The Research Process
The general steps in the research process are provided at the top of the page. By clicking on the arrows to the left and right of the research process, you can scroll to the part of the research process you are most interested in and select the FAQs that you would like to read more about under each part of the process. The research process is usually a cycle and while it often starts at “Identifying and Prioritizing,” patient partners can be involved in any step of the process, so it is presented here without a start and end.
What are Roles in the Research Process for Patient Partners?
You may find it helpful if there is more than one patient partner on a clinical trial team. This may depend on you and your situation as well as your role of patient on the team. Many patient voices on a team can help with diversity and commonality of lived experiences and also help to ensure balance so that no one feels over-burdened or out-numbered. Research is a process, and there may be a number of areas in which patient partners can play a role:
- Identifying and Prioritizing. This refers to identifying and prioritizing objectives and outcomes of a clinical trial and may include you sharing what research is important to you as a patient based on your own experiences and helping develop the research question that the team will answer.
- Design. This refers to providing input in to the design of a clinical trial and may include giving feedback from your lived experience perspective on: the research plan, the materials that would be provided to potential participants, the planned outcomes for the study that would be measured, etc.
- Development of the Grant Proposal. This may include helping develop the research questions to be answered, helping define characteristics of clinical trial participants, providing input to help design a clinical trial that fits into the lives of patients.
- Preparation for Execution of the study. This might include reviewing materials such as posters and informed consent wording that will be provided to potential participants. You might also know organizations that would be willing to share information about the study with their own stakeholders or individuals who might wish to consider participating in the study.
- Data Collection. Depending on your involvement with the research team, you might be involved in working with participants in the study, for example, to help administer surveys or participate in interviews or focus groups.
- Analyizing and Interpreting Data/Results. When the study’s data is analyzed, you might work with the team to understand what the results are and offer opinions based on your lived experience about the results.
- Dissemination. This means helping share the results, which might involve working the team to develop lay summaries about the results of the study, participating in presentations about the study, and writing or reviewing manuscripts about the study. You might also share these materials and results with organizations to which you have links and that would be interested in learning about the research and its results. Sometimes you will hear these activities called Knowledge Translation and Exchange.
- Implementation. This may include developing a plan to implement the findings of the research in to everyday practice.
- Monitoring and Evaluation. This may include regular review of the clinical trial as it is ongoing, including recruitment activities, data collection and analysis, etc. It could also include being a Patient Representative on the Data Safety Monitoring Board (also called a DSMB). A DSMB is made of people who are external experts to the clinical trial. They regularly review data from the clinical trial and advise about safety of the participants, validity and scientific merit of the clinical trial.
What are the Guiding Principles of Patient Engagement in Research?
CIHR has principles for engaging patients as partners in research (including clinical trials):
- Inclusiveness: Patient engagement in research brings in different patient perspectives and research reflects contributions of these different individuals and perspectives. Patient partners are recognized as people bringing their lives and their experiences related to their health and healthcare to the research team.
- Support: Support and flexibility are provided to patient partners allowing them to fully participate in discussions and decisions. This means creating safe environments that allow for honest interactions, cultural competence, training, and education. This also includes financial compensation to recognize expertise and contributions of patient partners.
- Mutual Respect: Researchers, health care providers, and patient partners acknowledge and value each other’s expertise and lived knowledge. As a patient partner, you may come from a different cultural background than the research team and may have different expectations about appropriate ways of interacting. You may also feel that the words you use to describe your experiences are different from those the research team uses. Whatever your differences are, they are what contribute to your potential to provide unique insights and should be respected by the other members of the research team, as you respect theirs.
- Co-Build: Patient partners, researchers and health care providers work together from the start to identify problems and gaps, set priorities for research and work together to create and implement solutions.
Being Part of the Team and Getting Help You Need to Participate Fully
Here are some basic things you might consider about being a patient partner on the clinical trial team in terms of communication, participating in meetings, and generally being part of the team.
- There should be ways for you to participate that meet your needs. This might mean that if you can’t make a meeting for any reason, that you are still able to contribute (for example, through email, a meeting set up at a time that works for you, etc.)
- Find out who your point person on the team is, and who can support you if you need it. This person should be available to answer any questions you have about your role, clarification you might require about any tasks provided to you, and respond to any concerns you might have.
- Clarify if you are the only patient partner on the team or if there are other patient partners. Sometimes it is easier when there is more than one patient partner – the pressure is not only on you to represent the patient voice and experience. You may also learn about other patient partners’ experiences when you’re part of a team with more than one patient partner, which may be similar or different from your own.
