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Introduction

A pRoject Ethics Community Consensus Initiative (ARECCI) (formerly The Alberta Research Ethics Community Consensus Initiative) has identified a lack of guidelines and other resources to assist project leaders in considering the ethical implications of Quality Improvement and Evaluation projects.

In response to this need, the ARECCI Network developed the ARECCI Ethics Guidelines for Quality Improvement and Evaluation to help project leaders and administrators manage ethics-related risk. Another tool, the ARECCI Ethics Screening Tool, was developed in earlier phases of this initiative and is found elsewhere on this site.

Grounded in ethical principles, the ARECCI Ethics Guidelines for Quality Improvement and Evaluation consists of Six Ethics Considerations with detailed "Points to Consider" to aid project leaders and organizations to ensure respect for the rights of participants in these kinds of projects.

© Six Ethics Considerations*

  1. How will the knowledge gained from this project be useful?
  2. How will the described method or approach generate the desired knowledge?
  3. How will you ensure that the participant (or data) selection process is fair and appropriate?
  4. What have you done to identify and minimize risks as well as maximize benefits? Are the remaining risks justified?
  5. How are the rights of individuals, communities, and populations respected in this project?
  6. Is informed consent needed in this project?

These guidelines were developed specifically for use in an organization's established oversight process for QI and evaluation projects, particularly where such projects are screened to be more than minimal risk for their participants (e.g., using the ARECCI Ethics Screening Tool). At an operational level, the guidelines are meant to be integrated, if possible, into existing structures and used to provide an objective ethical assessment of the project in question (independent review). Therefore, the reviewers in such processes should be independent of the project with no vested interest, and their role is to strengthen how ethics are managed to ensure benefits are maximized and risks to participants are reduced and mitigated.

Thus, these guidelines are meant to be sensible at an operational level and to provoke thinking and discussion amongst the project team. They should be flexibly integrated into local context and practice. If your organization lacks an internal review process, these guidelines are a first step in documenting that ethics have been considered in the design and execution of QI and evaluation projects.

*These considerations are based on the July 2006 Hastings Center Report: The Ethics Of Using QI Methods To Improve Health Care Quality and Safety by Baily, Bottrell, Lynn, and Jennings and a subsequent publication in the Annals of Internal Medicine by Lynn et al. (May 2007) Ethical Requirements for the Protection of Human Participants in Quality Improvement Activities. Baily et al. outline the following ethical requirements for QI activities: social or scientific value, scientific validity, fair participant selection, favorable risk-benefit ratio, respect for participants, informed consent, and independent review.

**An independent reviewer is an individual or group removed from the project who have no vested, but who understand its context. The specific setting determines how such a review will be operationalized.

Instructions

The six ethical considerations for QI and evaluation projects developed by the ARECCI Network are provided below in question format. For each consideration, bulleted prompts are provided to guide the reader in addressing the question posed. In addition, "Points to Consider" are included to assist the application of each consideration to a specific project. The authors have tried to provide enough detail to be helpful, yet stay broad enough for a variety of contexts.

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