Does Your Research Require IRB Approval?
Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A project requires IRB review if it includes both research and human subjects. The IRB must make the final determination of whether or not a study requires review.
If you are wondering whether or not your research requires IRB oversight, the first question you should ask yourself is: Does your project involve human subjects? If your research does, then it requires IRB approval and you should continue reading this webpage. If it does not, then you do not need IRB approval.
Research That Involves Human Subjects
Below are a few examples of research that typically involve human subjects. This is not a comprehensive list and there are often exceptions to each research.
Activities that obtain data about individuals, systematically performed with the intent to generalize findings.
VIEWING IDENTIFIABLE PRIVATE INFORMATION
Identification of potential participants for a study or use of living individuals’ data for research purposes, whether or not the data will be recorded in an identifiable manner.
SURVEY, INTERVIEW, OBSERVATION
Collection of individuals’ data using surveys, interviews, or observation with the intent to generalize findings.
AUDIO OR VIDEOTAPING
Taping individuals for study in situations not normally expected to be recorded or when individuals can be identified from recordings.
Research That Does Not Involve Human Subjects
Below are a few examples of research that typically does not involve human subjects. This is not a comprehensive list and there are often exceptions to each research.
Study or use of data that cannot be readily associated with the living individual about whom the information relates. There are some exceptions. Be sure to contact IRB for assistance.
Activities involving individuals intended solely for internal use, performed to improve services or develop new services or programs, (e.g., satisfaction surveys) without intent to generalize findings, even if results will be presented or published; audits (internal or external) performed as a part of organizational operations. There are some exceptions. Be sure to contact IRB for assistance.
Collection and storage of private information, if the data may be used in the future for research purposes, whether or not the data will be recorded in an identifiable manner.
Examples of Research & IRB Approval
Below are examples of research and whether or not they need IRB approval. Research that do need IRB approval also have levels of review.
SURVEYS, QUESTIONNAIRES & INTERVIEWS WITH ADULTS
Not all survey, questionnaire, or interview research is minimal risk. For example, a survey or interview that asks questions about sensitive topics (childhood abuse, sexual functioning) likely to cause emotional stress or discomfort may require full IRB review. Some survey research may be classified as exempt from committee review if the information obtained is recorded in a way that the subject cannot be identified (either directly or through a code numbers or link); in other words, if the research data are anonymous.
A survey or interview study may also be considered exempt from committee review even when the data are not anonymous if the information being gathered could not reasonably place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation.
The most common classification for survey, questionnaire, or interview research is expedited approval. If the study is not anonymous and contains information that, if known, could be damaging as described above, but it does not rise to the level of more than minimal risk, it may be given expedited approval. Although the proposal application gives the investigator the opportunity to indicate a classification, the IRB makes the final determination as to the classification of exempt or expedited.
NORMAL EDUCATIONAL PRACTICES
Normal education practices are considered exempt from committee review, but must still be reviewed and approved by the IRB office. Some examples of this could be a students’
- Curriculum-related written work, test scores, grades, artwork and other work samples produced by children
- Curriculum-related oral and non-verbal communicative responses individually, such as in an interview, in small groups and with the whole class
- Responses (written, oral or behavioral) to curriculum-related activities
- Level of active participation in curriculum-related activities
Please note: A “normal educational setting” means preschool, elementary, secondary, and higher educational facilities, and after-school programs (if the project relates to tutoring, or homework help). In Special Education, normal educational practices correspond to the Individualized Educational Program (IEP), which is tailored to each student with an identified disability and may be implemented in diverse settings (school, home, work, community).
The following list outlines the ways in which a researcher may collect the information for their research.
- Videotapes and photographs of curriculum-related classroom activities
- Audio tapes of teacher-student and student-student discourse related to the assignment
- Teacher’s non-participant observation of curriculum-related activity of individual children or groups of children, noting what will be observed and how it will be analyzed, or whether it will be used as anecdotal evidence in the study
- Teacher’s commentary on students’ curriculum-related written work, artwork and other artifacts produced by children
- Student journals and communication books related to the curriculum
- Student grades and test scores
- Teacher journals, notes and reflective comments on student responses and participation in curriculum-related activities
- Questionnaires or interviews with students, parents and family members, teachers and administrators
- Non-participant classroom observations by colleagues, with the class teacher’s permission, stating what will be observed and how it will be used (i.e. How data will be analyzed or whether it will be used as anecdotal evidence)
Research for University Courses
Research conducted solely for pedagogical purposes may be excluded from IRB review, under the following conditions:
- The instructor’s intention is to teach professional research methods such as interviewing, surveying, or experimental design
- The data are gathered solely for the purposes of teaching how to analyze them
- The results will remain in the classroom
These data can be presented at the end of the semester within the confines of the institution, for instance, at Scholars Day. However, if the results will be published (including on Digital Commons), presented at a larger conference off-campus, or generalized in some other way, it will be necessary to obtain IRB approval.
