The guidelines provided below are intended for a broad KSU audience. Some disciplines may require more restrictive procedures. Please click on the question to see the answer.
Q1: What is an Institutional Review Board (IRB)?
A1: An IRB is a committee established to protect the rights and welfare of all human subjects who volunteer to participate in research studies conducted under the auspices of the university. The purpose of the IRB is to review all research involving human subjects and to ensure that potential research-related risks (physical, social, emotional and financial) are minimized and fully disclosed in order that volunteers can make an informed decision to participate. All research involving human subjects is reviewed and conducted according to relevant university, state and federal regulations.
Q2: What is the IRB definition of research?
A2: If data are collected from human participants and if the results may at some future point be published in a journal, presented at a conference, or will be disseminated beyond the classroom, then the IRB considers it research, and thus, under the guidance of the IRB. Data collected strictly for university accreditation (SACS) need not be reviewed by the IRB.
Any research activity that to any degree involves using human subjects as research participants, under the auspices of Kennesaw State University, whether undertaken on a large or small scale, whether it is preliminary or full designed, whether it is conducted by students, staff or faculty, whether it is externally funded or not, and whether it involves minimal risk or more than minimal risk, is subject to the KSU IRB regulations. This includes the collection and/or analysis of data from human beings intended for publication, presentation, or dissemination beyond the classroom and must be reviewed and either approved/exempted/denied by the IRB.
A3: Must submit for IRB review:
- While projects conducted for routine assessment of teaching effectiveness, curriculum, university processes and procedures, and customer satisfaction may be considered exempt, only the IRB can determine if a study is exempt and therefore requires submission for review and either approved /exempted /denied by the IRB.
- If a KSU faculty/staff/student is conducting interviews, surveys, or simply observing people, then these projects require submission for review and must be either approved/exempted/denied by the IRB.
- Application for Teaching Awards/Recognition - the need for IRB approval would depend on with whom the data is being shared.
- If KSU internal colleagues, then no approval is required.
- However, if being shared with anyone else, then it cannot be used without obtaining prior consent. A sentence can be included in the syllabus that would suffice for use of de-identified data and we can assist with the verbiage if needed.
Not needing submission for IRB review:
- Data collected strictly for university accreditation (SACS) need not be reviewed by the IRB.
- Faculty assessments and information provided to Chairs/Deans during annual reviews:
- Depending on how it is employed, student data shared among KSU colleagues who have been FERPA and Buckley certified does NOT require review and approval. That data (neither identified nor de-identified) then cannot be used for any other reason without obtaining prior consent. A sentence can be included in the syllabus that would suffice for use of de-identified data which would be provided in aggregate form and we can assist with the verbiage if needed.
- HOWEVER, if a KSU colleague wishes to then use the data to obtain funding or provide the analysis to an external source as an example of success, recognition, etc., then IRB approval of exemption should be obtained prior to the information being shared because the IRB cannot provide retroactive approval for any data previously collected without consent.
Q4: I've heard that the federal regulations make certain categories of research exempt. If my research fits into one of these categories, does this mean that I don't have to have it reviewed by the IRB?
A4: No. The IRB has the responsibility for determining whether or not a study is exempt. Any collection of data from living humans must be reviewed and either approved/exempted/denied by the IRB.
Q5: Do I need IRB oversight even if I am only conducting interviews, surveys, or simply observing people?
A5: Yes. Please review KSU IT policies and standards under Email Usage prior to sending out any mass communications. IRB approval info must be included at the beginning of all email solicitations.
Q6: I plan on videotaping and/or recording participants in my research. Are there any special guidelines I need to be aware of?
A6: Yes. The subject(s) must be informed that the data is being collected through such recordings unless approval for deception has been granted by the IRB. Consent forms must describe specifically who will use these recordings, how they will be used, for what purposes, how long they will be stored, and how they will be disposed of at the end of the study. Use of such data for other purposes must be disclosed and permission obtained for subsequent use in a special part of the consent.
