PQIs The New PQI Process When is PQI research? To REB or not to REB? These are some of the questions Donna Manca Charmaine Kabatoff

PQI Update All residents will be required to complete a PQI –1 st & 2 nd year residents –Faculty advisors – review PQI & check off before & after completion Develop & circulate PQI Resource Manual –Circulate to faculty –Circulate to residents EBM workshop August 16 & 17, 2010

The RED BOOK Curriculum Guidelines Related to the Family Physician as a Resource Family physicians must be able to assess their own skills, knowledge, and practices through practice audit and other quality assurance activities. –Residents must learn the basic principles of quality assurance, including setting standards, measuring performance against those standards, and follow-up to ensure they were met; –Residents must participate in practice audit activities during residency training.

Faculty Advisor Review & sign-off Check-list –Before doing PQI –After PQI complete

When is PQI Research? Quality improvement projects –usually exempt from Research Ethics Board (REB) review and approval. –Occasionally it can be difficult to determine when practice quality improvement is actually research that requires ethical approval to protect participants. If there is any doubt it is best to check with the Research Program or the REB.

What is Research? In general- Research –a systematic investigation to establish facts, principles or generalizable knowledge. Practice evaluation –systematic collection of information about the activities, characteristics and outcomes of practices/programs to make judgments about the practice, improve clinic effectiveness, and or inform decisions about future programming/initiatives for the practice.

When is the project PQI? The activities or findings surrounding the project are restricted to a specific program/practice/clinic The project is designed to detect deficiencies, errors, cost control measures, service delivery times or satisfaction with service delivery

When is the Project Research? Generalizable –Findings expand beyond the practice population Interventions –a clinical departure from routine care provided to patients Comparisons are made –randomization or the use of a control group or a placebo –designed to test a specific hypothesis or answer a specific qualitative or quantitative question Information is collected beyond that routinely collected in clinical care There is explicit requirement for review by an REB as part of its funding arrangements Personally identifiable health information collected

PQI Though a PQI may not require REB approval ethical principles and privacy legislation still apply.

Health Research Ethics Board (HREB) administers all research conducted in the health sciences faculties of the University of Alberta, Alberta Health Services facilities, and Covenant Health hospitals reviews all research conducted by health sciences faculty, students and staff at those institutions

HREB - two review panels Biomedical Panel This REB deals with applications that involve invasive interventions and invasive measures, regardless of how significant a part the intervention or measure has in the overall project, for example: –administration of drugs, vaccines, natural health products –use of an unlicensed device –surgical procedures –collection of blood or other specimens

HREB - two review panels Panel B This REB reviews applications for research that primarily involves non-invasive interventions (behavioural, educational, psychological and training) or concerns privacy, confidentiality and survey methods. For example: –Non-invasive interventional trials –interviews –chart reviews –surveys –questionnaires –educational strategies –observational or descriptive research –registries

Scope of research requiring ethics review “Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans” - current national standard for all research involving human subjects General Faculties Council (GFC) policy – Section 66

Research Requiring Ethics Review What does the TCPS say All “research” that involves living human subjects, tissues, biological fluids… requires review and approval by an REB before that research is started. Involving humans can mean –interventions –chart reviews –analysis of discarded biological specimens –surveys, questionnaires

Research Requiring Ethics Review TCPS and GFC 66… Research about a living individual… if based exclusively on publicly available information, documents, records is not required to undergo ethics review…except if the subject is approached directly for interviews or for access to private papers…

Research Requiring Ethics Review GFC … c. whether participants are drawn from University sources or from any other sources (eg, workplaces, residences, public places, day care centres, non-University hospitals, other universities, the military, public/private/separate schools); i. whether information is collected via direct observation, apparatus, questionnaire, interview, or review of records or other materials not normally available to the public; j. whether it is experimental, correlational, qualitative, or descriptive in nature; o. whether or not it is intended for publication or other public presentation.

Quality Assurance TCPS and GFC 66 Quality assurance studies, performance reviews of an organization, or its employees or students within the mandate of the organization, or testing within normal educational requirements, are not subject to REB review unless they contain an element of research in addition to assessment. Researchers shall seek the advice of their REBs whenever there is any ambiguity or doubt about the applicability of the UA Standards to a particular project.

Is this research requiring ethics review? Quality Assurance vs. Research A Resident does a PQI project in a rural setting. The rural physicians in the clinic are interested in understanding how other clinics manage their patient records. The resident decides to develop a survey and send it to rural family physicians in 4 other clinics to determine how they manage patient records.

Is this research requiring ethics review… Some considerations… –Is this a post-secondary student research project (whether for a class or a thesis) being carried out under the auspices of the U of A? –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? –What does GFC 66 say? (l. whether the information collected has as its focus the human participant or some aspect of the environment with which the human participant interacts;) –QA – is this your practice that you are auditing?

Jurisdiction TCPS says…The institution in which research involving human subjects is carried out shall mandate the REB to approve…ongoing research involving human subjects which is conducted within, or by members of the institution… GFC …researchers shall submit their proposals for ethics review to the appropriate REB established by the Faculty in which the research shall be conducted.

Jurisdiction cont… A medical student is doing a practicum in a rural setting. She wants to interview young single women as part of a project she is doing. The physician she is working with suggests that she obtain REB approval through a local resource. Where should the student obtain REB approval?

Health Information Act Issues related to your role as a custodian of health information Access to health information is considered within ethics review of a research proposal Who has access to potential subjects records Which hat are you wearing…researcher or custodian…

KEY POINTS When in doubt CHECK IT OUT –Check if REB approval is needed –Contact: Charmaine Kabatoff, Faculty and Students need to obtain REB approval through the UofA Remember you are a custodian of health information. Obtain copies of REB approval & HIA researcher agreements where needed Risks of not obtaining REB approval can include –Harms to participants, complaints to CPS or the privacy commissioner, lawsuits, etc

Resources HERO has links to resources –Government of Canada panel on research ethics (Tri-council policy statement, tutorials, etc) Health_Information_Act.pdf