EIU Office of Research and Sponsored Programs

IRB Frequently Asked Questions

What must be reviewed by the IRB?
What levels of review are conducted by the IRB?
What training do I need in order to conduct research with human subjects?
Do I have to request approval for each project in a research methods course?
What do I need to do in order to have a proposal reviewed by the IRB?
How much time is required for IRB review?
What if my research project was approved by the IRB and I want to change it?
Is informed consent required for all research projects?
What is required in an informed consent or assent form?
Is approval required to utilize publicly available data?

What must be reviewed by the IRB?

Any research activities that involve human subjects.

Research means a systematic investigation—including research, development, testing, and evaluation—designed to develop or contribute to generalizable knowledge.  Dissemination of findings to a scientific audience is a sufficient criterion for identifying generalizable knowledge. Dissemination includes, but is not limited to, honor's, master's, and doctoral theses; presentation at a scientific meeting or conference; submission to or publication in a scientific journal; and Internet postings. 

Human subject means a living individual about whom an investigator obtains (a) information or biospecimens through interaction with the individual, or (b) identifiable private information.

Examples of work that must be reviewed by the IRB:

• Research on individual or group characteristics or behavior (including but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior)
• Research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
• Clinical studies of drugs and medical devices, studies involving collection of body fluids, collection of biological specimens for research purposes by noninvasive means.

Examples of work that is not considered research and does not require IRB review:

• Interviews by journalists conducted solely for the purpose of writing an article in a newspaper, magazine, or other media outlet are not considered research and do not require IRB review.
• 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 directly on the specific individuals about whom the information is collected.

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What levels of review are conducted by the IRB?

There are three levels of IRB review: exempt, expedited, and full review. The researcher will request a review type with their submission, however, the IRB makes the final determination based on established criteria. The following is a brief overview of that criteria:

Exempt review of research is conducted by the IRB chairperson, IRB vice chairperson, or a designated IRB member. Exempt review can be conducted for the following research scenarios:

1. Research conducted in educational settings that is not likely to adversely impact students’ opportunity to learn or the assessment of educators. 
2. Research that only includes interactions involving educational tests, surveys, interviews, or observation of public behavior (including audiovisual recording) when certain criteria is met.
3. Research involving benign behavioral interventions involving an adult subject via verbal or written responses or audiovisual recording when certain criteria is met.
4. Secondary research for which consent is not required (uses of identifiable private information or identifiable biospecimens), when certain criteria is met.
5. Research and demonstration projects that are conducted or supported by a Federal agency, or otherwise subject to the approval of agency heads, and are designed to study, evaluate, improve, or otherwise examine public benefit or service programs. 
6. Studies involving taste and food quality evaluation and consumer acceptance studies, when certain criteria is met.
7. Research involving the use of identifiable private information or identifiable biospecimens for secondary research use for which broad consent is required, when certain criteria are met.
8. Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use for which broad consent is required. 

Expedited review of research is conducted by the IRB chairperson or vice chairperson, as well as a designated IRB member. Expedited review can be conducted for the following research scenarios:

1. Some clinical studies of drugs and medical devices, when certain criteria is met.
2. Some studies involving collection of blood samples, when certain criteria is met.
3. Collection of biological specimens for research purposes by noninvasive means.
4. Collection of data through noninvasive procedures (not involving sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
5. Research involving materials (data, documents, records, or specimens) that are collected solely for non-research purposes (such as medical treatment or diagnosis).
6. Collection of data from voice, video, digital, or image recordings made for research purposes.
7. Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (Note: Some research in this category may meet the criteria for exempt review. This listing refers only to research that is not exempt.)
8. Continuing review of some research previously approved by the IRB
9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two through eight do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

Full reviews are conducted for research activities in which the involvement of human subjects involves more than minimal risk, does not fall within the exemption or expedited review categories, or involves certain vulnerable populations. Review takes place at the first IRB meeting scheduled at least 2 weeks after submission of the research proposal.

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What training do I need in order to conduct research with human subjects?

CITI Program Training must be completed by Faculty and Students conducting independent research (including research for a thesis). This training can be completed online at: http://www.citiprogram.org/

Students in a research methods class should be trained by one of three methods detailed in the IRB policy (also detailed on Form H: Course Certification Request Form).

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Do I have to request approval for each project in a research methods course?

No, provided the research is not intended to contribute to generalizable knowledge or place the subjects at more than minimal risk, and is not intended for publication. In this circumstance, faculty may file for certification of all projects in the course by using Form H: Course Certification Request.

• Vulnerable populations include children, prisoners, pregnant persons, mentally disabled persons, economically or educationally disadvantaged persons, individuals who are unable to give informed consent due to a physical or mental condition, or individuals whose circumstances may make them vulnerable to coercion (e.g., probationers).

• Asking identifiable subjects about illegal activities (e.g., underage drinking), that may place data at risk of subpoena.
• Placing identifiable subjects at risk of a breach of confidentiality that may lead to criminal or civil liability, or damage the subject’s financial standing, employability, or reputation.
• Placing subjects at more than minimal risk due to psychologically sensitive subject matter (e.g., interviews covering traumatic events).

