Frequently Asked IRB Questions

What is the IRB?

An Institutional Review Board (IRB) works to ensure ethical treatment of human participants in research. It serves to educate the community about the commonly accepted standards for ethical treatment of volunteer research participants. It reviews submissions for new and ongoing research to ensure it complies with those standards. In so doing, the IRB committee has the authority to approve, disapprove or require changes in research that involves human subjects (i.e., people). You can read more about ethics and the history of IRBs.

What criteria does the IRB use to evaluate proposals?

The IRB follows the regulations set by the Office of Human Research Protections (OHRP), a government agency that is part of the Department of Health and Human Services (HHS). The process involves a weighing of the costs or risks (to participants) and the benefits (to society). The OHRP guidelines provide a basis for Goucher’s can read Goucher’s Policy on the Use of Human Subjects.

How do I know if my project needs to be reviewed by the IRB?

The IRB only needs to review research that includes people as participants. Your project needs to be submitted before IRB for review before contact with human subjects if it meets the following criteria:

• It has the goal of generating generalizable knowledge.
• It involves human participants.
• You plan to publish or present this research outside of Goucher College. (If this is a study for a class project that will not be externally shared, refer to the next FAQ on this topic.)

If you are still not sure whether your project needs IRB approval, start by discussing this with your research supervisor or instructor (as appropriate), and/or reach out to the IRB Coordinator.

Do class projects have to be submitted for irb review?

Many class projects do not need to be reviewed by IRB, as long as they are considered low risk, not involving vulnerable populations, and not shared beyond Goucher. It is expected, however, that students and faculty involved in these projects will uphold the same standards for ethical treatment of research participants as projects subject to IRB review.

Instructors can act as “IRB proxy” in approving class projects. Instructors and students must complete the CITI ethics training for “Social and Behavioral Science Investigators” prior to interacting with human subjects. The IRB strongly recommends that instructors ask students to review the information on the Goucher IRB web site and complete the appropriate IRB form (likely Expedited for class projected) so that instructors can “approve” the projects. Contact the IRB Coordinator with questions or concerns about whether projects may require official IRB review.

In some cases, however, it IS necessary for students to submit their projects for IRB review. You must submit your project for IRB review IF it meets any of these criteria:

1. You wish to include individuals in your study who are under age 18, with two exceptions:
• Goucher students under age 18 may participate in research studies, but must have permission from a parent/guardian to consent to research studies on file with the IRB Coordinator; see IRB web site for details).
• Projects for the graduate program in education involving K-12 students under age 18 are exempt from additional IRB review, as long as the scope of the project is in the realm of typical educational experiences and standard assessment.
2. You are including individuals from vulnerable populations in your study (e.g., minors under age 18, those with a history of alcohol or drug abuse or other mental illness, victims/survivors of abuse and trauma, the homeless, those who are suicidal, undocumented immigrants, refugees, incarcerated people, and ex-convicts). 
3. Your research concerns sensitive topics (e.g., information related to sexual preferences/practices or illegal behaviors, information that if released could be damaging to the individual). 
4. You intend to publish or present the results outside of Goucher (e.g., online or paper publication, conference presentations).
5. You are directly identifying the individuals taking part in your study by name (prohibited except in cases approved by your instructor).

Does my senior thesis or independent study project have to be reviewed?

Yes, if it meets the criteria for human subjects research, unless it falls under the category of Class Projects (see above FAQs). Contact your faculty supervisor or the IRB Coordinator with any questions.

I am doing a research project involving minors under age 18. Are there any additional requirements to which I must adhere?

For research involving minors, you will need to submit the IRB-Full Form because they are considered a vulnerable population. The consent form must be signed by the parent or guardian of the minor, and the minor should (when possible or appropriate) sign a separate assent form. The assent form does not have to include all of the elements of an informed consent document, but it must give the participant enough information about the project that he or she can make an informed choice about whether to participate. The assent form should also be written in a way appropriate to the age of the participant. See the sample Parent Consent Form (Children) and Child Assent Form under Resources for IRB Members & Researchers.

