Developing a competency framework for health research ethics education and training

Abstract

Health research ethics (HRE) training programmes are being developed and implemented globally, often with a goal of increasing local capacity to assure ethical conduct in health-related research. Yet what it means for there to be sufficient HRE capacity is not well-defined, and there is currently no consensus on outcomes that HRE training programmes should collectively intend to achieve. Without defining the expected outcomes, meaningful evaluation of individual participants and programmes is challenging. In this article, we briefly describe the evolution of formal education in HRE, articulate the need for a framework to define outcomes for HRE training programmes, and provide guidance for developing HRE competency frameworks that define outcomes suited to their contexts. We detail critical questions for developing HRE competency frameworks using a six-step process: (1) define the purposes, intended uses and scope of the framework; (2) describe the context in which practice occurs; (3) gather data using a variety of methods to inform the competency framework; (4) translate the data into competencies that can be used in educational programmes; (5) report on the competency development process and results and (6) evaluate and update the competency framework. We suggest that competency frameworks should be feasible to develop using this process, and such efforts promise to contribute to programmatic advancement.

INTRODUCTION

Significant resources are being invested in short-term and long-term health research ethics (HRE) training programmes around the world—including at non-degree, master’s, doctoral and postdoctoral levels. Many of these programmes aim to enhance the capacity required for ethical conduct andregulatory oversight of health-related research. While individual programmes may set and achieve program-specific outputs (such as training a specified number of people), there is no consensus on the HRE learning outcomes that trainees should achieve or how individuals completing such programmes might optimally contribute to improving HRE systems. As has become apparent in professional education and training more broadly, without clearly defining such outcomes, meaningful evaluation of individual participants and programmes (eg, return on programme investment) is challenging.

In this article, we briefly describe the evolution of formal education in HRE, articulate the need to define outcomes for HRE training programmes, and provide guidance for developing HRE competency frameworks that are suited to their contexts using a six-step framework.

EVOLUTION OF HRE EDUCATION

Formal HRE educational programmes are relatively new. For centuries, research practice was predicated on societal and institutional norms and professional self-regulation.¹ As the global biomedical research enterprise expanded and became more sophisticated, formal policies and structures were developed to protect human subjects and prevent overt breaches of ethical conduct.²

Formal courses focusing on the ethical conduct of human subjects research began to become common in USA universities and health science centres in the 1980s.³ However, high profile lapses in ethical research practice continued, and relying on the traditional mentor-protégé model as the predominant method for HRE education appeared to be untenable.^{3 4} Consequently, in 1990, the US National Institutes of Health (NIH) began requiring education in the ‘responsible conduct of research’ (RCR) to be incorporated into all research training grants.⁵ Almost a decade later, research at high-profile institutions was halted due to concerns about lack of meaningful local institutional review board (IRB) oversight and awareness of research ethics principles and regulations among researchers, leading to educational requirements to include researchers and members of IRBs.⁶ The RCR training requirement later expanded and applied to anyone involved in research supported by the US federal government. RCR educational materials subsequently have become abundant, but RCR programmes have been criticised for lack of standardisation^{7 8} and for not effectively promoting ethical behaviours^{9 10}; and their uptake internationally has been uneven.

The need for international HRE education became increasingly apparent after perinatal HIV transmission trials in the 1990s raised ethical concerns about the treatment of human subjects in low-income and middle-income countries (LMICs). Most agreed that local contextual factors were critical to determining whether research was being conducted in an ethical manner and that greater capacity in HRE expertise in LMICs would be helpful.^{11 12} The first Global Forum for Bioethics in Research, in November 1999, was initiated by the Fogarty International Center (FIC) at the NIH; it was sponsored by WHO, the Pan American Health Organization and NIH to discuss these issues. There, 120 individuals from 34 countries concluded that ‘a consortium of sponsors is urgently needed to develop a long-term training initiative in the bioethics of research, which would be offered in various countries.’¹³