Research Involving Other Institutions or Locations
Q7: Do I need IRB approval if my human subjects research will be conducted some place other than the University campus?
A7: Yes. To ensure that the KSU investigators comply with federal and university regulations, it is important that the University, through the IRB, be aware of where and by whom such research is being conducted.
Q8: Do I need IRB approval if my protocol is already approved by another IRB?
A8: If your protocol has been approved at another university, you will need to provide the KSU IRB with a copy of the approved protocol, consent document, survey instrument, and approval letter.
Q9: If I obtain human subjects data from other researchers, is IRB approval required?
A9: Yes. Unless your research is determined by the IRB to be exempt from continuing review, both you and the other researchers must have approvals from the IRBs at your respective institutions.
Q10: My research will be done in another country. Do I have to obtain IRB review and approval?
A10: Yes. You will need to provide the university (through the IRB) proof of authorization to conduct your study from the officials in that country (e.g., letter from an administrator, agency official, etc.). Review the International Compilation of Human Research Standards in order to determine if there are specific procedures that you must follow for the country in which you will be conducting your research.
Research Conducted by Graduate and Undergraduate Students
Q11: As a faculty member, what are my responsibilities to my advisees or students who are conducting research on human participants?
A11: The faculty advisor to a project is responsible for making sure that research projects assigned to students or conducted by non-faculty staff meet KSU IRB guidelines. Faculty advisors are responsible for:
- Informing students/advisees of the ethical principles for the protection of human subjects and applicable polices and procedures;
- Reviewing and approving student/advisee’s projects prior to submission of their applications to the IRB to assure compliance with KSU instruction for submitting an IRB application for review;
- Submitting the final application to the IRB along with the Faculty Advisor Routing Sheet via your official KSU email address;
- Monitoring student/advisee projects to ensure proper implementation of project;
- Assuring that end-of-project reports are submitted to the IRB within the time frame outlined in the KSU IRB study approval letter;
- Assuring that unanticipated problems or adverse events, outlined in the Reporting of Unanticipated Problems Involving Risks to Participants and Others policy, are promptly reported to the IRB, and that proposed changes in the protocol are submitted to the IRB prior to implementation.
Q12: My students are collecting information from human subjects for a class project. Must their proposals be approved by the IRB?
A12: Yes. Any individual conducting research on human subjects under the auspices of KSU, including faculty, staff, administrators, and students, must have the approval of the IRB. Students, and non-faculty staff and administrators must have a faculty advisor for their research projects. The faculty advisor is responsible for submitting student project proposals to the IRB along with the Faculty Advisor Routing Sheet (appears as the first page of the IRB Approval Request or IRB Exemption Request forms) via your official KSU email address. Classroom projects involving no outside reporting or publication may be declared exempt by the IRB. For these types of classroom projects, complete and submit the IRB Approval Request Short Form.
Q13: What will happen if I, or my students, conduct research on human participants that has not been approved by the IRB?
A13: In the case where research with human participants is in process, without having obtained the prior approval of the IRB, the IRB Chairperson will send a memorandum to the researcher(s) asking them to suspend the research project, and to comply with KSU guidelines by submitting a research proposal to the IRB. The research project should not resume until IRB approval is obtained. If the project has been completed, other considerations exist. Research involving humans that is not approved by the IRB is out of compliance with university regulations and the data may not be usable. This includes research conducted for master’s theses and doctoral dissertations. In addition, peer- reviewed journals often will refuse to print research that was not approved by an IRB.
Research Employing Student Data
Q14: Can I recruit students from my own classes to participate in my research?
A14: If you are the instructor or teaching assistant, or anyone the students would see as having power and authority over them, then the answer is "maybe." This is because the students could perceive the situation as one in which they really cannot refuse, even if they really didn't want to be in your study. You must avoid even the perception of coercion. If your students have special skills that make them particularly valuable as potential research participants, the IRB may approve your request to use them provided that you structure your protocol in such a way that the coercive potential is eliminated. Also refer to FAQ3 for additional information.
Q15: If I am contacted by anyone (internal or external) asking to obtain data on my students, what should I do?
