Health Services Research
Scenario #1: Research Choices
You are a geriatric home health nurse interested in conducting research on barriers to medication and treatment plan adherence amongst the elderly. Through your practice you have noticed that some patients are very good at following their doctor’s advice and treatment plan, attending scheduled appointments and so on. However, other patients can be very frustrating; they do not take their medications, miss multiple appointments and do not follow guidelines on diet and exercise.
Your supervisor has asked you to design and implement a system to recognize patients who are ‘non-compliant’ and develop a way to ensure that they follow their treatment plan. There is a budget of $5,000 to conduct the research that will inform the design and implementation of this system. To date, you have developed a survey to be mailed to 8,000 seniors across Canada. You are excited about doing this as you should get a big ‘N’ and be able to publish the results in a good journal. However, a colleague is concerned that your survey is not being translated into other languages. She believes that cultural and linguistic issues may be at the heart of some ‘non-compliance’ behaviour. While you acknowledge that this might be possible, translating the survey into different languages would consume nearly your entire budget, and you would then have to conduct your survey with a much smaller (and less representative) sample. In addition, the translation process would take a few weeks, and you need to get the research completed quickly in order to apply for additional research funding in the next budget cycle.
Discussion questions
- What are the most substantial ethical issues involved in this case? How do these issues impact the research study you are conducting?
- What do issues like sample size and who you sample have to do with ethics?
- What is problematic about conducting research on only certain segments of the population?
- Do researchers have an ethical obligation to make research inclusive? How would you balance this objective with the obligation of making research timely, efficient, and economically viable?
- Does it make a difference if you do not anticipate any differences in results between different sociocultural groups?
Scenario shift
You discuss your concerns about the cost and time associated with translation with your colleague. Although she has no data to back up her opinion, based on her extensive experience as a home health nurse, she believes that a large portion of those who are non-compliant are from a specific ethnic group who speak English as a second language. Your colleague is also from this ethnic group and speaks both English and X. She suggests that she could translate the survey into X quickly and at no cost so it could also be given to individuals from her ethnic group.
Additional discussion questions
- What are the benefits and drawbacks of having the translation done by this colleague?
- Does translating the survey into another language make the research more ethical? Why or why not?
- Should a researcher ever make assumptions about their research or assume a result? In what ways can this be helpful or harmful to the research endeavor? To the research subject?
- Should the researcher consult with community members regarding the research? Why or why not? If so, who?
Relevant ethics guidance documents
- TCPS2 Chapter 4: Fairness and Equity in Research Participation
- Community-based research sections in TCPS2 Chapters 9 and 7
- Although this chapter is interested primarily in qualitative research, many elements also apply to other types of research. TCPS2 Chapter 10: Qualitative Research
Links to the Ethics Cycle conceptual framework
- Through this scenario, participants can address issues under the following topics:
- Design project (the choice of collaborators can impact how researchers design projects and may also impact how they access resources or human participants);
- Recruit participants (who is recruited into a study has a significant impact on the data collected; the methodologies used; and the results);
- Draw conclusions (researchers should be aware of how the conclusions of their studies impacts individuals and groups);
- Adapt knowledge to context (research should empower and give voice and agency to human participants);
- Sustain knowledge use (researchers should seek to build capacity and consider lost opportunity costs associated with their studies);
- Monitor knowledge use (researchers should be aware of conflicts of interest and responsibilities when monitoring knowledge use).
Links to real life case studies
- Gottlieb, S. (1999). NCI defends research involving minority groups. Nature Medicine, 5(3), 254.
- Stahl, S.M., & Vasquez, L. (2004). Approaches to improving recruitment and retention of minority elders participating in research. Journal of Aging and Health, 16(5 suppl), 9S-17S.
- Giuliano, A.R., Mokuau, N., Hughes, C., Tortolero-Luna, G., Risendal, B., Ho, R., et al. (2000). Participation of minorities in cancer research: The influence of structural, cultural, and linguistic factors. Annals of Epidemiology, 10(8), S22-S34.
Discussion Guide
- Ethical issues to be discussed include: social justice; fairness and equality in research participation; validity/utility of results; and research translation.
- According to TCPS2, researchers do have an ethical obligation to make research fair and inclusive. For example, ethnic minorities, those who speak a different language, the elderly, children, prisoners, etc., should not be unjustifiably excluded from research participation as they may then also be excluded from enjoying the benefits of research results. However, resource constraints (including time, capacity of the research team, and money) also need to be taken into account and weighed in consideration of overall potential benefits and harms.
- The evidence informing these expectations should be explored (e.g., existing data, observational perspectives, unjustified opinions). Potential outcomes of correct/incorrect expectations should also be considered (i.e., who will benefit from results, who will the results negatively impact).
- Benefits include rapid turnaround and cost savings, while drawbacks include potential bias/inaccuracy in translation. Does access to quick and cheap translation justify going forward with this research?
