| IRB Frequently Asked Questions | |||||||||||||
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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 or presented at a conference, then the IRB considers it research, and thus, under the guidance of the IRB. Data collected strictly for teaching improvements or for university accreditation (SACS) need not be reviewed by the IRB. Q3: What types of research must be submitted to the IRB? A3: 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 or presentation or dissemination to an external audience. Q4: Do I need IRB oversight even if I am only conducting interviews,
surveys, or simply observing people? Q5: I plan on videotaping and/or recording participants in my research. Are there any special guidelines I need to be aware of? Research involving Other Institutions or LocationsQ6: Do I need IRB approval if my human subjects research will be conducted some place other than the University campus? A6: 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. Q7: Do I need IRB approval if my protocol is already approved by another IRB? A7: If your protocol has been approved at another university, you will need to provide the KSU IRB with a copy of the approval. Q8: If I obtain human subjects data from other researchers, is IRB approval required? A8: 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. Q9: My research will be done in another country. Do I have to obtain IRB review and approval? A9: Yes. Moreover, you may also need to provide the university (through the IRB) that you have authorization from the officials in that country to conduct your study there. Q10: 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? Scholarship of TeachingQ11: What about teacher evaluations and other types of assessment we do in our classes and departments? Q12: What if I am engaged in the Scholarship of Teaching (SOT)? Should I seek IRB approval before starting to collect data? Research By StudentsQ13: My students are doing research on human subjects for a class project. Must their proposals be approved by the IRB? Q14: As a faculty member, what are my responsibilities to my advisees or students who are conducting research on human participants? A14: 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:
Q15: What will happen if I, or my students, conduct research on human participants that has not been approved by the IRB? A15: 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 on StudentsQ16: Can I recruit students from my own classes to participate
in my research? Q17: If the IRB approves my request to use my own classes to participate in my research, are there any guidelines I need to follow? A17: 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:
ConsentQ18: Do I always have to obtain informed consent? A18: 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 instances: (1) 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 and in some cases, (2) research that is conducted in established educational settings, involving normal educational practices. Q19: Do research participants always have to sign an informed consent? A19: 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. Q20: Are there some instances in which oral consent is permissible? A20: 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 shall sign both the short form and the copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form. Q21: What consent materials are required for research with minors (children, persons under the age of 18)? A21: Human subject research with minors (children) requires completion of a parental consent form and a child assent form. Q22: What's the difference between an Assent Form and a Consent Form? A22: 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. Q23: Is a child assent form always required? A23: 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. Q24: What do you mean by “child assent script"? KSU ProceduresQ25: When should I submit my application for IRB review? A25: 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 irb@kennesaw.edu as soon as you have it ready. Q26: How long will it take for me to obtain approval to do my study? A26: It depends on the nature of your study and the characteristics of the people you intend to recruit.
Q27: How will I know when my study is approved? A27: 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 students(s)/advisee(s) study is approved. Q28: After I download the IRB form from the Internet and complete it, in what format should I send it back? A28: Please save the form as a word document, fill it out, and send it as an attachment to an email to irb@kennesaw.edu. Q29: Where should I send my completed form? A29: Send your forms as email attachments to irb@kennesaw.edu. Q30: Are handwritten applications acceptable? A30: No. All pages must be typed or prepared on the computer by the applicant following the designated format. Handwritten applications will be returned to the researcher or faculty advisor without being reviewed. Q31: What do I do if I make changes to my research protocol after I've received approval? A31: Please notify the IRB of any changes you wish to make to your research protocol before implementation. We will contact you if we require additional information or review prior to approving the changes. Q32: How long is my approval valid? A32: 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. Q33: Who do I contact with questions about the IRB? A33. Contact the IRB Chair, Dr. Ginny Zhan, at gzhan@kennesaw.edu or at x6679 or you may contact the IRB Administrator, Paula Strange, at irb@kennesaw.edu or at x2268. |
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