- Internal: Depending on how it is employed, student data shared among KSU colleagues who have been FERPA and Buckley certified does not require review and approval. That data (neither identified nor de-identified) then cannot then be used for any other reason without obtaining prior approval. A sentence can be included in the syllabus that would suffice for use of de-identified data and we can assist with the verbiage if needed.
- If a KSU colleague wishes to then use the data to obtain funding or provide the analysis to an external source as an example of success, recognition, etc., then IRB approval of exemption should be obtained prior to the information being shared because the IRB cannot provide retroactive approval for any data previously collected without consent.
- External: If access to research subjects, including students, is gained through cooperating institutions not under the control of KSU, the institution(s) must be identified on the IRB form and evidence provided that the authorized official of that institution(s) is or will be informed of the study. If such subjects are placed at more than minimal risk, documentation of the institutional approval will be required.
Q16: If the IRB approves my request to use my own classes to participate in my research, are there any guidelines I need to follow?
A16: Yes. College students, employees and other persons in subordinate positions or positions of lesser power/status provide an easily accessible group with the potential for undue influence to impede free choice in the consent process. For student subjects, investigators need to consider the following:
- If course credit is given for participation, alternatives for receiving equal credit that are no more burdensome than the participation in research must be offered to those not participating;
- Policies regarding course-related research participation must be clearly understood;
- Incentives for participation may not be unduly influencing;
- Student subjects must have the ability to decline participation;
- Confidentiality must be maintained for self-disclosures of a personal nature.
Q17: Do I always have to obtain informed consent?
A17: Investigators involving a human being as a subject in research must obtain the legally effective informed consent of the subject or the subject’s legally authorized representative. The exceptions are few. The IRB has the authority to waive the federal requirements for informed consent in the following instance: research in which the only involvement of human subjects is that of anonymous observation, for example, observational studies of public behavior when obtaining consent would not be practicable.
Q18: Do research participants always have to sign an informed consent?
A18: No, not always. The IRB may waive the requirements for the investigator to obtain a signed consent form for some or all subjects, if it finds either: (1) that 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 (as in an interview or survey that addressed the participant's HIV status). Each subject will be asked whether they want documentation linking them with the research, and the subject’s wishes will govern; or (2) 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. If consent forms will not be used, the researcher must explain in the application to the IRB how informed consent will be obtained if using the cover letter.
Q19: Are there some instances in which oral consent is permissible?
A19: There are several research situations, all involving no more than minimal risk, where the IRB can authorize you to obtain consent orally. For example, in the case of phone surveys, consent may be obtained verbally and recorded by the investigator without the participant’s actual signature. Or, if your participants cannot write, the IRB will waive this requirement, provided that the study presents no more than minimal risk. Otherwise, you would have to obtain written consent from someone authorized to act on behalf of the participant. Additionally, if the risk to your participants would increase markedly because they signed a consent form (as in an interview or survey that addressed the participant's HIV status), then the requirement could also be waived. You'd still need to obtain informed consent, but it could be obtained orally. When oral consent is used, there needs to be a witness to the oral presentation. Also, the IRB must approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness must sign both the short form and the copy of the summary, and the person actually obtaining consent must sign a copy of the summary. A copy of the summary must be given to the subject or the representative, in addition to a copy of the short form.
Q20: What consent materials are required for research with minors (children, persons under the age of 18)?
A20: Human subject research with minors (children) requires completion of a parental consent form and a child assent form.
Q21: What's the difference between an Assent Form and a Consent Form?
A21: An assent form is used to gain consent from minor subjects (under the age of 18 years old). This form should be either written or read to subjects in language and terms that they can understand. A consent form is used to gain permission from parents or other adult subjects (18 years of age or older) for participation in the research study. For children, both assent and parental consent are required.
Q22: Is a child assent form always required?
A22: Assent must be sought from the child unless: (1) the child is incapable of providing assent (due to age or condition), or (2) the intervention holds out the prospect of direct benefit to the child and the intervention is available only in the context of the study. In these two situations, consent from parent(s) is sufficient.
