ARECCI: Innovation in Project Ethics ( PACE 2015)

Why ARECCI? Why an innovation? Research ethics process well known No process for non-research projects Program evaluation, quality improvement, needs assessments, knowledge transfer, health technology assessments REB’s would get these projects, but not their role to review and members not qualified to assess First minutes of ARECCI meetings in 2003 Started facilitating courses in 2005

Research and non-research Similarities Systematic Use same methods Ethics considerations Differences Designs (e.g., QI projects) Legislation exists for research Local vs generalizable knowledge

ARECCI Framework Principles: Screen all projects Determine primary purpose Improve local process or care (non-research) Use only local participants (non-research) Increase scientific knowledge (research) Generalize findings to other places (research) Determine category of risk Determine appropriate ethics review

ARECCI Framework Ethics Screening tool Primary purpose: research or not Category of risk Appropriate ethics review

ARECCI Ethics Screening Tool

ARECCI Ethics Screening Tool: Step 1 If the answer is yes to any of the following questions, the project is automatically considered research and the tool proceeds down the research pathway.

ARECCI Ethics Screening Tool: Step 1

ARECCI Ethics Screening Tool: Step 2

If “yes” to more green than blue

If “yes” to more blue than green

If your score is high

Step 3: Applying the QI and Evaluation Risk Filter

Ethics Screening Score Cutoff Points: Determining Category of Review

Screening tool

ARECCI Framework Ethics Guidelines tool Six guiding questions

ARECCI Ethics Guidelines for Quality Improvement and Evaluation Projects

Ethics Guidelines Tool

Guidelines tool

ARECCI Framework Courses: Project Ethics Second Opinion Reviewer Train the Facilitator Second Opinion Review Webinars Annual Forum

ARECCI Elevator Speech ARECCI helps build capacity in organizations to prevent ethical risks from becoming harms when employees conduct projects that involve people or their information. ARECCI fills a void in the world of ethics review. There is an established process for the ethics review of research, but many projects aren’t considered research, yet there ethical risks. Before ARECCI, people didn’t have help in addressing these risks. ARECCI offers professionals and practitioners easy-to-use online decision-support tools, ethics training and a unique consultative process, called the Second Opinion Review. Clients or patients benefit because they have peace of mind knowing that their welfare is being considered. Participants trained in ARECCI increase their knowledge and competence in conducting projects. Organizational leaders feel more confident knowing that risk has been minimized and mitigated. This increased confidence can ultimately lead to increased activity.

Community of Practice Person 1 to ARECCI Manager: “Have you been involved in any discussions around the link between ARECCI and planning (vs QI/evaluation)? I would love to connect with others who may be ruminating over this as well.” ARECCI Manager to Person 1: “A SOR candidate who has done similar thinking for her capstone is (Person 2); I`ve copied her on this .” Person 1 to Person 2: “Would you have 30min to connect in the next few months (no rush) to discuss what you’re working on? Person 2 to Person 1: “Absolutely, I would love to meet….Looking forward to hearing from you.”

How Can ARECCI Help EMS? Quality Improvement Project { example } ABC EMS Service - Provides BLS/ALS service for 4 communities - Forty staff { 75% EMT; 25% Paramedic } - Each service does approximately calls per month

How Can ARECCI Help EMS? Quality Improvement Project Goal: to determine if a new piece of equipment will improve patient care and lower costs Description: ABC EMS have been contacted by a vendor to trial a new healthcare product. This product has been used in several South American countries and the hope is to spread to North America.

How Can ARECCI Help EMS? Quality Improvement Project The Gluco-Thercometer combines the functions of a tympanic thermometer and glucometer to give two readings with one machine. The cost for this device is cheaper than the combined cost of the two separate instruments

Project Plan The four services will use this device on patients from four nursing homes located in the communities during a six month trial period. Since the patients are being transported by EMS, they will automatically become part of the project Data will be recorded by EMS crews and compared to the data copied from the patient’s charts at the hospitals by the EMS crews

Project Plan Outcome Measures If the new device agrees with most of the readings from the hospital devices, they will be purchased and put on all cars { this device is currently being reviewed by Health Canada so it can not be officially used until approval }

Project Plan Three months into the project a patient’s family has questions… -They have not seen this instrument before, is it safe? -Will it affect the treatment given? -Shouldn’t we have to give permission to be included in this trial?

Let’s have Another Look… Three months into the project a patient’s family has questions…

Let’s have Another Look… Three months into the project a patient’s family has questions… Three months into the project…things STOP

How could this have been prevented? The ARRECI Screening Tool would have identified several potential risks, such as …… An ARECCI Guideline tool would have assisted in structuring the project

Lessons Learned Apply the ARECCI tools early in the planning phase Identify risks Mitigate risks Use the Guideline to help with the project plan