Welcome to our Learning About Research Data blog series! Through these blog posts, co-authored by our new partners at PolicyWise for Children & Families, we aim to demystify data sharing and data management in research. Headquartered in Alberta, where our national CHILD-BRIGHT Data Coordinating Centre is also based, PolicyWise is a not-for-profit organization that mobilizes and integrates evidence to inform policies and service delivery with the goal of improving the well-being of children and families. PolicyWise also manages an online platform that allows researchers to easily store and share research data about study participants while maintaining privacy and confidentiality.
Part 2 – It Takes a Village: Understanding the Roles of Different Stakeholders in Research
Conducting research is always a team effort. That's especially true when it comes to types of research that involve human participants and their data. Such research is logistically complex and requires a high level of due diligence to ensure it is rigorous and conducted in a safe and ethical manner. Understanding who the key players, or stakeholders, are in research is important foundational knowledge for understanding more advanced topics in reusing data, some of which will be discussed later in this blog series. Below, we will describe the roles of 6 key stakeholder groups that help drive research forward and highlight where they intersect with data sharing.
Researchers: Principal Investigators, Research Team Members, and Patient-Partners
The primary researcher, or the Principal Investigator (PI), is the person who takes the lead in a study. A PI usually leads the design of a study, including developing a grant proposal to secure funding and working out the details around data collection. The PI is also responsible for submitting the study to an ethics board for approval. The PI must be qualified to lead and conduct a study, both in terms of experience and education. The topic of research at hand is often part of their life’s work, with the study making up one of many pieces to a bigger puzzle in their field of study.
Importantly, the PI does not work alone. They lead a team of researchers and staff to complete a study. Research teams are often composed of researchers from a variety of disciplines, including some with content expertise on the medical condition being researched, some with expertise in methodologies such as medical imaging or interpreting genetic information, and others who are experts in statistics.
In recent years, and especially since the establishment of the Canadian Institutes of Health Research’s (CIHR) Strategy for Patient-Oriented Research (SPOR) program, health researchers have begun engaging those with lived experience as partners in research. A patient-partner is an individual with lived experience of a health condition as a patient, family member of a patient, or caregiver of a patient, and they can provide valuable insights as a member or advisor on a research team. Patient-oriented research actively involves patients and their families in “governance, priority setting, developing the research questions, and even performing certain parts of the research itself.” This novel way of involving patients as partners makes the research more relevant and paves the way for research findings to be shared with those whom it impacts most.
Participants
The key component to research involving humans is—you guessed it—people! Most advances in health research would not be possible without studying how innovations fare in the real world, with real people and patients volunteering to participate. The role of the participants has evolved significantly over time, with participants more empowered today to contribute their perspectives to the research than in the past. Respect for research participants is now enshrined in policies like the Tri-Council Policy Statement (TCPS2), and a research ethics board (REB) will ensure these policies are upheld (more about TCPS2 and REBs below). The possible risks and benefits of participating vary from study to study, but participating as a research participant is a great way of contributing to the advancement of modern research.
Institutions
The university or hospital where the PI works plays a key, although often hidden, part in the research process. Just like a chef needs a restaurant to sustain their craft, research would be nearly impossible without the support of research institutions. They provide physical spaces like clinics and laboratories, and equipment like magnetic resonance imaging (MRI) scanners. Institutions also provide staff that support researchers on a wide range of administrative matters, such as legal and financial services and systems and infrastructure for secure data collection. With this institutional support on hand, researchers can spend more of their time focusing on research. Investigators are also often employees of the institution and teach and/or provide clinical care in parallel with conducting research.
Research Funders
Research is an expensive endeavour. It requires expertise, infrastructure, and materials to reach an answer that can contribute to improving the well-being of patients and communities. Public funding is a significant source of financial support for Canadian researchers. Governments at various levels earmark money for research as a way of investing in the future, both in terms of social and economic goals. The Canadian Tri-Council is a prime example. The Tri-Council is composed of three federal agencies that provide funding for research in Canada. These three agencies are: the Canadian Institutes of Health Research (CIHR), the National Science and Engineering Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC). Over a billion dollars flow through these agencies to researchers every year!
The federal government is certainly not the only source of research funds in Canada. Take CHILD-BRIGHT for example: CHILD-BRIGHT is not only funded by CIHR, but also 28 non-federal funding partners from across Canada. These funding partners include hospital foundations, universities, and private industry. Their fundraising efforts, along with the contributions of individual donors, make a big difference to the advancement of research. Many funders are moving from encouraging to mandating the sharing of research data to increase the value of data collected from participants and to increase transparency.
Research Ethics Boards
A research ethics board (REB) has one of the most important roles in research. At any given institution, there may be multiple boards handling various areas of research, such as a board for animal research, a board for brain research, and a board for cancer research. REBs are composed of subject matter experts and community members who review research studies to ensure that they are feasible and conducted ethically. For example, an REB will review the research team’s process for recruiting potential participants to join a study. This process, called the informed consent process, is a cornerstone of clinical research. Informed consent ensures that: the research team educates potential participants about the study in understandable language, the potential participant understands the study and what is expected of them while participating, and that their participation is completely voluntary, among other points.
An REB will also pay close attention to the details on data collection and data security. The Tri-Council requires every research study be reviewed and approved by an REB before enrolling participants. In Canada, the Tri-Council publishes a guideline called The Tri-Council Policy Statement (TCPS2), which stipulates how research involving humans must be conducted and defines standards of how research should be carried out.
Independence is key to the function of REBs. They must act without influence from investigators, funders, and others who may have real or perceived conflicts of interest related to the outcomes of a study. Overall, REBs work to ensure the safety of study participants by providing independent oversight of research from beginning to end, and ensuring that the research team complies with ethical guidelines.
The Broader Research Community
Research findings need to be shared to inform improvements in practice. Sharing between researchers and the broader research community occurs in many ways, including speaking at events like conferences and publishing in scientific and medical journals. By submitting their research methods and findings to conferences and journals, the broader community of researchers can challenge the work, if necessary, and provide constructive feedback. This process is critical in ensuring the validity of a study. When researchers submit their findings for publication in a journal, it is reviewed by other researchers who are not affiliated with the study, but are experts in the field. This is referred to as peer review. More recently, some academic journals have added patients as reviewers in this process in an attempt to ensure the findings are relevant to patients and to make the research process more patient centric.
In recent years, some publishers have advanced the transition toward data sharing by requiring researchers make their study data available openly and publicly, or at least available upon a reasonable request. Sharing data in this way is akin to adding a layer of crowd-sourced oversight to research to ensure that conclusions are reproducible, rigorous, and impactful. So, by disseminating their results in these different arenas such as conferences and journals, researchers can build upon each other’s work and advance scientific knowledge, all while building future collaborations.
Summary
Primary researchers, research teams, patient-partners, research participants, institutions and their employees, research ethics boards, and the broader research community are some of the key stakeholders in research. However, there are many more under-appreciated professionals behind the scenes who handle other aspects, such as by resolving intellectual property issues, testing blood samples, or conducting data analysis. It really does take a village to make research happen, with each contributor bringing their unique skills to a research project to collectively bring it to fruition. We hope that the information in this post serves as a general orientation of the key stakeholders in research, but also as a resource for future blog posts about important considerations with reusing data in research.
For more information about the roles that these stakeholders play in research, check out Module 1 from the Patient-Oriented Research Curriculum in Child Health.