Introduction

Every health study reaches beyond the research team. Someone answers the survey, someone opens a clinic waiting room to recruiters, someone approves the release of administrative records, and someone reads the findings and decides whether to change a service. Teams that identify these people early and decide deliberately how to involve them tend to ask better questions, recruit more successfully and produce findings that are used. Teams that leave this work until recruitment often find that a clinic will not cooperate or that a community feels it was studied without being asked.

This lesson uses the fictional Cedar Valley Social Connection Study as its main example. A small research team at a British Columbia university, led by the fictional Dr. Maya Hart, is planning a mixed-methods study with the fictional Cedar Valley Health Authority on loneliness and social isolation among adults aged 65 and older. The health authority serves about 210,000 residents, of whom about 46,000 are aged 65 and older. Its largest community is Cedar City (about 90,000 people), and the region also includes smaller communities such as Riverside, North Bench and Kestrel Lake, 24 primary care clinics and a First Nations health partner, the fictional Cedar Valley First Nations Health Centre. In Lessons 2 and 3 the team wrote its research questions and drew a causal web and a directed acyclic graph. In this lesson the team works out who has an interest in the study and how to involve them.

1.1 What an Interest Holder Is

An interest holder is a person, group or organization that can affect a study, is affected by it, or holds rights, knowledge or resources that bear on it. The idea comes from management research, where Freeman (1984) argued that an organization is answerable to every group that can affect, or is affected by, the achievement of its objectives. Health researchers adopted the idea because a study, like an organization, succeeds or fails through its relationships with the people around it.

The definition is broad on purpose. It includes the people the study is about, the organizations that make it possible, the bodies that approve or fund it, and the people who will use or hear about the findings. A useful list of interest holders is therefore longer than a list of participants.

Roles that interest holders play

Naming the role each interest holder plays helps a team decide what each group needs. The cards below describe six common roles. One person or organization can hold several roles, and roles can change as a study proceeds.

Roles can overlap in ways that create tension. A Cedar Valley advisory group member helps design the interview guide, so interviewing the same person would mean studying advice the team had helped to write. The team therefore decided that advisory group members would not be interviewed, although they remain free to complete the regional survey like any other resident.

1.2 Why Interest Holders Matter

Involving interest holders takes time and money, so a team should be clear about what it gains. Open each of the five reasons below for an explanation and a Cedar Valley example.

1.3 Identifying Interest Holders: A Practical Method

Teams often list interest holders from memory and stop when the list looks complete. The five steps below are more reliable, and they suit a small study as well as a large funded one.

Step 1. Start from the question and the design. The research question names a population, an exposure or phenomenon, and an outcome, and the design names the settings and data sources. Each of these points to interest holders. The Cedar Valley PECO question about loneliness and emergency department visits points to older adults, emergency departments, the health authority and the administrative data that record visits.

Step 2. Ask four guiding questions. The table below lists four questions that together cover the main roles, with the answers the Cedar Valley team recorded.

Step 3. Run a snowball check. Ask each interest holder already identified who else should be involved. Clinic managers may name the home care nurses who visit housebound patients, and a seniors' centre may name a cultural association whose members do not attend the centre.

Step 4. Run an equity check for missing voices. Ask which groups are affected by the topic but are rarely heard in research or planning. For a study of loneliness, the people most affected are often the hardest to reach, because isolation itself keeps them away from the community programs, clinics and online spaces through which research teams usually recruit. Groups to consider include older adults who are housebound, have hearing loss or cognitive impairment, speak a first language other than English, have low incomes, identify as Two-Spirit, lesbian, gay, bisexual, transgender or queer, or lack internet access.

Step 5. Record the result. Write the list in an interest holder register, which Section 2 develops.

1.4 The Cedar Valley Interest Holder List

After the snowball and equity checks, the team sorted its interest holders into the three layers shown below: the people the study is about, those who decide, enable or hold rights over it, and wider audiences.

The table below records what each main group wants, can contribute, and may bear or risk. The last column reminds the team that every interest holder gives something up by taking part.

