IRB Common Questions
The IRB Chair will review your proposal and evaluate its risk level. Every case is different, but in general the IRB Chair and IRB staff will contact you by email with our response. Low-risk proposals generally get a response within one week, and moderate risk proposals usually take two weeks. High-risk proposals require full Board review, which only happens monthly during the academic calendar year. If the IRB Chair requests changes to your methods, documentation, or other items, you do not need to submit a new proposal—you will have the opportunity to update your proposal on Axiom Mentor.
No, you should update the relevant sections of your protocol within Axiom Mentor.
The approval process can take several weeks depending on the complexity of your project, the subjects you intend to work with, the completeness of your application materials, and other factors. Plan to submit your application at least three weeks before you want to start your research. For complex or high-risk projects, the IRB will review the materials at a full board meeting. Such meetings happen monthly during the academic year.
Institutional Review Boards were a response to a disturbing series of terrible crimes committed against vulnerable populations in the name of scientific investigation, particularly in the 20th century. The most notorious examples are the Nazi experiments that came to light in the Nuremberg Trials, and one product of those post-war investigations was a code of professional behavior (The Nuremberg Code) that remains foundational to the ethics of research on human beings.
Equally disturbing cases in the U.S. (e.g., The Tuskegee Syphilis Experiments) led the federal government in the early 1970s to develop standards for proper treatment of human research subjects, and to require research institutions to comply with those standards. Establishing an IRB to oversee ethical compliance is one of those requirements. IRBs remain important as additional sets of eyes to evaluate research plans for safety and protection of rights, concerns that can be overlooked in a researcher’s enthusiasm for his or her work.
Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. That is, an investigation designed to draw general conclusions, inform policy, or produce generalizable findings beyond the people, programs, or organizations being studied. Research using human subjects, even if it is done simply to verify existing hypotheses, theses, theories, or ideas, is considered original research, and requires review by the IRB.
Individual student research projects (e.g. at the Vermont campus, that includes courses with numbers that start with 5xx, 6xx, 7xx; at the Middlebury Institute of International Studies: DPPG 8616, DPPG 8698, IEMG 8699, LING 9640, TIAG 8645), even if conducted as part of the institutional curriculum, are considered research, and require review by the IRB.
For the purposes of this policy, the following are not considered “research” and thus do not fall under the purview of the IRB:
- Scholarly and journalistic activities (e.g. oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus only on the specific individuals about whom the information is collected
- Works that deal entirely with secondary sources (public data sets are considered such secondary sources)
- Activities in which human subjects perform exclusively for instructional purposes (though the intent or effort to publish data from such activities—at any time— converts these activities to original research involving human subjects)
- Data gathering for the purposes of fundraising by the external affairs offices; market research for the purposes of admissions recruiting; recruiting efforts for faculty or staff; statistical data collected for the management of institutional affairs; and attitudinal research of alumni, students, or parents
- Information collected for entertainment purposes
If you still are uncertain about whether it meets the definitions on this page, please contact the IRB! A quick email may be all it takes to determine whether or not you need to seek IRB approval.
Q I don’t plan to ignore my research subjects’ untreated syphilis or to do experimental lobotomies on mentally ill patients. Why do I need IRB approval?
The IRB is meant to protect human subjects from all kinds of potential harm, not just physical. Most research at Middlebury College won’t expose subjects to the kinds of harm notorious in those infamous historical cases. But many of our research agendas might expose subjects to psychological, emotional, or (occasionally) physical risks about which they ought to be informed and to which they normally ought to be able to consent.
Fill out the IRB’s application form on Axiom Mentor (read the Quick Start Guide, then log in to Axiom Mentor) describing what you intend to do, the subject pool you intend to work with, and the measures you intend to employ to obtain informed consent and protect subjects’ privacy. You’ll also need to take an online course on the ethics of research on human beings. This course takes roughly three hours to complete. After you take the tutorial and pass the quiz, the site will provide a certificate of completion for you, and within 24 hours, your completion will be tracked on Axiom Mentor.
Courses in which the curriculum consists substantially of independent student research are subject to IRB approval. Faculty members seeking approval for a course must submit an application form for the course.