Q23: What do you mean by “child assent script"?
A23: When you intend to collect data from children who are capable of comprehending, after obtaining consent from one or both of their parents, you must tell the children what to expect if they agree to participate in your research. You must make as certain as possible that the child understands that he or she has a free choice in the matter. The words that you use to present your study to the children are your "script." The children must give you a positive affirmation of their interest in participating. This is their way of exhibiting "assent.” Mere failure to object should not be construed as assent.
Q24: When should I submit my application for IRB review?
A24: You may submit your application at any time. You do not need to wait for the IRB’s scheduled monthly meetings. In many instances, your proposal may not require review by the full board. So, you should submit applications to email@example.com as soon as you have it ready.
Q25: How long will it take for me to obtain approval to do my study?
A25: It depends on the nature of your study and the characteristics of the people you intend to recruit.
- Allow 10-14 business days for projects that involve surveys and interviews given to most adults, providing that you record the data in such a way that there is no possibility that the subjects can be uniquely identified by an outsider and that any disclosure of the their responses outside the research could not reasonably place the subjects at risk of criminal or civil liability or be damaging to their financial standing, employability, or reputation.
- Allow 4-5 weeks for studies that, in the judgment of the IRB, involve more than minimal risk to the participants because your study will need to be reviewed at a monthly IRB meeting. If the IRB needs you to make extensive changes to your study and tables further discussion of it for the next meeting, then clearly the time could be longer. Most studies that come to this IRB, however, are of such a nature that they need not be reviewed at a monthly meeting.
- NOTE: If revisions are requested, this may increase the approval timeline.
Q26: How will I know when my study is approved?
A26: You will receive a letter at the email address that you provide when you submit your protocol to the IRB. Faculty members will receive a letter when their student(s)/advisee(s) study is approved. If you have not received an email by the 14th business day, you should contact us at firstname.lastname@example.org to determine your approval status.
Q27: After I download the appropriate IRB form from the Internet and complete it, in what format and where should I send it?
A27: Only typed Word documents will be accepted for the IRB application. Handwritten applications will be returned to the researcher or faculty advisor without being reviewed. Additional materials may be submitted as either Word documents or PDF; however, no survey links will be accepted. Please send all materials as an attachment to an email to email@example.com.
Q28: What do I do if I need to make changes to my research protocol after I've received approval?
A28: Notify the IRB of any proposed changes to your research protocol prior to implementation. Submit a Progress Report online and send copies of revised consent documents or survey instruments to firstname.lastname@example.org. We will contact you if we require additional information prior to approving the changes. If your research was classified as exempt from continuing IRB oversight, you are still required to submit proposed changes for review. This allows the IRB to ensure that your revised research continues to fall within the exemption classification.
Q29: How long is my approval valid?
A29: Student approvals are valid until the end of the current semester in most cases. Most other approvals are valid for one year from the approval date. If data collection will not be completed before your approval expires, you must submit a request for yearly renewal sufficiently in advance of the expiration date to permit uninterrupted completion of your project.
For research classified as exempt, you are free to conduct your research without requesting a yearly renewal, if no changes are required.
Q30: Who do I contact with questions about the IRB?
Research Record Retention
Q31: How long must research records be maintained?
A31: According to federal guidelines at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.115, all records relating to conducted research must be retained for at least 3 years following completion of the research. If you will be leaving KSU before those 3 years of oversight are completed, you must contact the IRB with information detailing who at KSU will maintain your research records after your departure OR to which institution your research study and records are being transferred.
Unanticipated Problems in Research
Q32: What is an unanticipated problem or adverse event in research, and how do I report such to the IRB?
A32: Researchers encountering a problem or event that is both unanticipated and indicates that the research places subjects or others at a greater risk of physical, psychological, economic, or social harm than was previously known or recognized, must promptly report such problems or events to the IRB. Guidance on reporting requirements may be found under the Reporting of Unanticipated Problems in Research tab at http://www.kennesaw.edu/irb/.