The team now has more than a dozen interest holders and cannot involve all of them in the same way. Section 2 introduces two tools that help it decide where to put its effort: the power-interest grid and the influence map.

Introduction

A list of interest holders tells a team who is involved. A map shows how those interest holders relate to the study and to one another, which helps the team decide where to put its limited time and money. Mapping also makes the team's assumptions visible. When a team writes down that a clinic has high power over the study, or that older adults have little, other people can see the judgement and challenge it. For this reason a map is most useful when it is drawn with partners and revised as the study moves forward.

This section introduces two mapping tools. The power-interest grid places each interest holder by how much it can affect the study and how much the study matters to it. The influence map shows the relationships among interest holders, including the indirect routes through which a team can reach people. The section ends by combining both in a single working document, the interest holder register.

2.1 The Power-Interest Grid

The power-interest grid was described by Eden and Ackermann (1998) as part of their work on strategic management, and Bryson (2004) adapted it for public and nonprofit organizations. It has two dimensions. Power is an interest holder's ability to affect the study: to approve or block it, to fund it, to grant or refuse access to people, places or data, or to shape how its findings are received. Interest is how much the study's process or findings matter to the interest holder: how directly the topic affects its members, its services or its decisions. Each interest holder is rated on both dimensions and placed in one of four quadrants.

2.2 Building a Grid Step by Step

Teams can draw a grid on a whiteboard in twenty minutes, although the discussion that produces it is the valuable part. The steps below make the discussion systematic.

Step 1. Start from the register. Take the list of interest holders produced in Section 1. Split groups that differ in power or interest, such as the six partner clinics and the other 18 clinics.

Step 2. Agree on rating anchors. Ratings are only comparable if everyone uses the same scale. The Cedar Valley team used a five-point scale with written anchors for the low, middle and high points, shown in the table below, and agreed that ratings of 4 or 5 count as high.

Step 3. Rate each interest holder and write down the reason. A rating without a reason cannot be checked. The reason also helps the team notice when two members rate the same group differently for different reasons.

Step 4. Place the interest holders and discuss the result. Look for surprises, such as a group the team had planned to involve closely that turns out to have little interest, or a context setter whose requirements could delay the study.

Step 5. Date the grid and plan to revisit it. Power and interest change as a study moves from design to data collection to reporting.

2.3 Reading the Grid with Care

The grid is a quick and useful summary, and it has limits that a careful team keeps in mind. The quadrant labels come from management practice, where the aim is often to keep a project on track. In health research, and especially in research concerned with equity, the labels can point in the wrong direction if they are followed without thought.

2.4 Influence Maps

The grid places each interest holder on its own. It does not show that one interest holder can influence another, which is often the most useful thing for a research team to know. An influence map is a diagram in which interest holders are drawn as nodes and arrows show who influences whom. Bryson (2004) describes influence diagrams of this kind as a companion to the power-interest grid. A related participatory tool, Net-Map, asks interest holders themselves to draw the actors, the links between them and stacks of counters, called influence towers, that show how much influence each actor has (Schiffer & Hauck, 2010). Drawing the map with interest holders, rather than for them, also gives the team a chance to learn about relationships it could not see from outside.

To draw an influence map, a team takes five steps. It places the interest holders from its register on a page, with the research team included as one node among others. It draws an arrow from each interest holder to each other interest holder it influences. It labels or colours each arrow by the type of influence, such as formal authority or approval, funding, advice, or trust and everyday contact. It marks the strength of each link, for example with line thickness or a dotted line for weak links. Finally, it studies the map for patterns, which the tabs below the figure describe.

2.5 The Interest Holder Register

The grid and the map are easiest to use when their results are recorded in one place. An interest holder register is a table with one row per interest holder, which the team updates throughout the study. The table below lists the columns the Cedar Valley team used.

The grid and the map tell the team where it stands with each interest holder. They do not yet say how deeply each group should be involved in each decision. Section 3 introduces the IAP2 Spectrum of Public Participation, patient-oriented research and community-based participatory research, which give the team a vocabulary for that decision.

