Frequently Asked Questions
Q: Do I have to submit my research proposal to the IRB?
A: IRB review and approval is required for projects that:
- Meet the federal definition of research;
- Involve human subjects; AND
- Include any interaction or intervention with human subjects or involve access to identifiable private information.
Please visit Does My Research Require IRB Review? for more information.
Q: How do I submit an application to the IRB?
A: Instructions for IRB application submission are given on the Submitting an IRB Application page.
Q: What are the types of IRB review?
A: There are three (3) types of review paths for an IRB application: Full Board, Expedited, and Exempt. Please visit Policies and Guides for more information about these three types of human subjects review.
Q: What is the faculty advisor's role in a student's research project?
A: The faculty advisor is an active mentor to the student researcher and shares the responsibility for the ethical conduct of the research with the student. The advisor is expected to discuss the general principles of research ethics prior to the initiation of any project involving human subjects, help students determine whether their project requires Institutional Review Board (IRB) review, and guide students through the IRB application process. The advisor must support the student in the conduct of the research project after IRB approval is attained.
While student investigators can prepare their IRB application and supporting documents, they are not authorized to electronically submit their IRB application. The faculty advisor must upload the IRB application on the student's behalf. Please visit Submitting Your IRB Application for more information.
Q: I'm doing a class project. Does it have to be reviewed by the IRB?
A: Class project that involve human participants and systematic research methods,
but present no more than minimal risk and do not result in generalizable research
are not typically considered human subjects research. Frequently, faculty develop
course-related activities or students propose independent research projects that are
designed to provide opportunities to practice research methods (e.g., interview, observation
and survey techniques; data analysis; research design). If such projects are limited
in scope, present no more than minimal risk to participants, and do not lead to generalizable
results, they do not require human subjects review. However, regardless of whether
the IRB reviews research for a class project, it is expected that any research conducted
by students, faculty, or staff will uphold the same ethical treatment of research
participants as projects that are reviewed by the IRB.
Q: Do projects that are presented at the Academic Festival have to be reviewed by the IRB?
A: Only if the findings of those projects meet the criteria addressed in the question above. If you plan to publish your findings in a scholarly journal or present them to a professional conference, then your project needs to be reviewed by the IRB.
Q: Does secondary analysis of an existing data set gathered for another purpose require a new research project for review?
A: Yes - if the existing data set includes identifiable data AND private information about a living individual. Secondary analysis of existing data may include the review of medical records, student records, data collected from previous studies, audio/video recordings, etc. that were initially collected for another purpose.
- In order to be existing, the information must be "on the shelf" (i.e., it has already been collected) at the time that the current research is proposed.
- Identifiable means the identity of the subject is known or may be readily ascertained by the investigator or associated with the information. In general, information is considered to be identifiable when it can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems, or when characteristics of the information obtained are such that by their nature a reasonably knowledgeable person could ascertain the identities of individuals.
- Private information is defined as information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical or school record). Information that contains identifiers and can be accessed freely by the public (without special permission or application) is not "private" and the research therefore does not therefore involve human subjects. For example, a study involving only analysis of the published salaries and benefits of public university presidents would not need IRB review since this information is not private.
Public data: Public use data sets (such as portions of U.S. Census data, data from the National Center for Educational Statistics, National Center for Health Statistics, etc.) are data sets prepared with the intent of making them available for the public. The data available to the public are not individually identifiable and therefore their analysis would not involve human subjects.
De-identified data: If the dataset has been stripped of all identifying information and there is no way that it could be linked back to the subjects from whom it was originally collected (through a key to a coding system or by any other means), its subsequent use by the lead researcher or another investigator would not constitute human subjects research, since it is no longer identifiable. However, keep in mind that even though a dataset may have been stripped of direct identifiers (names, addresses, student ID numbers, etc.), it may still be possible to identify an individual through a combination of other characteristics (e.g., age, gender, ethnicity, and place of employment).
Coded data: Secondary analysis of coded private information is not considered to be research involving human subjects and would not require IRB review if the investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information pertains. However, if a student is analyzing coded data from a faculty advisor/sponsor who retains a key, this would be human subjects research, because the faculty sponsor is considered an investigator on the student's protocol, and can readily ascertain the identity of the subjects since he/she holds the key to the coded data.
