What is research?
Research is broadly defined as a systematic investigation designed to develop or contribute to generalizable knowledge, or investigation designed to test a hypothesis.
Who must apply for review by the Institutional Review Board (IRB)?
Anyone who intends to conduct research that involves human subjects must apply for and receive IRB approval before beginning the research. This applies to ALL research involving human subjects. Social science, behavioral, historic, linguistic and marketing research studies must be reviewed by, and receive approval from, the IRB (this is a representation of likely studies, and not an exhaustive list). Check with the IRB Administrator or the IRB Chair if in doubt about the need for IRB review.
When can I begin my research?
Research can only begin once you are notified that your project has been approved by the IRB administrator. Therefore, subjects should not be contacted or recruited before the approval notification is obtained.
Do students undertaking class projects need to obtain IRB approval?
Research activities such as class projects, with the goal of providing research experience to the students, by definition, research practica, are not intended to add to generalizable knowledge and thus do not meet the federal regulatory definition of research. For more information to help you determine whether or not your project is considered research according to the federal definition, please see the Who Must Apply section.
What’s the worst that can happen if I don’t get IRB approval?
Aside from potential negative ethical implications for the subjects and for the researcher, bypassing IRB review brings other risks:
- Funding may be withheld - Federal sponsors, and virtually all private sponsors, require IRB approval as a condition of funding.
- Sponsors may postpone review of proposals for which review is not complete or pending at the time of proposal submission. Some sponsors will not release funds to UC for the researcher’s use without IRB approval.
- Articles may not be published - Many professional journals require evidence of IRB approval when considering articles for publication.
- Ursinus College will not support unapproved research. Liability issues arising from unapproved research become the responsibility of the researcher. Persons conducting unapproved research are deemed to be acting outside the scope of authority granted them by Ursinus College. Ursinus College will not, therefore, provide a researcher of an unapproved study the resources to answer a liability complaint.
What is the difference between full, expedited, and exempt review?
Studies are reviewed by a fully-convened IRB meeting each semester. The Board discusses the study and makes a decision about the approval of the study. This type of review is carried out for studies greater than minimal risk to subjects.
Studies are reviewed by IRB Chair and one other member of the board. Members review the appropriate materials and consults with the PI, if necessary, to come to a decision about the approval of the study. This type of review is carried out for studies that involve minimal risk to subjects and fit into an expedited review category of research (see Review Categories). These reviews are conducted on an ongoing basis.
Certain categories of human subject research (for instance: non-sensitive and anonymous survey and some pedagogical research) are exempt from federal human subject research regulations. Those wishing to undertake such exempt research should still obtain confirmation of the exempt status by submitting the Exemption Request.
Do oral histories need to have IRB approval?
A decision on whether oral history (or other activities solely consisting of open-ended qualitative type interviews) are subjected to Federal regulations for the protection of human research subjects is based on the prospective intent of the investigator AND the definition of “research”, “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Typically Oral history activities are designed to create a record of specific historical events and, as such, are not intended to contribute to generalizable knowledge. However, when oral history procedures are used to contribute to generalized knowledge, that research does meet the definition of research under Federal Code 45 CFR 46.102(d) and must be reviewed by the IRB.
It is recommended that all researchers undertaking oral history projects contact the Ursinus IRB Chair to discuss their proposed oral history activities to ascertain whether the project requires IRB approval.
When will I hear from the IRB about approval of my study?
The length of time a study will take to be approved depends on the type or level of review required. Listed below are approximate times for approval.
Exempt Review (from application submission to granting of exemption): 7 - 10 business days
Expedited Review (from application submission to primary review): 14 business days
Full-Committee Review (days after the semester committee meeting): 7 days
Note on approval time: These times are averages for studies that are not assigned stipulations by the IRB or require additional information. Studies that are assigned stipulations will take an additional amount of time depending on how fast these stipulations are met and when they can be reviewed, either through expedited review or full-IRB review.
How do I submit a change in protocol to the IRB?
If you are only adding or removing Faculty or Student P.I.s then you should complete the Add/Remove/Change IRB Personnel Form.
Other changes/additions require filing the Revision/Addendum/Amendment form. Please remember to highlight all changes to documents (Protocols, Consent Form, Study Instruments).
A change in protocol will be reviewed by the same method in which the study was first reviewed, either by the full-committee or through the expedited review process unless the change is minor and can be managed through expedited review.
When do adverse events need to be submitted to the IRB?
Principal investigators are required to report serious adverse outcomes and unexpected events involving risks to human subjects or others at the time they occur. The event should be reported to the IRB in no more than one week of the investigator becoming aware of the event.
The adverse event form should be submitted electronically to the IRB office.
What if a study contains deception or concealment?
The board defines three types of deception or concealment in studies:
- Concealment of the hypothesis is done in a majority of studies and the board does not take this type of concealment into consideration when reviewing studies.
- Concealment of some portion of the purpose or procedures occurs when the consent form or researcher does not tell the participant all of the procedures or the true and whole purpose of the study up front. This method is often used in studies that involve race or other issues in which knowing the purpose would bias participants.
- Deception occurs when false information is told or given to participants.
If deception or concealment is used in research the following four requirements must be met:
- The concealment or deception must be justified.
- The participant should be told in the consent form that some information is being withheld.
- A debriefing must be completed after the research to give the participant the complete information.
- The participant must have the option of withdrawing his or her data after the study.
Can passive consent be used in a study?
Passive consent occurs when a person is included in research unless the participant actively objects to being in the research. This is most commonly seen when a letter is sent to parents and the child of the parent is included in the research unless the parent objects.
Passive consent is not considered true consent. A waiver of consent must be justified and granted if this method is used.
*Adopted with permission from the University of New Hampshire IRB