F5 Ethical Review?  But It's Only a Quality Improvement Project - M. Redekopp
Upcoming SlideShare
Loading in...5
×
 

Like this? Share it with your network

Share

F5 Ethical Review? But It's Only a Quality Improvement Project - M. Redekopp

on

  • 667 views

 

Statistics

Views

Total Views
667
Views on SlideShare
622
Embed Views
45

Actions

Likes
0
Downloads
4
Comments
0

1 Embed 45

http://qualityforum.ca 45

Accessibility

Categories

Upload Details

Uploaded via as Microsoft PowerPoint

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment
  • I will be referencing and presenting work conducted in Alberta over the past several years: A pRoject Ethics Community Consensus Initiative (ARECCI), that addresses the need for ethical oversight of QI and program evaluation projects in order to ensure patient/client/resident safety. This work includes the development of guidelines, tools, and processes that can help to ensure ethical conduct of a project in order to protect people.
  • Ethics Screening: All knowledge-generating projects would benefit from screening for ethical implications to manage risk for participants Ethics screening and review processes ought to encourage (not impede) knowledge-generating projects while ensuring risk and harm to people are minimized
  • 04/08/10 The ARECCI ethics screening tool is a decision-support tool. Its purpose is to facilitate thinking during project planning to help uncover or identify risks to participants. This identification then helps the project leader/team ensure the management of those risks. Caution: The scores are not intended to provide a scientific determination but are an indicator of the level of ethical risk in a project. The tool has been shown to be valuable in identifying those projects which have a higher level of ethical risk.
  • 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. As health care professionals, we are governed by your professional association and receive guidance regarding ethics from that entity. However, 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 tools such as 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.
  • 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. 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.
  • 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. 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.

F5 Ethical Review? But It's Only a Quality Improvement Project - M. Redekopp Presentation Transcript

