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Office of Research
1. Who needs to submit an application
to the Institutional Review Board? 15. If I'm a student doing a class project, do I need IRB approval? If I'm a faculty member requiring a class research project, do I need IRB approval?
1. Who needs to submit an application to the Institutional Review Board? All Rowan University faculty and staff are planning to conduct research with human subjects must submit an application for approval by the IRB. Some (but not all) sudents who are planning to conduct research with human subjects must submit an application. Students conducting research related to their MASTER'S THESIS or DOCTORAL DISSERTATION must submit an application for IRB approval if their research involves the use of human subjects. Student-conducted research that is conducted solely
within the confines of the classroom or within a departmental research
participant pool and: 2. What does the Rowan University IRB consider to be research? The Rowan University IRB defines "research" as a systematic investigation designed to develop or contribute to generalizable knowledge. 3. When do I apply for IRB approval? You must apply prior to beginning your research. You must have the permission of the Rowan University IRB before identifying research subjects, beginning intervention, or collecting data. Check submission schedule on the Research Website for the due dates for IRB submission. 4. How long should it take to get a response from the IRB? You should receive a response within two weeks after the scheduled IRB meeting. 5. What if I need an answer more quickly? Try to plan your research so you allow for the time it takes to receive an IRB approval. But, if you need a response before the usual approval dates, contact the IRB Chair. We will try to expedite the review. However, the IRB reserves the right to hold a full review of the proposal and/or request revisions prior to approval. 6. What kind of response should I expect from the IRB? The IRB will give you one of three types of responses: 7. What is an exemption? Who can apply? Federal law allows the IRB to exempt some research from a full review. This saves time and effort. The IRB application form describes the exemptions. If you think your research should be exempted, indicate this in a cover letter explaining which exemption you think applies to your research. To determine whether your research might be granted an exemption, consider your answers to the following questions: a. Does your research involve deception of your subjects? Yes No If you answered yes to a, your research cannot be exempted from IRB review. b. Will your research be conducted in an educational setting and involve the evaluation or comparison of normal educational practices? Yes No c. Does your research involve the use of educational tests, surveys or interviews or observations, with no possibility of identification of the subjects and no possibility that the subjects might be placed at risk of criminal or civil liability, or of damage to their financial standing, employability or reputation? Yes No d. Are you surveying, testing, interviewing or observing public officials, and there is no identifying material of individual persons? Yes No e. Does your research involve the collection or study of previously existing data, documents, records or specimens that are publicly available and/or cannot be linked to the individual contributors of the data? Yes No f. Does your research involve study, evaluation or examination of public policies or procedures, and is your research subject to federal department or agency supervision? Yes No g. Does your research involve food tasting of food without unsafe levels of additives? Yes No If you answered yes to b-g, your research may be exempt. Please refer to more detailed explainations in the application itself or the Website of the U.S. Department of Health and Human Service Office for Human Research Protections (OHRP). 8. Do I have to include the survey, questionnaire, or test I plan to use? If you have developed your own research instrument or made modifications to a published instrument, you must submit it with your application. If you are using a published instrument, include the complete citation for that instrument (author, publisher, date of publication) and a brief description of the instrument with your application. 9. Do I need permission from my research participants? Yes. You may use the recommended consent form contained in Appendix B of the IRB Application Form (Click for Word version), or follow the guidelines presented in the application form to develop your own form. If the only record linking the subject with your research would
be the consent form, and the research presents no more than minimal
risk of harm to subjects, you may not have to prepare a consent
form. Instead you may state at the top of your research instrument
or on an accompanying cover letter on department stationary: 10. Do I need permission from anyone else? If your research is with children or with any other group who may not be able to provide informed consent, you must get signed permission from a parent or legal guardian. If you are conducting research in an institution other than Rowan University (e.g., a school, hospital, community agency), you must have signed permission from an administrator from that institution on the institution's letterhead. 11. Do I have to complete the training in Human Participant Protections Education? Yes. You must complete the training before the IRB can approve your application. Rowan University maintains a Federalwide Assurance (FWA) with the Office of Human Research Protection (OHRP), U.S. Department of Health & Human Services. This Assurance includes a requirement for all research staff working with human participants to receive training in ethical guidelines and regulations. Click here to complete the CITI training program. You can work at your own pace. You do not have to complete the training in one session. You can return later and pick up where you left off. When you have successfully completed the training, an e-mail will be sent to the Research Office indicating that you completed the training. 12. I am a student. Does my instructor need to sign anything? Yes. You need to complete the name of your instructor and contact information on the first page of the instruction form and your instructor needs to sign the assurance on the last page (as do you). 13. Does the IRB Application form have to be typed? Yes. You can complete the form online or copy the form to your computer and complete it offline. The IRB will not accept handwritten applications. 14. Who can I contact for more information? Check out the Compliance Website, or e-mail the Research Office or IRB Chair if you have any questions regarding the IRB or the use and rights of human participants in research. 15. If I'm a student doing a class project, do I need IRB approval? If I'm a faculty member requiring a class research project, do I need IRB approval?The professor needs to be certified, and will need to help students determine if they need to apply for IRB approval; however, the professor should instruct the students on IRB policies and/or require the student to have IRB training or its equivalent. Student-conducted research that is conducted solely within the confines of the classroom or within a departmental research participant pool and is a general requirement of a course, has the sole purpose of developing the student's research skills, and will be overseen by a faculty member, may not be subject to IRB review. 16. If I'm an emeritus, may I submit an IRB application for approval? Yes. Emeritus needing IRB approval may submit an IRB application to the IRB Committee. 17. If I'm an adjunct, may I submit an IRB application for approval? Yes. Adjuncts needing IRB approval may submit an IRB application to the IRB Committee; however, they must provide their off-campus contact information. 18. If I have no affiliations with Rowan University, but want to do research involving the Rowan population, can I? No. Someone in Rowan needs to be involved (for liability considerations). 19. If I submit an IRB application in the summer, when will it be reviewed? Summer applications are reviewed within two weeks after submission. There is no deadline for applications. 20. Do I need certification from CITI if I have a NIH certificate? All faculty, students, administrators, staff who are doing research for/at Rowan University must complete the CITI Responsible Conduct of Research (RCR) training. The subsets of RCR (1. Human Subjects/2. Animal Care and Use) tests are optional if applicants have a current National Institute of Health (NIH) certificate. New applicants and applicants whose NIH certificate have expired, must complete the CITI RCR and Human Subjects training. Shreekanth Mandayam Harriet Hartman, Ph.D. IRB Chair Rowan University 856-256-4500, ext. 3787 Karen Heiser
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