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IRB Frequently Asked Questions

Q: Is there a way to get feedback on proposals before formal submission to the IRB?
A: Proposals can be submitted to the Chair, or any other cooperating member of the IRB, for
prior review, but such review is rarely necessary. RPAs submitted to the IRB are
assigned a reviewer as soon as possible, and that reviewer contacts the project’s Contact
Person concerning any necessary changes to the RPA.


Q: Are there examples of successful proposals to which students and faculty could have
access? Do these examples include an array of research designs?
A: Because RPAs are considered confidential, the IRB does not make copies of them
available to the public. However, one can always request a copy of a successful RPA
directly from the researcher(s) who submitted it.


Q: Are there examples of consent forms for an array of potential research participants,
including children?
A: The RPA contains a checklist of information that should be included in a consent form.
Examples of consent forms are not available from the IRB because a consent form is
project specific. However, if one is conducting research similar to that conducted by
another researcher, one can request copies of that researcher’s consent forms directly
from the researcher.


Q: In research involving minors, is ‘assent’ always required from the children?
A: The presumptive answer is “yes,” but each project is different (and each project is
reviewed independent of other projects). Obviously, very young children are not in
apposition to provide assent. A justified request to waive ‘assent’ can be included in the
RPA.


Q: What is the turn-around time for a 15-week class of 20-25 students if all students submit
to the IRB? This is a concern given the IRB is scheduled to meet only once a month.
A: Turn-around time is difficult to estimate because each project must be reviewed on its
own merits and there are many conditions that affect turn-around time (complexity of the
project, quality of the RPA, etc.). Many projects do not require a full meeting of the IRB
(this is called Expedited Review), and turn-around time for such projects is not affected by
the schedule of regular IRB meetings. However, for those projects that do require a
meeting of the full IRB, the IRB Chair will make every attempt to schedule additional IRB
meetings to meet demands for reviews.


Q: Do members of the IRB come to talk with classes to provide an overview and give insight
into expectations?
A: There currently exists no organized program for classroom visits. However, the IRB Chair
has agreed to meet with any class within normal scheduling reservations. Other IRB
members may also be so willing, and interested individuals are encouraged to contact
IRB members concerning such visits.


Q: If a faculty member does not know the answer to questions about the IRB, should the
faculty member contact a member of the IRB or should the student do that?
A: Ideally, the faculty member should contact the IRB; that way, the faculty member will
know the answer for the next student who asks that question. Practically, however, it
doesn’t matter who contacts the IRB, so long as the answer is relayed to all members of
the research team.


Q: How are people appointed to the IRB? Can we have access to vitas of IRB members?
Do all reviewers have PhDs or personal research experience?
A: The Vice President for Academic Affairs appoints members of the IRB. Curriculum Vitae
for each member of the IRB can be obtained by asking the member for a copy;
presumably, each member of the IRB will comply as a matter of professional courtesy. By
design, all reviewers do not have personal research experience. The federal regulations
require that at least one member of the IRB be a nonscientist. The purpose of this
requirement is that each proposed project must be evaluated from many different
viewpoints, not merely from the viewpoint of the scientific quality of the project.


Q: Particularly in the College of Education, is there a good way to determine whether a
project is a “research” project or something more of a “systematic inquiry” conducted just
for the teacher’s own development of insight into teaching? Are there tips for making an
ethical decision about which type of project it is? For example, if a project is not to be
published or shared outside the college classroom setting, and there is no attempt to
imply that the project could or should contribute to the professional literature, and the
implications are just for SELF and not other teachers, and the teacher sets out with the
goal of collecting data solely to better understand and improve classroom practices, does
this mean that the teacher is probably not doing “research”?
A: The federal regulations include the phrase “systematic investigation … designed to
develop or contribute to generalizable knowledge.” Applying the results of one project to
other samples, to other situations, or to a scientific theory all involve “generalization.” In
practice, it is rarely the case that someone engages in a systematic investigation without
some desire for generalization. However, “generalized knowledge” is usually interpreted
in the context of sharing the results with others or making the results available so that
others may apply the results to different samples, situations, or theories. If a project is
designed solely for the purposes of informing one’s self, and there is no intention or
action to share the results of the project with others, then the project probably falls
outside the purview of the IRB. However, the federal regulations require the IRB to make
this determination, so the investigator is required to employ the IRB Decision Tree
provided on the SVSU IRB website.


