Ethics in Quality Improvement

Quality Academy Cohort 6

Melanie RathgeberMERGE Consulting

1. Understand key differences that distinguish research projects from QI projects

2. Be familiar with theory and work of experts in outlining ethical considerations for QI

3. Know where to go for further investigation on ethical considerations for your QI work

Objectives

Mythbusters:

Research Ethics Board (REB)

Do you have experience in applying to a REB for a research or quality improvement project?

Checklist from UBC Research Ethics Board (REB)

• Distinguishes between

– Research projects

– Projects that are solely for Quality Assurance

• Research Ethics Boards only review projects that have a research element

Checklist from UBC Research Ethics Board (REB)

1.

Is the project / study being presented to the public, colleagues, the institution, your department or others (including students) as a “research” project: that is, do you consider the project research?

Yes No

2. Is the project funded by (or being submitted to) a grant/award competition from a funding agency that requires research ethics review?

Yes No

3. Is this a post-secondary student research project (whether for a class or a thesis) being carried out under the auspices of UBC?

Yes No

4. Does the project involve “randomization” to contrast interventions to participants or other systematic sampling techniques to divide participants into different groups?

Yes No

5. Does the project involve a comparison of interventions or processes and “control” settings or groups either to test a new intervention or to assess the effectiveness of a process change?

Yes No

6. Does the project involve pilot testing or evaluation of a new intervention, treatment or program, for which it would be difficult to estimate a balance of risk and benefit in advance?

Yes No

7. Is the project design and methodology rigorous enough to statistically support generalizations beyond the particular population that will participate in the project?

Yes No

Why might we want to have an ethical review or discussion for QI work?

- Formerly Alberta Research Ethics Community Consensus Initiative

Ethics in QI – Hasting Centre guidelines

Lynn et al. The ethics of using Quality Improvement methods in Health Care, Annals of Internal Medicine. 2007; 146: 666-73.

QI = any systematic data guided activities designed to bring about immediate improvement in a health care setting

IRB (Institutional Research Board) is not the right process

Ethics in QI: Hastings Centre Report(www.thehastingscenter.org)

Seven Ethical Considerations as they relate to QI:

1. Social or scientific value

– Gains justify risk (can include any extra visits, paper work, surveys)

– Gains justify expense

2. Scientific validity

– Is it properly structured to achieve its goal?

– Consider context and how to make something happen in local context

Seven Ethical Considerations as they relate to QI:

3. Fair subject selection

- Consider other QI programs going on in your organization

- Consider vulnerable populations

4. Favorable risk-benefit ratio

– Focus particularly on individual

Seven Ethical Considerations as they relate to QI:

5. Respect for potential and enrolled participants:

- Includes respect for privacy and confidentiality

- Only that health information that is necessary for the QI activity

- Same confidentiality obligations as for health care providers

6. Informed Consent

– Not required unless poses more than minimum risk

Access to personal health information

QI is considered an essential part of normal health care, therefore, consent for QI is assumed in consent to receive health care (within reasonable limits and no more than minimal additional risk)

QI staff/teams can use health information in the same way staff use it to provide care

A person who does not normally have access to participant records for clinical care and whose use of records is for a secondary purpose – constitutes need for an ethical review at the organizational level.

Hastings Centre:

Hastings Centre:

Alberta (ARECCI):

Alberta (ARECCI):

Access to personal health information

VCHVCH

Seven Ethical Considerations as they relate to QI:

7. Independent Review

- If conditions exist that justify a need for a review – should be an external review body – but not a REB

- Should be internal to the organization

- In general, ongoing monitoring of ethical principles in QI activities should become part of the clinical care or management structure

ARECCI Ethics Guidelines for QI and Evaluation Projects

Decision Support Tools

http://www.aihealthsolutions.ca/arecci/areccitools.php

1. GUIDELINES TOOL -> probing questions – identification of ethical considerations for your project

2. SCREENING TOOL -> guidance on what level of review to consider

“Together, these two decision-support guides can assist you in evaluating your projects to ensure that ethics considerations are included and that you have done due diligence to protect people and their health information”

ARECCI Guideline Tool:

Screening Tool:

Should go to an Second Review Process if there is more than minimal risk

Practice with Screening Tool:

http://www.aihealthsolutions.ca/arecci/areccitools.php

Mythbusters:

Key Resources

• Ethics Board if your QI project has a research component

– usually if your findings can be generalized outside of your local setting

• ARECCI Ethics Guidelines for QI– Guideline Tool to help you apply and consider ethical principles– Screening Tool to determine level of review needed

• Ask your Quality Department about policies or guidelines

• SQUIRE guidelines for publishing QI

http://qualitysafety.bmj.com/content/17/Suppl_1/i3.full.pdf+html?sid=f8652069-7e90-4721-a40a-1aba380c3194

http://squire-statement.org/