Navigating the Process of Ethical Approval: A methodological note

Eileen Carey, RNID, BSc. (hons), MSc. Abstract Classic grounded theory (CGT) methodology is a general methodology whereby the researcher aims to develop an emergent conceptual theory from empirical data collected by the researcher during the research study. Gaining ethical approval from relevant ethics committees to access such data is the starting point for processing a CGT study. The adoption of the Universal Declaration on Bioethics and Human Rights (UNESCO, 2005) is an indication of global consensus on the importance of research ethics. There is, however, a wide variation of health research systems across countries and disciplines (Hearnshaw 2004). Institutional Research Boards (IRB) or Research Ethics Committees (REC) have been established in many countries to regulate ethical research ensuring that researchers agree to, and adhere to, specific ethical and methodological conditions prior to ethical approval being granted. Interestingly, both the processes and outcomes through which the methodological aspects pertinent to CGT studies are agreed between the researcher and ethics committee remain largely ambiguous and vague. Therefore, meeting the requirements for ethical approval from ethics committees, while enlisting the CGT methodology as a chosen research approach, can be daunting for novice researchers embarking upon their first CGT study. This article has been written in response to the main challenges encountered by the author from an Irish perspective when seeking ethical approval to undertake a CGT research study with adults with intellectual disabilities. The emphasis on ethical specifications meant that the CGT author had to balance ethical principles and rules with issues of ‘not knowing before one is in a position to know’ and ‘trusting in emergence’. Ethical prescription challenged the emergence inherent within CGT methodology. While acknowledging the need for ethical requirements, this paper is intended in particular to illuminate methodological challenges which may confront novice classic grounded theorists, and offer some insight into the practicalities of balancing the requirements of ethics committees with the requirements of the CGT methodology. The author demonstrates that the meticulous nature of the CGT methodology must not be overshadowed when meeting the requirements of ethics committees. The author seeks to encourage novice classic grounded theorists to approach ethics committees with research proposals which reflect the fundamental principles of CGT methodology while challenging experienced classic grounded theorists researchers to stand firm on ethics committees supporting such proposals. Introduction In Ireland in 2009, there were 26,066 people registered on the National Intellectual Disability Database (NIDD, 2010). Of the above figures 25, 556 people with intellectual disability are in receipt of services, 98% of the total population registered on the NIDD (NIDD, 2010). The current focus of Irish service delivery when working with and for this group of people is Person Centred Planning (PCP). The National Standards for Disability Services define a person centred service as one which is designed, organised and provided around what is important to the person from his or her perspective (NDA, 2004). CGT methodology fits closely with some of the principles of person centred planning in that it focuses on explaining what the main issue of concern for the person is and how he/she continually resolves this concern. Currently, in Ireland, there is a dearth of research representing what is actually happening in the lives of people with intellectual disabilities. CGT methodology is particularly suited to looking at rarely explored phenomena where extant theory would not be appropriate. In such situations, a grounded theory building approach is anticipated to generate novel and accurate insights into the phenomenon under study (Glaser and Strauss, 1967)....

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...