If theses or other publications are written as a result of the research in the course, then the Primary Investigator must submit the Application for Review of Research Involving Human Subjects and all other required materials to the IRB for review.

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What do I need to do in order to have a proposal reviewed by the IRB?

Complete formal training in protection of human subjects (CITI Program Training).

Submit all forms and materials to the Office of Research and Sponsored Programs (ORSP), 1102 Blair Hall, or e-mail to eiuirb@eiu.edu. Proposals must include the following:

• Application for Review of Research Involving Human Subjects (including detailed responses to all Research Description prompts).
• Informed consent form (unless you have a valid reason for waiver of this requirement)
• Questionnaires, surveys, tests, or other materials that will be administered to subjects.
• If applicable, any recruitment materials that will be used, such as: advertisements, letters, flyers, and/or social media posts.
• If applicable, written permission from other institutions or agencies involved in the research (e.g., school board, hospital, agency, prison)

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How much time is required for IRB review?

Study protocols submitted for exempt or expedited review are reviewed by members of the IRB on a continual basis. Protocols are processed in the order they are received, regardless of estimated project start date. Initial review will be completed within 10 business days. If a protocol is incomplete or imprecise, it will be returned for completion/revision, and the resubmitted revised protocol will be reviewed within 10 business days. Complete and precise protocols that are Exempt from Further Review will be reviewed by an IRB member within 10 business days, and completed and precise protocols that qualify for Expedited Review will be reviewed by two IRB members within 20 business days.

Studies requiring full committee review can only be reviewed at one of the regular monthly meetings of the IRB. These studies should be submitted to ORSP no less than two weeks prior to the next scheduled monthly meeting of the IRB.

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What if my research project was approved by the IRB and I want to change it?

Any proposed modifications to the research project’s protocol or informed consent forms must be approved by the IRB prior to implementation.

To request a modification review, file Form D: Request for Modification of Existing Protocol with the Office of Research and Sponsored Programs.

For minor modifications that do not change the substance of the project, the level of risk to the subjects, or the level of review required, the review timeline will be fairly short. For more than minor modifications, the review process and timeline are the same as for a new application.

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Is informed consent required for all research projects?

Yes, with a few exceptions.

Informed consent assures that potential subjects understand the nature of the research project and can make an informed, voluntary decision about participation. The researcher is responsible for ensuring that informed consent is obtained in writing from the subject or the subject’s legally authorized representative. Typically, informed consent is documented through the use of a written informed consent form that has been approved by the IRB and signed by the subject or the subject’s legally authorized representative. The person who signs the informed consent form must be given a copy as a reference.

Research projects involving children as subjects typically require the written permission of one or both parents or guardian via the informed consent process. In addition to parental or guardian permission for a child to participate in a research study, the assent of the child must be solicited, if the child is capable of providing assent.

If an adult who is decisionally-impaired is the subject of research, written permission is typically required of the guardian of the potential participant via the informed consent process. In addition to guardian consent, the assent of the potential participant must be solicited, if the person is capable of providing assent.

Informed consent forms and assent forms, if applicable, must be submitted to the IRB for review.

The IRB may approve a waiver of some or all of the informed consent requirements provided that:

• 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 practically be carried out without the waiver or alteration; and
• Whenever appropriate, the subjects will be provided with additional pertinent information after participation

Additionally, Federal regulations allow the IRB to waive written documentation of informed consent for research that falls within one or more exemption categories. In this case, participants still receive informed consent, but signatures are not collected (for example, a researcher who is using a survey may include the elements of informed consent in a letter of invitation to participate and by completing the survey subjects are consenting to participate in the research study).

The requirement to obtain a signed informed consent for some or all of the subjects can be waived provided the IRB finds either of the following:

• The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality; or
• 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.

Any waivers to informed consent procedure or documentation must be requested by the researcher in the Application for Review of Research Involving Human Subjects. 

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What is required in an informed consent form?

An Informed Consent Form Checklist and Informed Consent Form Template are provided on the ORSP website, and provide the basic elements that must be included in an informed consent form. 

If children or persons who are decisionally-impaired are the subjects of research, Assent Guidelines are provided on the ORSP website.

In all cases, the language used to present informed consent needs to be appropriate for the targeted subject population.

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Is approval required to utilize publicly available data?

Many private organizations and public agencies make individual level data available to the public. If data files have been reviewed by the appropriate IRB and have been classified as public use data files, then it is not necessary to obtain EIU IRB review and approval to use public use data files.

When utilizing public use data files, be aware of the following:

• Not all publicly available data has been classified as public use data. It must be indicated on the documentation supplied with the file that the data has been reviewed by the appropriate IRB before it was made available to the public.
• IRB approval is required when obtaining individually identifiable data (from the sponsor of the public use data file or any other source) and merging with a public use data file.

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