- Translation of the survey may make the research more ethical if it makes the research more inclusive/accessible and encourages participation from diverse groups. But, if your colleague’s assumptions turn out to be incorrect, was this a justified use of your time and the time of your participants? Consider issues like lost opportunity costs.
- Assuming results may lead to issues such as premature conclusion-drawing, bias, etc. However, reflecting on what is already known and the expertise of the researcher (especially if it is objective) may be beneficial in that it makes the research endeavor more efficient.
- Issues to consider in whether community consultation may be appropriate include: building community trust and support for the research (e.g., to improve recruitment rates or uptake of results); accessing local/community knowledge; methodological issues/constraints; sensitivity of research; potential impact of research findings; possibility of discrimination/stereotyping; and potential benefits and harms of not including/including the community.
Scenario #2: Reporting Research Results
You are a researcher funded through a public health research group and CIHR. Your research focuses on mental health services for adolescents, specifically in rural and remote communities. You have spent the past two years conducting a research project in collaboration with a small non-Aboriginal community in a southern region of Canada. The research was designed and conducted in a way that was consistent with community-based participatory research and as such, the community has been involved in every aspect of the research process, including identifying the research question, research methods, and analysis.
The research involved following adolescents who received two different types of intervention. The first group received face-to-face counseling on a weekly basis, a computer and internet to access an online support group and counseling program, and a stipend to attend a vocational training or educational program for one year. The second group received remote phone counseling once a week and monthly phone mentorship by a career counselor.
Your analysis of results suggests that there is no significant difference between those who received the more intensive counseling and services and those who received remote support. However, the community leaders are concerned that reporting these results will lead to budget cuts for health services in their community. They urge you not to report the results but instead request additional funds to examine the issue in more detail. They are convinced that further study will confirm that the more intensive program is actually more beneficial to adolescents over the long term.
Discussion questions
- What are the ethical issues at stake in this case?
- As a researcher, what are your obligations to the community? Does the fact that this is a community-based participatory research project make a difference to your decision?
- What are your obligations as a researcher? What role does research integrity play in this case (if at all)?
- What are your obligations to the funders? And to Canadian society?
- What decision would you make if you were unsure or unconvinced by the research findings?
Scenario shift
You receive a small amount of new funding to continue the study for three additional months and conduct supplementary telephone surveys regarding the effectiveness of the two interventions. At the end of the three months, you collect the survey responses and analyze the results. You are surprised to see that there now seems to be a marked difference in the effectiveness of the intervention between the two groups, with those who received the more intensive treatment appearing to do much better across all measures than those who received remote support. Given the results from the initial research, you are surprised by this finding, and are concerned that the research participants may have been ‘coached’ to provide certain answers to the surveys.
Additional discussion questions
- What should you do in this situation? What are your obligations as a researcher?
- What are some of the possible consequences of doing nothing?
Relevant ethics guidance documents
- Policy on Open Access to Research Outputs [ PDF (940 KB) - external link ]
- TCPS2 Chapter 9: Research Involving the First Nations, Inuit and Métis Peoples of Canada
- The Health Canada/Public Health Agency of Canada REB website
- Tri-Agency Framework: Responsible Conduct of Research (2016)
Links to the Ethics Cycle conceptual framework
- Through this scenario, participants can address issues under the following topics:
- Draw conclusions (how researchers draw conclusions has important impacts on individuals and groups) ,
- Publish results (publishing negative results (or a null result) is important scientifically and ethically and has impacts on resource allocation, among other things) ,
- Adapt knowledge to context (research should give voice and agency to as well as empower participants) ,
- Toward continued KT (it is important to carefully justify the use of scarce resources used in research including funding opportunities),
- Toward KT of results (selecting which evidence and results are disseminated has important ethical implications for participants and other researchers)
Link to relevant article
- Bekelman, J.E., Li, Y., & Gross, C.P. (2003). Scope and impact of financial conflicts of interest in biomedical research. JAMA, 289(4), 454.
Discussion Guide
- Ethical issues at stake include: respect for communities/groups; fair distribution and allocation of resources; and beneficence.
- Obligations and responsibilities relate to issues of trust, respect, ongoing research/collaborations, etc. It is also important to weigh these obligations with obligations to your funder and obligations as a researcher to your field of study.
- TCPS2 Guidelines for conducting research with First Nations, Inuit, and Métis Peoples of Canada (TCPS2, Chapter 9) may be considered. For example, it may be appropriate to consult the community to actively engage community members or representatives in all aspects of the research design and the translation of results including collaborating on the development of the research objectives and methodology, recruitment process, and so on.
- Obligations to funders include: responsible, appropriate, and ethical use of funds; timely dissemination of findings and results; the commitment to produce high quality and accurate results; etc. Obligations to society and the Canadian taxpayer include responsible use of funds/resources and the timely dissemination of findings and results.
- The implications of premature release of uncertain results versus delaying results due to genuine uncertainty should be discussed.
