No. The IRB is only concerned about projects that involve human subject participants and meet the federal definition of research.
Here are the definitions of research and human subjects as provided in the federal regulations 45 CFR 46:
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains 1) Data through intervention or interaction with the individual, or 2) Identifiable private information.
Studies that fit any of the categories below typically do not need IRB review.
- Data collection for internal departmental, school, or other University administrative purposes. Examples: teaching evaluations, customer service surveys.
- Service surveys issued or completed by University personnel for the intent and purposes of improving services and programs of the University or for developing new services or programs for students, employees, or alumni, as long as the privacy of the subjects is protected, the confidentiality of individual responses are maintained, and survey participation is voluntary.
- Information-gathering interviews where questions focus on things, products, or policies rather than people or their thoughts regarding themselves. Examples: canvassing librarians about their libraries’ inter-library loan policies or periodical purchases or interviews with company engineers or managers about how a product is made.
- Course related activities designed specifically for educational or teaching purposes, where data are collected as part of a class exercise or course requirement but are not intended for use outside of the classroom. (Many SoTL activities that are designed for scholarship presentations outside of the classroom may fall under an exempt review category. Please see the Belmont IRB Levels of Review page at http://www.belmont.edu/irb/review.html.If you have any question as to whether or not your project meets this de finition, contact the Belmont IRB chair at irb@belmont.edu prior to beginning the project.
- Biography research involving a living individual that is not generalizable beyond that individual.
- Quality improvement projects may or may not need IRB review. Projects where this is a clear intent to contribute to generalizable knowledge and use the data derived from the project will need to be reviewed. If you have any question as to whether or not your project meets this definition, contact the Belmont IRB chair at irb@belmont.edu prior to beginning the project.
- Case history or Case Study which are published and/or presented at national or regional meetings are not considered research if the case is limited to a description of the clinical features and/or outcome of a three or fewer participants and do not contribute to generalizable knowledge. Note: Investigators should contact the IRB if they are uncertain as to whether or not they are contributing to generalizable knowledge.
- Publicly available data do not require IRB review. Examples: census data, labor statistics. Note: Investigators should contact the IRB if they are uncertain as to whether the data qualifies as “publicly available.”
- Coded private information or biological specimens that were not collected for the currently proposed projects do not need IRB review as long as the investigator cannot link the coded data/specimens back to individual subjects. If the data/specimen provider has access to the identity of the subjects (e.g. subjects’ names, addresses, etc.), the investigator must enter into an agreement with the data/specimen provider that states under no circumstances will the identity of the subjects be released to the investigator. Note: Investigators cannot independently make this determination. These projects require verification from the IRB Chair or their designee. (http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html#c1)
- Some examples of Non-Engagement in Research include: when an institution’s employees or agents act as consultants on research but at no time obtain, receive, or possess identifiable private information, perform commercial services for the investigators, or inform prospective subjects about the availability of research. Note: the examples above are not an all inclusive listing. (http://www.hhs.gov/ohrp/policy/cdebio.pdf)
Belmont University approved IRB forms can be found at http://www.belmont.edu/irb/forms-instructions.html.
Yes. All investigators (faculty, staff, and students) who work on a research project that involves human subject participants must complete the free, online National Institutes of Health Protection of Human Subjects training. This includes all co-investigators on any project. This training takes a few hours to complete but may be saved and recovered until completed. The module is accessed at https://phrp.nihtraining.com/users/login.php. Once you have completed the training and passed the online test, you will receive an electronic certificate of completion. That certificate must be uploaded into the Mentor system and be updated every five years. (See sidebar General Directions for IRB Submission for how to upload your NIH certificates.)
To submit an application to the IRB, go to www.belmont.edu/irb. At the bottom of the page click on this link: https://www.axiommentor.com/login/axlogin.cfm. The institution ID is belmont and you will use your MyBelmont credentials to access the system. See sidebar “General Directions for IRB Submission” for more information about how to submit your application.