- Share as much or as little as you are comfortable with about yourself and your experiences. As a patient partner on the team, you will share information about your experiences, but you should feel comfortable about what you share and who is in the room or part of a meeting when you share it. What you share and how much is completely up to you. You may find yourself sharing more information with the team as you develop a relationship over time with them.
- It might be helpful to have a ‘role description’ about what the expectations are for you being part of the team. You should also be able to talk to your point person about whether or not this role may need to change to accommodate you at all for any variety of reasons.
- If you are not comfortable diving right in to work on the team, don’t be afraid to ask lots of questions or for resources to help you. Your point person on the team will be able to answer any questions you might have about things such as data extraction, ethics, etc. Also, there may be a webinar or course you would like to attend or perhaps the team can recommend some reading materials for you.
- If you feel there is a power imbalance and you aren’t able to fully express what you wish or if you feel you are not being listened to, consider having a call with or email conversation with your point person on the team. Let them know how you feel and why you feel this way. See if you can work with them to come up with a solution that works best for you or if they have some suggestions that can help you.
- Sometimes teams don’t work out – and it’s alright if you feel that for whatever reason the team is not a good fit for you. You should not feel that you have to continue with the team if this is the case. If you are comfortable providing honest feedback for the principal investigator about why this is the case, that would likely be helpful to the team.
Ground Rules for Meetings and Communications
Some basic guidance to follow around meetings and conversations include:
- Arrive prepared, having read any materials that have been sent ahead of time (and if materials are not provided to you with enough time in advance, let the meeting organizer know you felt that way).
- Listen to understand someone’s point or point of view rather than react.
- Speak directly to the issue at hand to stay on topic and focused.
- Participate in discussions, provide feedback, raise issues, disagree constructively in an open and collaborative manner.
- Respect other people’s opinions, even if you don’t agree with their point of view.
- Recognize and value the expertise and experience that all others bring to the discussion.
- Use given names, rather than any formal titles (i.e., avoid Dr., Prof., Mr., Mrs.).
- Don’t be afraid to ask for clarification if you don’t understand something.
- Respect privacy and confidentiality. Understand what you can talk about publicly outside of meetings (if you can).
This document offers some tips in terms of meetings that include patients, public, researchers, and others: http://www.invo.org.uk/wp-content/uploads/2018/01/Top-Tips-3-Participating-in-a-meeting-v1.pdf
Being a member of a research team might be new to you and including a patient partner on the research team might also be new to other members of the research team. This also means that you will learn and develop new ways to communicate with other members of the team. A few things you might consider in your approach to communicating:
- Ask the researchers to limit their use of scientific or medical acronyms and jargon. And keep reminding them if you need to, ask them to explain what the acronyms mean, or ask for a glossary to help you out.
- There might be a lot of email communications – if this is not a format that you are comfortable with, let them know. Maybe phone or video calls work better for you. Or maybe there is a chance to meet in person.
- Be honest with the research team when they ask you for specific feedback or input. It’s ok if you don’t agree with their approach and respectfully explain why.
Expense Reimbursement and Compensation
A paper on this topic that has been written by four Canadian patient partners can be found here. The paper outlines what you might consider with respect to expense reimbursement and compensation as well as how you might even approach the conversation with the principal investigator you are considering working with.
It is best practice for your expenses to be paid as a patient partner on a clinical trials team. It should not cost you money to be part of the team. Expenses may include transportation, supplies, meals, conference registration, etc. Many organizations will also book travel arrangements for you so you are not out of pocket in terms of getting expenses reimbursed.
Sometimes compensation is provided to you for your time and expertise as a patient partner, and sometimes it is not. If this is important to you, this is a discussion that you can have with the main researcher on the team, and below we provide some guidance for you around some considerations and ways to approach this topic (if compensation is important to you).
A few things to consider about compensation:
- Is not always a payment of money, and it is important for equity with you being part of the research team.
- May be a mix of monetary and non-monetary (e.g., charity donations) – this is up to you and sometimes the ability of an organization to donate to charity may be limited.
- Should reflect the level of expertise, commitment, responsibility, type of work, and the degree of participation contemplated.
- A one-on-one discussion on compensation should occur at the start of the project with the principal investigator who invited you to be part of the team, so that you can discuss what compensation looks like.
- Rate structures are based on unit of time or level of engagement. There is some specific amounts provided below.
- All income is subject to relevant tax laws and regulations. In Ontario, compensation above $500 is generally taxable income.
