Common misunderstandings in Project Ethics
Quality Improvement (QI) and evaluation projects have become increasingly important, multiplying in number and growing in complexity. Although ethics oversight principals and processes are well established for research projects, a gap exists for non-research projects. Many QI and evaluation projects have ethical implications, but ethics screening and review processes are often limited and inconsistently applied. This uncertainty and inconsistency often leads to misunderstandings about how and when ethical implications should be addressed in QI and evaluation projects. Reviewing the following common misunderstandings and our responses to them should help clarify these issues for you and reinforce that sound practice requires integrating ethical considerations into your QI and evaluation projects to ensure that people are protected and respected.
MISUNDERSTANDING: QI and evaluation projects do not need ethics review.
MISUNDERSTANDING: If all QI and evaluation projects required review, nothing would ever get done.
MISUNDERSTANDING: All projects with more than minimal risk need to be reviewed by an REB.
MISUNDERSTANDING: You must get ethics approval from an REB to publish the results of QI or evaluation projects.
MISUNDERSTANDING: I am guided by my professional ethics and I’m ethical. My work does not need to be judged.
MISUNDERSTANDING: Providing health services to individual patients is essentially ongoing “quality improvement” and it’s impractical to review these as quality projects.
MISUNDERSTANDING: General consent to treatment is sufficient.
MISUNDERSTANDING: QI and evaluation projects do not need ethics review.
While Research Ethics Boards (REBs) review all research projects, there is currently no similar process for QI and evaluation projects. Yet, QI and evaluation projects can pose the same risks to participants as research projects. For example, the design and implementation of QI and evaluation projects can be similar to research projects, and QI and evaluation projects often deal with at-risk or otherwise vulnerable populations in intrusive ways. Historically, participants in health-related non-research projects, including QI and evaluation, have not been given the same protections through ethical scrutiny as research subjects. Therefore, organizations need to consider the implementation of internal ethics review processes that identify, assess, and address ethical risks to participants in all QI and evaluation projects undertaken.
MISUNDERSTANDING: If all QI and evaluation projects required review, nothing would ever get done.
Considering ethics in your projects is not meant to be a barrier or an add-on to your practice. Rather, ethics ought to be an integral part of project practice to ensure the rights of people are respected while contributing to the improvement of health services. The ARECCI Network recommends that all QI and evaluation projects need ethics screening. However, that does not mean that all projects will require ethics review. The level of review depends on the project’s level of risk. Generally, the greater the level of risk, the more scrutiny the project requires. The ARECCI Network has developed two decision-support tools to help integrate ethics into projects that are suitable for the past pace of the health care environment.
MISUNDERSTANDING: All projects with more than minimal risk need to be reviewed by an REB.
For research projects, this is true: REBs review all research projects that involve human subjects. However, this is not true for QI and evaluation projects. Even though a full ethical review may be needed because a QI or evaluation project has higher risks, that review would not be completed by an REB. Because of the embedded nature and pace of QI and evaluation projects, organizations need to implement an alternate process of review for ethical oversight in which higher risk projects undergo independent review by an individual or group who is removed from the project but who clearly understand its context. This process needs to be integrated into existing structures and processes within an organization with timely responses to support the pace at which QI and evaluation projects need to be implemented. ARECCI has developed educational modules to prepare internal reviewers of projects.
MISUNDERSTANDING: You must get ethics approval from an REB to publish the results of QI or evaluation projects.
While REB approval is necessary for research projects to be published, the intention to publish QI and evaluation projects does not by itself determine the need for REB review. Depending on the publication, QI and evaluation projects may only need to demonstrate that they have undergone ethical scrutiny such as screening with the ARECCI Ethics Guidelines for Quality Improvement and Evaluation Projects and the ARECCI Ethics Screening Tool. Conversely, a QI or evaluation project may involve an element of research and require REB approval even if there is no intent to publish the results.
MISUNDERSTANDING: Ethics screening for all QI and evaluation projects is too time consuming and adds additional levels of complexity to an already resource-costly process for QI and evaluation projects.
Ethics screening doesn’t have to be time consuming or complex. The ARECCI Ethics Guidelines for Quality Improvement and Evaluation Projects and the ARECCI Ethics Screening Tool are designed to be accessible and user friendly. Using the Ethics Guidelines for Quality Improvement and Evaluation Projects while developing your project can streamline the process and strengthen your project by making you aware of ethical implications or risks that you might not have considered. Depending on the level of familiarity with your project, assessing the level of risk using the ARECCI Ethics Screening Tool can take less than five minutes. Most importantly, recognizing and managing the risks in your projects means that you are less likely to place yourself, participants, your project team, and your organization in jeopardy.
MISUNDERSTANDING: I am guided by my professional ethics and I’m ethical. My work does not need to be judged.
As a professional, you are governed by your professional association and receive guidance regarding ethics from that entity. However, the ethical foundations of your profession and practice may not be sufficient to ensure the protection of people within your project. In addition, not everyone involved in your project may be guided by professional ethics, or they may apply varying ethical guidelines that have a potential for different ethical interpretation. Using the ARECCI Ethics Guidelines for Quality Improvement and Evaluation Projects and the ARECCI Ethics Screening Tool assures that ethics are consistently applied in your projects.
MISUNDERSTANDING: Providing health services to individual patients is essentially ongoing “quality improvement” and it’s impractical to review these as quality projects.
Individual patient care is not a project. But when you want to aggregate data from multiple patients to improve health services, this then becomes a project that may benefit from ethical screening to ensure that all stakeholders are protected and respected.
MISUNDERSTANDING: General consent to treatment is sufficient.
Even a signed general consent form will not protect you from legal liability. Consent must be specific for the proposed project and obtained as appropriate for the level of risk to participants. Ethics screening helps you determine the level of risk to participants and ensures that appropriate consent has been obtained from them. Consent can be verbal or written and incorporates volunteerism, capacity, and full disclosure of relevant information.