- As a researcher your responsibilities include the creation of knowledge that is accurate, so concern for biased or spurious results should be addressed. If you suspect tampering or have evidence of tampering, these suspicions should be evaluated carefully and fully. However, it is important to avoid unjustified accusations that could lead to serious and negative long-term consequences for that community, erode trust, and permanently damage relationships among all involved parties.
- The consequences of disseminating/publishing incorrect results should be discussed. Wasted or misdirected resources and other tradeoffs should also be considered. Inaction is not a morally neutral choice.
Scenario #3: Surgical Robots
You are a health economist collaborating with a health science research team at a Canadian university to study the uptake of their new technology. Your lab members have invented a new surgical robot with funding from CIHR. This new robot aids in prostate surgeries and leads to quicker surgeries, less blood loss, and faster recovery times for patients. It also lengthens the careers of surgeons because it is ergonomically designed. However, the robot is expensive to use because it involves additional training for the surgical team and special maintenance. At the current time it is only available to patients who wish to pay extra for this service. It will not be covered by provincial health insurance and is too expensive for most Canadians.
Discussion questions
- Is it fair to create health products using public funds that will not be available for all Canadians? Why or why not?
- How might the benefits from this research benefit all Canadians?
- Suppose that you were going to be interviewed by a reporter about this research. What would you tell her? How do you think citizens might react to the story she writes and should you care?
- In what ways do CIHR investments into surgical robots impact the Canadian health care system? Other health technologies?
- Do Canadian researchers have an ethical obligation to develop technologies or products that citizens in developing countries can afford? Or should they only be concerned with the health of Canadian citizens?
Scenario shift
A prominent hockey player recently underwent surgery using the robot and heralded the robotic surgery as being far superior to the usual form of surgery. As a result, there has been a huge increase in demand for prostate surgery via the robot, and several large medical centres have requested a robot for their surgical departments. Your team does not have the capacity to cope with the increased demand and you are considering starting a spin-off private company to produce the robots. However, to do this you would likely need to dedicate more than half your time to the private company, and would also require the dedicated assistance of several research team members who were initially involved in developing the robot.
Additional discussion questions
- Is it acceptable for you to start the spin-off company and retain your position at the university? Why or why not? How might you manage any conflicts of interest (such as conflicts of commitment)?
- Who stands to benefit from the spinoff company? Are there any trade offs?
- What are your obligations to your university in this situation? Other researchers? Your department? Future patients? Your research team?
Relevant ethics & legal guidance documents
- TCPS2 Chapter 7: Conflicts of Interest
- Government of Canada, Science and Technology for Canadians. Access to Research Results: Guiding principles
- Canada Health Act
Links to the Ethics Cycle conceptual framework
- Through this scenario, participants can address issues under the following topics:
- Apply knowledge (intervention) (fair allocation of resources is an important consideration when implementing interventions);
- Further research (it is important for researchers to have sound ethical and scientific justifications for additional research);
- Toward next generation research (experience gained through the knowledge translation process should be used to inform next generation research);
- Sustain knowledge use (researchers should seek to build capacity and consider lost opportunity costs associated with their studies) (KT);
- Assess knowledge; barriers to knowledge (it is important to address the accessibility of knowledge and ensure that knowledge and research outcomes are available equitably) (KT).
Links to real life case studies
- Meet Jack the surgical robot, on the edge of prostate cancer treatment
- A new age of surgical robotics research | VCH Research Institute
Discussion Guide
- Consider issues such as: fair and equitable use of resources; social justice considerations; and benefit-sharing.
- This research may benefit Canadians in a number of ways including: moving science forward; leading to other discoveries that might help all Canadians; decreasing surgery wait times; and eventually providing surgery remotely to rural communities.
- Consider the potential impacts of public exposure of your research and how it may make you feel. Would you feel uncomfortable in explaining/justifying any of your actions? If so, this may help you identify areas of ethical ambiguity or concern in your research that deserve further examination/thought. Researchers should care about public opinions regarding scientific research. CIHR funded research is conducted using public funds and is intended to benefit Canadian citizens.
- CIHR investments into such technologies may impact the Canadian health care system in a number of ways such as: attracting top researchers, attracting pharmaceutical and device companies, stimulating economic growth, taking away from other areas of health research/ technologies etc.
- Reflect upon the social justice and resource allocation issues at play.
- Discuss conflicts of interest (in terms of commitment/time and financial conflicts); how should it be approached/reported/discussed/acted upon? It is important to note that some conflicts of interest can be managed effectively and ethically if dealt with in an open, honest, and transparent manner.
- Consider financial benefits (to you, your company, shareholders, etc.) and financial and other implications for your university (e.g., technology transfer agreements), other researchers/collaborators/students, and broader societal implications and benefits.
- Financial, research outcome oriented, and social obligations should be discussed. Equity, benefit sharing, and legal issues should also be considered.
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