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:
1. Meet the federal definition of research
Federal regulations define research as "a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."
2. Involve human subjects
Federal regulations define a human subjects as "a living individual about whom an investigator conducting research obtains (1) data through intervention or intervention with the individual or (2) 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. Please note that while student investigators can prepare their IRB application and supporting documents, they are not authorized to electronically submit their IRB application. The student's faculty advisor must upload the IRB application on the student's behalf.
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: If my research qualifies as exempt, does this mean that I don't have to submit a protocol for review?
A: No. Federal regulations identify specific categories of research activities that are exempt from the federal regulations on the protection of human subjects in research. While a project may be exempt from the regulations, the ethical principles of conducting research with humans still apply (minimizing risk, maximizing benefit, and ensuring privacy) and all of the rights and protection afforded to human subjects in research are required in Exempt status cases. The IRB (not the investigator) decides whether a particular study can be classified as “exempt.” Therefore, even if an investigator is certain that a research project qualifies as an exempt study, it must be submitted to the IRB for review. If the research is determined to be exempt, written approval will be provided to the investigator.
Q: Does expedited mean that my application will be reviewed faster?
A: No. Expedited Review is for research projects that may be reviewed and approved without convening a meeting of the entire IRB. The term "expedited" can be misleading: reviews of this type are not "quicker" or conducted with less rigor, rather fewer reviewers are required. Expedited review can be considered when research activities present no more than minimal risk to human subjects and involve only procedures listed in one or more of the expedited review categories.
Q: What is the definition of minimal risk?
A: Per 45 CFR 46.102(i), minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Q: Do student research projects conducted for a thesis or as part of independent study need to be reviewed by the IRB?
A: Student research projects are reviewed in the same way as any other human subjects research conducted by faculty or staff. Any project conducted under the auspices of the College that meets the federal definition of research (systematic investigations leading to generalizable results) involving human subjects (living people whose personal data or private information are the subject of the investigation) requires review and approval by the IRB.
Examples of student research projects that require IRB review include systematic investigations with human subjects that will result in:
- Publication (e.g., journals, books, electronic media, web sites, and student theses) or public presentation (i.e., outside the classroom and/or College) of findings.
- Preservation of data or information that may be included in a longer-term generalizable research project by the faculty or another researcher.
Student investigators (after consultation with their faculty advisors) who are planning to conduct a research project involving human subjects must prepare an IRB application for their faculty advisors to submit on their behalf for review and approval prior to initiating any research activity/study procedures intended to produce generalizable knowledge.
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 be familiar and discuss with the student researcher the ethical and regulatory requirements of human subjects research 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, giving special attention to maintaining participant protections (including privacy, confidentiality, and informed consent), minimizing risk, and ensuring voluntary participation and withdrawal. It is also the faculty advisor’s responsibility to assure that ongoing IRB reporting requirements (e.g., unanticipated problems, continuing reviews, etc.) are met in a timely manner, even after the student graduates.
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: Do projects that are presented at the Academic Festival or as part of the Faculty Student Summer Research Program have to be reviewed by the IRB?
A: It depends. Students conducting research involving human subjects do not need to have their projects reviewed by the IRB if all three of the following conditions are satisfied:
- The project does involves minimal risk to subjects
- The project does not involve vulnerable populations (e.g. prisoners, people under 18 years of age, pregnant women, mentally impaired persons, or other vulnerable groups)
- The results will never be distributed outside the classroom and/or College
However, if there is even a remote chance that the data or the report/manuscript will be used in the future for a conference presentation, scholarly journal or a related research project, the research, then your project needs to be reviewed by the IRB.
Q: I'm conducting research as part of a class project. Does it have to be reviewed by the IRB?
A: 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 class projects involve human subjects and systematic research methods, but are conducted primarily for instructional purposes, are limited in scope, present no more than minimal risk to participants, do not involve vulnerable populations, and do not lead to generalizable results to be distributed outside the classroom and/or College, then IRB review is not required. 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 oral history projects need to be reviewed by the IRB?
