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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?
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:
The Rowan University IRB defines "research" as a systematic investigation designed to develop or contribute to generalizable knowledge.
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. IRB applications are handled on a rolling basis, except for Full Board Reviews. Please refer to the IRB homepage to review the submission schedule for protocols and applications identified as requiring a Full Board Review.
You should receive a response within two weeks after the scheduled IRB meeting.
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.
The IRB will give you one of three types of responses:
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. Exemption for some protected classes, such as but not limited to children, prisoners, cognitively impaired, may not be granted an exemption due to the particular vulnerability of those subjects.
To determine whether your research might be granted an exemption, consider your answers to the following questions:
If you answered yes to b-g, your research may be exempt. You can indicate exemption on your application, but a researcher cannot self-exempt. During the review of the application, the IRB will determine whether or not the research is 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).
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.
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:
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.
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.
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). As a student, the faculty advisor is considered the Principal Investigator, but that does not mean that a student cannot solely plan, conduct, and report on the research. The ultimate responsibility lies with the faculty advisor.
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.
For Master and Doctoral students performing human subject research to use in their thesis or dissertation, IRB approval is required. For undergraduates who are participating in an assigned class project/exercise that is related to or has a component of human subjects research, then the professor or instructor should to be certified in the protections of human subjects. The professor or instructor will need to assist students when determining a research project is not considered human subjects research requiring IRB review. The professor should instruct the students on IRB policies and/or require the student to complete Students - Class Projects training in CITI. To determine if a classroom exercise is subject to IRB review, go to IRB homepage and review the Classroom Exercise Section of the webpage.
Any externally funded project requires the Principal Investigator must be a permanent employee (faculty member or staff member) of Rowan University at the time of sponsored program award acceptance and project excution. If a faculty member or staff member does not meet the PI eligibility requirements above, then please contact the Research Office or Office of Sponsored Programs for more information.
Office of Human Research Protections and code of federal regulations define researcher as such:
Who are “investigators”?
The HHS regulations at 45 CFR part 46 use the term “investigator” to refer to an individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB. For the purposes of the HHS regulations, OHRP interprets an “investigator” to be any individual who is involved in conducting human subjects research studies. Such involvement would include:
Yes. Emeritus needing IRB approval may submit an IRB application to the IRB Committee.
Yes. Adjuncts needing IRB approval may submit an IRB application to the IRB Committee; however, they must provide their off-campus contact information.
No. Someone in Rowan needs to be involved (for liability considerations).
Summer applications are reviewed within two weeks after submission. There is no deadline for applications, and these applications are handled on a rolling basis.
No, a current NIH certificate is satisfactory and acceptable. However, when the NIH training certificate expires (NIH certificates expire in 3 years), then CITI Human Subject training in your field of expertise or study must be completed. 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. https://www.citiprogram.org/ Note that there may be additional training requirements for faculty, students, administrators, and staff who are doing research through an externally funded grant, of which the Research Office will inform you.
All research done at Cooper Medical School must be approved by its IRB Committee. Click here for directions, template, and application form. If your project does not fit the template, please click here for the Investigator-Initiated Protocol Template.
23. Do I need to complete and submit an IRB application for my class survey related to curriculum development?
Internal curriculum development does not require a review by the IRB, and therefore, does not require the completion and submission of an IRB application. However, if a classroom survey related to curriculum development is associated with a sponsored project and will contribute to generalizable knowledge/publication/reporting to the public, then the curriculum development survey is subject to IRB review.
Harriet Hartman, Ph.D.
856-256-4500, ext. 3787
Compliance & Contracts Specialist
856-256-4500, ext. 4058