the IRB Review Completed Projects?
federal regulations and Miami University’s policy,
are very clear: research projects using human subjects are
to be submitted and approved by the IRB before any research
activity is initiated. Consistent with this policy, the
IRB never conducts a review (or approves) a completed project.
Occasionally a researcher realizes that he or she has begun
or even completed a project without seeking IRB approval.
Although these should never occur, in the past these have
sometimes happened due to some other process (e.g. a professor
would like to incorporate some previously obtained information
from a class in a professional article that he/she did not
get previous IRB approval to obtain) and sometimes by neglect
or ignorance (e.g. a graduate student conducts a masters
thesis in which he/she interviews people about their knowledge
of particular Greek myths. However, no one ever told the
student that he/she needed IRB approval). In cases such
as these, the researcher should submit a proposal describing
the project; this proposal should describe the circumstances
that led to the research in addition to description of the
project. This application will be examined by the full IRB
and the IRB will render a decision about whether the rights
of subjects/participants had been adequately protected during
the course of the project. This decision will be given to
the researcher. Naturally, future projects of the researcher
should be approved in the normal/required manner.
my project an oral history and what do I do if it is?
of disciplines do not perform experiments using human subjects,
but do interview a few individuals about their own lives.
Frequently, a record, e.g. a video or audiotape, is made
of the interview and is deposited in a public archive, either
a library or museum, along with other artifacts associated
with the person. Historians, folklorists, musicologists,
or psychologists may conduct these studies.
raise a number of questions for an IRB:
The first question is whether
the activity is research and therefore falls under the
purview of the IRB. The glib answer to this question is
that oral histories are not research unless the researcher
thinks about it. What is meant by this is the following.
Sometimes, a scholar will obtain the oral history of an
individual or two and will deposit the history in a library
and/or museum so that others can view it. However, the
scholar does nothing more; he or she does not publish
a paper comparing this history to others or provide a
historical context in which to analyze this history. In
this case, the project is not research and therefore does
not have to be approved by the IRB. The ethical guidelines
of the scholar’s professional organizations should
still be followed in this case, however. The more common
situation is the following. Several oral histories are
obtained with the intention of comparing them. In addition
to depositing the materials in a depository, the scholar
provides the cultural context of the histories or writes
a critical analysis of the histories. In this case, the
scholar is a researcher who is using human subjects and
therefore the project must be approved by the IRB before
it can be initiated. Professional guidelines still apply.
A second question that
arises about this type of project concerns the issue of
confidentiality. The usual stance of IRBs is that a project
remains ”open” and therefore requires continuing
review by the IRB and active protection of the dataset
by the researcher until all personal identifiers have
been removed. However, in oral histories, frequently the
subject/participant is proud of his or her history and
wants to be identified with the history. Usually the deposited
materials include explicit personal identifiers (i.e.
the person’s name, age, picture, professional title,
etc.). The procedures of Miami’s IRB allow the researcher
in such a case to petition the IRB to ‘close’
the project with personal identifiers attached to the
data file. This petition takes the form of a letter to
the IRB that makes the request; this letter usually accompanies
a continuing review application. A necessary condition
for the IRB to grant the petition is that the consent
form explicitly mentions that the subject’s/participant’s
name, etc. will be included in the dataset, including
deposited materials. The location, or nature, of the expected
depository should also be mentioned in the consent form.
A good idea, although not an absolute requirement, is
that the subject/participant be asked to consent twice.
The first consent is granted at the beginning of the project
and is the consent to be interviewed and recorded by the
researcher. The second consent is granted by the subject/participant
after he/she has been given the opportunity to examine
his or her materials, allowed to add or delete material
and is consent to deposit the material with his/her identifiers
attached. If the subject/participant is granted (or not
granted) the right to alter the researcher’s analysis,
this should be mentioned in the consent form.
do I do if I am conducting research at institutions other
usually conduct their research using Miami personnel (i.e.
students, faculty or staff), but occasionally the research
is conducted at another institution. The general policy is
that approval must be obtained from all appropriate ethics
boards. Researchers should be aware that different institutions
have different procedures for granting approval and they are
responsible for satisfying the requirements of each. The following
describes the most common cases. In the following examples,
the principal investigator (PI) refers to the person who is
responsible for the project:
The PI is at
Miami and the research is conducted at another university:
It is very
unusual for a university or college not to have an IRB
and policies related to human subjects research oversight.
