Some technical projects and assignments require collaboration with individuals who possess field or industry-specific knowledge, competence, competencies, and skills. Such individuals are needed to perform different tasks or assume certain roles and responsibilities such as planning, monitoring and evaluation, strategy setting, policy making, auditing, research, review, management, advising, training, interviewing candidates, and membership of committees and working groups, to name a few. They are usually referred to as subject matter experts (SMEs), and the knowledge they pass on to the project is intuitive or tacit (Centers for Disease Control and Prevention-National Center for Injury Prevention and Control, n.d.). SMEs play a pivotal role in standardization. The International Society for Quality in Health Care (ISQua) considered the “input from technical experts” among the core requirements for the development of Health and Social Care Standards (ISQua, 2018, p. 23). The outcome of collaboration with an SME is value and credibility added to the standardization project.

The purpose of this article is to propose a framework to manage the relationship with SMEs in regulatory standard development, referred to in this article as a regulatory standardization project.

An SME is an individual who possesses “bona fide expert knowledge” (U.S. Office of Personnel Management, 2019, p. Glossary-14), skills, education, training, expertise, experience, and a track record of working in a particular field or business area. Potential SMEs should “have been in their roles for a long enough period of time for their knowledge and skills to be ‘second nature’”(The University of Waterloo-IST Project Management Office n.d.).

Criteria for selecting a subject matter expert should include inter alia their years of experience; records of achievement; licensure or ex-licensure from a professional body or governmental authority; recommendation letters; and basically, any proof that they hold values that can be added to the standardization project.

SMEs are essential members of the standard development project team. They can help with the following tasks:

  • Scoping of the standard (i.e., identifying the most critical areas to focus on when such areas have not been identified in a need assessment).

  • Sharing real-life examples of issues that support the standardization approach based on their hands-on experience.

  • Proofreading and editing.

  • Sharing perspectives, insight, and critique.

  • Acting as devil’s advocate to sharpen and well-round the standard.

  • Sharing lessons learned from other jurisdictions.

  • Engaged as researchers and literature reviewers.

  • Providing advice to address change requests from stakeholders during the project.

The professional relationship with an SME progresses through a life cycle of phases that consists of:

Recruitment; Rendering; Recognition/remuneration; Retention/removal, which is described as the “4R’s” framework (Figure 1).

Figure 1.

A four-step framework to manage the relationship between the project team and SMEs.

Figure 1.

A four-step framework to manage the relationship between the project team and SMEs.

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Recruitment

In this phase, the standardization project team identifies, screens, verifies, short-lists, and contacts potential SMEs. Several biodata hubs can be utilized for this exercise including member directories of professional societies and organizations; certificant directories of professional certification organizations; business-oriented, career-oriented, or professional social-networking platforms; job banks; scientific and professional journals.

Upon SME’s preliminary approval of the scope of work, engagement with SMEs must be made formal through a contract or agreement. The details and type of the contract depend on several factors including the domestic legal requirements (e.g., labor laws/employment regulations); regulatory body by-laws; complexity, and timeframe of assignment. Formality will impose obligations and ascribe certain rights to both parties (regulatory body and SME). See for example a model contract of the European Commission (2022) and a template agreement by the City of Portland (n.d.). The contract should include Terms of Reference (ToR) or equivalent provisions that provide background about the project and clarify the purpose and scope of the regulatory instrument, the roles of SMEs, expected deliverables, type and frequency of engagements (meeting, email, focus groups, etc.), reimbursement, and code of conduct.

SMEs should observe a code of conduct that describes certain behaviors expected of them while carrying out their assigned tasks, including the obligation to:

  • Abide by the scope, schedule, and quality attributes of the assignment.

  • Avoid conflict of interest that may jeopardize the quality, credibility, and reliability of their contribution to the task.

  • Act in the public interest.

  • Participate in their personal capacity rather than as representatives of any entity or persons including their institutions.

  • Share state-of-the-art information that enriches the standard.

  • Respect and protect the privacy, confidentiality, intellectual property, and ownership of data, information, and references.

  • Reflect impartiality, objectivity, and independence.

A code of conduct document should be shared with and accepted by SMEs before starting any assignment. A record of the signed code of conduct must be maintained. It could also be part of the contract. (See examples of code of conduct in European Commission, 2023; International Labour Organization, 2021; The World Health Organization, n.d.).

Other important elements that must be agreed upon with SMEs include expected timeframe, quality of deliverables, performance indicators, and methods of communication. The availability of SMEs is of paramount importance and should be factored in when finalizing the project schedule. Performance indicators must cover timeliness and quality of participation among other parameters.

The number and specialties of SMEs depend on the wider scope of the standardization project, the collective competencies and skill mix of the project team, and technical areas of the scope that are beyond the capabilities and expertise of the team. For example, developing a scope of clinical practice document for dermatologists requires the involvement of dermatologists, whereas developing a standard for the diagnosis of brain death requires the input of a multi-specialty group of experts including neurologists, neurosurgeons; intensivists; critical care nurses; social workers; pediatricians; neonatologists; psychologists; medico-legal experts; pharmacists; radiologists; electroencephalographic (EEG) technicians or technologists; bioethicists.

Compensation for SME services is yet another factor to be considered. Some SMEs are willing to work voluntarily, pro bono, or for nominal fees, whereas others may demand a specific per-hour rate or per-assignment flat rate. With free of charge type of engagements, the project team should seek to obtain a strong commitment from SMEs to complete the tasks on time, otherwise, busy SMEs might not keep the momentum throughout the lifecycle of the project.

