- Who needs to submit an application to the Institutional Review Board?
- What does the Monmouth University IRB consider to be research?
- When do I apply for IRB approval?
- How long should it take to get a response from the IRB?
- What if I need an answer more quickly?
- What kind of response should I get from the IRB?
- Do I have to include the survey, questionnaire, or test that I plan to use?
- Do I need permission from my research participants?
- Do I need permission from anyone else?
- Do I have to complete the training in Human Participant Protections Education?
- I am a student. Does my instructor need to sign anything?
- Does the IRB form have to be typed?
- Can I submit the form electronically?
- Do I need to debrief participants?
- Who can I contact for more information?
- If I am required to complete revisions, are they reviewed immediately once they are submitted?
All Monmouth University faculty, staff and students who are planning to conduct research with human participants must submit an application for approval by the IRB.
Some (but not all) students who are planning to conduct research with human subjects must submit an application. Students conducting research related to their Senior Thesis, Honor’s Thesis, or Graduate school research that is intended for public dissemination, 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:
- is a general requirement of a course,
- has the sole purpose of developing the student’s research skills,
- is not intended for presentation or publication outside the classroom, and
- will be overseen by a faculty member
may not be subject to IRB review. Check with your supervising professor for guidance as to whether you must submit your research protocol for IRB review or departmental level review.
Monmouth University follows the Code of Federal Regulations, Title 45 CFR Part 46, Public Welfare, Protection of Human Subjects, specifically code 45 CFR 46.102(l) provides the following definition and guidelines:
(l) Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research:
(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
Please also see the IRB Mission Statement.
You must apply prior to beginning your research. You must have the permission of the Monmouth University IRB before identifying research subjects, beginning intervention, or collecting data. Check submission schedule on the Monmouth University IRB Web site for the due dates for IRB submission.
Depending upon the level of review, you will receive a response within two to five business days notifying you of the status of your application regarding its completeness. Upon receipt of the IRB application and supporting materials, the IRB Coordinator will perform a “Completeness Check” to determine if the application is neat, organized, free of obvious content or grammatical errors and that all necessary information is included with the application. The IRB Coordinator will e-mail the application back to the Principal Investor with a list of changes necessary to consider the application complete. Upon completion of the requested changes, the PI should re-submit the application to the IRB Coordinator via e-mail with the changes highlighted in yellow to speed the review process. The Completeness Check and request for changes will be repeated by the IRB Coordinator until the application is complete.
It is important to note that applications will not be forwarded to the IRB for review in any form until the application is deemed complete. The application submission date is the date at which the application is deemed complete by the IRB Coordinator.
Instead of receiving submissions on a rolling basis, they will be accepted by email to firstname.lastname@example.org on Wednesdays of every week in the semester, processed on Thursdays and Fridays and researchers should receive a response by the following Monday. The process for submitting and reviewing projects that require Full Review will remain the same. You can still submit to the IRB any day; however we cannot guarantee processing until the following Wednesday.
Try to plan your research so you allow for the time it takes to receive IRB approval (including the completeness check). However, if you need a response before the scheduled meeting dates, contact the Office of the IRB and IACUC. We will do what we can to review your materials as quickly as possible, while evaluating each application for completeness and adherence to the Criteria for IRB Approval of Research. If your research requires a full review, it will be considered at the next scheduled IRB meeting.
After the appropriate level of IRB review, there are three possible outcomes for an application:
- Approval: Upon final approval the IRB Coordinator will notify the PI via email and send the official approval notice. The research may proceed as stated in the application. IMPORTANT: Research can not start until the application receives final approval.
- Revise and Resubmit: Based on a review by members of the IRB, certain revisions may be necessary which will require the application to be resubmitted prior to final approval. The IRB Coordinator will email the PI with a list of the required revisions. The research as described in the application cannot begin until revisions are made, the application is re-submitted, and final approval is given by the IRB. PI’s are encouraged to discuss any questions about the necessary changes with the IRB Chair.
- Not Approved: Based on a review, the research as described in the application cannot receive approval due to the risk involved. PI’s are encouraged to discuss any questions about the IRB’s decision with the IRB Chair.
Yes, please include all materials that participants will complete, questions participants will be asked, and/or materials that are part of any experimental manipulation (e.g., instructions, vignettes, scripts, etc.). If you are using a published instrument, include the complete citation for that instrument (author, publisher, date of publication). If you have developed your own materials or measures, please note that as well. Also include any links to videos or other materials that are the internet.
Yes. You may use the recommended informed consent forms (as applicable) located on the IRB Website: Informed Consent, Letter of Consent, Informed Consent for Research Conducted Online, Parental Consent, Child Assent.
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 signed consent form. (Instead you may state at the top of your research instrument or on an accompanying cover letter on department stationary—Letter of Consent):
- A statement that all participation is voluntary,
- A statement that you are conducting research and the reason for it (e.g., master’s thesis, publication, etc.),
- Purpose of the research – what you are investigating,
- A statement that all responses will be kept confidential,
- A statement that participants need not respond to all questions,
- If participants are your own students, a statement that class standing will not be affected in any way based on participation, and
- The name and telephone number of the Principal Investigator (PI) and faculty sponsor (if applicable).
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. (Parental Consent Form, Child Assent Form; please also see Additional Protections for Children Involved as Subjects in Research)
If you are conducting research in an institution other than Monmouth University (e.g., a school, hospital, community agency), you must have signed permission from an administrator from that institution on the institution’s letterhead. (Research in Schools Form, Off-Campus Research Verification Form)
Yes. You must complete the training before the IRB can approve your application. Monmouth 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 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, you will be able to print out a certificate of completion. You can save the training certificate as a PDF or JPEG by right clicking and highlighting “Save as” and then paste it to the end of the IRB application template, as appropriate.
Yes. There is a supervising professor’s consent form available on the IRB Web site. Prior to submitting your application, your supervising professor must review your IRB application and complete the Supervising Professor’s Consent Form and Checklist.
Yes. You must submit the IRB application electronically as an attachment to email@example.com. For student researchers, your supervising professor should submit the initial application on your behalf. You should sign the signature page then scan it into Microsoft Word or as a .pdf document, and e-mail it along with your application to firstname.lastname@example.org. Alternatively, you can take a picture of the signature page and save it as a JPEG and paste it onto the application. Be sure that all documents associated with your application (informed consent, measures, etc.) are in the document with your application and attached to the e-mail.
If you are utilizing deception, or if you are conducting research on a sensitive topic that could potentially cause distress, or prompt subjects to consider personal matters, debriefing is required. However, it is suggested that researchers debrief participants whenever possible to help educate participants about the research question under examination and the research process more generally. By debriefing participants, you explain the research question, or hypotheses fully and allow the participant to ask any questions he or she may have about the study. In a study involving deception, debriefing should explain the deception, explain why the deception was necessary, and allow the participant the option of removing his or her data from the study. A debriefing script or form must be submitted with the application as an attachment.
Contact the Office of the IRB and IACUC if you have any questions regarding the IRB for the use and rights of human participants in research.
No. All submissions are reviewed in order of receipt, including revised submissions. They are placed in a queue and are reviewed in order of receipt.