What is the purpose of the IRB?
The IRB reviews all research proposals to insure protection of both the project participants (e.g., safety and privacy) and Clarke University (e.g., liability). To this end, each proposed project is reviewed to consider such things as the possible physical, mental, and emotional participant risks, invasiveness, and research design.
Do I need IRB approval?
In general, research involving human subjects needs IRB approval. Research is defined as “as systematic investigation designed to develop or contribute to generalizable knowledge” (Code of Federation Regulations, 45 CFR 46.102d). If the research is designed to draw conclusions or contribute new information to the field of study, it requires IRB approval. Any research in which the data is shared with others through publication, presentation or grants should obtain IRB approval before initiating the project. All of the following may be considered research:
- Pilot studies
- Observational Studies
- Case studies
- Analysis of existing data
Are there types of research that do not need IRB approval?
Certain types of projects may not need formal IRB approval:
- Teacher and student evaluations
- Program evaluation
- Projects designed to enhance curricula offerings at Clarke
- Marketing research designed to market the institution as a project
- Market surveys that do not lead to publication or dissemination of findings
- Searches of existing literature
- Quality assurance activities or evaluation projects designed for self-improvement or program evaluation, not meant to contribute to “generalizable” knowledge
- Interviews of individuals where questions focus on things not people (eg. questions about policies)
Who should submit an application to the IRB?
Any faculty, staff, or student who is conducting research as a part of their job, for their class, and/or utilizing Clarke databases or facilities is required to submit an application to the IRB. This is true even if the project is funded by an outside agency or is being conducted in collaboration with another institution (i.e., IRB approval from another institution does not substitute for Clarke IRB approval).
How does the IRB define research?
Research is defined as any formal or informal, both academic and non-academic, data collection involving human participants (e.g., surveys, interviews, observations). For example, a survey being conducted as part of Clarke operations still must receive IRB approval.
Anyone who conducts research of this type without first filing the project with the IRB and obtaining approval is in violation of Clarke’s research standards.
What qualifies as a classroom assignment?
In some instances, faculty members may require students to conduct research as part of a course assignment to learn about the process of doing research. These projects do not meet the strict definition of research since there is no intention to generalize the information; however there is a need to ensure that the assignments do not compromise any IRB or ethical principles. It is important for students to have learning in the ethical and procedural nature of IRB and the need to protect human subjects.
Faculty may obtain a course level review for student research projects when all the following criteria are met. Note this only applies to classroom assignments and does not include independent research projects, scholars projects, or any graduate level scholarly research. These always need IRB review.
- The assignment is part of a regular class at Clarke University, taught either face to face, online, or in a hybrid format
- The assignment will be completed during the semester in which the student has registered for the course
- The purpose of the assignment is for the students to learn about the process of engaging in research and not to actually engage in research which would be used for publication, formal reports, or other formal means that would add to the body of knowledge in a particular field
- The project is eligible for exempt or expedited review
- The instructor has completed the on-line training and filed their certificate with the Chair of the IRB
Faculty wishing to use this option should submit the course level IRB form to the committee prior to the beginning of the class in which the assignment occurs.
To emphasize, if you have ANY intention of using future classroom data for presentations, publications, or any other dissemination purposes, you are required to obtain IRB approval prior to the collection of such data, including the conduct of related classroom activities.
How do I submit an application to the IRB?
Submit completed application and all other necessary documents in a single PDF to firstname.lastname@example.org. The file should be labeled as follows: Lastname_Firstinitial_Keyword_IRB_version#.pdf (eg: Mai_J_Balance_IRB_v2.pdf).
Incomplete applications will be returned to the Principal Investigator (PI) without review (i.e., an application is incomplete if the questions are unanswered, information is left blank or pertinent forms are missing).
Please consult the IRB homepage for application deadlines.
What is the role of a faculty advisor?
All students conducting research projects are required to name a faculty advisor. By signing the protocol form the faculty advisor both attests to the veracity, accuracy, and completeness of the application and identifies him/herself as the one held responsible for insuring that the research is conducted in compliance with research standards.
