Updated: Feb 28, 2022
You have decided to start a quality improvement (QI) project on improving access to fascia iliaca nerve blocks for hip fractures in your emergency department (ED). You have also gathered an interdisciplinary team of experts within your ED to help you identify structure, process, outcome and balance measures to use in your QI project. But how can you ensure you collect your data ethically when executing this project?
Welcome back to another HiQuiPs post where we continue our discussion on measurement in QI and move towards a discussion of navigating ethics in QI effectively!
Now that you’ve decided what type of data you need to collect during your quality improvement (QI) project, your next step is to identify an ethical, legal and practical way to collect the data from your institution.
Ethics approval can be difficult to navigate, as it was originally designed to protect patients from the risks of unproven therapies. An increasing number of institutions now recognize the specific needs and low risk nature of quality improvement and have alternative approval for projects meeting certain criteria. So, check with your institution’s research ethics board (REB) or quality improvement leadership about the process you should follow. If you’re unsure how to contact your institution’s REB board, ask your colleagues, department heads, or try searching the “Name of your Institution” AND “research ethics board” on Google!
Do I need to get research ethics approval?
As mentioned, you will have to determine whether your project is a QI project or a research project that requires REB approval or alternative QI approval. Many institutions now offer a checklist of questions that you can answer to determine if your project is considered QI or research, including:(1)
Does your project develop or test the efficacy of a new intervention that has not been studied before?
Does your project involve the prospective assignment of patients or providers into different procedures or therapies?
Does your project include a control group for whom the procedure or therapy or study intervention is withheld to allow an assessment of its efficacy?
Does your project involve blinding caregivers to any element of care?
Does your project involve the prospective evaluation of a drug, procedure or device not currently approved by Health Canada?
Does your project involve exploring a previously unknown phenomenon with a marketed or approved product (i.e., off label use of a drug/device)?
Does your project involve the use of a national or provincial registry/database from which a hypothesis will be tested?
If you answered no to all the questions above, there is a good chance your institution has a QI-specific oversight process that will be less onerous since your project presents no additional physical risks for your patients.
QI approval is still rigorous (and often required)!
Even with an REB exemption, you will have to explain how you will minimize any risks (including privacy) through a QI-specific review process. One tool from Alberta which is gaining popularity and can help you consider risks is the “A pRoject Ethics Community Consensus Initiative” (ARECCI) Ethics screening tool.(2) The ARECCI tool provides guidance and decision support assistance on projects that are not clearly required to receive REB review. For instance, one aspect of the tool provides you with risk filters that help you as a project lead, identify ethical risks from the perspective of participants in the project. After you have used the tool, it will produce a summary that will summarize the risk of the project, and recommended action for your project.
If your project is exempt from the REB process, your institution usually will require forms for expedited or QI specific review. In this case, you may need to consider several questions as you complete these forms. For example, questions surrounding a project seeking to provide patients with a nerve block to treat pain from a hip fracture may include:
How will your project eventually affect patient care? In this case, how strong is the evidence base for the new practice (i.e., is this standard of care)?
Will informed consent be needed in your project? (Miller & Emanuel, 2008) If you are unsure, you can consult your institution’s ethics or QI department for guidance. If consent is needed, it is likely you will need additional REB approval.
For most QI projects, one of the biggest risks to manage is patients’ privacy and confidentiality.(3) It is very essential to follow your institution’s and regions rules surrounding data privacy and exchange (e.g. PHIPA in Ontario).(4) In general, data should not leave your institution’s system, especially if they contain personal health information. For example, avoid using your personal email and stick to your (likely) clunky institution remote portal if you are working outside the hospital.
So what now?
While the planning for each QI project is unique and dependent on your institution’s guidelines, we suggest the following steps to ensure your team, and your patients get the most out of your QI project:
Draft a plan for data collection and analysis that is routinely accumulated in practice as much as possible (i.e. avoid chart review and questionnaires that require additional work producing often unreliable data).
Once you have a plan, meet with your decision support analyst. They will often have an intake form that will guide your request. While these can seem arduous, they will drastically improve the chances of clear communication so that you can use and collect the right data.
Check reporting guidelines, and adjust your protocol accordingly. Many journals include “ethical considerations” in their publication guidelines, and frameworks like the SQUIRE 2.0 guidelines can help you organize a QI project in a way that is safe, thoughtful and impactful.
Check your data to confirm it makes sense clinically and try to automate the updating of the data if your system permits this. This can help in guiding your PDSA cycle!
Always keep in mind that while QI does not pose the same risk that clinical trials pose, it still has privacy risks. Handle your data with care, and always ask for guidance from your institution’s ethics department.
Conventional QI interventions do not typically involve the use of unproven therapies, and so they should pose nonexistent or extremely low risk to patients’ physical safety. Still, there are many considerations for QI projects to minimize other risks to patients. Be sure to follow your institution’s safeguards to avoid privacy risks to patients and your team, and contact your institution to understand the ideal pathways to receive approval for your project.
We are also always looking for content that interests you! So please email us and let us know if there are any specific areas you would like to read about.
Senior editor: Ahmed Taher
Copyedited by: Matthew Hacker Teper
Ottawa Health Science Network Research Ethics Board. Is your project Research or Quality Improvement? Is your project Research or Quality Improvement? Published November 2016. Accessed June 7, 2021. Available from: http://www.ohri.ca/ohsn-reb/forms/Checklist%20Research%20or%20QI%20-%20revised%20November%202%202016.pdf
Alberta Innovations. ARECCI Ethics Screening Tool. ARECCI Ethics Screening Tool. Accessed June 7, 2021. Available from: http://www.aihealthsolutions.ca/arecci/screening/457383/19784375ec380d2deb136e20596742c9
Taylor H, Pronovost P, Sugarman J. Ethics, oversight and quality improvement initiatives. Qual Saf Health Care. 2010 Aug 6;19(4):271-274. doi:10.1136/qshc.2009.038034
Government of Ontario . Personal Health Information Protection Act, 2004. Personal Health Information Protection Act, 2004. Accessed June 17, 2021. Available from: https://www.ontario.ca/laws/statute/04p03