Q: Related to a research course, given that we have 15 weeks, what should one do in the
event of indecision about whether it is research or inquiry?
A: As noted elsewhere, the IRB is tasked with deciding whether or not a project involving
data collection from humans falls within the purview of the IRB. Therefore, the short
answer to this question is that the project should be subjected to the IRB Decision Tree
and, if necessary, submitted to the IRB as soon as possible. The Decision Tree contains
questions that enable the IRB to make a very fast determination of projects in this regard,
so the length of the semester should not pose a problem.


Q: Does the committee give feedback on proposals that were not approved? What if I don’t
agree with the feedback?
A: It is rarely the case that a proposal will be rejected, although it has happened in the
history of the SVSU IRB. Instead, the IRB Liaison works with the project’s Contact Person
to ensure that the proposal will be approved. If the investigators do not agree with the
Liaison’s feedback, they are free to request that another Liaison be assigned. The goal of
the IRB is to be able to approve every proposed project. However, when investigators
choose not to cooperate with the IRB, then the project could be rejected, in which case
the investigators may not proceed with the project.


Q: Do course assignments that deal with human subjects need to go through the IRB?
A: If the project involves accessing humans and constitute a “systematic investigation …
designed to develop or contribute to generalizable knowledge,” then it needs to be
submitted to the IRB. Course projects that are conducted only to provide students with
experience at research procedures and do not involve producing generalized knowledge
probably do not need to be submitted. Refer to the IRB Decision Tree for more
clarification.


Q: How might a faculty member teaching a research-oriented capstone course manage the
submission of 20-25 proposals to the IRB? Have some faculty members been successful
with this, and are there any tips that might be supplied?
A: One suggestion is to alert the IRB Chair of the large number of incoming proposals so
that the Chair can make arrangements (extra meetings, etc.) to ensure timely review of
the proposals. The review process is faster when RPAs have been completed properly,
so the faculty member can speed up the process by ensuring that only adequate RPAs
are submitted to the IRB. Advice from other faculty members who have supervised
multiple projects simultaneously should be sought as well. Having the IRB Chair, or some
other IRB Member, visit the class to explain what is required in an RPA would certainly be
helpful.


Q: Is there such a thing as “retroactive” approval?
A: No. All projects must be reviewed and approved prior to data collection.


Q: What happens if I don’t go through the IRB?
A: Instances of research that has not been approved by the IRB are referred to the Vice
President for Academic Affairs for action; the IRB has no enforcement mechanism; the
IRB is an advise-and-consent group. Ultimately, although there are many, many steps in
between, an institution that does not conform to the federal regulations can be stripped of
all federal funding and denied participation in all federally funded programs.


Q: How are “competence” and “informed consent” defined?
A: “Informed consent” is generally defined as the situation in which a prospective human
subject has been provided with sufficient information about the research so as to make a
meaningful decision about whether or not to participate in the research. Assuming
“competence” refers to the ability of prospective participants to make an informed
decision, this term is usually defined both in terms of an individual’s ability to understand
the information provided as well as utilize the information to make a decision. Certain
individuals are legally excluded from making a decision, such as minors. The ability to
understand the information presented depends upon a combination of the information
processing skills of the prospective subject, the complexity of the information to be
understood, and the level at which the information is presented.


Q: How is “action research” defined by the IRB?
A: “Action research” is not defined by the IRB. Different disciplines define the phrase in
different ways, and the IRB is not in a position to accept one discipline’s definition over
another discipline’s definition. As far as the IRB is concerned, research is research,
regardless of the adjective that may be used.


Q: Is IRB-related training required before faculty can do research and, if so, where can we
get the training?
A: Yes, training is required. The IRB website contains URL(s) for approved on-line training.
Other types of training may satisfy the requirement, but such training needs to be
approved by the IRB Chair in advance.


Q: What is “program evaluation” in comparison to “research”?
A: Program evaluation is usually defined as a systematic investigation for the purpose of
determining the strengths and weaknesses of an organized effort to produce social
change. When such investigations also include the purpose of developing or contributing
to generalized knowledge, then, from the IRB’s perspective, program evaluation is
research.