Can I include Goucher students who are under the age of 18?

Yes, if they have their parent or legal guardian complete the "Parental Consent for Goucher Students Who Are Under 18 Years of Age To Be Subjects in Research Studies" DocuSign form, which can be requested from (and confirmed through) the IRB Coordinator. Students under age 18 must have this form on file prior to participating in your study.

What do I need to know about online survey research?

Mostly, you still follow all the guidelines in the IRB Forms. There are a few special circumstances involved in some online survey research projects. First, you will likely have an electronic or typed signature in place of a “real” (wet) signature for the consent form. Also, especially in the case of surveys that ask about sensitive topics, it may be best from an ethical standpoint to keep the online survey anonymous for extra assurance that the person’s name cannot be connected to their responses. In this case, describe why you are not obtaining an electronic signature in the appropriate IRB Form, and instead have participants click a checkbox to indicate consent, or simply state at the end of the consent form that by clicking “Next” to continue the survey, they are indicating consent to participate. Second, you will need to submit your exact survey questions in the IRB Form. Many survey software programs allow you to download the formatted questions, which can then be inserted in the form; or you can attach this as a separate PDF with your proposal. Whenever possible, you can include a preview or test link to your survey for IRB members to access.

Maybe. If the data (i.e., posts) are publicly available, such that they do not require account logins or private access, then you do not need to go through IRB review because this is not ‘private information.’ If the data you want to use require private access, then you should submit your project for IRB review prior to data collection. In all cases, including with publicly available information, standard human subjects ethical considerations apply. For more information, check out the University of Pennsylvania and University of Maine IRB pages.

What is the difference between "anonymous" and "de-identified" data?

It is important to use the terms “anonymous” and “de-identified” accurately in your proposal. They have different and specific meanings in the context of research. If your data are truly “anonymous,” this means there is no way to connect a participant’s identifying information (including name) to their responses/data. Almost always, this means that the researchers themselves do not know who participated in the study. A good example of “anonymous” data is online survey research that simply asks potential participants to click to indicate consent (but does not require an electronic signature). As noted in the above FAQ, sometimes this is the best choice for research dealing with sensitive topics. More commonly, to protect confidentiality of participants’ data, you would “de-identify” it as soon as possible; this means you remove any identifying information (including names) that could link the data/responses to the participant themselves. Often, researchers keep a master list linking names to ID numbers in a separate location, but the dataset itself only contains ID numbers and not names (or other identifiers that could violate confidentiality).

How do I know whether my project should be submitted for exempt, expedited, or full review?

Goucher is governed by federal regulation 45 CFR 46, as applied via our Policy on the Use of Human Subjects. This policy contains information about which types of human subjects research fall into the three review categories of Exempt, Expedited, and Full.

Exempt. Some limited categories of human subjects research can be “exempt” from review. When research is deemed Exempt (following OHRP regulation 46.104), the IRB can use less stringent application of review requirements than it must apply to riskier and federally regulated research. In this instance, you would submit the IRB-Exempt Form , which would then be reviewed by the IRB Chair (or proxy) to ensure compliance with the regulations and that human subjects are duly protected. An abbreviated list of the most common Exempt categories is included in the IRB-Exempt Form, and you can read the full list of Exempt Review categories from The Office for Human Research Protections (OHRP).

Expedited. Research appropriate for Expedited Review has minimal risk and does not use vulnerable populations. In this instance, you would submit the IRB-Expedited Form, which would then be reviewed by at least two (2) IRB members. An abbreviated list of the most common Expedited categories is included in the IRB-Expedited Form , and you can read the full list of OHRP Expedited Review categories.

Full. Research that carries more than minimal risk and/or uses vulnerable populations must go through Full Board Review. In this instance, you would submit the IRB-Full Form, which would then be reviewed at a convened meeting of the IRB.