If a class project evolves into a research project that the student/instructor wishes to publish or generalize, then the research will need to undergo IRB review. This should occur as soon as it is known that the data will be used for research. If this is not determined until after the research is completed, the investigator should submit a protocol to the IRB requesting permission to use existing data.
Pilot studies with human research volunteers, no matter how small, must obtain IRB approval. You can include the pilot study as a smaller section of the complete protocol, or you can get approval for the pilot study first, then come through the IRB again for a review of the full “parent” study. At this stage, you may have modified your research to take into account the results of the pilot study. (For example, you may decide to change the survey questions as a result of the pilot study, or change inclusion/exclusion criteria.)
The researcher’s intention plays a large part in determining whether research is an oral history or not. If the intention is to interview informants who have a unique perspective on a particular historical event or way of life, and the researcher also intends to let the informant’s stories stand on their own as a “testimonial” or in an archive, with no further analysis, the research is most likely oral history.
However, if the surveys or interviews are conducted with the intention of comparing, contrasting, or establishing commonalities between different segments or among members of the same segment, it is safe to say your research will be regular survey/interview procedures, because you will be generalizing the results.
Historians explain a particular past; they do not create general explanations about all that has happened in the past, nor do they predict the future.
Moreover, oral history narrators are not anonymous individuals, selected as part of a random sample for the purposes of a survey. Interviewees are selected because of their personal relationship to the topic under investigation. An oral history interview provides one person’s unique perspective. A series of oral history interviews offers up a number of particular, individual perspectives on the topic, not information that may be generalized to all research volunteers in the event or time under investigation.
Oral history interviews are not analyzed in the same way that qualitative data is generally analyzed. No content analysis, discourse analysis, coding for themes or other qualitative analysis methods of data analysis are performed on the interviews. They stand alone as unique perspectives.
It is primarily on the grounds that oral history interviews, in general, are not designed to contribute to “generalizable knowledge” that they are not subject to the requirements of 45 CFR part 46 and, therefore, can be excluded from IRB review.
SECONDARY ANALYSIS OF EXISTING DATA
Research involving the secondary analysis of existing data must be reviewed by the IRB to ascertain whether or not it requires IRB oversight.
Such research will be considered exempt if one or more of the following are true:
- The sources of such data are publicly available
- The information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects
- The dataset has been stripped of all identifying information and there is no way that the data could be linked back to the subjects from whom it was originally collected
Such research will qualify for an expedited or full-board review if:
- The source of the data is not publicly available data and/or contains private identifiable information about living individuals
CONTENT EXPERTS/CONSULTANTS/KEY INFORMANT
It may not be necessary to get IRB approval if interview questions are with experts about a particular policy, agency, program, technology, technique, or best practice. The questions are not about the interviewee themselves, but rather about the external topic. For instance, questions will not include demographic queries about age, education, income or other personal information.
IRB review will be required when a researcher is interviewing individuals about content, but there is a research question or hypothesis involved and when a researcher intends to analyze and generalize the results–that look for common themes in the collected data, try to universalize the interviewees’ experiences, or quantify the results in some way.
EXAMPLES THAT MAY BE EXCLUDED FROM IRB REVIEW
In all the following examples, the questions are focused on the facts about the program, policy, software, curriculum, procedures or project. The researcher will simply report the facts as they are related by the content experts. You may not need to submit a protocol or an informed consent form for IRB approval if one or more of the following are true. You are,
- Interviewing managers in a company about their billing procedures, or their use of a particular software program
- Interviewing or surveying teachers about what should be included in the development of a particular curriculum unit
- Asking a panel of nurses and doctors to review your antismoking program for teens for correct medical content
- Interviewing social agency directors about their client intake procedures
The following decision flowcharts can help you determine whether your project requires IRB oversight.