Complying with the policies of any institution is the
responsibility of the researcher. Miami researchers who
are the PI on a project and are representing Miami or
who are a co-PI receiving federal funding to conduct
research must seek Miami IRB approval. If Miami personnel
are not the PI on a project and are not receiving external
funds in support of the research, but are collaborating,
the Miami Compliance Office may accept the review of
the external collaborator's (PI's) IRB . The Miami IRB
may or may not accept the external review. The externally
approved protocol will be examined to determine if the
review process meets Miami standards. The Miami compliance
office will attempt to minimize the
of IRB's involved
with the review of a project.
The PI is from
another university and the research is conducted at Miami:
PIs who desire to conduct
human subjects research at Miami University must have
IRB approval from their home institution (or in the absence
of such an IRB, a request can be made for the Miami IRB
to conduct a review). To document adequate IRB oversight
to Miami, external researchers must submit a copy of their
protocol and a copy of the approval letter to the compliance
office at email@example.com.
that Miami’s IRB and Compliance Office only considers
the protection of human subjects; it does not grant authority
for the PI to conduct the research at Miami. Therefore,
the authority to conduct research must be obtained from
the appropriate university official relative to the research
to be conducted (e.g. Dean of the College, Dean of Students,
Director of Clinical Training, Department Chair etc.)
in addition to the compliance office clearance regarding
HS protections. It is a good idea to reference this authorization
when submitting your IRB approval materials to your home
do I conduct research at a hospital, or other clinical setting?
have IRBs so that the procedure is similar to that described
in the section entitled “PI at Miami; Research Conducted
at Another University.” Conducting research with clinical
subjects is more complicated because there are two sets
of regulations that must be satisfied. There are the IRB
regulations and the HIPAA regulations governing the privacy
of patient records. The PI is required to be aware of both
sets of regulations and satisfy both. Also, since research
in this area is considered a “specialized population”
according to our training standards, the PI must also complete
the on-line supplemental training module on “HIPAA
and Human Subjects Research” prior to submitting an
IRB application for approval.
do I conduct research in elementary and secondary Schools?
Most schools do not have
IRBs. Projects conducted within a school system would
have to be approved by the school IRB if the school has
an IRB committee as well as Miami’s IRB. However,
school principals and/or superintends frequently act like
an IRB and as such need to approve projects. There is
no policy that requires that a school official provide
a written approval statement; however, the more a research
project interferes with normal school activities the more
likely that the IRB will require written approval. For
example, a project in which two different types of classroom
activities are compared and both types of activities have
been used in other educational settings, then documenting
approval is not required. However, in a project in which
students are removed from a study hall in order to be
interviewed by the researcher, the IRB would require a
note from a school official that states that he or she
is aware of the project and approves it.
The role of the IRB is
to protect human subjects, in this case, students in a
school system. However, the IRB is aware that researchers
sometimes need to be protected. When conducting research
in a school system, researchers should be sure to have
the appropriate school officials on their side. Imagine
the case in which a researcher is studying drug use in
public schools. If a parent contacts the principal to
complain about the questions being asked of his or her
child, the researcher needs to have evidence that the
principal is aware of the study and has approved it. If
a principal has given verbal approval, it is possible
that he or she will disavow the study if complaints are
received. Such disapproval would be more difficult if
the approval was documented. Also, since research in this
area is considered a “vulnerable population”
according to our training standards, the PI must also
complete the on-line supplemental training modules on
“Research with Children-SBR and/or Research in Public
Elementary and Secondary Schools-SBR” prior to submitting
an IRB application for approval.
am conducting an on-campus survey about services/pedagogy
at MU, do I need to submit a protocol?
