Frequently Asked Questions
- My project involves minors. Is this subject to UTC policy SA0575 – Programs for Minors?
- The review process:
- Categories of review:
- How is the review category determined?
- What type of research is considered exempt?
- What type of research is considered expedited?
- What type of research requires full board review?
- What type of research qualifies for a classroom exemption?
It could be. Please be sure to review the full UTC policy SA0575 on the Safety and Risk Management website and comply with all campus regulations.
The length of the review process depends on several factors including when the application is received by the Office of Research Integrity, the type of review, and the quality of the application. Exempt reviews generally take about 3-5 days from the time the application is received by the IRB Chair. Expedited reviews are often completed in 2-3 weeks from receipt, and full board reviews are usually completed within 5 weeks of receipt. The IRB Chair and Committee at UTC are not full time staff. As such, submissions received prior to holidays and other times when faculty are very busy (Spring Break, midterms, finals) may experience delays.
Be advised that incomplete applications represent one of the main reasons applications are delayed. Be sure to fully complete all forms and applications, include appropriate attachments, and receive appropriate signatures prior to submission.
It's always frustrating when computer systems and software do not operate as expected. If you are having trouble accessing or completing the forms, please contact ORI and we will email you the document as an attachment.
Yes. Please indicate the preferred email address on the application form. Note that non-UTC email addresses occasionally get flagged by the UTC servers as "junk-mail" and may delay the processing of your application.
We prefer that all applications are submitted electronically. All follow-up correspondence with the IRB will be conducted via email. Should you not have a personal computer, the UTC Library has many computers designated for student and faculty/staff use.
Specific criteria for IRB approval of research are discussed in more detail in the IRB policy; however, the following elements are central to IRB decisions. In order to ascertain the level of review, several factors will be considered including whether:
Risks to subjects are minimized;
Risks are reasonable in relation to anticipated benefits;
Selection of subjects is equitable;
Informed consent is sought from each subject; and
Informed consent is appropriately documented.
There are five categories of review for projects involving human subjects in research settings. The categories include:
Full Board Review
Continuing or annual renewal
Generally speaking, new applications will qualify as exempt or expedited reviews. A small number of cases might qualify for full board review. Applications that automatically require full board review involve more than minimal risk to participants. Continuing or annual renewal applications apply only to projects that have previous IRB approval. Classroom assignment applications may only be submitted by faculty members on a limited basis for projects that are not necessarily research in nature but are designed to familiarize students (through assignments) with the process of research.
Any study that uses vulnerable populations such as children, cognitively impaired individuals, incarcerated people, or pregnant women is not eligible for exemption. Research on these populations requires expedited review.
Some limited types of research are exempt from IRB monitoring; however, federal regulations, funding agencies, and UTC policy prohibit investigators from making this determination on their own. Only the IRB Chair or his/her designee is allowed to make that determination, thus researchers must submit an application to ensure that the research meets the criteria for an exemption.
Service projects involving human subjects (including grants and programs that provide services and include an evaluative component that might be determined to be research) are encouraged to contact the IRB Chair and/or submit a proposal to ensure that they are exempt from IRB review.
The investigator must receive a letter from the IRB Chair stating that the research is exempt before the proposed research may proceed. There is no such thing as an emergency exemption and no university official other than the IRB Chair may designate research as exempt.
Specific Categories of Exempt Research
According to federal Department of Health and Human Services (DHHS) regulations for protection of human subjects in 45 CFR 46.101, research may qualify as exempt if:
- The research is conducted in established or commonly accepted educational settings, involving normal education practices, such as 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.
- The research involves the use of educational tests (cognitive, diagnostic, aptitude, achievement) survey procedures, interview procedures or observation of public behavior, unless the information obtained is recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects or any disclosure of this information outside the research could reasonably place the subject at risk of criminal liability or civil liability or be damaging to the subject's financial standing, employability or reputation.
- The research involves the use of educational tests, survey or interview procedures, or observations of public behavior when the human subjects are elected or appointed public officials or candidates for public office.
- The research involves the use of educational tests, survey or interview procedures, or observations of public behavior and federal statutes require without exception that the confidentiality of the personally identifiable information will be managed throughout the research and thereafter.
- The research involves the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects
Research that fails to meet any of these criteria may not be considered exempt.