Q: I am not collecting any identifying information in my research project. Do I need to submit an IRB application?
A: Yes, if your research project involves active data collection. All research projects involving intervention or interaction with human participants, regardless of whether or not identifying information is being collected, must be submitted for review prior to beginning the research study.
However, if your research project involves use of existing information collected from human participants (e.g., secondary datasets, existing biological samples), but there are not any identifiers linking individuals to the data/samples, then the activity may not require IRB review.
Q: Can researchers be subjects in their own studies? Does self-experimentation require IRB review?
A: Yes, researchers can be subjects in their own studies. However, Skidmore considers this type of research (investigator self-experimentation) as research with human participants, and generally requires the same review and approval as research that recruits other people as subjects. Alhough investigator self-experimentation may not raise the conventional ethical concerns outlined in the Belmont Report, all human research projects should undergo ethical review to assure the safety of people involved and the integrity of the research at the College. While researchers may be aware of the risks of self-experimentation, they may also be more willing to accept risks that are ill-advised. Application for review with the IRB office allows a neutral third party to raise concerns and/or propose measures to promote the welfare of researchers.
Q: Do some departments have their own review boards? What should I do with my proposal if I am in one of those departments?
A: Yes, the Psychology Department has its own Participant Review Board (PRB). Dr. Jessica Sullivan is the liaison to Skidmore's IRB. If you are a member of the Psychology Department and would like to have your research project reviewed by the PRB, complete the Research Proposal Template and e-mail it along with supporting documentation to Dr. Sullivan.
However, please note the PRB is not a formally recognized entity under Skidmore's Federal Wide Assurance (FWA), which is the only type of assurance currently accepted and approved by the DHHS Office for Human Research Protections (OHRP). Therefore, it is highly advised that if your research falls under either expedited or full board review, OR if you intend to publish the results of your research, you submit your research project to the IRB for review and approval.
Your project must be submitted to the IRB if:
- It includes as participants, prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised persons, including those who are economically or educationally disadvantaged, OR
- It involves sensitive issues including sexual behavior, illegal conduct, drug and/or alcohol use, OR
- It involves deception, OR
- It involves more than minimal risk, meaning that the probability and magnitude of discomfort anticipated in the proposed research are greater than ordinarily encountered in daily life or in the performance or routine physical or psychological examinations or tests.
Q: Once an IRB application is submitted, what happens?
A: The IRB application and all supporting documents go to the IRB Chair, who determines the type of review (e.g., exempt, expedited or full). If the Chair determines that the research falls under expedited review, the application will be reviewed by the Chair and two other members of the committee; if the research requires a full-board IRB review, the IRB will convene at its next scheduled meeting.
Subsequent to the review, the IRB application and supporting documents will be returned to the investigator with any comments, requests for clarifications, and/or suggested edits provided by the reviewing IRB committee members. The investigator will then be asked to return the materials highlighting any revisions made and providing responses to the reviewing IRB committee members' comments.
When the reviewing IRB committee members are satisfied with the revisions and/or clarifications, the IRB Chair will send the investigator a final, clean copy of the IRB application and supporting documents. The IRB Chair will then issue an approval letter along with any initialed, date-stamped informed consent / verbal assent forms.
Q: How long does it take to get my project reviewed by the IRB?
A: The IRB seeks to be as timely and responsive to review requests as possible. While the IRB is typically able to review an application within 5 business days, it may take up to two weeks to review an application depending on the classification. If your application requires the IRB to convene for a full-board IRB review, your application and supporting documents must be received at least one week before the next scheduled meeting. See Meeting Schedule and Submission Deadlines for more details.
Q: Can the IRB approve a research project retroactively?
A: No. There is no provision in the federal regulations that allow for IRB approval of research that has already been conducted. If data was collected for purposes that the IRB determines to be non-research (e.g., program evaluations for library or educational programs not initially intended to be used for research), IRB approval can be sought for the data analysis going forward.