Alongside other funders, such as the Wellcome Trust (UK) and the European and Developing Countries Clinical Trials Partnership, for nearly two decades, FIC has funded long-term training in research ethics as a means of strengthening capacity in research ethics across LMICs. In its first 10 years, 20 FIC-funded training programmes enrolled 600 long-term trainees from 74 institutions in LMICs.¹⁴ In 2015, FIC committed to funding programmes for an additional 10 years and currently supports two companion funding opportunities: (1) master’s level programmes,¹⁵ which emphasise strengthening LMIC institutional capacity to deliver bioethics education; and (2) doctorate and pos-doctorate educational opportunities,¹⁶ which emphasise training researchers and experts in bioethics. This investment in bioethics in general and bioethics education in particular is consistent with a trend towards enhancing health-related ethics education for the general population¹⁷ and the growth in numbers of bioethics master’s and doctorate programmes globally.^{18 19}

NEED FOR AN OUTCOMES FRAMEWORK FOR HRE EDUCATION

The proliferation of HRE educational programmes has not been guided by a shared understanding of what learning outcomes they should collectively achieve.^{7 20} This limitation was apparent in experiences implementing assessment and evaluation plans for FIC-funded programmes.²¹

Contemporary approaches to educational programme development overwhelmingly advocate for clearly defining their intended outcomes. Competency-based education became the predominant model of outcomes-based education as it took root in the 1970s.²² While there is no single definition of competency applied across fields, competencies can be considered to be the abilities of an individual that are observable and that integrate knowledge, skills, values and attitudes as applied to a function in a life role.^{22 23} Competency frameworks are now ubiquitous in science and health education^24–26 and have been developed and used as the basis for certification programmes for professionals in clinical ethics^{27 28} and clinical research.²⁹ Competencies not only serve to define the goals of a programme for its constituents, but can also inform critical aspects of programmes that increase their value to individual participants, including: recruitment, admissions and selections; career advising and other programme support services; and curricular design, teaching and assessment strategies.

Competency frameworks can also be used to evaluate the outcomes of educational programmes. For example, individuals who graduate from a long-term HRE programme may go on to create policies that improve HRE systems at a national level, participate on a local research ethics committee, or conduct human subject research; alternatively, they may decide to pursue a career path that does not apply their HRE training. While the resources devoted to each individual’s education are likely to be similar, each individual’s respective contributions to enhancing HRE system capacity would not be. Clearly defining what HRE education programmes are expected to achieve would afford the measurement of their effectiveness not only on learning, but also their impact on infrastructure and practice.

DEVELOPING A COMPETENCY FRAMEWORK FOR HRE EDUCATIONAL PROGRAMMES

Despite the broad application of competency-based education, there is perhaps surprisingly no standard method for developing competency frameworks.³⁰ Based on the best available evidence, Batt et al proposed an approach to competency framework development in health professions that is logical and systematic, ensures frameworks are suited to their contexts, and can accommodate a variety of competency framework uses.³¹ This approach describes six steps: (1) define the purposes, intended uses and scope of the framework; (2) describe the context in which practice occurs; (3) gather data using a variety of methods to inform the competency framework; (4) translate the data into competencies that can be used in educational programmes; (5) report on the competency development process and results and (6) evaluate and update the competency framework. Here, we describe the critical questions to address at each step and how this approach might be applied to developing competency frameworks for HRE education (table 1). We discuss the six steps in turn, although, in practice, the framework development process is non-linear, and earlier steps may need to be revisited as later steps are considered.

Table 1.