A: A decision whether oral history or other activities solely consisting of open ended qualitative type interviews are subject to IRB review is based upon the prospective intent of the investigator. If the activity meets the federal definition of research (systematic investigations leading to generalizable results), IRB review is required.
The evaluation of such activities depends on whether the investigator is engaged in the creation of "generalizable knowledge" that is, whether the activity represents a systematic investigation in which the investigator engaged in such activities intends to develop or contribute to generalizable knowledge. Oral history activities, as described to OHRP by the oral history representatives, in general are designed to create a record of specific historical events and, as such, are not intended to contribute to generalizable knowledge.
General principles for evaluating Oral History type activities:
Oral history activities, such as open ended interviews, that ONLY document a specific historical event or the experiences of individuals without an intent to draw conclusions or generalize findings would NOT constitute "research" and would not require IRB review.
- Example: An oral history video recording of interviews with World Trade Center (WTC) survivors is created for viewing in a museum. The creation of the videotape does NOT intend to draw conclusions, inform policy, or generalize findings. The sole purpose is to create a historical record of specific personal events and experiences related to the attack on the WTC and provide a venue for WTC survivors to tell their stories.
Systematic investigations involving open-ended interviews that are designed to develop or contribute to generalizable knowledge (e.g., designed to draw conclusions, inform policy, or generalize findings) WOULD constitute "research" and require IRB review.
- Example: Open ended interviews of surviving Gulf War veterans to document their experiences and to draw conclusions about their experiences, inform policy, or generalize findings.
Oral historians and qualitative investigators may want to create archives for the purpose of providing a resource for others to do research. Since the intent of the archive is to create a repository of information for other investigators to conduct human research, the creation of such an archive WOULD constitute research and require IRB review.
Example: Open ended interviews are conducted with women basketball players in order to create an archive for future research. The creation of such an archive would constitute human subjects research since the intent is to collect data for future research.
Even if your oral history project does not need to be reviewed by the IRB, the project should be conducted in a way that is consistent with the Oral History Evaluation Guidelines of the Oral History Association.
Q: Does secondary analysis of an existing data set gathered for another purpose require a new IRB application?
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: I'm using an online survey as part of my data collection. What are some things I need to consider?
A: If data collection will occur through the use of an online survey, special attention must be paid to how a participant’s data will be secured. This entails having a familiarity with: the survey software being used, the types of information being collected (IP address, email address), the options the survey software provides regarding what information to collect, the ways in which information will be stored, and how any identifying information will be de-linked from survey data, etc. All investigators using online surveys must ensure that personally identifiable information (PII) is not collected with survey responses.
If you are using Qualtrics as your survey tool, please note that by default, the Anonymous Link collects the user’s IP address, which is considered PII: https://www.qualtrics.com/support/survey-platform/distributions-module/web-distribution/anonymous-link/.
You must enable the setting “Anonymize Response” in order to remove the respondents’ IP address and location data from your results. Instructions can be found here: https://www.qualtrics.com/support/survey-platform/survey-module/survey-options/survey-termination/#AnonymizingResponses.
Also by default, there is no limit to how many times a respondent can use the Anonymous Link. If you want to prevent multiple responses from the same respondent, you must enable the setting “Prevent Ballot Box Stuffing.” Instructions can be found here: https://www.qualtrics.com/support/survey-platform/survey-module/survey-options/survey-protection/.
If you are using SurveyMonkey as your survey tool, please note that the default option for every collector type is to store certain information to help you track respondents.
You can prevent IP addresses from being recorded in survey results by making results anonymous in your collector settings. Instructions can be found here: https://help.surveymonkey.com/articles/en_US/kb/How-do-I-make-surveys-anonymous.
If IP addresses are necessary to the research, include in the informed consent that you will be recording this information.
Q. What is a "waiver of documentation" of informed consent?
A: Per 45 CFR 46.117(c), a waiver of documentation of informed consent is a request whereby a signed informed consent document is not required. Examples include implied and verbal consent. Consent will still be obtained from participants; however, they will not be required to sign the consent form. There are only two circumstances when the IRB may waive the requirement to obtain a signed consent form:
The only record linking the participant and the research would be the consent document AND the principal risk would be potential harm resulting from a breach of confidentiality. Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant's wishes will govern; OR
The research presents no more than minimal risk of harm to participants AND involves no procedure for which written consent is normally required outside of the research context (for example, no risk surveys or interviews).
