What are the rules about conducting research at WCTC?
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 College Advancement.
What is covered by this policy?
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.
Why is Institutional Review required?
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.
What is involved in an Institutional Review of Research?
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.
What is an IRB?
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.
What is a cooperating institution?
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.
What kinds of IRB review are there?
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.
What is an IRB Exemption, and how do I get one?
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 cannot 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.
What is an Expedited Review?
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;
these categories can be found here. A project that would otherwise qualify for exemption
may not qualify if it uses a protected population.
What is minimal risk?
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.
What kinds of risks are WCTC students likely to face as research participants?
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.
What is a Full Review?
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.
What is informed consent?
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.
What is a waiver of documentation of consent?
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.
What is a protected population?
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.
Is protection of research participants the only consideration?
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.
How do I start the process?
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, Director of Institutional Research & Effectiveness, Room A-155 to obtain
WCTC approval.
Are there other resources I can turn to?
The Office of Human Research Protections website is the authoritative source on all
things IRB.
