Working With Human Subjects

Types of Review

Check with your institution’s review board to determine what level of review is needed for your human subjects research. Often, a local review board will identify categories of research (based on federal guidelines) for expedited review or for exemption from review. Expedited and exempt projects still require that research protocols be completed; the type of review applies to how the local review board handles your protocol. Expedited review and exemption require less time than a full review, which can take up to three weeks initially (and the IRB may ask for multiple rounds of revision in your protocol before final approval). Exempt projects and expedited review can require considerably less time, sometimes as little as a week. You should plan to check on the specific processes on your campus to see which of these categories your research falls into.

Full Review

“Full review” refers to a meeting of all committee members after reading the completed protocol, consent forms, recruitment materials, and data collection tools. Generally, all these materials will be submitted 1-2 weeks before the committee meets. The committee discusses each protocol in detail, raising any questions or concerns about any of the documents. The committee may require revisions (large and small) before final approval. In rare instances, the researcher may be invited to meet with the committee.

At CSU, the IRB meets only once a month. The typical deadline for submitting copies of all materials is 5 p.m. on the second Thursday of the month. RICRO sends materials to committee members who meet the following week to approve protocols or request revisions before approval. Reports are emailed to PIs within 10 working days following the meeting. Meeting dates are posted on the IRB Webpage: http://web.research.colostate.edu/ricro/hrc/dates.aspx.

Expedited Review

For those projects that involve no more than minimal risk to subjects and that involve the specific procedures noted below, expedited review by two IRB members is an option. The researcher submitting the protocol requests an expedited review, and an IRB administrator determines whether expedited review is appropriate. Thus, researchers should submit thorough applications for this initial judgment.

Protocols requesting expedited review can be submitted at any time. Responses from RICRO are sent to PIs within 15 working days. If the IRB administrator asks for full review, the researcher will be informed of the new review date.

Alternatively, meeting with an IRB administrator to talk about the protocol will usually result in a determination about whether expedited review is probable. Especially for graduate students on a tight deadline, this conversation can help students to understand what materials to submit and when, saving time in the long-run even if a full review is required.

Only limited data collection methods qualify for expedited review, and many of these relate to clinical studies and physiological samples not summarized here. Those methods pertinent to studies in rhetoric and composition (or English studies more broadly) include

Remember, for expedited review, the design overall must present no more than minimal risk to participants.

Exempt Projects

Please remember that even if your research meets criteria for exemption, you must submit an Exempt Form and supporting materials to qualify for exempt status.

Exempt projects at CSU fall into specific categories with conditions that the research must meet in full:

  1. Research on educational practices
  2. Research using educational tests or certain non-invasive data collection techniques (i.e., surveys, interviews)
  3. Research on existing data
  4. Consumer acceptance studies (i.e., taste testing)

Not all research in these categories will meet the specific conditions required for exempt review. Exempt research on educational practices, for instance, can include ONLY research on regular and special education instructional strategies OR research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

« Previous
Continue »
Introduction