Reminder: Effective January 21, 2019, the federal regulations governing human subjects research have been updated. Please visit the Revised Common Rule web page for more details.

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."

and

2. Involve human subjects

Federal regulations define a human subjects as "a living individual about whom an investigator (whether professional or student) conducting research (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."

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(j), 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 (a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge) involving human subjects (a living individual about whom an investigator (whether professional or student) conducting research (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens) 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, websites 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, study closure forms, 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 student research projects involving human subjects need to be reviewed by the IRB if they will be posted in Creative Matter?

A: IRB review is required for research projects that involve human subjects and meet the federal definition of research, which is defined as “a systematic investigation designed to develop or contribute to generalizable knowledge.” Generalizable knowledge applies to research projects in which the researcher intends to draw conclusions that will contribute to general knowledge in the field or apply the findings to a larger population. Generalizable knowledge also occurs when the researcher intends to share the results with an audience outside the college, such as through journal articles, presentations at conferences or an online repository such as Creative Matter. As a result, if a student’s thesis involves human subjects research, IRB approval must be secured before that work can be made openly available in Creative Matter.

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 not involve more than minimal risk to subjects
The project does not involve vulnerable populations (e.g. prisoners, people under 18 years of age, pregnant women, cognitively 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, 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: No. Under the revised Common Rule that went into effect January 21, 2019, four categories of activities were removed from the definition of research to make clear that they are NOT within the Rule’s jurisdiction, as follows:

Scholarly or journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship) that focus directly on the specific individuals about whom information are collected
Public health surveillance activities (collecting, analyzing, and using data to target public health and disease prevention)
Authorized operational activities for national security missions
Data collection and analysis that enables the conduct of certain activities carried out as part of the criminal justice system

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 that 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.

Exceptions:

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 data set 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 data set 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: What is the difference between the terms coded, de-identified, and anonymous?

Coded: Direct personal identifiers have been removed (e.g., from data or specimens) and replaced with words, letters, figures, symbols, or a combination of these (not derived from or related to the personal information) for purposes of protecting the identity of the source(s); but the original identifiers are retained in such a way that they can be traced back to the source(s) by someone with the code. Note: A code is sometimes also referred to as a “key,” “link,” or “map.”
De-identified: All direct personal identifiers are permanently removed (e.g., from data or specimens), no code or key exists to link the information or materials to their original source(s), and the remaining information cannot reasonably be used by anyone to identify the source(s).
Anonymous data: Unidentified (i.e., personally identifiable information was not collected, or if collected, identifiers were not retained and cannot be retrieved); information or materials (e.g., data or specimens) that cannot be linked directly or indirectly by anyone to their source(s).

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 data sets, 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, 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, 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. The IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if it finds any of the following:

That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;
That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

When you submit your Request for Waiver of Documentation of Informed Consent with your IRB application, the IRB will take into consideration the risks and potential harms involved in the research and consent process before granting the waiver.

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, provided that the IRB finds and documents that all of the following conditions are met:

The research involves no more than minimal risk to the subjects;
The research could not practicably be carried out without the requested waiver or alteration;
If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

When you submit your Request for Waiver or Alteration of Informed Consent with your IRB application, the IRB will evaluate whether the above conditions are met before granting the waiver.

Q: Do I need to request a waiver of parental consent when recruiting students who are enrolled in PS 101/102 to participate in my study?

A: Yes. Students enrolled in PS 101/102 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 101/102 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. Although 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: 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 possibly one other member 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 five 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 1) where necessary to eliminate apparent immediate hazards to the subjects and 2) minor changes to IRB protocols classified as exempt as follows:

editorial or administrative revisions to consent documents or other study documents
adding non-sensitive questions to a survey or interview or revising current questions
increasing or decreasing number of participants, unless you are adding a new participant population

Amendment requests should be emailed to the IRB Chair. The email should summarize the proposed changes, and the most recently approved IRB protocol should be attached with the proposed changes outlined using track-changes. The Chair will determine whether or not the proposed changes require additional review by the IRB.

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 two of the three 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: Is annual Continuing Review required for my approved protocol?

A: The revised Common Rule eliminates continuing review for many minimal risk studies. Unless an IRB determines otherwise, continuing review of research is not required if:

The research was initially approved under expedited review;
The research is reviewed by the IRB in accordance with the limited IRB review procedure described in several of the exemption categories (specifically 2 and 3 at Skidmore College); or
The research was initially approved by a convened IRB and has progressed to the point that it involves only one or both of the following activities:
- Data analysis (including analysis of identifiable information or identifiable biospecimens), or
- Access to follow-up clinical data from procedures that subjects would undergo as part of clinical care.

If an IRB chooses to conduct continuing review even when these conditions are met, the rationale for doing so must be documented.

If the IRB determines that these regulations can be applied, IRB approval will not expire and continuing review applications will no longer be required. However modifications and reportable events should still be submitted. Additionally, investigators must submit a Study Closure Form within 30 days of the termination of all research involving human subjects under the approved protocol.

If you have a currently active study that was approved prior to January 21, 2019, you should continue to operate under the old common rule regulations, and you will be contacted approximately two weeks before the study's expiration. At the time of your next continuing review, the IRB chair will determine if the new regulations can be applied. Your IRB approval letter will then include an expiration date or a notice that continuing review is no longer required.

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 three 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 six 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 three 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.

Frequently Asked Questions

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