  • 1. Ethical review? But it’s only a quality improvement project!   Monica Redekopp RN PhDDirector, Professional Practice, Nursing & Allied Health Vancouver Coastal Health - Richmond
  • 2. Within healthcare, quality improvement (QI)and program evaluation projects have becomeincreasingly important, multiplying in number andgrowing in complexity.
  • 3. These projects often deal with people and theirdata - including at-risk or otherwise vulnerablepopulations.The possibility of risk to participants raises thequestion of ethical conduct and oversight of QIand evaluation projects.
  • 4. QI and program evaluation projects often usedesigns and methods similar to research.This leads to questions about whether theyshould be distinguished from research todetermine ethics review requirements.
  • 5. Everyday Example (1) Tracheostomy changes / tracheostomy weaning are an important aspect of the care provided to a patient who requires long term airway control or mechanical ventilation. Patients with tracheostomies reach milestones / benchmarks in their care plan necessitating an adjustment in tube size or configuration. The current process recommended that the “first change” cannot occur until 14 days post surgical placement. The question that was identified: Can a “first change” be implemented earlier than the 14 days that the existing guideline recommended?
  • 6. Everyday Example (1) Evidence concerning timing of first tracheostomy change was found to be lacking. Respiratory Therapists proposed to conduct a pilot project that included a tracheostomy change at 7 days if the patient met tube change criteria (pre-existing) and was ready to progress with the weaning process. If the pilot was successful, the existing guideline would be changed. Given the high risk to patients with this procedure, was review by an Research Ethics Board required?
  • 7. Everyday Example (2) A Public Health team wanted to know which factors contribute to falls in the community that result in injury and the need for patients to be seen in the Emergency Department of the local hospital. It was planned to conduct a chart audit of all individuals presenting to the hospital ED to determine what these contributing factors were. From this data, themes and trends could then be identified and used to develop and implement prevention strategies to prevent falls in the community.
  • 8. Everyday Example (2) It was planned that this would not only keep those in the community healthier, but hopefully, would reduce ED visits for fall related events. There was an opportunity for a graduate student to do this as a practicum project. This student was not a member of the Public Health team nor a staff member of the hospital. Given that the student was not a member of the health service team and would be reviewing confidential medical records, is a submission to a Research Ethics Board required?
  • 9. Everyday Example (3) Since a Home IV Antibiotic program was implemented, patients could now come home and be taught by the home care nurses to manage their own IV antibiotic infusions. Even though the home care nurses support the patients through this process, it remains a daunting task. One patient shared with us: “It looked so easy when the nurse in the hospital did it!” This problem is further complicated for those who do not speak English.
  • 10. Everyday Example (3) A home care nurse proposes to create a patient education DVD (including 5 languages) to teach community clients how to self- manage IV therapy in the home setting. It is proposed that this will contribute to better outcomes for clients, reduce the amount of time and workload of home care nurses. The home care nurse proposes to evaluate the use of this patient education tool and determine the influence on client learning, client and nursing satisfaction, and time spent teaching the clients to become competent in running their own IVs at home.
  • 11. Everyday Example (3) A survey approach (post implementation only) and assessment of client competency with their IV skills is planned. The home care nurse plans to conduct the project evaluation with another nurse. The home care nurse queries about ethical risks with this project and whether she needs to submit this project to a Research Ethics Board.
  • 12. True or False? Only research projects need an ethics review. There is no need for an ethics review for QI and evaluation projects. I am governed by the ethical standards of my professional association and therefore my QI or evaluation project does not require an ethics review.
  • 13. True or False? Having to include an ethics review for QI and evaluation projects would be a barrier and would probably prevent them from being conducted. Ethics screening is time consuming and complex. This would just add to the cost of conducting a QI or evaluation project.
  • 14. True or False? All projects – whether research, QI or program evaluation – with more than minimal risk should be reviewed by a Research Ethics Board (REB). Ethics approval from an REB is always required if you plan to publish the results of a QI or evaluation project.
  • 15. The Issues Gray areas in distinguishing research from non-research such as program evaluation and quality improvement for purposes of ethics review. How to ensure ethical risks for participants are identified and managed in non-research projects.
  • 16. We will be discussing: Why an ethical lens is needed in the conduct of quality improvement or program evaluation projects that involve people or their information. What type of ethical oversight is required for knowledge- generating activities such as QI and evaluation.
  • 17. A pRoject Ethics Community Consensus Initiative (ARECCI) Used with permission
  • 18. Striking a Balance
  • 19. Project Ethics Applies ethics considerations across a range of knowledge- generating investigations (evaluation, QI, and research projects) so that people or their information are protected and respected. Involves the integration of ethics considerations from the planning through to the reporting stages of a project.
  • 20. Where does Project Ethics fit? Professional Codes of Ethics: Focuses on the individual practitioner and his or her personal conduct. Bioethics: Is the application of moral principles, values, and thinking to problems that arise in the delivery of health services or research related to health. Project Ethics: Focuses on the conduct of projects.
  • 21. Main Beliefs in Project EthicsEthical principles apply across a range of projects: Research Quality Improvement Evaluation 21
  • 22. Main Beliefs in Project EthicsEthics Screening: To be done for all research, QI, or evaluation projects that involve people or their data to identify ethical risks and determine review requirements. 22
  • 23. Main Beliefs in Project EthicsEthics Review: Benefit from increased clarity, consistency, transparency, and efficiency. Research Ethics Board (REB) review is needed for research projects. Evaluation and QI projects that may present a higher risk to people need ethical review, but do not need Research Ethics Board (REB) review. The review of evaluation and QI projects must be flexible and integrated in the organization to encourage and not impede worthwhile projects. 23
  • 24. Main Beliefs in Project EthicsOrganizational oversight: Organizations that conduct evaluation and QI projects should also assume responsibility for their ethical oversight. 24
  • 25. Project Ethics Principles1. Screen all projects to determine ethical risks and review requirements2. Sort according to project primary purpose3. Determine category of risk for project participants4. Review according to category of risk for the project
  • 26. What is Ethical Risk? Risk is defined as the “possibility of suffering harm or loss” Ethical risk is defined from the perspective of the participant in the project in terms of the possibility of suffering harm or loss based on what is wrong for a person, family, or community
  • 27. What is Ethical Risk? Ethical risk includes, without limitation, real or potential threat:  To privacy and confidentiality of individuals or communities  Physical, mental, psychological, emotional, financial or legal impact on individuals or communities  Additional burden to the system if gains of project do not justify risks imposed and resources spent
