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

Ethical review? But it’s only a quality improvement project!

Monica Redekopp RN PhD Director, Professional Practice, Nursing & Allied Health

Vancouver Coastal Health - Richmond

Within healthcare, quality improvement (QI) and program evaluation projects have become increasingly important, multiplying in number and growing in complexity.

These projects often deal with people and their data - including at-risk or otherwise vulnerable populations.

The possibility of risk to participants raises the question of ethical conduct and oversight of QI and evaluation projects.

QI and program evaluation projects often use designs and methods similar to research.

This leads to questions about whether they

should be distinguished from research to determine ethics review requirements.

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?


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?


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.


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?


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.


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.


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.

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.

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.

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.

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.

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.

A pRoject Ethics Community Consensus Initiative (ARECCI)

Used with permission

Striking a Balance

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.

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.

Main Beliefs in Project Ethics

Ethical principles apply across a range of projects:

Research

Quality Improvement

Evaluation

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Ethics 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.

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Ethics 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.

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Organizational oversight: Organizations that conduct evaluation and QI projects

should also assume responsibility for their ethical oversight.

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Project Ethics Principles

1. Screen all projects to determine ethical risks and review requirements

2. Sort according to project primary purpose3. Determine category of risk for project participants

4. Review according to category of risk for the project

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

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

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.

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

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)


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.

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.


The QI review process should maintain a strong adherence to principles for ethical practice and the management of projects.

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?

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?


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.


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


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.


How are the rights of individuals, communities, and populations respected in this project?

Consider the impact on a participant's 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.

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.

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

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.

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.

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

ARECCI Ethics Screening Tool

Step 4: Determines Category of Risk and

Recommended Review Action

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

Organizational Processes

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

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.

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.

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.

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.

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.

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.

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

Spiritual

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