Developing a competency framework for health research ethics (HRE) training programmes

Step	Definition	Critical questions to address	Key considerations for HRE
1	Define purposes, uses and scope	► What is the purpose of the framework? ► How will it be used? Who will use it? ► What will its scope be—to whom will it apply? ► What resource and time constraints apply to the competency framework development process?	► Define terms used when referring to HRE programmes. ► Identify general and specialised uses. ► Identify urgent HRE needs and what resources are available.
2	Describe the context of practice	► What system are individuals working in? ► What roles, jobs or positions do they have in that system?	► Consider using empirical methods to describe HRE systems and identify individual functions therein. ► Political boundaries may be useful for demarcating the HRE system.
3	Gather data to inform the competency framework	► What existing data could inform competency framework development? ► What new data are needed? How and from whom will they be collected?	► Draw on existing data and literature that have described core aspects of HRE. ► Use mixed/multiple methods when collecting new data to ensure the framework suits the HRE system.
4	Translate data into competencies	► Who will use the data to create competencies? ► How will competencies be organised and articulated?	► Consider reporting abilities required, activities performed and/or stages of progression of ability within a role. ► Develop and draft-specific competencies language with a small, qualified team. ► Validate the draft via different subject matter experts and stakeholders. ► Pilot the draft in settings where it might be used.
5	Report framework development and results	► How will the process and final framework be reported?	► Transparently report the development process. ► Share in multiple venues using versions appropriate for the venue.
6	Evaluate and update the framework	► How will the framework’s uses be evaluated? ► What criteria will determine when the framework will be updated? ► Who will be involved in the process of revising the framework?	► Evaluate its uses. ► Assign criteria to trigger revisions. ► Designate responsibility for updates.

Step 1: defining the purposes, intended uses and scope of the framework

• What is the purpose of the framework?

• How will it be used? Who will use it?

• What will its scope be—to whom will it apply?

• What resource and time constraints apply to the competency framework development process?

The diverse and multidisciplinary nature of HRE practice is perhaps one of its essential characteristics,^{32 33} but the inconsistent use of terms relevant to the field presents challenges to specifying a common set of educational outcomes. For example, within single publications ‘research ethics’ has been applied to research related to health and research in other fields, such as business, social sciences and engineering.^{34 35} In some countries, ‘bioethics’ programmes focus dominantly on research ethics issues and approaches, yet in many others, they encompass a wider range of topics, such as clinical ethics and professional ethics, as well as public health ethics and environmental ethics.³⁶ A first step in developing a competency framework for HRE programmes would be to agree on the definitions of terms used to describe the programmes. It would then become possible to describe to which particular educational programmes the framework would apply, and how the framework would be implemented. For example, will the framework be used primarily by curriculum developers to guide educational programmes for learners who have general career aspirations in HRE, or more focused on use by regulators to assess and certify those who perform or hope to perform a specific function in an HRE system, such as serving on a research ethics committee? If a framework is to serve both purposes, it may have a foundational aspect that applies to a broad group of learners, with specialised aspects that apply to fewer individuals.

Another key consideration in step 1 is to identify the resources available to develop the competency framework and the urgency with which the framework must be put into place. These are likely to vary across settings and must be considered at the planning stages to ensure the most efficient use of resources.

Step 2: describing the context in which practice occurs

• What system are individuals working in?

• What roles, jobs or positions do they have in that system?

Consistent with recommendations for enhanced systems-level thinking in the health sector,³⁷ Batt et al’s approach necessitates understanding the system and specific roles in which individuals would apply their competencies.³¹ Defining what encompasses an HRE system is not straightforward because systems differ across geographic, political, cultural and institutional settings. There could also be smaller HRE systems (eg, an institution’s system) embedded within larger systems (eg, a national system) and connections among networks of HRE systems (eg, multinational networks). As a starting point, because HRE systems are likely to incorporate government actors, policies and regulations, using political boundaries to demarcate an HRE system may be most practical.