Q: What is “generalized knowledge”? Can you give examples to clarify this construct?
A: Generalized knowledge is knowledge obtained under one set of circumstances that is
subsequently applied to a different set of circumstances. The most obvious example in a
research context involves data collected for the purpose of testing an hypothesis deduced
from a theory. Other examples in a research context include using the results of one
program evaluation to design or implement another program, using the results of an
investigation into one teaching technique to employ or alter that technique for a different
course. The key to the concept is the use of information obtained in one particular setting
to understand or produce change in another setting. Not all generalized knowledge is
obtained through systematic investigation, and not all systematic investigations produce
generalizable knowledge. In order to be generalized, for example, others must be made
aware of the knowledge in some fashion. Refer to the IRB Decision Tree for further
clarification.


Q: If I am a qualitative researcher, do I need to go through the IRB?
A: Probably yes. The key is whether or not your qualitative investigation involves humans, is
systematic, and is done for the purpose of developing or contributing to generalized
knowledge.


Q: According to federal regulations, some research is “exempt”. Does this mean I do not
need to go through the IRB?
A: No, you must submit an RPA. “Exempt” is a classification that is used by the IRB to
determine whether or not the IRB needs to maintain continued supervision of the
research. Obviously, the IRB cannot determine whether or not research fits the “exempt”
category if the IRB does not know about the research.


Q: I plan to conduct online research. Are there any special things I need to do?
A: At one level, there is nothing special. Online research must be reviewed by the IRB just
the same as any other research. However, there probably are issues related to online
research, such as informed consent, that you may need to handle differently from “inperson”
research. Therefore, it may be a good idea to become familiar with information
concerning justifications for waiving written documentation of consent (getting signatures
on a consent form). The distinction between confidentiality and anonymity also comes to
mind as something that may be relevant to online research (but not exclusively to online
research).


Q: Do I always need to have a consent form signed?
A: The presumptive answer is “yes,” but the regulations allow for waiving this requirement if
the subject’s signature poses more risk than the absence of the signature, such as in
particularly sensitive projects for which knowledge that a person merely participated
might be deemed damaging in some way, or for projects in which obtaining signatures
places an undue burden upon the researcher that the would severely, negatively impact
the likelihood of accomplishing the research.


Q: Our program is getting ready for accreditation. As part of the accreditation process, we
need to show student work samples to a board of reviewers. Can we mandate/require
students to post their work to an online portfolio with the idea that their work may be
shared with accreditation program reviewers? What if students don’t want to post their
work? Is this an IRB issue?
A: As stated, this does not appear to be an IRB issue. The information is not being collected
for the purpose of developing or contributing to generalized knowledge. However, it’s
always best to consult the IRB Chair in such circumstances to ensure that there are not
issues or circumstances that bring the effort into the purview of the IRB. Note that each
project must be considered on its own merits; there are almost no “blanket” statements
about research that can be made.


Q: Do ALL faculty have to take the online IRB course or just those submitting to the IRB?
A: Any individual affiliated with SVSU who wishes to conduct human-subjects research must
complete training that has been approved by the IRB. This includes anyone connected
with a particular research project. However, someone who has recently completed
training for one project need not complete additional training when collaborating on a
different project. Faculty who do not intend to conduct human-subjects research, either
individually or in collaboration with others, need not complete the training.


Q: If I am conducting research somewhere else, do I still need to submit the project to
SVSU’s IRB?
A: Yes. The purview of the IRB extends to any research conducted by anyone affiliated with
SVSU. The only time you need not submit an “elsewhere” project is when your
participation includes absolutely no connection with SVSU (no SVSU affiliation in the
publication, presentation, or publicity release, no submission to fulfill any job
requirements at SVSU, etc.)


Q: Do researchers who are not affiliated with SVSU ever have to submit their research to
SVSU’s IRB?
A: Yes, if the project is conducted on SVSU’s campus or through SVSU facilities.


Q: What kinds of research need to be submitted?
A: The most straightforward answer to this question is that one should refer to the IRB
Decision Tree. Generally, any research in which humans will be questioned or otherwise
observed needs to be submitted to the IRB. Research involving animals other than
humans should be submitted to the Institutional Animal Care and Use Committee
(IACUC).