CPTC Institutional Review Board (IRB)

Research at Clover Park Technical College

Any researcher interested in working with the students, faculty or staff of Clover Park Technical College as research subjects, must notify the CPTC Institutional Review Board (IRB) before commencing any research activities. The CPTC IRB is part of a comprehensive Human Research Protection Program at the institution that functions under federal guidelines, state and local policies.

Although federal guidelines allow for activities that do not meet the criteria of research to be exempted from IRB oversight, CPTC leadership and policies require that all activities including contact with the students, faculty and staff of the institution be subject to a determination by and oversight of the IRB.

How Do I Know if my Project is Research?

You can generally determine if your project is research by answering a few questions. The federal regulation defining research on human subjects is located in 45 CFR 46.102(d).

1. Is your activity a systematic investigation designed to develop or contribute to generalizable knowledge?

a. If you answered yes, continue to point 2.
b. If you answered no, it likely does not meet the definition of research according to 45 CFR 46.102(d).

2. Does your activity involve human subjects?

a. If you answered yes, continue to question 3.
b. If you answered no, it likely does not meet the definition of research according to 45 CFR 46.102(d).

3. Is the data being collected through intervention or interaction with the individuals?

a. If you answered yes, continue to question 4.
b. If you answered no, it likely does not meet the definition of research according to 45 CFR 46.102(d).

4. Does the data contain individually identifiable information?

a. If you answered yes, continue to question 5.
b. If you answered no, it likely does not meet the definition of research according to 45 CFR 46.102(d).

5. Is the information private?

a. If you answered yes, your research requires IRB review.
b. If you answered no, it likely does not meet the definition of research according to 45 CFR 46.102(d).

In addition to the requirements of 45 CFR 46.102(d), the CPTC IRB has expanded monitoring responsibilities that require all parties interested in conducting research projects beyond those that meet the federal definition to declare the presence of a project involving contact with the faculty, staff and students of CPTC or any of their institutional data.

If there is any doubt as to whether or not your activities could qualify as human subjects research, please contact IRB@cptc.edu directly to discuss it.

Qualifying for Expedited Review

Research can typically qualify for expedited review if it has already been approved by another institutional IRB through reciprocation. At CPTC, it may also qualify for an expedited review if the activities do not generally meet all of the criteria required for research. An expedited review is a desk review by the Chair of the IRB that does not require a full convening of the board.

The Process

The first step in the process (

Visual diagram with captions

) for approval is to submit the IRB application. The application requires that researchers submit any documentation submitted to another institutional IRB, if they are working under an existing approval from another institution or entity. Most research that already has an approval can be subject to expedited review, but the CPTC IRB reserves the right to make an independent determination related to the work, including requiring it to be presented to the full board.

Once an application is received, the IRB will respond to the researcher with a notification of receipt. Within two weeks, the board will make an initial determination. The initial determination may be:

That the activities as presented are Exempt and the researcher is clear to proceed with an approval.
That the activities are qualified for Expedited Review and the board will issue an Expedited Review letter. Upon receipt of the letter, the researcher is clear to proceed.
That the activities require the Full Review of the board and that the board is convening on a specific date mentioned in the response.

The Full Review

If required to appear before the board in a full review, the researcher will have an opportunity to discuss their research in detail. Board members will typically ask questions about the research process and protocols as they relate to the sample group and population being studied. A primary mandate of this board is to make ethical determinations about the fitness of this research as it pertains to protecting human subjects, so a likely focus of the inquiry will be on the safeguards that are put in place to ensure their health, safety and wellbeing as well as the protection of any data generated by the work.

The board generally will vote to make one of three determinations on the work:

That the research is Approved as described and may proceed.
That the research is Conditionally Approved and comes with conditions, which will be spelled out in the approval letter that must be accepted by the researcher in order for the research to commence.
That the research as described to the board is Denied and may not proceed.

If a researcher is denied, he or she may not proceed with any of the research activities. The research must be significantly reworked and again presented to the board as a new request during the next cycle.

Contingencies and Restrictions

Note that all approvals issued are contingent on there being no material changes to the research processes and protocols as outlined in the materials submitted to the board. Changes to the research necessitate additional oversight which may require additional determinations by the board and must be communicated in writing as soon as possible, before implementing any change to the subjects.

Restrictions that are put in place by the board on Conditional Approvals are requirements that must be enforced for the life of the research project. The failure to enforce or otherwise honor a restriction may result in a notification to discontinue the project.

Expiration

Approvals issued by the board normally expire one year from their date of issue. If a research project is approaching the one-year mark from its initial date of approval, the researcher must submit a request to extend the research project which, if approved, will grant a one-year extension. This process must be repeated for the life of the project. The failure to submit an ongoing project for extension may result in a notification to discontinue the project.

Getting Started

The first step in the approval process is to complete the

IRB Review application

. Several things may be required prior to starting the application, such as:

A copy of all documentation submitted to any other institutional IRB, including their confirmation of approval
A copy of your survey instrument or description of your protocol
Your research plan
Proof of coursework in human subjects research protection such as programs offered by the Collaborative Institutional Training Initiative (CITI) or the National Institutes of Health (NIH).

Having a completed application with all required attachments will ensure that the review process is not unnecessarily delayed.