Instructions for Investigators Conducting Research Involving Human Participants

Kennesaw State University requires prior review and approval to be obtained from the Institutional Review Board (IRB) for all research involving human participants, including plans to gather data from participants for master’s theses and other student projects.  The following steps will facilitate the preparation of a protocol for submission to the IRB.

1. Get IRB Certified at http://www.citiprogram.org/

Prior to conducting research, each investigator, including faculty, staff and students, MUST complete a training course in human subjects protection to obtain IRB certification. KSU has selected the Collaborative Institutional Training Initiative (CITI) online training program as the official certification program for KSU-affiliated personnel. The program consists of a basic course of modules for biomedical and social/behavioral researchers, as well as general interest modules. To begin the course, please register as being affiliated with KSU and create a member profile. If you completed NIH training at the National Cancer Institute site prior to 8/20/07, you may elect to submit an electronic copy of that certification for three years following issuance of the certificate. Certification must be renewed every three years. Please contact the IRB Administrator by email or by telephone at (678) 797-2268 if you have questions regarding the CITI site.

2. Read the Kennesaw State University Assurance of Compliance

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

3. Complete an IRB Approval Request Form

Each question on the IRB Approval Request form must be answered before an application will be considered complete. A detailed explanation of questions 2-8 follows.

#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 form or cover letter.

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 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 consent 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. IRB generally recommends against extra credit in classes.

#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.

#4. Benefits: 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.

#5. Informed consent is a requirement. Informed consent means the knowing consent of an individual (or his/her authorized representative) so situated as to be able to exercise free choice without undue inducement or any element or force, fraud, deceit, duress, or other forms of constraint or coercion. The consent may be signed (see sample consent form) or not (see sample cover letter), but consent is required. If participation is expected to be anonymous, then consent may be achieved with a document such as a cover letter. Review of the consent form check list will help ensure that your consent form or cover letter contains all of the required elements. Different consent forms may be used, but forms must address all of the items included in the sample consent form and letter.

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.

#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 Parkinson disease, Latinos or others with limited understanding of English, pregnant women, students and employees.

#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 identifying information will be retained and indicate measures used to protect the participants' confidentiality.

#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.

4. Electronically Submit Documents to the IRB for Review

Investigators must email the following documents to irb@kennesaw.edu for review:

Protocols from student investigators must be reviewed by the supervising professor (faculty advisor) first. The supervising professor may then submit the required documents to irb@kennesaw.edu. Protocols received directly from students will not be reviewed, with the exception of M.Ed., Ed.S. and Ed.D. program students. Students in these excepted programs, after faculty advisor review of the study, may submit required documents as long as their email reflects that they are part of an excepted program and the faculty advisor appears as a cc: in the submission email. For research being carried out by non-faculty staff, it is necessary that a faculty member supervise the research. Please submit all documents in either .DOC, .PDF, or .HTML format.

5. Important Things to Know

It is essential that your study 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 one week; however, approval in some cases can only be given by the entire IRB, which meets once per month. See meetings page for details.

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

Immediately report significant changes or unanticipated problems involving your research to the IRB through submission of an online Progress Report.