Thiel College

Institutional Review Board


The Institutional Review Board (IRB) is responsible for overseeing all research done at Thiel by faculty, students or staff that involves human subjects. The Thiel IRB committee is composed of people in the local academic community.

The goals of the IRB are to ensure that researchers understand and uphold the following two standards dictated by federal law:

  • Human subjects should not be placed at undue risk
  • Subjects should give uncoerced, informed consent to their participation in the research

The IRB is not a college committee in the usual sense; it is subject to the regulations of a federal agency: the Office for Human Research Protections (OHRP) within the Department of Health & Human Services (DHHS).

The federal government requires that all research involving human subjects conducted by an institution that receives federal funding be reviewed in advance by an IRB at the institution. Even if a specific research project is not funded by the government, the IRB is still expected to review it because Thiel receives federal funding.

The Process

The process begins by taking the IRB Quiz (Does My Project Require an IRB Application?) to determine whether your study requires IRB approval. If it does, you can start the formal application process by following the application instructions.

During the academic year, applications are processed on the Thursday after submission at 5 p.m. The IRB would like to see a fully-developed plan and accompanying documentation (e.g. a questionnaire or scripts when the subjects are likely to be interviewed). In the case where students are the researchers, the applications must be reviewed by a research adviser before they are processed by the IRB.

When an application is turned in, the chair asks a member of the board to be the primary reviewer. This reviewer reads the application and supporting materials. Then, he/she prepares an analysis and a recommendation for distribution to other IRB members. If they agree with the recommendation, the reviewer sends an email message to the applicant explaining the finding.

The normal findings are:

  • Many applications can be “exempt from IRB review” because they either make use of existing records, involve standard educational/psychological tests, or for other reasons listed in the federal regulations. However, it is up to the IRB (not the researcher) to determine whether a project is exempt.
  • Most other applications can be dealt with on an “expedited basis” because there is no more than minimal risk of harm to the human subjects and they fall into one of several categories or research listed in the federal regulations.
  • An occasional application will require a “full review.” This can entail a delay of several weeks because the IRB must hold a convened meeting. Projects that will misinform or mislead the human subjects so as not to taint their responses will always trigger a Full Review.

Most applications are dealt with in a week to 10 days. The researcher should not wait until last minute to submit his/her application. Delays may result from unusual circumstances, during finals or during breaks, but 90 percent of delays are due to inadequate or missing consent forms. We urge all applicants to submit a consent form. (In some cases, the IRB may determine that your research is exempt, in which case you are not required to submit a consent form. However, it is in your interest to submit a consent form regardless in order to avoid any unnecessary delays.)

Doing research that involves human subjects is a privilege, not a right. The IRB has dealt with numerous applications and will work with applicants on meeting the federal requirements. However, the IRB cannot approve projects submitted after the fact (prior review is necessary to insure compliance with federally defined criteria for ethical treatment of human subjects, particularly when the intent is to contribute to generalizable knowledge (learn more).

Thus research that is done without IRB approval MUST NOT BE USED IN ANY PRESENTATION OR PUBLICATION. Please be aware that IRB approval is critical for both Thiel related work (e.g. comps), as well as professional endeavors outside of Thiel. In fact, increasing restrictions are being placed on publication in professional journals of research conducted without IRB approval. Thus, we urge you to plan ahead and consider possible future uses of the data to be collected (e.g. class projects that do not require IRB approval would require IRB approval if used for comps and/or publication); and obtain necessary approval in advance. If you have collected data without IRB approval for a class project or other non-research purpose and later decide to pursue research that might build on or potentially use this data (for example, in a comps project), you must contact the chair of the IRB to discuss restrictions and possible ramifications.

By teaching students about the ethical treatment of human subjects, working with them on the applications and treating this matter as an opportunity for ethical reflection rather than an irksome requirement, faculty are helping to prepare students to understand obligations they may be expected to shoulder as adults.

A variety of helpful materials may be found at the United States Department of Health & Human Services (DHHS) website.

Documents  

Forms

If the quiz above determines a formal application is required, complete the IRB application form, create a consent form and write a list of questions (if the subjects will be interviewed).