Introduction

Once a team knows who its interest holders are and how they relate to the study, it must decide how deeply to involve each of them. Some groups need only to be told what the study is doing. Others should be asked for advice, and some should share in decisions or make decisions themselves. These choices differ between groups and between phases of a study, and they carry obligations: a team that asks for advice must be prepared to use it and to explain what it did with it. This section gives you a vocabulary for these choices and introduces two Canadian traditions of research partnership, patient-oriented research and community-based participatory research.

3.1 From Arnstein's Ladder to the IAP2 Spectrum

The most cited account of participation is Sherry Arnstein's (1969) ladder of citizen participation, written about urban renewal and anti-poverty programs in the United States. The ladder has eight rungs grouped into three bands. The lowest band, nonparticipation, contains manipulation and therapy. The middle band, which Arnstein called tokenism, contains informing, consultation and placation: people are heard, but they have no assurance that their views will change anything. The top band, citizen power, contains partnership, delegated power and citizen control. Arnstein argued that participation which leaves power where it was frustrates the very people it claims to include, and her ladder remains a useful test for any engagement plan.

The IAP2 Spectrum of Public Participation, published by the International Association for Public Participation (IAP2 International Federation, 2018), is widely used to plan engagement in Canadian health organizations. It describes five levels of involvement in a decision. Each level has a goal and a promise to the people involved, and the promise is the part that matters most in practice, because it tells people what they can expect. The figure and table below paraphrase the five levels.

No level is correct for every situation. Informing is the right level for interest holders who need to know about a study and have no decision to make, and empowering is appropriate only for decisions that the team can genuinely hand over. A common failure is a mismatch between the level promised and the level delivered, for example when a team describes its advisory group as collaborators but presents finished decisions for comment. A team should therefore promise only the level it can honour.

3.2 Choosing a Level for Each Group and Phase

Engagement is planned for each interest holder and for each phase of the study. A group that is consulted on the research question may collaborate on recruitment and be informed about the analysis. Four questions help the team choose a level. How much can the decision still change? How much does the group want to be involved, and in what? What support, such as training, travel or payment, would the group need? What has the team already promised? The answers are recorded in an engagement matrix, a table of phases against interest holders. The table below summarizes the Cedar Valley matrix by phase.

3.3 Patient-Oriented Research and SPOR

In 2011 the Canadian Institutes of Health Research launched Canada's Strategy for Patient-Oriented Research (SPOR). CIHR describes patient-oriented research as research that engages patients as partners, focuses on priorities that patients identify, and aims to improve patient outcomes. SPOR uses the word patient broadly: it includes people with personal experience of a health issue and their informal caregivers, including family and friends. In SPOR's terms, patient engagement means meaningful and active collaboration in the governance, priority setting and conduct of research and in sharing what it finds. A patient partner is a person with lived experience who takes part in a study in this way, as a member of the team, a co-investigator or a member of an advisory body.

CIHR's Patient Engagement Framework (CIHR, 2014) sets out four guiding principles. The cards below define each one and show how the Cedar Valley team applied it.

Several practical matters follow from these principles. Each partner role needs terms of reference, a short document stating the purpose of the group, its responsibilities, the decisions it makes or advises on, the time commitment, payment, confidentiality expectations and how members can leave. Compensation should be planned in the budget from the start. CIHR has published guidance on compensating patient partners, and teams should explain the options, because payment can affect some partners' income support or taxes and some partners prefer reimbursement of expenses only. Accessibility needs particular attention with older partners, for example meeting rooms with good acoustics, large-print documents, meetings at times that suit people who rely on others for transport, and a choice between meeting in person and by telephone. SPOR SUPPORT Units (Support for People and Patient-Oriented Research and Trials), located in provinces and territories across Canada, offer training and advice on patient engagement. When the study is written up, the GRIPP2 checklist (Staniszewska et al., 2017) helps teams report how patients and the public were involved, and Lesson 12 returns to reporting guidelines.

