You need IRB approval; What do you do next?
What level of review do you need?
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
- Classroom assignments
Generally speaking, most applications will qualify for exempt or expedited review. In most cases, if a full board review is required, it will be initiated by the IRB Committee based on an expedited review application. 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.
NOTE: Should your policy involve minors, please review UTC policy SA0575 – Programs for Minors for applicability.
Following is a description of how to determine the different levels of review. If you prefer a graphic aid, the Office of Human Research Protections (OHRP) has developed a number of decision charts which may be accessed here: OHRP Human Subjects Regulations Decision Charts.
What type of research is considered exempt?
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 the Director of ORI 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 or Director of ORI 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.
What type of research is eligible for expedited review?
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 56.110). 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.
What type of research requires full board review?
Any research that involves more than minimal risk to respondents requires full board review. In rare instances, initial applications may require an application for 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.
What type of research requires annual or continuation review?
IRB approval is valid for one year. At that time, investigators must file an Annual Review Form noting the project is complete or requesting 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. IRB Applications that qualified as exempt do not require an annual review.
What type of research qualifies as a classroom assignment?
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 Class Project Form to the Chair of the IRB 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 a 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 these 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.