There is little guidance about specific information on compensation of patient partners on research projects, but the tables below have been put together by the CIHR SPOR Chronic Disease Networks and include input by all stakeholders (including patient partners). Note that depending on your background, expertise, etc. these rates may vary.
|RATE STRUCTURE BASED ON UNIT OF TIME|
|Hourly rate||$25||For activities less than 4 hours|
|Half day rate||$100||+/- 4-hour commitments|
|Full day rate||$200||+/- 8-hour commitments|
|RATE STRUCTURE BASED ON LEVEL OF ENGAGEMENT|
|Level of Engagement||Example of Activity||Suggested Compensation|
|Availability of email; willing and able to participate in a few meetings by phone or in person||Contributes advice and feedback for decision making by research team||Works within a specific clinical trial||In-person meetings will require expense reimbursement in addition to compensation||$500 to $800 per year, depending on number of meetings and other requirements|
(References: Recommendations on Patient Engagement Compensation, The Change Foundation. Should money come into it? The Decision Tool. 2017, The Change Foundation. 7 things to think about when considering compensation for patient and family caregiver engagement. 2017, Peer payment standards for short term engagement. February 2018, Patient partner compensation in research and health care: the patient perspective on why and how)
More Information about Research and Clinical Trials
CTO’s website provides you with basic information about clinical trials here.
There are other resources that provide you with basic information about clinical trials including:
An Introduction to Patient-Reported Outcomes
You may hear the term Patient-Reported Outcomes (PROs) in clinical trials, especially when patient partners are part of the team and helping define a clinical trial’s outcomes. More information is provided about PROs here. Patient-Reported Outcomes (PROs):
- are outcomes that people report about their health condition such as how well they may physically function, their symptoms, and their overall well-being (1)
- aim to represent a person’s view/feelings about their condition without interpretation from health care providers or anyone else (1).
- are important to understand and capture health outcomes that are important to patients (2-4).
- can provide a fuller picture of the effects of the treatment on patients’ lives (5). Common measures in clinical trials include things like health care use and mortality, but these don’t necessarily also capture other aspects that are important to participants in their daily lives.
(references: US Food and Drug Administration. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health and Quality of Life Outcomes. 2006;4:1-20, Kluetz PG, O’Connor DJ, Soltys K. Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada. The Lancet Oncology. 2018; 19(5):e267-e74, Calvert M, Kyte D, Price G, Valderas JM, Hjollund NH. Maximising the impact of patient reported outcome assessment for patients and society. BMJ. 2019;364:k5267, Wiering B, de Boer D, Delnoij D. Patient involvement in the development of patient‐reported outcome measures: a scoping review. Health Expectations. 2017;20(1):11-23, Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan A-W, King MT, et al. Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO extension. Jama. 2018;319(5):483-94.)
Evaluating Patient Engagement Partnerships
You may be asked to provide feedback about your experience of being a patient partner in research to the clinical trials team. There are some surveys that have been developed to do this or you might be asked for informal feedback. You are encouraged to be honest about your experiences so that the team can improve upon their patient engagement efforts based on your experiences with the team.
As an example, there are patient partner surveys designed to understand the patient partner experience in the patient and researcher partnership:
- Patient Partner Surveys (initial, mid-, and end-project surveys). The first survey is designed to be done early in the partnership, the second to be done mid-way through the partnership, and the end-project survey is to be delivered at the end of the research.
- Another patient partner survey that can be given at any time in a research project.
Sex and Gender in Research
Sex and gender are important to clinical trials. For example, some diseases affect one sex more than the other and learning more about why this is the case will help find better interventions for the disease overall. In the words of CIHR “To be truly personalized, health-care approaches must account for both biological and socio-cultural differences to determine how disease and drug outcomes differ for men, women, boys, girls and gender-diverse people.”
The terms sex and gender are often used to mean the same thing but they do not. We have included the definitions of these terms for you:
- Sex: Sex is based on biology, as in being female or male. It is based on physical and physiological features such as chromosomes, gene expression, hormone levels and function, and reproductive/sexual anatomy.
- Gender: Gender refers to how one views oneself (e.g. girl, woman, boy, man, and other gender diverse people). Gender is based on socially constructed roles and influences how people see themselves and each other, how they act and interact, and the distribution of power and resources in society.
Writing a paper with the research team
- There is very little guidance on the topic authorship for patient partners within the purview of POR and the International Committee of Medical Journal Editors (ICMJE). A recent publication entitled ‘Guidance on authorship with and acknowledgement of patient partners in patient-oriented research’ provides guidance for patient partners and investigators on the publishing process, and also has a brief description of some key publishing terms and the process of publishing. Since writing and submitting a manuscript may be unfamiliar to you, this paper may be helpful. Guidance on what constitutes authorship and what constitutes acknowledgment is also provided.