The IRB will take into consideration the risks and potential harms involved in the research and consent process before granting a waiver of documentation of informed consent.
Q: May the requirement for obtaining informed consent be altered or waived?
A: The IRB may waive or alter the requirement of informed consent under 45 CFR 46.116(d), provided that the IRB finds and documents that all of the following four conditions are met:
- the research involves no more than minimal risk to the subjects;
- the waiver or alteration will not adversely affect the rights and welfare of the subjects;
- the research could not practicably be carried out without the waiver or alteration; and
- whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Q: Do I need to request a waiver of parental consent when recruiting students who are enrolled in PS 101 / Introduction to Psychological Science to participate in my study?
A: Yes. Students enrolled in PS 101 / Introduction to Psychological Science are typically freshmen and may be younger than 18 years of age, and are therefore considered children. However, you may include a Request for Waiver of Parental Consent - PS 101 Students with your IRB application in order to include these students as part of your participant pool and allow them to fulfill the research-participation component of PS 101.
Q: What is "implied" consent?
A: Implied consent is a type of a waiver of documentation of informed consent. Implied consent is the tacit indication that a person has knowingly agreed to participate in research by performing a research activity or task. By completing the research task (e.g., completion of a questionnaire, interview, survey, etc.), the participant has provided consent to participate in the research.
Q: How is the consent process handled for online surveys?
A: For online surveys, it is sometimes appropriate to use implied informed consent. Participants would still need to be presented with the consent information, but would be informed that their consent is implied by submitting the completed survey.
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 Chair of the PRB and 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 legally 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 should 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.
Q: How do I request an amendment to an approved IRB protocol?
A: Plans to deviate from the approved protocol and/or supporting documents must be submitted to the IRB as an amendment request and approved by the IRB prior to the implementation of any changes, regardless of how minor, except where necessary to eliminate apparent immediate hazards to the subjects.
The amendment request should be emailed to the IRB Chair explaining the changes to the most recently approved protocol. The Chair will determine whether or not the proposed changes require additional review. If there are significant changes, a revised IRB application and any relevant supporting documents with the revisions highlighted to the most recently approved protocol should be attached to the email.
Q: I need to make changes to my approved IRB protocol. Do I submit an amendment request or a new IRB application?
A: The IRB typically requires a new IRB application (versus submitting an amendment request) when there are significant changes to 2 of the 3 following areas:
- Purpose of the study
- Participant population
- Procedures (i.e., what you're asking participants to do, research activities being carried out, etc.)
The IRB also usually requires a new application (versus submitting an amendment request) when there are significant changes to the study design or methodology that alter the study scope or aims, such as:
- An addition or significant alteration of research questions or hypotheses
- An addition of instruments that significantly alter the original scope of the study
If you are unsure whether your proposed changes can be submitted as an amendment request versus a new IRB application, please get in touch with the IRB. Remember that plans to deviate from the approved protocol and/or supporting documents must be submitted to and approved by the IRB prior to the implementation of any changes, regardless of how minor, except where necessary to eliminate apparent immediate hazards to the subjects.
Q: How long must I retain IRB records?
A: Different regulations apply to how long you are required to store records after the completion of research, and you must keep records for the longest applicable period of time. Federal regulations require research records to be retained for at least 3 years after the completion of the research (45 CFR 46). However, research that involves identifiable health information is subject to HIPAA regulations, which require records to be retained for at least 6 years after a participant has signed an authorization. Finally, research sponsors may require longer retention periods. In sum, you must keep your research records for at least 3 years and possibly longer, depending on the longest applicable standard. Another good practice is to retain data until there is no reasonable possibility that you will be required to defend against an allegation of scientific misconduct.
Notice that these regulations do not specify when you must destroy data, only state the minimum amount of time you must retain it. As long as you can guarantee that your research records are secure, you can keep them indefinitely. However, when research records are to be destroyed instead of stored securely, you should remember to protect your participants’ confidentiality throughout the process.