Rendering

In this phase, SMEs carry out their assigned tasks and responsibilities. The actual engagement with SMEs runs through several iterations of review and revision or cycles of consultations as illustrated in Figure 2. During each cycle, the project team creates or updates the draft and performs other tasks related to the project (e.g., doing further research; context analysis to ensure the proposed standard is aligned with the current best practices and regulatory framework; arranging for the translation of the standard into another domestic language; studying SMEs’ input and analyzing stakeholders’ feedback, record keeping; etc.). A robust version control procedure must be implemented to ensure that SMEs and the project team are working on the same document version in any consultation round.

Figure 2.

A schematic representation of interaction with SMEs and stakeholders during the standardization project.

Figure 2.

A schematic representation of interaction with SMEs and stakeholders during the standardization project.

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Communication and exchange of information and insight can be done through email, meetings, surveys, and the Delphi technique. Meetings with SMEs can be held virtual or in person and can be one-to-one or as a focus group, to arrive at a rational, and evidence-driven consensus. The regulatory body should establish ground rules for expert focus group meetings that ensure SMEs get equal opportunity to present their viewpoints, arguments, and supporting evidence without monopolizing or diverting the discussion toward individual agendas.

In focus group meetings, a project team member should act as facilitator or moderator, another member should record the minutes of the meeting and support the moderator. Although recommendations vary, the number of experts attending a focus group session should not exceed 6 SMEs. The project team may need to hold several meetings with different groups of SMEs to discuss certain topics, challenges, and stakeholder feedback.

The standardization officer or project team must keep track of all notes and suggestions received in each round of consultation as these will be shared with the same or the next batch of SMEs. It is advisable to always engage a “first-time reviewer” (i.e., first-timer) in the final consultation round to ensure fresh insight from people who were not involved in the previous discussions.

The standard development function must also have a document control procedure to maintain a paper trail that facilitates quality assurance and internal audit of the standardization tasks. Individual SME feedback must be categorized into evidence-based or personal-experience-based.

As stated earlier, SMEs provide extra knowledge that is not available at the level of standardization function permanent staff; however, the latter still have the responsibility to compare and contrast SMEs’ input. SMEs’ opinion is “based on experiential evidence” (Walden University, n.d.), and if it is unsubstantiated, it usually ranks low in the hierarchy of evidence. And they might have different priorities about the content of the standard, which influence their recommendations. Accordingly, it is prudent that the strength of evidence presented by SMEs is carefully graded utilizing a fit-for-purpose evidence classification. (For further discussion about the hierarchy of evidence see Evans, 2003; NSW Government-Department of Communities and Justice, 2020; Walden University, n.d.; Winona State University, 2023).

It is not unusual to have diverging views and opinions from SMEs who work in different fields, with diverse educational backgrounds and scope of practice. The project team should aim at achieving consensus between SMEs and keep alignment with the latest knowledge. Reconciling divergent recommendations is fraught with challenges. Utilizing consensus-building techniques including the Delphi technique and focus group meetings, virtual or in-person is essential.

Just like any human being, SMEs have their blind spots. According to Nesta (2016, p. 12): “Research has shown that experts can sometimes get it horribly wrong, and they are not immune from a whole range of social and cognitive biases.” Yet SMEs have pivotal roles to play in standardization projects, but their contributions must be examined and aligned with other sources of information and knowledge. For further discussion on experts’ biases see Abels et al., 2023; and Wilson et al., 2020.

Recognition/remuneration

At this stage, the regulatory standard is developed, and no further involvement of SMEs is needed. SMEs’ efforts must be acknowledged in the form of a letter of appreciation or acknowledgment, and financial compensation if this was specified in the contract.

Retention/removal

In this last phase, SME performance is evaluated against a set of performance indicators. A decision should be made on whether to keep or remove that SME from the list of experts for future standardization work.

This article proposed a framework to manage the relationship between the standardization project team and SMEs, to ensure that the relationship remains fair, mutually beneficial, and adds value to the project and its stakeholders and beneficiaries. The “4R’s” framework can be considered as standalone steps or integrated into an overarching project management or standard development approach.

Moutaz Zakkar (PMP; CPHQ; ASQ CQA; IIA CGAP; ASHRM CPHRM; ASQ CSQP) is a Senior Specialist of Workforce Policies and Standards, at the Department of Health- Abu Dhabi-United Arab Emirates. He is a pharmacist by training and has over 25 years of experience and a wide range of expertise in the fields of regulatory standardization, organizational standardization, quality auditing of different pharmacy practice settings, performance monitoring and medical supply chain management. Email:[email protected]; LinkedIn:http://www.linkedin.com/in/moutazzakkar

Moutaz Zakkar (PMP; CPHQ; ASQ CQA; IIA CGAP; ASHRM CPHRM; ASQ CSQP) is a Senior Specialist of Workforce Policies and Standards, at the Department of Health- Abu Dhabi-United Arab Emirates. He is a pharmacist by training and has over 25 years of experience and a wide range of expertise in the fields of regulatory standardization, organizational standardization, quality auditing of different pharmacy practice settings, performance monitoring and medical supply chain management. Email:[email protected]; LinkedIn:http://www.linkedin.com/in/moutazzakkar

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