3.4 Community-Based Participatory Research

Community-based participatory research (CBPR) is a collaborative approach in which community members, community organizations and researchers share in every phase of a study, combining knowledge and action to improve health and reduce health inequities (Israel et al., 1998; Minkler & Wallerstein, 2008). Patient-oriented research usually begins within a health care system and engages people as patients and caregivers. CBPR usually begins with a community, defined by place, identity or shared experience, and treats the community as a partner with its own priorities, knowledge and power.

Israel and colleagues (1998) set out principles that remain widely used, and a later version added an emphasis on local relevance, capacity building and long-term commitment (Israel et al., 2003). In CBPR, the partnership recognizes the community as a unit of identity, builds on the strengths and resources already in the community, and shares decisions equitably in all phases of the research. It promotes co-learning and builds capacity among all partners, balances research with action for the mutual benefit of all partners, and attends to local relevance and to the social and physical environments that shape health. It proceeds through a cyclical and iterative process, shares findings with all partners and involves them in dissemination, and requires a long-term commitment. For further reading, students who have taken HSCI 230 can return to its Lesson 1 Section 2, which describes the Kahnawake Schools Diabetes Prevention Project, a long-running CBPR partnership between the Mohawk community of Kahnawake and academic researchers.

3.5 Avoiding Tokenism

Tokenism occurs when engagement is offered in name only: people are invited to meetings, but their views have no effect on decisions. It wastes partners' time, damages trust and can make later research in the same community harder. The safeguards below are practical steps a team can build into its plan.

The approaches in this section apply to every interest holder in a study. Engagement with First Nations, Inuit and Métis communities draws on them and adds obligations that come from the rights of Indigenous Peoples, from TCPS 2 Chapter 9 and from principles of Indigenous data governance such as OCAP®. Section 4 turns to these obligations and then to writing the engagement plan itself.

Introduction

Sections 1 to 3 described engagement with every kind of interest holder. Research that involves First Nations, Inuit or Métis Peoples brings additional obligations, because Indigenous Nations and communities are rights holders with authority over research that involves their members, lands, knowledge and data. HSCI 230 Lesson 1 introduces the principles of OCAP®. This section turns such principles into the practical work of a research partnership: approaching a community, meeting the expectations of TCPS 2 Chapter 9, writing a research agreement and planning engagement.

The guidance here is general. Protocols for introductions, meetings, decision making, the involvement of Elders and knowledge keepers, and the review of research differ from one Nation and community to another. A team learns the protocols of a specific community by asking that community, and students who intend to work with Indigenous communities should seek training and mentorship beyond this lesson. The Cedar Valley partnership below is fictional, and its arrangements are the choices of one fictional partnership.

4.1 Rights Holders and a Distinctions-Based Approach

First Nations, Inuit and Métis are three distinct Indigenous Peoples in Canada, each with its own histories, languages, cultures, governments and relationships with the Crown. There is also great diversity within each. British Columbia alone has about 200 First Nations, with many distinct languages and forms of governance. A distinctions-based approach recognizes these differences and plans engagement with the specific Nations, communities and organizations involved. A pan-Indigenous approach, which treats all Indigenous Peoples as one group, can lead a team to consult the wrong body, apply one Nation's practices to another, or overlook Métis and Inuit people.

The authority of Indigenous Nations over research rests on their inherent rights of self-determination. Aboriginal and treaty rights are recognized and affirmed in section 35 of the Constitution Act, 1982, and the United Nations Declaration on the Rights of Indigenous Peoples affirms the right of Indigenous Peoples to self-determination, and British Columbia's Declaration on the Rights of Indigenous Peoples Act (2019) commits the province to bring its laws into alignment with the Declaration. Research has also given communities reasons for caution: studies have been carried out without meaningful consent, samples and data have been used for purposes participants never agreed to, and findings have described whole communities only through their problems. This history, to which Lesson 5 returns, explains why many Indigenous communities now expect to direct research that involves them.

