Research Protections

Non-Research Determination

This section includes Quality Improvement Projects, Case Report/Series Projects, and other activities not considered "research".

Quality Improvement Projects

BRI Institutional Review Board is charged with protecting human subjects during research activities being conducted at Virginia Mason and BRI under the federal regulations. Some activities however may NOT be considered “research” as defined by FDA and DHHS regulations (e.g. Quality Improvement [QI], Quality Assurance[QA], Outcomes Analysis, Case Reports, etc.) and do not require IRB oversight.

BRI IRB recommends individuals conducting projects that “may” come close to being considered research and/or needs a formal IRB determination for future publications/presentations, to complete a QUIP Worksheet and submit to IRB for a determination. See the following bullet points for more information.

Case Report/Case Series

A Case Report Study/Series is a medical or educational activity involving the presentation or publication of information and analysis for the purpose of highlighting an interesting experience, observation, treatment, relationship, or outcome. It may involve a prospective intervention or prospective collection of specimens or data that is not part of standard service or care.

For IRB purposes, a Case Report is a retrospective analysis of one, two, or three clinical cases that does not meet the regulatory definition of “research”, (i.e. "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.") Therefore, the activity does not have to be reviewed by an IRB. If more than three cases are involved in the analytical activity, the activity will constitute “research.” It is considered best practice to use this Medical Consent Form to obtain patient authorization for use of their information whenever possible. The form can also be found on Vnet.

To request an IRB determination for Case Report Study/Series for future publications/presentations, complete a QUIP Worksheet. Include a copy of the release/consent form signed by the patient (if applicable) and send to IRB for a determination.

Authors who remove HIPAA identifiers (18 PHI identifiers, including unique patient characteristics) from the data prior to submission and publication of an article do not need to obtain a signed privacy authorization. Investigators who wish to publish case report data with HIPAA identifiers will need to obtain from the patient a signed HIPAA compliant authorization. This authorization does not need to be submitted to the IRB for review.

Projects with no Human Subjects

BRI Institutional Review Board is charged with protecting human subjects during research activities being conducted at Virginia Mason and BRI under the federal regulations. Some activities however may NOT be considered “human subjects” as defined by FDA and DHHS regulations and do not require IRB oversight (e.g. use of anonymous samples/data from and external entity, use of coded samples/data without ability to ever re-link, use of publically available data/samples available to the general public, etc.).

BRI IRB recommends individuals conducting projects with data/samples that “may” NOT be considered a “human subject” and/or needs a formal IRB determination for future publications/presentations, to complete a Human Subject Determination Form and submit to irb@benaroyareserach.org for review. See below for more information.

Human Subjects

DHHS regulations: "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."

FDA regulations: "an individual who is or becomes a participant in research, either as a recipient of the test article or as a control." The activity involves human subjects if EITHER of the following checked YES:

  1. An individual will be a recipient of any test article (i.e. drug, medical device) or as a control.
  2. An individual on whose specimen a medical device will be used.