Concordia College, Moorhead, MN

Institutional Review Board

Is What I Do Subject to IRB Review?

It depends on three criteria:

1. Are you affiliated with Concordia College or planning to collect data from individuals in the college?

The CC IRB has the authority to approve, require modifications in, or disapprove ALL research involving human subjects conducted at CC, as well as research conducted elsewhere by CC’s faculty, staff, and students.

In many cases, the CC IRB will honor the decision of another institution’s IRB with regards to a given research study. This means that, many times, researchers who otherwise would have had to obtain the CC IRB approval of their research do not need to go through the CC IRB review process if another institution’s IRB has granted them approval of their research.

2. Does your study 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 (i.e. information about behavior in a context in which individual can reasonably expect that no observation or recording is taking place, or information provided for specific purposes that the individual can reasonably expect will not be made public (e.g., a medical records))

3. Is your study considered a research activity?

Research is defined as a systematic investigation (i.e. carried out according to a plan and permitting logical conclusions to be drawn) that includes research development, testing, and evaluation (usually involves a large random sample of anonymous subjects who are asked to respond to a standard questionnaire), and is designed specifically to develop or contribute to generalizable knowledge (i.e. the investigation allows researchers to create generalizable information which is presented to a public audience).

The CC IRB has the authority to approve, require modifications in, or disapprove ALL research involving human subjects conducted at CC, as well as research conducted elsewhere by CC’s affiliates.

If your purpose or intent changes after data has been collected, you should submit your study protocol to the IRB for review and request permission from the IRB to use existing data. The IRB may request that you go back and obtain consent from subjects, or it may grant a waiver of the requirement to obtain consent.

CC IRB delegates (Department chairs who completed the IRB education requirement and chairs’ appointed representatives who completed the IRB education requirement) may review research protocols that meet the criteria for exempt status. Only CC IRB committee members may review expedited status and full-board status research protocols.

Some data collection activities might not be considered research. These activities do not need to be approved by the CC IRB or its delegates if they involve minimal risk and meet the criteria for exempt research. Click on the “Classroom Information Gathering Activities” link on the CC IRB web page for more details.