While the concept of a ‘research ethics system’ has been described for over a decade,³⁸ and the term continues to be used,³⁹ there is no elaborated HRE system framework that sufficiently identifies the varied ways individuals can improve HRE system capacity in general or in particular contexts. Therefore, using empirical methods to delineate what comprises the HRE system would likely be necessary. System-mapping methods include using influence, multiple-cause and human-activity system diagrams.⁴⁰

Participatory network mapping methods—which engage stakeholders in clarifying how individuals in the system relate to one another to perform the functions of the system—may be especially useful and have been used in low-resource settings.^41–43 In applying this type of method, representative stakeholders who participate in the HRE system would clarify the problem(s) that the system is intended to address or goals it should achieve, identify those entities that have a role in performing and assuring the system’s function, define the relationships each entity has with one another, and rate the influence that each has on the issues that HRE systems address.

For example, stakeholders could likely identify protection of research participants as a key issue that HRE systems are designed to address, and that ethics review committees, research institutions, government ministries, investigators, patients and others are actors within the system that work together to affect it. Next, stakeholders might rate individuals who take part in policy-making in government agencies or in reviewing research protocols as part of an ethics review committee as having greater influence than individual investigators over ensuring protection of research participants. In completing this process, system stakeholders would know explicitly what issues HRE systems must address, where individuals can make a difference within an HRE system for a given issue, and where the highest value is likely to be provided when training individuals to increase HRE system capacity.

Step 3: gather data using a variety of methods to inform the competency framework

• What existing data could inform competency framework development?

• How and from whom will they be collected?

The next step requires gathering evidence that informs what competencies would be required to perform particular functions within the system.

A recent review of the development of 190 published competency frameworks for healthcare professions³⁰ described nine categories of methods used in gathering data, which were (from most common to least): literature review (61%); group techniques (eg, workshops) (61%); stakeholder deliberations (45%); mapping exercises (38%); consensus methods (28%); surveys (26%); focus groups (19%); interviews (16%) and practice analysis (12%).

Existing statements and documents provide a foundation for developing HRE competencies. These include: national and international standards for conducting human subjects research⁴⁴; peer-reviewed empirical and scholarly work^{20 45–47}; commentaries⁴⁸; sponsor statements^{11 14–16}; guidance from relevant accrediting agencies and certifying organisations (eg, Accreditation of Human Research Protection Programmes,⁴⁹ Public Responsibility in Medicine and Research,⁵⁰ Association of Clinical Research Professionals⁵¹) and RCR requirements.^52–55

The goal of gathering new data is generally to better understand the perspectives of stakeholders within the respective HRE system to ensure that the framework would be suited to their contexts. A combination of empirical methods would likely be necessary and could be selected based on project scope, methodological capacity, and resource and time constraints. As an example of complementary empirical methods that could make efficient use of resources, stakeholder deliberations could be used to generate a draft framework, which could then be shared for feedback from a broader, more diverse population within the system using surveys. One may also consider seeking feedback from those who were considered to be external to the system to understand what may generalise to other contexts.

Step 4: translate the data into competencies that can be used in educational programmes

• Who will use the data to create competencies?

• How will competencies be organised and articulated?

After data are collected, they need to be aligned with the goals of competency framework development that were identified during step 1, such as, learner assessment or programme design and evaluation. There are no set rules for writing specific competencies that individuals must perform. Competency frameworks differ in the extent to which they are analytical (ie, focus on component knowledge, attitudes or skills needed to perform a role); synthetic (ie, focus on the activities that are performed within a role) or developmental (ie, focus on stages of progression of ability when performing a role).⁵⁶ A framework that combines features of all three framework types is likely to be most useful in practice.⁵⁷ Assuming that the activities that one would perform in a given role were described when defining the HRE system in step 2, the focus in this step could be articulating the domains of competence needed to perform respective roles within the system, how those domains relate to specific practice activities, and how one progresses across a domain from novice to expert (eg, milestones).

Drafting competency framework language is often best done by a small group with sufficient resources, expertise and diversity of perspectives. While most evaluation of the framework occurs after the framework has been disseminated, pilot testing a draft framework in authentic environments before dissemination could enhance its utility.

Table 2 illustrates a possible organisation of potential domains, subdomains, and competencies for HRE training based on existing literature and our experience, although is not meant to be comprehensive and exhaustively cover all relevant topics and competencies.

