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Office of Research

Submitting an IRB Application for Review

Submitting an IRB Application

The following steps will facilitate the preparation of a protocol for submission to the IRB.

1. Get IRB Certified

Prior to submitting a human subjects research application to the IRB, each investigator (faculty, staff and student) taking part in a study MUST complete a training course in human subjects protection to obtain IRB certification. KSU has selected the Collaborative Institutional Training Initiative (CITI) web-based training program as the official certification program for KSU-affiliated personnel. Proposals will not be reviewed until the IRB documents that all members of the research team have completed the training.

To begin the course, please register as being affiliated with KSU and create a member account. Faculty and staff members are required to complete the Social & Behavioral Research Investigators or the Biomedical Research investigators course. Students should complete the Students Conducting no more than Minimal Risk Research course unless the faculty advisor requires completion of one of the more intensive courses (always check with your advisor before registering at CITI). For further details on the appropriate training course to complete, check out IRB Training Certificates & CITI Registration Steps.

Certifications must be renewed every three years. For researchers taking part in a study who are not employees, students, or staff at KSU, the IRB will accept a training certificate issued through the researcher’s home institution.

2. Read the Kennesaw State University Assurance of Compliance

pdf iconAssurance of Compliance

Submission of an application for review by the IRB indicates that this policy has been read and understood by the investigator.

3. Does Your Project Require IRB Review and Approval?

Using the IRB Oversight Decision Tree, determine whether the proposed research is considered to be human subject research under the federal regulations, which requires IRB review.

4. Complete an IRB Application Form

Determine whether your study may be classified as exempt from continuing IRB oversight or requires an expedited or full board review by accessing the IRB Exemption Screening Checklist.

If the study may be exempted, complete the Exemption Request Form. For studies that cannot be classified as exempt, complete the IRB Approval Request Form (a detailed explanation of Questions 2-8 of this form follows).

Question 2: The description of the research should include brief comments on:
  • a. Purpose of research: Briefly describe the purpose of the research. Describe the problem to be investigated, the reason for conducting the research. Include any broadly stated research questions or issues being investigated. You may wish to include hypotheses.
  • b. Nature of data to be collected: Describe the type of data to be collected such as demographic data, answers to open-ended questions, responses to Likert scaled statements, specimen to be collected, video tapes, audio tapes, etc.
  • c. Data collection procedures: Describe the manner in which data will be collected. This section should describe exactly what participants are being asked to do; e.g., participants may be asked to participate in a focus group discussion, or participants may be asked to complete an online survey using SurveyMonkey.
  • d. Instruments to be used: Describe the “instruments” to be used; i.e., questionnaire, interview outline, survey, etc. Email a copy of each with your approval request form and consent document(s). For those conducting classroom research, detail whether instruments are being used strictly for research purposes or are part of normal classroom activity.
  • e. Method of selection/recruitment of participants: Describe how participants will be identified and contacted; e.g., if students in classes will be asked to complete a survey, then list the specific classes and instructors. It is generally better if the person administering a survey is not the instructor of record. Attach any recruitment advertisements to be used.
  • f. Participant age range, number and gender: Provide expected age range even if all participants are expected to be adults. If there is a chance that participants may include minors, make certain that appropriate parental consent and child assent is included. Provide the expected number of participants and the expected distribution of males and females.
  • g. Incentives, follow-ups, compensation to be used: Describe incentives that will be given to participants as well as any methods used to avoid penalizing those who do not participate. The IRB generally recommends against extra credit in classes.
Question 3. Risk:

Provide a complete description of any procedures that may involve any risk to the participant and indicate alternative procedures that may be used, if any. The legal or ethical concerns involved should be addressed, safety precautions to be taken should be listed, and a justification for procedures involving risks or discomforts included. If the research involves any potential risks to the participant, participants must be advised of the risks and the availability and limits of treatment for any sustained injuries. Note that risks may be physical, psychological, social, economic or legal.

