Right of Way

Right of Way:Does your project need ethics review?

Lori d’Agincourt-Canning, PhD, Ethicist, C&W Ethics ServiceGeoff Schierbeck, Quality Leader, BCPSQC

Objectives

At the end of this session, participants will be able to: Identify similarities and differences between quality improvement

studies and research

Understand ethical requirements that QI studies should meet

Demonstrate knowledge about why/when a project warrant REB review

Have a practical opportunity to assess project risk using the ARECCI tool

What is quality improvement (QI)?

Covers a broad range of activities whose goal is to monitor, evaluate or improve the quality of health care delivered

Uses an array of methods and can look like practical problem solving, an evidence-based management style, or an application of a theory-driven science of system change

QI projects often encourage health care workers to use their experience, along with insights from others, to identify promising improvements, implement changes on a small scale, monitor and interpret effects, and decide about additional changes and wider implementation (Bailey, 2008)

Examples

Quality assurance Program evaluation Cost containment Health services research Outcomes monitoring research

(Baily, 2008)

What is research? (UBC Policy #89)

Research involving human subjects is defined as any systemic investigation (including pilot studies, exploratory studies, and course based assignments) to establish facts, principles or generalizable knowledge

Research may involve living subjects through their physical participation and/or through collection or use of personal health information, tissue (including foetal and "waste" tissue), biological fluids, embryos, foetuses, human remains and cadavers

Research and QI Similarities

Systematic Guided by data Varying degrees of complexity and

methodological rigor Produces ‘generalizable’ knowledge (?)

Research and QI differences

Research Distinct & separate from

care delivery Participation is voluntary Independent ethics

review

QI Implemented in care

delivery context in which it is carried out

Expected part of health care Participation is not

completely optional No formal process for ethics

review

Gray zones

Designed to be generalized Risk of harm to be participants Intent to publish Evaluation research (vs. program evaluation);

secondary analysis of data

There is considerable overlap Researchers at Johns Hopkins University coordinated a quality-improvement research project aimed at reducing catheter-related infections in 103 ICUs at 67 Michigan hospitals.

The study evaluated a protocol designed to routinely implement five evidence-based procedures: having clinicians wash their hands, using full-barrier precautions during insertion of central venous catheters, using chlorhexidine for skin cleansing before catheter insertion, minimizing the use of the femoral site for catheter insertion, and removing unnecessary catheters. In addition to the training of clinicians in such standard infection-control procedures, the project involved the use of a checklist to ensure adherence to the protocol

The result was a dramatic decrease in catheter-related infections: at baseline, the participating hospitals had a median of 2.7 infections per 1000 catheter- days; after 3 months, the median had dropped to 0, and it remained there for 18 months

Overlap

Publication of the results, however, triggered an investigation by the OHRP

The REB at Johns Hopkins had judged that this quality-improvement program was exempt from federal regulations governing human-subjects research; the published report noted that "informed consent was waived because the study was considered exempt from review.

The OHRP judged that the project was not exempt since it prospectively implemented a protocol of infection-control interventions and tested hypotheses regarding its effectiveness. Publication of study results suggests that a goal was to produce generalizable knowledge and therefore the researchers should have obtained informed consent.

(Miller and Emanuel, 2008 )

Underlying principle

Protecting people in

quality and improvement

projects is just as

important as protecting

people in research

studies

Ethics considerations: QI & evaluation studies

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? Are the remaining risks justified? (What are the risks of not doing the project?)

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

6. Is informed consent needed in this project?

Key ethical issues

Respect for persons Risk-benefit ratios Confidentiality Data stewardship Patient protection Staff protection Consent

Alberta Research Community Consensus Initiative (ARECCI)

Goal: To develop a simple screening tool that would

allow evaluators to determine if a project is research and needs REB review Focuses on determining level of risk Assigning guidelines to have appropriate review based

on level of risk

Goal of ethics screening tools

To implement and facilitate consistency of ethics review in any project involving people or their information

ARECCI Ethics Screening Tool

ARECCI Ethics Screening Tool: Step 1

ARECCI Ethics Screening Tool: Step 2

Applying the QI Risk Filter

Time to Google

ARECCI screening tool

Scenario

A Hospital Emergency Department has noticed that there has been a dramatic increase in their left-without-being-seen (LWBS) population recently. Upon investigation, the site manager found that there was a distinct pattern to this increase. Recently an inner city agency that deals with intravenous drug users began offering primary care service at the agency through a primary care physician. This physician also worked in the ED. The manager wondered if there was a connection since most of the population that was leaving had an inner city address close to the agency.

The manager contacted the inner city agency and began her investigation. It became clear that the majority of the LWBS’s were, in fact, the population that she had suspected. Because LWBS’s have the potential of presenting huge patient safety risks, a QI process was put in place to address the cause and possible solution. The agency staff were contacted again and asked to provide Provincial Healthcare Numbers (PHN’s) of their clients to the hospital. The PHN’s were going to be used to study the service that these clients received from the hospital. Also the clients’ use of family physicians was going to be tracked. Therefore, the Medical Service Claims would be tacked through the Provincial Ministry and matched to the hospital data collected through the administration database to which the hospital had access.

Due to the interesting results, the hospital and the agency decided that they wanted to publish the findings in a scientific medical journal.

Goal of ethics screening tools

To implement and facilitate consistency of ethics review in any project involving people or their information

When to use?

• For any project involving people or their information

• When developing or drafting a project to ensure that ethics is integrated

• When it is unclear whether the project, QI or both and what degree of ethics review is needed

• When unsure of the level or risk involved in a project

(D. Lake, 2008)

Recognizing Risks & Benefits

There is always risk Most risk when you don’t review or look

for it! Always ask:

Who might be at risk? The category of risk? How to minimize or mitigate that risk? What about benefits?

Difficulties in recognizing risk

Unfamiliar or too familiar Pressure (time, resources, vendors, individual

health service providers, etc.) Projects change over time (people, focus,

lead, scope)

In Summary

QI projects are integral to improving health and human service quality

Ethical issues exist in QI projects and should be considered at all stages

Ethics screening is quick using the ARECCI Ethics Screening Tool

Higher categories of risk require greater levels of ethical scrutiny

ARECCI tools support the decision-making process

Where to access ARECCI tool

Alberta Heritage Foundation for Medical Research http://www.ahfmr.ab.ca/arecci/guidelines

ARECCI Ethics Guidelines for Quality Improvement and Evaluation Projects

ReferencesARECCI website: Baily, MA Taking Stock: Strengths, Issues, Gaps in the Ethical Oversight of Health

Projects. Protecting People While Increasing Knowledge: Ethics in Health Research Conference, Calgary, Alberta, CA, May 5, 2008.

Lake, D. Online tool for evaluating the primary purpose of knowledge generating activities. Protecting People While Increasing Knowledge: Ethics in Health Research Conference, Calgary, Alberta, CA, May 5, 2008

Lynn, Baily, Bottrell et al. The ethics of using quality improvement methods in health care. Ann Intern Med. 2007;146:666-673

Miller, P. & Emanuel, E. Quality-Improvement Research and Informed Consent. NEJM 2008; 358 (8):765-767

Taylor, H. Pronovost P, Sugarman J. Ethics, oversight and quality improvement initiatives. Qual Saf Health Care 2010;19:271e274.

Does Your Project Need Ethics Review?

Questions or comments…