  • 28. Who Should Review QI Projects? QI projects and research projects share ethical considerations for the protection of people. However, QI/evaluation projects have a different purpose, occur in a different context, and under a different mandate.
  • 29. Who Should Review QI Projects? Research:  Rigorous techniques to control for contextual factors  Aim is to produce results intended to be generalizable across settings to the population interest QI/Evaluation:  Part of expected management activities within an organization  Aim is improvement in local processes, thus local contextual factors
  • 30. Who Should Review QI Projects? Research:  REB members assess a finalized design and methodology  Once approved, the research protocol must be strictly adhered to throughout the project QI/Evaluation:  Includes flexibility in the project plan – results are continually reviewed and acted upon (Plan Do Study Act)
  • 31. Who Should Review QI Projects? The differences between research and QI projects require different processes for ethical review. The review process for QI needs to be more flexible than that for research. Projects assessed as minimal risk may be managed by those conducting the project.
  • 32. Who Should Review QI Projects? Projects found to have more than a minimal risk for participants require an independent review.  An independent reviewer is a knowledgeable individual or group (either inside or outside the organization) removed from the project but who still understands its context.  An independent review provides an objective ethical assessment of the project that can assist the project leader to identify how to reduce, eliminate, or mitigate the risks.
  • 33. Who Should Review QI Projects? The QI review process should maintain a strong adherence to principles for ethical practice and the management of projects.
  • 34. Ethics Considerations for Projects How will the knowledge gained from this project be useful? How will the described method or approach generate the desired knowledge? How will you ensure that the participant (or data) selection process is fair and appropriate? What have you done to identify and minimize risks as well as maximize benefits? Are the remaining risks justified? How are the rights of individuals, communities, and populations respected in this project? Is informed consent needed in this project?
  • 35. Ethics Considerations for Projects How will the knowledge gained from this project be useful?  Results should be “need to know” not “nice to know”  What is hoped to be found out?  Who will benefit?  How will the information be disseminated and used?
  • 36. Ethics Considerations for Projects How will the described method or approach generate the desired knowledge?  Badly designed QI projects that do not result in the required information waste limited time and resources.  Results from QI projects with a sound approach or design are more likely to produce information that can guide decisions to improve quality.
  • 37. Ethics Considerations for Projects How will you ensure that the participant (or data) selection process is fair and appropriate?  Participants need to be those who are the key stakeholders involved in the service delivery  Must consider whether a particular group might be overburdened
  • 38. Ethics Considerations for Projects What have you done to identify and minimize risks as well as maximize benefits? Are the remaining risks justified?  QI projects need not be risk free.  Potential risks must be identified very explicitly and then minimized, eliminated, or mitigated.
  • 39. Ethics Considerations for Projects How are the rights of individuals, communities, and populations respected in this project?  Consider the impact on a participants privacy and confidentiality.  Need to develop specific plans for storing the collected data, for determining how long to keep it and in what form, and for deciding who will have access to the data.  Need to ensure compliance to privacy legislation.
  • 40. Ethics Considerations for Projects Is informed consent needed in this project?  Not all QI projects need informed consent. The broad consent that patients or clients sign when being admitted to a program or services may be sufficient.  Project leaders need to determine whether broad consent is, or is not sufficient within the context of their project.  Examples of projects that may need consent:  Involving a power relationship between the person collecting data and the participant providing the data;  Those in which a conflict of interest might exist;  Those that have a higher than minimal risk.
  • 41. Guidelines, Tools, and Processes Project Ethics guidelines, tools, and processes:  assure identification of ethical risk  point to ways to manage these risks  assure the public that you have acted to conduct your project ethically
  • 42. Ethics Guidelines ARECCI Ethics Guidelines for Quality Improvement and Evaluation Projects http://www.aihealthsolutions.ca/arecci/guidelines  Responds to the needs of QI project personnel who do not have well-documented guidelines or processes to help with ethical questions in their projects.  Provides a framework for the independent review of higher- risk QI projects.
  • 43. Ethics Screening Tools Vancouver Coastal Health Research Institute: Does Your Project Warrant Review By a Research Ethics Board? http://www.vchri.ca/i/pdf/Guidance_ResearchEthicsBoard_Jan2012.pdf Series of 11 questions. If you answer “yes” to any of the questions, a submission to a UBC Research Ethics Board is required.
  • 44. Ethics Screening Tools ARECCI Ethics Screening Tool http://www.aihealthsolutions.ca/arecci/screening  Step 1 Rules out obvious research projects  Step 2 Determines Project Primary Purpose  Step 3 Screens for ethical risk to participants  Step 4 Determines category of risk and recommended review action
  • 45. ARECCI Ethics Screening ToolStep 4: Determines Category of Risk and Recommended Review Action
  • 46. Implications for Projects Consistent ethics practice across projects to manage ethical risk needs to include:  A standardized process for ethics screening and review of all knowledge-generating activities (research, QI and evaluation) which involve people or their information  integration of concepts and tools in appropriate organizational processes  education of all those who lead and manage QI and evaluation projects
  • 47. Organizational Processes
  • 48. Building Capacity: ARECCI Project Ethics Level 1 Course Level 1 Train-the-Trainer Program Level 2 Program with credential to prepare:  2nd Opinion Reviewers  Organization’s Recognized Review Webinar Series – every 3months Annual Project Ethics Forum A Project Ethics Community of Practice (CoP) is evolving
  • 49. True or False? Only research projects need an ethics review. There is no need for an ethics review for QI and evaluation projects. I am governed by the ethical standards of my professional association and therefore my QI or evaluation project does not require an ethics review.
  • 50. True or False? Having to include an ethics review for QI and evaluation projects would be a barrier and would probably prevent them from being conducted. Ethics screening is time consuming and complex. This would just add to the cost of conducting a QI or evaluation project.
  • 51. True or False? All projects – whether research, QI or program evaluation with more than minimal risk should be reviewed by a Research Ethics Board (REB). Ethics approval from an REB is always required if you plan to publish the results of a QI or evaluation project.
  • 52. Summary Ethical issues exist in QI and evaluation and should be considered at all stages of a project. Knowledge - generating activities such as QI and evaluation exist with a different purpose and mandate and therefore their ethical oversight needs to be different from research.
  • 53. Summary QI and evaluation projects need to be screened to identify ethical risks and determine review requirements. Projects do NOT need to be risk free, but strategies to minimize and mitigate any identified risk ought to be planned ahead. Documented use of tools and guidelines, and seeking a second opinion for riskier projects can help demonstrate you have taken reasonable measures to protect people.
  • 54. Summary Use of Project Ethics concepts, guidelines, tools, and processes:  assure identification of ethical risk;  point to ways to manage these risks;  assure the public that you have acted to conduct your project ethically.