Table 2.

Example domains, subdomains and representative competencies for health research ethics education programmes

Domain	Subdomain	Example competency
Foundational knowledge of research ethics	Ethical theory and philosophy	Describe fundamental ethical theories that inform research ethics practices.
	Policies, laws and regulations	Describe relevant legal and regulatory policies that influence ethical research practice.
	Research methods	Demonstrate an understanding of common research designs. Identify research designs that are suited to answer a research question.
Ethics review	Research protocols	Systematically analyse research protocols to determine if its risks are justified by potential benefits.
	Consent	Systematically analyse consent documents to determine appropriateness.
	Community engagement	Evaluate whether plans for engaging study communities are adequate given the nature of the research and context.
	Vulnerable populations	Identify characteristics of populations that make them vulnerable to exploitation or harm. Recommend precautions that are indicated to mitigate those possibilities.
Communication and teamwork	Written communication	Clearly articulate complex ethics concepts in writing.
	Oral communication	Effectively engage in ethics deliberation.
Scholarship and pedagogy	Original research	Develop a research design for an ethics topic.
	Teaching	Prepare and deliver teaching materials that relate to core research ethics competencies.
Ethics advocacy	Ethics policy development	Critique and suggest revision to national research ethics policies.
	Raising public awareness	Engage in promotion of research ethics awareness among the public through appropriate venues (eg, mass media, social media).
Leadership and professionalism	Responsibility	Accept responsibility for judgments and recommendations related to research ethics practice.
	Lifelong learning	Engage in continuous professional development to keep research ethics knowledge and practice current.
	Disclosures and conflicts of interest	Provide appropriate disclosures and manage conflicts of interest.

Step 5: report on the competency framework development process and results

• How will the process and final framework be reported?

When a competency framework is ready for potential broader use, its development process should be reported in as much detail as possible. Reporting along this six-step approach could enhance the acceptability and validity of the final framework.

The competency framework itself can be disseminated in multiple venues and versions. A complete, detailed version that describes all aspects of the framework, which could be accompanied by a user guide, would be beneficial to those who are considering applying the framework directly to educational programmes. A simpler version, that defines domains and subdomains, could be made publicly available to inform stakeholders (eg, learners, institutional officials, the public) about the competencies expected of HRE professionals. Most competency frameworks benefit from a graphic illustration of how domains, subdomains and the levels of competency within them relate.⁵⁸

Step 6: evaluate and update the competency framework

• How will the framework’s uses be evaluated?

• What criteria will determine when the framework will be updated?

• Who will be involved in the process of revising the framework?

Ideally, the final competency framework will be usable in all the ways intended in step 1. For HRE education programmes, the competency framework could be applied to the outreach and selection of training candidates who are most likely to address identified needs within the HRE system. For participants enrolled in a programme, the framework could be used to develop and implement a baseline assessment, track learner progress and target educational interventions based on learners’ demonstrated needs. Success across programmes can be measured by graduates’ influence on the HRE system defined in step 2.

As competency frameworks become applied more broadly, they may turn out to have flaws such as being hyperlocalised, or conversely may have more general applicability than originally anticipated. Ongoing evaluation of a competency framework will allow identification of its strengths and limitations.

Contexts and knowledge evolve over time, making it essential that frameworks be updated to remain fit for purpose. Because change can be difficult to predict, identifying criteria that would trigger minor or major revisions may be a more effective approach to planning updates than setting a time period for when the framework would be reviewed. Specifying which individuals or groups are responsible for ongoing evaluation and revision of competency frameworks is also critical to ensure that there is appropriate accountability and representation among system stakeholders.

CONCLUSIONS

The many existing and emerging HRE training programmes across the globe would benefit from clearly articulated training outcomes. Competency frameworks that are suited to their contexts should be feasible to develop and offer a pathway to evaluate, enhance and assure programme quality and cement their value to participants and society.