The Cedar Valley case shows why distinctions matter. The fictional Cedar Valley First Nations Health Centre serves several First Nations communities and is the team's partner for research with them. The region's older adults also include First Nations people living in Cedar City away from their home communities, as well as Métis and Inuit residents, whom the health centre does not represent. The team recorded these groups separately in its register and planned to ask the health centre, and organizations serving Indigenous people in Cedar City, how best to approach engagement with each.

4.2 TCPS 2 Chapter 9 in Practice

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) is the research ethics policy of Canada's three federal research agencies. Its Chapter 9, Research Involving the First Nations, Inuit and Métis Peoples of Canada, sets out how researchers and communities should work together. The items below summarize its main expectations in general terms; researchers should read the chapter in full, and Lesson 5 returns to it.

4.3 OCAP® in Practice

OCAP® is a registered trademark of the First Nations Information Governance Centre (FNIGC). The acronym stands for ownership, control, access and possession, and it names a set of First Nations principles about how First Nations data and information should be collected, protected, used and shared. OCAP® expresses First Nations jurisdiction over their own information. It applies to First Nations, and each First Nation interprets and applies the principles in its own way, so a team learns how its partner understands them. FNIGC offers an online course, The Fundamentals of OCAP®, which is the appropriate next step for students who expect to work with First Nations data.

A practical way to use the principles is to turn each into questions for the research agreement. The table below paraphrases each principle and shows the answers reached in the fictional Cedar Valley partnership; another First Nation might reach very different answers.

Some data are governed by other agreements as well. The linked records that the Cedar Valley team requests through Population Data BC remain under the data stewards' conditions and are analyzed in a secure research environment, so the team cannot transfer them to any partner. The research agreement therefore covers what the team can control: how results from the linked data that concern the health centre's communities are reviewed, interpreted and reported. The team raised this question with its partners at the start.

4.4 Research Agreements

A research agreement is a written document in which researchers and a community or organization set out how they will work together. A consent form records one person's decision to take part, and a data sharing agreement governs a specific transfer of data; a research agreement may refer to both. Its content is negotiated, and the table below lists elements that agreements commonly address.

The figure below shows how the fictional Cedar Valley partnership developed. The relationship came before the protocol, and the agreement was signed before ethics review and data collection.

4.5 Writing an Engagement Plan

An engagement plan is a short document that states whom the team will engage, how, when, at what level and with what resources. It draws on the register, the engagement matrix and any agreements. A one-page plan forces the team to set priorities and is short enough for partners to review, and it is revised as the study proceeds. The Cedar Valley plan below uses eight headings, with illustrative budget figures.

The worked example is written in plain sentences that partners can read, states levels by phase so that the team's promises can be checked, and gives a specific budget, because unbudgeted engagement is often the first activity cut when money runs short. Lesson 6 develops budgets and timelines for the whole project.

Bringing It All Together

This lesson treated interest holders as part of the design of a study. Section 1 defined interest holders broadly, named the roles they play, and gave a five-step method for finding them that ends with an equity check for missing voices. Section 2 introduced the power-interest grid and the influence map, which together show where each interest holder stands and how the team can reach the people its study is about, and it set out the limits of the grid, including its treatment of rights holders and of groups with high interest and little power.

Section 3 gave you the vocabulary for deciding how deeply to involve each group: the five levels of the IAP2 Spectrum, the patient-oriented approach of Canada's Strategy for Patient-Oriented Research, and the shared decision making of community-based participatory research. The common thread is that each level carries a promise, and engagement only builds trust when the promise is kept. Section 4 described the obligations that arise when research involves First Nations, Inuit or Métis communities, including a distinctions-based approach, TCPS 2 Chapter 9, OCAP® as a registered trademark of the First Nations Information Governance Centre, and the research agreement, and it brought everything together in a one-page engagement plan.

The fictional Cedar Valley Social Connection Study ran through every section. Its register, grid, influence map, engagement matrix, research agreement and engagement plan together show a complete set of engagement documents.

The final reflection asks you to apply the eight headings of the engagement plan to a new study before you complete the final assessment.

Final Knowledge Assessment

Use this glossary to review the terms, frameworks and people introduced in this lesson on interest holder mapping and engagement.