methods woven in, based on the training and judgment of the researcher involved. The multi version view of GT is based on jargonizing with the GT vocabulary, not on the GT procedures (Glaser, 2009). I will speak here on the pure or orthodox view, knowing as I said in my reader, Grounded Theory, 1984-1994 (Glaser, 1995), that most researchers mix methods by jargonizing. Third, when Anselm Strauss and I wrote The Discovery of Grounded Theory in 1967 (Glaser & Strauss, 1967), Anselm would say to me, “Barney, we are 15 to 20 years ahead of our time.” He was right in my view, so I thought, “Good, I can do other things and bide my time.” Well, to my surprise, 15 to 20 years later, grounded theory has gone global, seriously global among the disciplines of nursing, business, and education and less so among other social-psychological-oriented disciplines such as social welfare, psychology, sociology, and art. Sociology Press sells books to Russia, Iran, Malaysia, Saudi Arabia, China, Poland, Netherlands, Australia as well as Northern Europe. Everywhere I travel, people come to my workshops at some expense and from some distance to hear me and to ask questions. People compete for my attention and to be my host. I embody what they embrace—grounded theory. We wrote the book in 1967, and...

Is That a Real Theory or Did You Just Make It Up? Teaching Classic Grounded Theory...

Odis E. Simmons, Ph.D. Abstract The title of this paper was derived from an incident I observed some years ago while accompanying a highly talented musician-songwriter friend to a performance. During a break, an audience member approached him to compliment the last song he had performed. He had written both the music and the lyrics to the song, one of many he had written. The audience member queried, “Is that a real song, or did you just make it up?” A touch amused, and not knowing whether he should be flattered or insulted, he politely replied, “It is a real song and I made it up.” This episode puts in mind a similar attitude in the social sciences that Glaser and Strauss (1967) noted, in which a small number of ’theoretical capitalists’ originate what are considered to be “real” theories and others are relegated to the role of “proletariat” testers. The means by which these theorists derived their theories remained largely mysterious. Unleashing proletariat testers was one of the chief rationales behind Glaser and Strauss’ development of grounded theory. It brought a democratic option into the social sciences that enabled anyone who learned the methodology to generate theory. The democratic ethos of the methodology may also have inadvertently unleashed an abundance of aspiring remodelers of the methodology, who unfortunately have eroded its primary purpose—to generate theories that are fully grounded in data rather than speculation or ideology. Introduction Since Glaser and Strauss published The Discovery of Grounded Theory in 1967, the methodology they originally conceived (1) has been subjected to numerous forms of methodological torturing. It has been misrepresented, misconstrued, distorted, and “remodeled” (Glaser, 2003) into varieties of “constructivist grounded theory” (Charmaz, 2000, 2006) and/or standard qualitative data analysis (Glaser, 2002, 2003, 2004) which has been “jargonized” (Glaser, 2009) with grounded theory terminology. Grounded theory, or at least what many secondary authors attempt to pass as grounded theory, has been “slurred” (Baker, Wuest, & Stern, 1992; Raffanti , 2006), “eroded” (Stern, 1994; Greckhamer & Koro-Ljungberg, 2005), “reconstructed” (Haig, 1995), “broadened” (Kools, McCarthy, Durham, & Robrecht, 1996), “diffused, diluted or distilled” (May, 1996), and “evolved” (Mills, Bonner, & Francis, 2006) to the point that much of what is called grounded theory has become a bit alien to classic grounded theorists who still honor its primary purpose, intent, and origins. Through all of these methodological machinations its original purpose has seemingly been forgotten. Before his passing, even Strauss (1987) and his co-author Corbin (Strauss & Corbin, 1990, 1998; Corbin 1998) diverged from the original articulation of the methodology that he and Glaser laid out in The Discovery of Grounded Theory (1967).  (2) Although Glaser has continued to write books about grounded theory as he and Strauss originally conceived it (3)  (Glaser, 1978, 1992, 1996, 1998, 2001, 2003, 2005a, 2006, 2008, 2009) the runaway perverting of the methodology continues largely unabated.(4 )  In my view, the primary reason for this is that the bulk of those who consider themselves to be grounded theorists gained their understanding of grounded theory through what Stern (1994) termed “minus mentoring” and I termed “bootstrapping” (Simmons, 1995). Although the number of researchers doing what has come to be called grounded theory has increased exponentially since 1995, the situation regarding systematic training in grounded theory has changed little. However, for the last decade or so Glaser has been teaching the nuances of grounded theory in periodic two day ’troubleshooting’ seminars in multiple locations within the U.S. and internationally....

Theories in Progress Series: Perpetual Identity Constructing...

Alison Clancy, RGN, M.Sc., B.NS, HDNS (Diabetes), Pgrad (Teaching and Learning), Ph.D. Candidate, University College Dublin Abstract For academics who work within higher education, the difficulties in finding the space and time to learn, to reflect and to self-evaluate have increased due to multiple expectations and demands of an increasingly competitive business environment. This substantive theory of ‘Perpetual Identity Constructing’ proposes that when academics are presented with an opportunity to enhance their development, they experience a 3-stage process that facilitates their constructing a preferred sense of their academic identity. This theory of managing a predisposed identity, deconstructing and then reconstructing a preferred academic identity demonstrates the critical importance of institutional support for providing academics with needed space and time to realise their full potential. Key words: Academic identity, possibility portals, learning spaces. Introduction In contemporary society, universities exist within a context of supercomplexity (Barnett, 2000a). Supercomplexity refers to the requirement that the university must respond to an over-abundance of information in a world that is now characterised by: [c]ontestability, changeability, uncertainty and predictability, these four concepts are surrounded by others such as change, turbulence, risk and chaos. Together, this set of concepts marks out the conceptual geography of our supercomplexity as an age of fragility… It is an age in which nothing can be taken for granted. In short all bets are off. It is an age of conceptual and thereby, emotional insecurity” (Barnett, 2000a, pp. 414-416) A consequence of this supercomplexity is uncertainty within higher education; ‘the individual increasingly stands alone, looking for security in the face of uncertainty’ (Annandale, 1998, p.19). The changing nature of higher education is a global phenomenon that has impacted the vast majority of academics with a ‘weariness and resistance to what is perceived to be externally imposed shifts in the higher education environment’ (D’Andrea & Gosling 2005, p.15). Lecturers are faced with increased class sizes, greater student diversity (McNay, 2005), more short term contracts and an ever-increasing research agenda (Boud, 1999). Consequently, academics have experienced so much difficulty in adapting to this rapid change that they no longer are sure of what is expected of them (Harris, 2005; Biggs, 2003; Trowler, 2001; Henkel, 2000). Biggs (2003) suggests that those now working in higher level institutions originate from one of two groups: the older, more mature academics who express that they no longer recognise the environment in which they work and the younger academics on short term contracts who lack employment security and therefore would not consider attempting anything that may be out of kilter with the organisation’s overall strategy. The difficulty in adapting to change is further compounded by the increased emphasis on accountability and a perceived lack of institutional support in pursuing needed change. The imposition of increased demands has led to a sense of powerlessness, particularly in terms of teaching and learning (Rowland, 2000). The established research agenda within many higher level institutions has left many academics frustrated in regard to their positions and their roles. This is further heightened by organisational structures that fail to foster teaching and learning. This sentiment of frustration has been expressed by Scott (2002, p. 27): In our knowledge intensive society, we are both teachers and researchers. The present separation between teaching and research damages both. You cannot communicate knowledge without adding to it and you cannot add to knowledge without communicating it. Every act of exposition, every dialogue with a student, has the potential for creating new insights; and all research findings must...