Federal regulations and institutional policy allow for expedited review of certain types of research that have been determined to place a human subject at minimal risk in a research setting (45 CFR 46.110 and 21 CFR). Much of the research in the social and behavioral sciences has no more than minimal risk and will be eligible for expedited review. The greatest risk is often a breach of confidentiality. Certain specific medical procedures also are deemed by federal policy to involve only minimal risk (such as gathering blood samples and some other non-invasive methods of specimen collection. Investigators should see the full UTC policy for a list of these specific procedures. In addition, if subjects will be randomized to treatment and control groups, then the study does not qualify for expedited review (and will need a full board hearing). Expedited review also is prohibited in cases when the identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability; be damaging to the subjects' financial standing, employability, insurability, or reputation; or be stigmatizing unless reasonable and appropriate protections are implemented so that risks related to invasion of privacy and breach of confidentiality are minimal.
Any research that involves more than minimal risk to respondents requires full board review. In most cases, the typical type of research conducted at UTC is eligible for expedited review. In some instances the IRB Chair or IRB Committee members may feel that an application requires a full board hearing. In those instances, the IRB Chair will notify the principal investigator on the application and request additional information if needed.
In some instances, faculty members may wish to require students to complete research projects in order to learn about the process of conducting research. These projects do not meet the definition of research as outlined in the IRB policy; however, there is a need to ensure that these class assignments do not compromise any of the principles outlined in the UTC IRB policy. It also is essential that students be socialized to the ethical and procedural concerns associated with institutional review practices and the need to protect human subjects.
Student research projects may be exempt from IRB review if the assignment meets the criteria outlined below. This procedure applies only to class assignments and does not include independent study projects, honors projects, theses, or dissertations. These types of research require normal review according to the UTC IRB policy.
Faculty members may elect to use the procedure outlined in this section of the policy for student research projects that involve classroom assignments (at both the graduate and undergraduate level) when all of the criteria listed below can be met:
- the assignment is part of a regular class which meets weekly (by any format; i.e., in person or electronically);
- the assignment will be completed during the semester in which the student has registered for the course (and therefore has faculty supervision);
- the purpose of the assignment is for students to learn about the process of engaging in research and not to actually engage in research which would be used for publication, formal reports, or other formal means that would add to the body of knowledge in a particular field;
- the project is eligible for exempt or expedited review (i.e., no project requiring full board approval may be dealt with under this procedure); and
- the instructor has completed the on-line training and has filed their certificate of completion with the Chair of the IRB Board (available at http://ohrp-ed.od.nih.gov/CBTs/Assurance/login.asp)
Faculty members who wish to use this procedure must:
- submit a Form C to the IRB at firstname.lastname@example.org indicating the course, the assignment, and a copy of their certificate of completion of training. This Form must be approved by the IRB Chair prior to any projects proceeding;
- require students to submit Form A for approval by the instructor (instead of the IRB Board);
- review and approve the exempt and expedited review forms submitted by the student to the instructor; and
- submit a Form D at the end of the semester which outlines the students name, project title, a short description of the project and certifies that the instructor has ensured that all human subjects protections have been met (including informed consent, anonymity, and minimal risk).
These files must be maintained for no less than three years by the faculty member and may be periodically audited by the IRB Chair and/or his/her designee.
IRB Approval is valid for one year. At that time, investigators must file a Form B noting the project is complete or request a renewal for projects that required expedited or full board review. Projects approved under the Full Board Review process require an annual review by the full board committee membership. The annual review date is an anniversary date that is one calendar year later than the date on the original IRB formal letter of approval.
Many institutions across the country utilize CITI to provide online training for researchers. If you completed a CITI HSR BASIC course through another institution and that certification is still current (i.e., it hasn't expired), you may submit the certificate to the IRB. If the listed course modules are deemed sufficiently similar to the IRB HSR Basic Course by the Office of Research Integrity, that certificate will meet the UTC training requirement.
How do I know if I should complete the Biomedical CITI HSR course or the Social/Behavioral CITI HSR course?
Choose the course based on your field of research, and not your research methods. For example, investigators in Nursing or Physical Therapy should complete the Biomedical course. Investigators in Criminal Justice or Education should complete the Social/Behavioral course. Note: The IRB will not typically evaluate whether or not the investigator is enrolled in the most appropriate course. Either CITI HSR Basic course will meet the UTC IRB training requirement.
No. In order to receive IRB approval on a submitted protocol, all investigators listed on the protocol must have completed an HSR Basic Course.
If you answer questions #2 - #11 on the "Select Curriculum" questionnaire, you may be enrolled in additional courses in Responsible Conduct of Research, Conflict of Interest, Laboratory Animal Research, Institutional/Signatory Official, Export Compliance, and Biosafety/Biosecurity. These courses may be required for other areas of research, but they are NOT required in order to receive IRB approval, nor will they be accepted as fulfillment of the IRB training requirement.