In many circumstances, it is necessary for researchers to obtain ethical approval from host institutions or appropriate organisations prior to conducting the research. For most social researchers, this usually means seeking approval to undertake a research project from an institutional ethics committee.
In the case of clinical trials, these usually have to be registered with an appropriate authority and registration numbers should be included in all papers that report their results. The International Federation of Pharmaceutical Manufacturers and Associations requires its members to register trials and the Declaration of Helsinki and the World Health Organization both suggest that clinical trials should be registered before participants are enrolled.
The World Health Organization (WHO) is urging research institutions and companies to register all medical studies that test treatments on human beings, including the earliest studies, whether they involve patients or healthy volunteers. As part of the International Clinical Trials Registry Platform, a major initiative aimed at standardizing the way information on medical studies is made available to the public through a process called registration, WHO is also recommending that 20 key details be disclosed at the time studies are begun. (WHO, 2006)
Despite this aim at standardisation, regulations about the type of study that requires ethical approval vary considerably from country to country. Some countries require ethical approval for all studies but most have more complicated requirements or guidelines.
In the United Kingdom, for example, the Health Research Authority, which coordinates and regulates ethical approval of research involving human subjects, specifically excludes projects from requiring ethical approval if they fall into the following categories: clinical audit; service evaluation; research and usual practice/surveillance work in public health. This is despite the ethical implications of some such studies including issues of confidentiality, possible coercion and threats to autonomy. There is also a definitional issue as to what constitutes an approval-exempt study and there may well be overlap with research studies that should seek approval.
Seeking approval (or not) is more complex in non-health or medical areas and the expectations are dynamic and changing over time. For example, Janet Cooper et al. (2004) reported a non-participant observation study of pharmacists (Lewis, 2000) who granted permission on the understanding that they would be observed to obtain a better understanding of their information behaviour. They were thus informed about the study and gave their consent (see Section 10.5 on consent) to be part of it given the study's aims. They were not, however, informed about what aspects of their behaviour were being observed, as they were not shown the observation sheet used to record the type of information sources used by the pharmacists, in case this biased their normal behaviour.
The researcher was a member of staff, which made permission for the study easier to grant, as the researcher was bound by staff codes of conduct on confidentiality. Cooper et al. explained that this non-participant study, reported in 2000, did not require ethical approval at the time because patients were not directly involved and the researcher was a member of library staff at the hospital. However, they concluded that: 'Nowadays, ethics committee approval would be required for any research that involved observation of health service staff in their workplace, particularly if they were interacting with patients and other health professionals' Cooper et al. (2004, np).
A more recent study of a social media advocacy campaign provides another example of research that has not had ethical approval as it was perceived as unnecessary. An international NGO undertook the campaign to elicit public support for a new law in a low-middle income country and research followed to explore the reaction to the campaign. A survey was used to collect data from people who signed an online petition in support of the proposed law. The data are reported in grouped format (counts and percentages), such that participants are not able to be identified from the results. The reported data (answers to the survey and grouped demographics of respondents) were considered low risk. All respondents had agreed to participate in the research.
In line with the changes in what constitutes an ethical issue in research, there is, increasingly, a tendency to require ethical approval for any research involving people: irrespective of any appraisal of the possibility of harm, of issues of informed consent, confidentiality, privacy and anonymity. There is a possibility, within this concern for ethical research, of over bureaucratisation, especially at institutional levels.
Richardson and McMullan (2007) suggested that overly rigid ethics committees can be counter-productive. David Calvey (2008, p. 908) claimed that this is in part due to sociology trying to ensure the highest ethical standards by supposedly learning from the National Health Service (NHS) and assimilating the NHS research ethics process, leading to the adoption of 'inappropriate medical models of doing social research'. Calvey has particular concerns about the stifling of covert research (see Section 220.127.116.11.1 and Section 10.5).
The general problem I have is that there is a sort of codification about the qualitative research journey, which is not always open to risk assessment, review and evaluation. There has been a rise in the bureaucratization around ethics, field research and risk taking and attempts at regulation, most commonly through University Research Ethics Committees, which, if wrongly managed and centre driven from above, can deter, fetter and discourage creative covert research. What these ethics codes articulate is ultimately a species of both protectionism and privileging. Research is a situated business and not open to rationalistic planning. It is in the particular cases of the here and now with participants that ethics are situationally accomplished. (Calvey, 2008, p. 908)
There is a broader albeit less easily resolvable issue of the legitimacy of those providing approval. Does a university ethics committee have any currency beyond the institution, if so how far? Is the reflections of a committee within an institution of sufficient weight to cross national boundaries? Indeed, there have been concerns raised about the ethicality of ethics committees themselves (Hammersley, 2006).
The process of submitting a research proposal to an ethics committee does at least ensure that the researcher has broached the subject of the ethical nature of the research. Whether the researcher abides by the terms of the approval, what can be done if the research oversteps the boundaries and how does anyone find out are much more problematic areas. Similarly, does registering research with a professional body of some kind really ensure that the undertaking is ethical?