The bottom line is that the IRB is working to protect human subjects as well as protect Belmont faculty, staff, and student researchers. Please see the IRB webpage, sidebar “Reviewing a New IRB Application” to see what IRB committee are considering in their reviews.
You will receive an electronic notification of the status of your application following IRB review. The IRB will identify any required revisions at that time. You may not begin your research until the IRB has given your application full and unconditional approval.
No. Projects that meet the federal definitions of human research may not be started until the review is complete and the primary investigator has received notification of approval and a date stamped consent form. Investigators are advised to submit their applications to allow for review and revisions.
If a research project involving human participants has been initiated prior to receiving IRB approval, study participants could be exposed to unnecessary risks, and their rights to sufficient information, fair recruitment, and a voluntary choice may be limited. In addition, failure to obtain this approval could pose liabilities for the researcher, as well as the institution. Federal regulations and IRB policy require that serious or continuing instances of noncompliance be reported to Institutional Official (i.e., Belmont’s Provost), the Office of Human Research Protections, as well as funding or other applicable agencies. Conducting a human research project that does not qualify for an exempt status without IRB approval is considered to be an act of serious noncompliance. In those instances where the IRB has determined that noncompliance has occurred, a report will be sent to the Provost’s office at which time the seriousness, as well as the specific circumstances of the events, and welfare of participants are considered. Suitable corrective actions will be proposed, and a determination made as to whether or not the data collected may be utilized
Yes. Questions and discussion are welcomed and support the collaborative work between researchers and the IRB.
There are 11 IRB members. Their contact information is on the IRB Committee page of this website. Although there is not an IRB member from every program/school/college, our members come from a variety of areas. Feel free to reach out to any of our members with questions.
If researchers are collecting data where no one, not even the researcher, will be able to tell where or from whom the data came from, then the data is considered to be “anonymous.” However, data which may be linked to an individual through use of codes, video/audio recording, or other identifiers would be considered to be “identifiable data.” If a researcher promises to keep identities of participants secure and private, not disclosing these identifiers to anyone other than the research team, the data is considered to be “confidential.”
There are actually many cases in which IRB review is not needed. The reasoning goes back to the definition of generalizable. Class activities are often meant specifically to satisfy a course requirement or to teach a particular lesson (e.g., interview, observation and survey techniques; data analysis; research design), and they are oftentimes not intended to spread beyond the classroom in a way that would suggest generalizable research. If such projects are limited in scope, present no more than minimal risk to participants, and do not lead to generalizable results (or what could be generalizable has already been contributed in the past), they do not require human subjects review. Students working on such projects should nevertheless ensure full disclosure about the purpose of their project and obtain participants’ permission for journalistic, photographic or video release of information or image, if applicable. We suggest that, at a minimum, students complete the training modules available through the NIH Office Extramural Research (https://phrp.nihtraining.com/users/login.php).
Course instructors are responsible for ensuring that students understand and abide by ethical obligations in carrying out their assignments. Additionally, instructors are responsible for reviewing student class project proposals and consent procedures to ensure that the methods and procedures are ethical and appropriate, and for monitoring student activities during the conduct of the project to ensure that the rights and welfare of participants are adequately protected. Instructors who have any questions are encouraged to consult with the IRB chair.
The IRB may approve projects that give extra credit to students who participate in a research project only when alternative means of obtaining equivalent extra credit with equivalent effort is made available to students who do not wish to volunteer as research subjects. The IRB carefully reviews the alternatives to ensure that students are not being coerced into participating.
For example, if volunteering for a survey project takes 30 minutes and the student's output is not evaluated for its quality to determine whether extra credit is given, the alternative should involve 30 minutes of effort and the output should not be evaluated (beyond assurance that a good faith effort was made).
Faculty should carefully consider if extra credit is really necessary. Many times, for example, a survey can be part of class participation where all students participate. In this situation, students can consent to the data being used in any kind of external dissemination