Research approvals iceberg: how a ‘low-key’ study in England needed 89 professionals to approve it and how we can do better

Abstract

BackgroundThe red tape and delays around research ethics and governance approvals frequently frustrate researchers yet, as the lesser of two evils, are largely accepted as unavoidable. Here we quantify aspects of the research ethics and governance approvals for one interview- and questionnaire-based study conducted in England which used the National Health Service (NHS) procedures and the electronic Integrated Research Application System (IRAS). We demonstrate the enormous impact of existing approvals processes on costs of studies, including opportunity costs to focus on the substantive research, and suggest directions for radical system change.Main textWe have recorded 491 exchanges with 89 individuals involved in research ethics and governance approvals, generating 193 pages of email text excluding attachments. These are conservative estimates (e.g. only records of the research associate were used). The exchanges were conducted outside IRAS, expected to be the platform where all necessary documents are provided and questions addressed. Importantly, the figures exclude the actual work of preparing the ethics documentation (such as the ethics application, information sheets and consent forms). We propose six areas of work to enable system change: 1. Support the development of a broad range of customised research ethics and governance templates to complement generic, typically clinical trials orientated, ones; 2. Develop more sophisticated and flexible frameworks for study classification; 3. Link with associated processes for assessment, feedback, monitoring and reporting, such as ones involving funders and patient and public involvement groups; 4. Invest in a new generation IT infrastructure; 5. Enhance system capacity through increasing online reviewer participation and training; and 6. Encourage researchers to quantify the approvals processes for their studies.ConclusionEthics and governance approvals are burdensome for historical reasons and not because of the nature of the task. There are many opportunities to improve their efficiency and analytic depth in an age of innovation, increased connectivity and distributed working. If we continue to work under current systems, we are perpetuating, paradoxically, an unethical system of research approvals by virtue of its wastefulness and impoverished ethical debate.

Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands

“…Although innovation in the area of ethics review may pose considerable challenge, some innovations in this area have recently been implemented and described [34][35][36]; for example, in a review of its research ethics processes, Médecins Sans Frontières developed four innovative practices, namely (1) introduction of a policy exempting a posteriori analysis of routinely collected data; (2) the preapproval of 'emergency' protocols; (3) general ethics approval of 'routine' surveys; and (4) evaluating the impact of approved studies [36]. Nevertheless, the aforementioned criticisms of current practices in ethics reviewsthat they impede research, fail to protect participants, are burdensome and inconsistent across sitescoupled with the calls to investigate and implement 'alternative' models of review, make clear that further innovation and evaluation is still much needed [36,37].…”

‘It Shouldn’t Be This Hard’: Exploring the Challenges of Rural Health Research

“…A culture of ‘us and them’ was seen to exist between frustrated researchers and RGO officers who themselves struggle to understand procedures, which vary from site to site and from jurisdiction to jurisdiction. Most importantly, these processes waste valuable health research funds that should be giving direct benefit to the Australian population [21], as well as the time and energy of those working towards better knowledge, understanding and system improvement. As has been recommended by others, there should be a clear process and pathway to differentiate what constitutes ‘low-risk’ research, and to track ethics and governance processes from initiation to approval and benchmark them [22] as has been proposed as part of HREC certification [23].…”

The Only Way is Ethics: Obtaining Approvals for NHS Clinical Research Projects

“…Setting up and running a research project can be a daunting endeavour, especially for clinicians for whom there is a professional aspiration and expectation to publish in the scientific literature [7] despite often lacking a formal research degree and allocated time for research activity. One particular challenge is navigating the myriad processes and procedures required to obtain governance and ethics approval to carry out research, which can be extremely complex and time-consuming even for projects seemingly entirely devoid of ethics pitfalls [8,9]. This article aims to give NHS clinicians a step-by-step guide to the basic processes and procedures required to obtain governance and ethics approval for these seemingly straightforward studies.…”