By Dr Laura Mackey, Post-Doctoral Researcher, ARCH

Most health-based researchers can identify with the enormous challenges faced during the recruitment stages of a study. Hours are spent lurking around hospital clinics, in the hope of convincing unsuspecting individuals to participate, only then to find them unsuitable as they do not meet the pre-defined inclusion criteria, or that they are unable to take part due to a parking meter that is about to run out, and so on…This is only one part of the uphill battle associated with recruitment. Once ethical approval has been approved (often after multiple reviews and clarifications), then the practical aspects of integrating the research project into a clinical setting must also be addressed. Previous investigations have identified a range of issues that are experienced by researchers, in particular, organisational issues such as lack of time, and conflicts between research and clinical responsibilities from the perspectives of clinical staff 1. In order to address these potential pitfalls during the recruitment stages, onsite recruiter training for clinical staff has been suggested, and the importance of fostering the development of a working relationship between the researchers and clinical staff has also been identified 1,2. However, due to widely reported time restraints experienced by clinical staff, it is not clear how and where such training courses could be implemented, and it is often the case that researchers remain naturally drawn to sites where good relationships have already been established.

Recruitment Connected Health Research


The ethical approval process is traditionally governed at each site where the study is undertaken, naturally focusing on protecting the patient by ensuring the researcher provides clear and concise information, in order for them to be able to provide informed consent. However, more recent changes to the research landscape has resulted in the emergence of patient-led engagement in research. For example, in the U.S. ‘PatientsLikeMe3 provides a platform from which the patient can actively participate in research, potentially guiding the development of research projects based on gaps identified from the patients themselves. Similar patient-orientated organisations exist in Ireland, such as IPPOSI 4, who work with industry, government and academia, to place the patient at the centre of health policy and research innovations. In addition, the Health Research Board is piloting the inclusion of ‘Public and Patient Involvement’ (PPI) in research, which allows members of the public to review submitted funding applications 5. These changes are shifting the dynamic from the vulnerable patient as seen by hospital-based ethics committees, to the empowered patient who chooses to use their experiences to shape future healthcare innovations through research engagement. This ‘participatory’ or patient-led approach coincides with the emergence of co-design research, and given that the connected health model of care advocates that ‘services or interventions are designed around a patient’s needs’ 6, a co-design methodology that facilitates the inclusion of all stakeholders is appropriate for this area. Crucially, for the first time it allows the patient’s voice to be heard when constructing research projects, which is vital for the development of user-friendly connected health technologies and future health services.

Recruitment Connected Health Research_2

However, the co-design or ‘equal partnership’ approach faces new organisational and recruitment dilemmas. Ethics committees are less equipped to effectively address potential issues related to co-design approaches, given the reliance on more traditional research methodologies such as RCTs 7. Also, no framework for the implementation of a co-design approach into clinical settings exists in the literature to date. Therefore, these combined with the aforementioned organisational restraints may further impede participant recruitment in connected health research, if not effectively addressed. Furthermore, the issue of fully informed consent must also be considered, specifically around the use and storage of patient data. In the traditional research environment, the researcher is considered the data controller, and is responsible for protecting all the data retrieved during the study. With the inclusion of connected health devices (e.g., activity monitors, health monitoring platforms, etc.), the researcher cannot necessarily guarantee full protection or control of the data, and traditional informed consent approaches as recommended by ethics committees do not adequately address this. In addition, as of May 2018 when the new General Data Protection Regulations (GDPR) are implemented, new measures to protect data subjects will come into place 8. Therefore, further effort is needed by both connected health-based researchers and industries to provide clarity and transparency on how and where the data is being managed, in order to meet both ethical consent and GDPR requirements. How this may impact on a participant’s decision to be involved in these types of research projects remains to be seen, and imminent action is required to mitigate potential participant drop off that may arise due to a lack of understanding around the management of connected health data.


  1. Donovan JL, Paramasivan S, de Salis I, Toerien M. Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials. Trials. 2014; 15:5.
  1. Patel MX, Doku V, Tennakoon L. Challenges in recruitment of research participants. Advances in Psychiatric Treatment. 2003; 9:3.
  1. Caulfield BM, Donnelly SC. What is connected health and why will it change your practice? International Journal of Medicine. 2013; 106.
  1. Goodyear-Smith F, Jackson C, Greenhalgh T. Co-design and implementation research: challenges and solutions for ethics committees. BMC Medical Ethics. 2015; 16:78.

You can contact Laura on Check out our website for more information about Laura’s research interests.

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