The most commonly asked question of the Intermountain Healthcare IRB in Salt Lake City has been: “Is this quality improvement or is it research?”
That question is very important to the IRB because it’s important for researchers to better understand regulatory definitions, says Shelby Moench, CIP, IRB administrator at Intermountain Healthcare.
“What we’re trying to point out is that sometimes QI projects can meet the definition of research,” Moench says.
The IRB has an online determination form that provides definitions and asks basic questions to help investigators and the IRB decide which are research and which are quality improvement. The four-page form, for instance, defines research as “a systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”
The determination form also includes the following questions:
• Section 1: Describe the target population. Who (or whose information) does the project include (employees, physicians, patients, etc.)?
• Section 2: Is your project a systematic investigation?
- Is this project (or activity) being designed and implemented for internal Intermountain Healthcare purposes (in other words, the information gained from this project is intended to be used within Intermountain Healthcare)?
- Does this project consist of operational activities?
- Does this project aim to expand the knowledge of scientific discipline or scholarly field?
• Section 3: Does this project involve human subjects?
A human subject is a living individual about whom an investigator (whether professional or student) conducting research obtains:
1) data through intervention or interaction with the individual, or
2) identifiable private information.
- Will you gather data about living individuals through intervention or interaction?
- Will you gather data about living individuals that is private?
- Will you gather identifiable data about living individuals, or is the individual’s identity already known or can be ascertained by the investigator?
- Data Collection Methods:
Describe the methods to be used to gather data:
- medical record review,
If conducting a medical record review:
- Describe the data you will review and collect (name dataset or database from where data will be abstracted, list the data elements, etc.).
- How was data originally gathered (from an existing IRB-approved protocol, a clinical data base, QA/QI database, etc.)?
- How will the data be analyzed?
- Who will analyze the data?
- Where will the dataset be stored?
- Will data be shared outside of Intermountain Healthcare?
- Can data be directly or indirectly (by code) linked to an individual?
- Conditions for determining status:
- Do you have any plans to supplement or modify quality improvement data?
- Do you have plans to make the data generalizable outside of Intermountain Healthcare?
- Do you plan to use the data to expand the knowledge base of a scientific discipline?
- Is the student project being conducted (in part or in full) to meet the requirements of a university-level degree program?
- Does the project assign participants to different treatment groups or arms?
- Does the project include a control group? In other words, will the project withhold a normally received intervention or treatment from some or all participants?
- Will individuals involved in the project be exposed to risks or burdens that would not be encountered otherwise? Consider physical, psychological, social, or economic factors.
- Will the project collect and record identifiers and/or personal health information (PHI) for purposes other than treatment, payment, or operations at Intermountain Healthcare?
- Is your project federally funded?
- Does your project include an FDA-regulated product?
The goal in educating researchers is to both publish educational materials, like the determination form, but also to educate investigators through one-on-one discussions about their projects, Moench says.
For instance, in one recent conversation, Moench met with an instructor who wanted to improve the process for educating employees and improve science by showing that her method of education was valid.
“I would say, no, that she didn’t know it was research because the project she described was in a gray area, and maybe it could be a quality improvement project,” Moench recalls. “These are not black-and-white decisions, and it’s not always easy to make a call.”
At Intermountain Healthcare, the IRB has the final say on whether a project is human subjects research or a quality improvement project. If the IRB calls a project research, then the researcher has to submit it for review or risk being out of compliance, she says.
“We’re hoping to get to the point where there’s an automatic form that tells people, ‘No, thanks, you don’t have to submit,’” Moench says. “But we don’t have the questions refined that way yet, so the form goes to my team for review.”