Frequently Asked Questions
- What are the rules about conducting research at WCTC?
- What is covered by this policy?
- Why is Institutional Review required?
- What is involved in an Institutional Review of Research?
- What is an IRB?
- What is a cooperating institution?
- What kinds of IRB review are there?
- What is an IRB Exemption (and how do I get one)?
- What is an Expedited Review?
- What is minimal risk?
- What kinds of risks are WCTC students likely to face as research participants?
- What is a Full Review?
- What is informed consent?
- What is a waiver of documentation of consent?
- What is a protected population?
- Is protection of research participants the only consideration?
- How do I start the process?
- Are there other resources I can turn to?
Research at WCTC is governed by WCTC Administrative Policy LEA-511 Research and Evaluation Studies. In short, this policy dictates that all research that utilizes WCTC facilities, staff or students must be approved by the Office of Institutional Research & Effectiveness.
Anything that involves students, staff and in some cases facilities, for purposes of collecting data that will be used for any purpose other than providing direct service to students or fulfilling a district-assigned responsibility must be reviewed. Even if the project ALSO provides direct service to students, if the data will be used for additional purposes it must be reviewed.
For your protection, as well as the college's. A principal investigator (PI) is responsible for rectifying any damage caused to a participant in his or her research project. For example, you don't want to be doing a survey that inadvertently asks a sensitive question and causes a student to have a mental breakdown; you could be sued to recuperate all costs associated with hospitalization or treatment. Institution Review is a service; the college provides expert advice to help you avoid such situations. Please be aware that if you conduct research without college approval, not only could you be held solely accountable for its consequences, you may also put your continued employment in jeopardy for violation of college policy.
In most cases, research at WCTC will be conducted in order to satisfy requirements for a Master's or Doctoral degree at another institution. In those cases, you will need to get Institutional Review Board (IRB) approval from the degree-granting institution, and WCTC will be a cooperating institution. If the research is NOT conducted in conjunction with another college or university, WCTC will conduct its own review of the project, applying the standards set forth in Federal regulations 45 CFR 46.
An Institutional Review Board (IRB) is an entity that reviews research to ensure compliance with Federal regulations such as 45 CFR 46. A formal IRB has registered an assurance with the Department of Health and Human Services (DHHS) and the Office of Human Research Protections (OHRP) that it will enforce and abide these regulations in overseeing research for a given institution. Research funded by any of the arms of DHHS (e.g. NIH) is required to provide evidence of IRB approval. Institutions that have filed assurances generally agree to review all research involving human participants whether they meet this criterion or not, which is why all four-year universities and many colleges have their own IRBs. Institutions like WCTC generally do not have projects that meet this requirement, so we do not have a formal IRB. WCTC uses the same procedures are used to review research, however, because they have become the standard of practice in the field.
A cooperating institution is one that agrees to allow a research project that has been approved by another institution's IRB be conducted at that institution. Students conducting thesis or dissertation research at WCTC, for instance, are doing the research under the umbrella of the degree-granting institution. If they wish to make use of WCTC students or facilities, however, the IRB of the degree-granting institution will require that the student provide evidence that WCTC has given permission for the project to be conducted here. If the proposal is acceptable to the college, we will provide a letter certifying that we agree to be a cooperating institution.
There are three kinds of IRB review: exemption, expedited review, and full review. The design of the research and what participants will be asked to do are the primary determinants of which type of review applies. For instance, an anonymous survey may qualify for exemption, while a survey that uses tracking numbers to see who has or hasn't replied cannot be exempt but may be expedited.
Some kinds of research only involve human participation in a peripheral way. For instance, the research may involve data that already exists, anonymous surveys, or comparison of instructional methods. There is a specific set of criteria defined in 45 CFR 46.101 (b) that can qualify a project for exempt status. An exempt protocol may also be eligible for a waiver of documentation of consent. Note, however, that the determination of whether a research project is exempt can not be made by the Principal Investigator; it must be made by an IRB or other official appointed by an institution. Even if a project is certified as exempt by an external IRB, it must still be approved by WCTC, as the project may still not be acceptable for other reasons.
For projects that are not exempt but involve no more than minimal risk to participants, an expedited process exists for obtaining IRB approval. As with an IRB exemption, there are specific criteria that must be met in order to qualify for expedited review. A project that would otherwise qualify for exemption may not qualify if it uses a protected population.
Minimal risk is defined as risk that is no greater than that which would be experienced if the individual was not participating in the research. For instance, there is a chance that a participant will be hit by a falling piano, but in most cases that risk would be no greater than if they were out walking for any other reason. This is minimal risk. If, however, the research places one in close proximity to suspended pianos, there would be more than minimal risk. Projects involving more than minimal risk require a full IRB review. WCTC has not, to date, ever approved a project that involved more than minimal risk.
The kinds of projects that have been historically conducted at WCTC do not subject participants to physical or health risks. The most common types of risk to consider are psychological (participation causes emotional upset), social (participation causes a loss of social standing), economic (participation damages employability), or legal (participation increases the risk of punitive action against the participant). It may be valuable to understand if students are taking street drugs, for instance, but answering the question puts the student at risk of social, economic and legal consequences. This may be the case even if the question is asked anonymously; if the context of the question or demographics collected about the respondent allow one to guess the identity of the respondent, it is the same as if the respondent provided his or her name. For example, if the demographics collected point to a male Hispanic in the Nursing program, there is likely only one individual that fits that description.
A full review is required when a research proposal involves more than minimal risk or used certain protected populations. At this time WCTC is not able to provide a full review; as a matter of policy, WCTC is unlikely to approve any project involving more than minimal risk.
A cornerstone of ethical treatment of human participants is that they know in advance what will be expected of them, what the risks might be, and that they are given the opportunity to freely consent to participate and withdraw that consent at any time without penalty. It may be tempting to add a research task to the activities taking place in a classroom, but to do so without obtaining prior informed consent is unethical. Because this is such a key element of research ethics and one of the most frequent causes for delay in approval most institutions have developed a template for what their IRB wants the consent form to look like.
In some cases, the informed consent form is the only document that explicitly connects the participant to the research (e.g. an anonymous survey). In that case, it is actually a greater risk to the participant to obtain signed consent forms. In those cases, a waiver may be requested; participants may still need to be informed up front, but participation is then taken as evidence of consent. This generally will only apply to exempt research projects.
Some populations require special handling, most often because of concerns about their ability to freely consent to participate in research. The traditional categories are pregnant women, minors, prisoners and cognitively impaired, but recent guidance has alerted IRBs to other possibly difficult situations.
WCTC's primary concern is the safety of human participants, but it is also concerned about its responsibility to our customers. Thus, as a general rule of thumb WCTC will not allow class time that students have paid for to be used for any purpose that does not directly benefit the student's learning (students may be recruited to take part in research conducted on the student's own time). For example, a survey that can help an instructor understand the world-view of Generation Y students is not likely to provide direct benefit, while an assessment of an individual student's learning style that can be used to foster more effective learning would.
Most likely, the process starts with your degree-granting institution and filing for IRB approval. However, we are willing to meet with you when you are still in the design stage and help you steer around common pitfalls when designing your project. Remember that to get approval, you will need to specify all of the details of your design and submit copies of all instruments and consent forms; the sooner you nail down the details, the better.
Once you have IRB approval, send your entire IRB packet with approval to Dr. Viktor Brenner, Institutional Research Coordinator, Room A155 to obtain WCTC approval.
The Office of Human Research Protections website is the authoritative source on all things IRB.