The majority of studies conducted at Middlebury don’t require a full board review, and their protocols should be submitted as soon as possible. Some complex or high-risk projects will require review at the IRB’s monthly formal meeting. Investigators who anticipate full board review should plan to submit their protocol at least one week prior to the next IRB monthly meeting.
Traditionally IRBs dealt with research in the “hard” sciences and some social sciences, because other disciplines rarely involved human subjects in their research. That’s changing, however, and human subjects—and therefore IRBs—are more frequently a part of research in the humanities. One recent example of the expansion of IRB concerns at Middlebury College beyond the hard sciences: a couple of years ago, a senior English major developed a research project on Dr. Seuss books, and in the process wanted to read one of his books to elementary school children and gauge their reactions. In this case, though, the Dr. Seuss book happened to be about nuclear holocaust, and the IRB was concerned enough about the emotional effect on the children that it required parental permission for the researcher to work with the elementary school class.
As Principal Investigator, you have a few ongoing responsibilities to the IRB. You must:
- Notify the IRB if you want to change your research methods or location during the one-year approval period
- Apply for an extension if you need a bit more time than one calendar year to complete your project
- Apply for renewal if your project will run for another year
- Submit a status report for your project to date if you want to renew or extend a project beyond the one-year approval period
- Keep all documentation related to the project, including signed consent forms, for at least four years from the approval date (if you are a student, arrange this with your advisor)
- Keep any publications resulting from your research for at least four years from the approval date (if you are a student, arrange this with your advisor)
Q I’m a researcher at another university and would like to include Middlebury students/faculty/staff in my subject pool. Do I need to go through the Middlebury IRB?
If you do not yet have IRB approval from your home institution, then it is appropriate for the Middlebury IRB to be the reviewing body of record. Please submit your project for Middlebury IRB approval. If you have already submitted to your own institution’s IRB, the process should be much more streamlined. We require copies of the IRB application and approval from your home institution and documentation of human research protection training for you and all project personnel (defined as anyone materially involved in the conduct or analysis of the study). We accept NIH or current CITI training completed within the last five years. After reviewing these documents we will let you know whether it will be possible to sign an authorization agreement with your home institution, whether modifications will be required, etc. Finally, please note that an approval from our IRB (or a determination that our review is not required) does not reflect a blanket endorsement for a specific research project conducted at Middlebury.
Q I’m not collecting data or interacting with people, but I’m using a secondary/restricted dataset. Do I need IRB approval?
It depends on what kind of information about participants you are obtaining and how you acquire access to the dataset.
Publicly Available Secondary Datasets: Research projects involving only analysis of secondary data that either never contained, or have been stripped of identifiers (e.g. names, address, etc.) and are publicly available do not require prior IRB approval because their use is not considered research involving human subjects under the federal Common Rule, 45 CFR Part 46. With public datasets, neither the Middlebury researcher nor any collaborating researcher on the project(s) has access to links that would connect these data to the individuals from whom they were derived. Some example sources of public use survey data include: US Bureau of the Census, Bureau of Labor Statistics, and National Election Studies.
Restricted datasets: If the data set(s) are available to researchers and others, but the data holder requires a “responsible use statement” or similar data security agreement to ensure appropriate use and protection of the data, then please submit the project for Level I review. Include copies of data use agreements. In such a case, neither the Middlebury researcher nor any collaborating researcher on the project is able to connect the data to the individuals from whom they were derived. No researcher on the project may attempt to re-identify any person from whom the data were derived. In the latter case, the researcher should submit a copy (signed, if necessary) of the data security agreement required by the institution responsible for the dataset agreeing not to make any attempt at re-identifying participants.
If, however, you are obtaining a dataset(s) that contains direct (e.g., name, address, birthdate, Social Security number, email address, etc.) or indirect (e.g., data that may be combined to readily identify an individual, such as exact GPS coordinates of someone’s house) identifiers, you need to obtain IRB approval before conducting the research. Depending on how sensitive these data are, Level II or Level III approval may be required. Again, the IRB will need a (signed) copy of the data security agreement required by the institution responsible for the dataset.
Any questions regarding whether a data set meets these requirements should be referred to the IRB.