Accordingly, should any student project be in non-compliance, the faculty advisor will be held in violation of Clarke’s research standards. In addition, the IRB will contact the faculty advisor if there are questions or concerns regarding the student project. For these reasons, the advisor should be conversant with the details of each project sponsored.
Do I need to include the specific consent form/procedures being used?
Yes. Written consent forms are thoroughly reviewed by the IRB to be certain each participant is a) accurately informed of the procedures, b) can understand what is being asked, c) can assess the potential risks involved, and d) can make an informed choice about participation. All consent forms should provide the participant with the opportunity to withdraw from the study at any time without retribution. Consent forms should be written in lay language, typically at the eighth-grade level.
If verbal consent will be used, the IRB will review the “script” utilized.
NOTE: PIs are responsible for keeping signed consent forms on file for three (3) years after the project’s conclusion. If the PI leaves Clarke prior to that time, the PI is required to leave sealed copies of the consent forms with the departmental chair.
What is a protected population?
These populations include the following categories: minors, prisoners, fetuses, mentally handicapped, mentally disabled, test subjects for new drugs or clinical devices, pregnant women, persons participating in illegal behavior or legally incompetent persons.
Typically, research involving these populations will require a full IRB review.
How will I know if my project is approved?
Written notification of the IRB decision will be sent via email from the IRB to the principal investigator and his or her advisor.
What if my project begins before I receive IRB approval?
You cannot begin data collection before you receive IRB approval. If projects are scheduled to begin on a date prior to IRB approval, those projects must be postponed until IRB approval is received. Projects begun prior to approval are in violation of Clarke’s research standards.
What if my project is not approved?
The IRB will notify the PI of any reason(s) why the project did not receive approval. The PI will be able to submit the application for future review after revising the proposal to meet the concerns of the IRB. Resubmission of revised proposals should be indicated as a new version (e.g., version 2). This should be reflected in the name of the newly submitted PDF.
How is project progress tracked?
Principal Investigators (PIs) are required to file progress and termination reports for any approved on-going research projects.
Progress reports are to be submitted at least annually for those projects not completed.
PIs that do not file the reports as required will be in violation of Clarke’s research standards.
What if the project results in complaints or injuries?
Any and all complaints, significant wrongs, unanticipated problems, or injuries (including physical, mental, and emotional harm) in relation to the project must be reported to the IRB Chair immediately. The adverse event form must be completed and sent to email@example.com. After informing the Chair, the PI must file a detailed written report of the incident(s) with the IRB Chair for review by the IRB. All incident(s) must also be included, in detail, in subsequent project progress reports submitted to the IRB.
Can the IRB withdraw an approval?
Yes. Under certain circumstances (e.g., verifiable complaints, harm, or violations), the IRB may rescind approval.
What if my project has changes after IRB approval is granted?
New IRB approval is required before any changes to an approved project may be implemented. Incorporating changes into an on-going project without first receiving IRB approval places the PI in violation of Clarke’s research standards.
Changes that require IRB approval include but are not limited to a) increasing the number of subjects/participants on whom data is collected, b) extending the period for data collection, c) altering measures in any way, and d) changing the amount of times measures are collected per subject.
A modification form must be completed and sent to firstname.lastname@example.org.
What does it mean to be in IRB violation?
Any person found to be in violation of Clarke’ research standards may be prohibited from conducting, supervising, or advising research under Clarke’s auspices for a period of time as determined by the IRB, but not to exceed three (3) years. Each violation will be reviewed on an individual basis. Repeat violations may result in the IRB prohibiting that individual’s research activity at Clarke for an indefinite period of time.
I have a proposal that needs approval. How long will it take to get approval?
Applications are accepted on a rolling basis. Submit completed application to email@example.com. Exempt and expedited applications are reviewed by a member of the IRB committee. Committee members will provide an answer in two to four weeks for the principal investigator. Full reviews may take slightly longer.
The length of the review process depends on several factors: time the application is received, type of review, and quality of the application. Submissions received prior to holidays or scheduled school breaks or at other times when faculty are very busy (advising and registration, midterms, or finals) may experience delays. Please allow enough time for IRB review before anticipating the beginning of your research.
Where can I find information about amended regulations?
Information about amended regulations which will go into effect January 19, 2018 can be found here.