What must I include in my application?

Find the appropriate template form for your project (IRB-Expedited, IRB-Exempt, IRB-Full) on the Goucher IRB web site (see above FAQ about review categories). This will guide you to include the following components:

1. Basic information about researchers, overview of research topic, risks and benefits, and how you will inform subjects about the research (e.g., informed consent, debrief).
2. Research proposal.
3. Consent form (as applicable).
4. Additional materials, which may include recruitment materials, study materials such as stimuli/measures/survey/interview questions, script, debriefing, etc.
5. A certificate of completion of the online CITI ethics training for "Social and Behavioral Science Investigators" for each investigator.

Where can I get training in the ethical treatment of human research participants?

Go to the Goucher IRB web site for information and a link to log in to complete the free CITI training for "Social and Behavioral Science Investigators." The training certificate expires after three (3) years, at which time the training should be taken again as needed. A currently valid CITI certificate must be on file with the IRB for each researcher on a project.

I'm a faculty member, and goucher students assist me in my research. What do I need to know?

Student researchers need to be listed on your IRB proposals. You will be asked to provide certificates of completion of the CITI training for "Social and Behavioral Science Investigators" for every researcher listed, both students and faculty. To add or remove researchers (including students) on your project after IRB approval, please submit an IRB-Continuing Review or Protocol Modification Form to the IRB Coordinator. You can find this and other IRB forms on the IRB web site.

I submitted my IRB proposal. How long will it take to get approved?

Once you submit your proposal to the IRB Coordinator, you should hear back within two (2) weeks. During this time, your proposal will undergo the level of review indicated by each category: for IRB-Exempt proposals the Chair or proxy, for IRB-Expedited proposals at least two IRB members, or for IRB-Full proposals by the majority of the full board. After this happens, your project may be (1) approved, (2) approved pending minor revisions, or (c) not approved. In the case of the latter two categories, you will receive information about revisions needed in order to be re-reviewed. Please be sure to use track changes for revisions before re-submitting to the IRB Coordinator. You will also be asked for a clean copy (with changes accepted) upon approval. Please also be aware that every stage at which new revisions are needed will add time until your proposal is approved. Plan your submission accordingly.

How do I safeguard the confidentiality of research materials?

You should always keep your research data files (including interview recordings and transcriptions) in a password-protected location on your computer or in the cloud. No one except the researchers should have access to these files. In most cases, you should remove identifying information such as names (unless your protocol is specifically approved to retain these identifiers) as soon as possible after obtaining the data. In some cases, the data may need to be encrypted. Most operating systems have their own built-in encryption software or you can use external software. If you need assistance, contact the Help Desk. In addition, especially for sensitive-topic research and/or vulnerable populations, you should name a date by which data will be destroyed.

How long is IRB approval good for?

Expedited and Full IRB approvals are valid for one (1) year. After a year has passed, you need to submit an IRB-Continuing Review or Protocol Modification Form to the IRB Coordinator to extend the approval for another year. Exempt research does not have an expiration date requiring re-approval. For all protocols (including Exempt), any personnel or methodology changes must be updated using this form (template on the IRB web site).

What should I do if I think my project is considered oral history?

Oral history projects typically involve a well-prepared interviewer questioning an interviewee and recording their exchange in audio or video format (definition from Oral History Association, or OHA). Oral history projects may not need IRB approval. Check out information on our web site about oral history projects, including a link to the OHA statement about IRBs. If you are a student, discuss this with your instructor or supervisor. If you are a faculty, address questions to the IRB Coordinator.

My research supports creative or journalistic work that does not intend to contribute to generalizable knowledge. Do I need IRB approval?

For such projects, you may need to provide participants with intellectual property release forms, but typically you would not need IRB approval. If you anticipate using this research for additional dissemination through publication or presentation of the findings of your research to generate generalizable knowledge, it is advisable to obtain IRB approval. Consult with your instructor, project supervisor, and/or IRB Coordinator with additional questions.