Question 4. Benefit:

Research involving human participants must not be conducted unless the benefit to the participant AND the importance to humankind outweigh any potential risk to the participant. Describe any and all benefits from conducting this study. Also note that benefits cannot be guaranteed.

Question 5. Informed Consent is a Requirement:

Informed consent means the knowing consent of an individual (or his/her legally authorized representative) is so situated as to be able to exercise free choice without undue inducement or any element of force, fraud, deceit, duress, or other forms of constraint or coercion.

Consent is obtained by using a consent form, which is signed by study participants, or by using a cover letter, which provides for unsigned consent if study participation is expected to be anonymous. For assistance in drafting signed consents, cover letters, parental consents, online survey cover letters, and child assent documents, see the IRB consent templates.

If deception is employed in your research, describe how participants will be deceived, the necessity for deception and your debriefing procedures, including the timing and information to be presented to the participant. The IRB requires a written debriefing for studies involving deception.

If you will be utilizing an online survey program to collect data, you must notify your participants in your consent document as to whether Internet Protocol addresses will or will not be collected by the online program, and the first page of your online survey must reflect the consent document.

Question 6. Vulnerable Participants:

In research with minors or other vulnerable populations, informed consent is especially necessary, and in most cases, will be obtained from parents or legal guardians. An understandable explanation of the research procedures and an opportunity to volunteer to participate should be supplied to the participants as well as their authorized representative. This is called “assent.” Their wishes determine their participation. If your research will not include minors, then the consent form or cover letter should state that only persons 18 or older are eligible to participate. Vulnerable populations may include cognitively impaired, economically disadvantaged, educationally disadvantaged, elderly, homeless seeking social services, people with limited or restricted physical or mental ability, people with limited understanding of English, pregnant women, students and employees.

Question 7. Future Risk:

Whenever possible, the participants should remain anonymous; otherwise appropriate confidentiality should be maintained. Procedures for maintaining confidentiality should be described in detail, including who will have access to the data and on what basis. If survey instruments are to be used, list the anticipated date identifiers will be removed from the completed instruments. Describe how data will be stored, as well as how and when it will be destroyed. Provide justification if identifiable information will be retained and indicate measures to be used to protect participants’ confidentiality.

Question 8. Illegal Activities:

Participants must be assured that their data will be confidential in any research, but if individually identifiable data relate to illegal activities by identifiable persons, no guarantee can be given if disclosure of the data should be required by law. When anonymous questionnaires are involved, but written informed consent must be obtained, the consent form can be signed and returned separately to prevent any possibility of linking names with the data.

5. Submit Documents for IRB Review

Faculty and staff may email their documents directly to irb@kennesaw.edu.

All student research requires supervision by a Faculty Advisor. In order to ensure that the advisor has reviewed the IRB application materials and agrees to supervise a student's proposed project, the advisor must complete a Faculty Advisor Routing Sheet and submit it and all additional application materials to the IRB on behalf of the student. Protocols received directly from students for initial review will be administratively rejected.

The following documents must be reviewed by the IRB:

All documents must be submitted in either Word or PDF format. Please note that the IRB will not accept and does not review documents presented via Internet Web links.

6. Important Things to Know

Your study must be submitted in sufficient time to allow for proper institutional review prior to the initiation of research or submission of an application to a funding agency. Approval can often be obtained within 10-14 business days; however, approval in some cases can only be given by the entire IRB, which meets once per month (with the exception of May, June, July, and December). See meetings page for details.

DO NOT DISTRIBUTE CONSENT FORMS OR BEGIN YOUR RESEARCH BEFORE RECEIVING A LETTER OF APPROVAL FROM THE IRB.

PROMPTLY report significant changes or unanticipated problems involving your research to the IRB by contacting the IRB Chair through submission of the online Progress Report. For detailed information regarding the reporting of unanticipated problems involving risks to participants and others, click here.