who evaluate the educational mission of the university
often conduct studies that includes interacting with human
subjects. For example, a University office may survey
a number of Miami faculty and students to evaluate attitudes
and opinions about their program and/or services. The
results of the survey are used to improve the quality
of the services provided by the office. The results of
the survey will only be seen by the people conducting
the study and will be used to change the operations of
the office rather than being generalized to apply to other
universities. Hence, this project is not research as defined
by the federal regulations and therefore this project
does not need IRB approval before being conducted. This
type of project is referred to as a Quality Assessment
If you are
contemplating conducting such a study, you should be aware
of a potential problem. Sometimes, a researcher intends
to perform a quality assessment project, but discovers
that the information that results from the survey is so
interesting that they want to publish the results since
individuals at other universities might benefit from the
study. Unfortunately, this desire changes the project
from being a QAP to an Educational Research Project, requiring
IRB approval. The IRB is loath to grant approval to already
completed projects. If you believe there is any chance
that you might want to publish or generalize the results
from a QAP, you should treat the project as a regular
research project and submit a proposal to the IRB. People
who are contemplating conducting such a study are encouraged
to contact the chair of the IRB to discuss whether your
project requires IRB approval.
online survey tools secure?
survey tools exist offering confidential treatment of data,
Miami also has software to conduct online surveys using a
secure server. See IT Help from the MyMiami page and search
"Prezza". However, whenever you are using an internet
based survey, the IRB suggests that you include something
like either of the following statements on the consent form
(and adhering to the statements):
every effort will be done to ensure confidentiality of your
responses, all Internet-based communication is subject to
the remote likelihood of tampering from an outside source.
IP addresses will not be investigated and data will be removed
from the server.
The responses you provide
today are being collected with software that is designed
to secure your data and provide you with confidentiality.
Nevertheless, despite these safeguards, there is always
a remote possibility of hacking or other security breaches
that could compromise the confidentiality of the information
you provide. Thus, you should remember that you are free
to decline to answer any question that makes you uncomfortable
for any reason.
do I go about compensating subjects for their time and travel?
There are limits to the
amount of compensation that a subject may recieve. It
cannot be an amount that would unduly entice a person
to volunteer, if it is a study that requires repeated
interactions with a subject, it should be clear to the
subject that payments will be pro-rated so that withdrawing
from a project does not forfeit compensation for prior
time invested by the subject.
Miami has a procedure and
a policy to help ensure confidentiality of subjects can
be maintained during the compensation process. These procedures
can be found at: Payments
paper copies of applications need to be submitted to the Compliance
As of July 2009, signed
paper copied of applications no longer need to be submitted
to the compliance office.
Researchers have experienced
difficulties when operating from a distance or when coordinating
submissions with student researchers. Therefore, applications
will be accepted by email attachment alone. However, undergraduate
and graduate students still need a faculty advisors involvement.
To ensure that faculty
advisors have the opportunity to review and approve of
applications, all applications have to be submitted by
the faculty advisor or an authorized staff member (e.g.
the project manager for a research center). The application
must be sent from the faculty/staff members Miami email
account to the IRB before any review will be conducted
(the use of your official email account is used in place
of your signature as the means of establishing accountability).
The suggested method of
submission by graduate and undergraduate students is:
A. The student researcher
emails the application to their faculty advisors as
two files (1. the cover pager template and 2. the research
description including all supplementary materials, e.g.
questionnaires and consent forms). The student researcher
should do so using their MU email account (this serves
in place of their signature).
B. The faculty/faculty
advisor reviews the application and provides the
with feedback. Once both are satisfied with the application,
the faculty member forwards it to the compliance
for processing (firstname.lastname@example.org) .
C. The compliance office
will manage the distribution to the IRB chair and IRB
D. The IRB members will
submit their comments to the IRB chair who will organize
the comments and send them to the researcher or the
faculty advisor or both depending on the nature of the
comments. In that message, the IRB chair will specify
the requirements for submitting the responses to the
reviewer comments (e.g. very simple suggestions/required
changes may not require faculty advisor input and approval).