Procedure for Incomplete Applications
All protocol submissions are received
and reviewed by the IRB Support Staff for processing. For purposes
of this SOP, an Incomplete Application is defined as an application
that contains one or more of the following: (a) incomplete or
missing cover page, (b) incomplete or missing a signed cover
page by the PI and/or his or her faculty advisor, (c) missing
supplemental materials such as consent forms and/or debriefing
statements, (d) non-completion of ethics training; and/or (e)
incomplete or missing subsections.
Once an incomplete application is received,
the IRB Support Staff and/or IRB Chair will conduct the following
(a) A written request will be made
to the PI and/or faculty advisor for the necessary application
(b) The PI will be notified at that time that his or her
protocol application will remain on hold in the OARS office
until all remaining documentation is received.
(c) Once all application materials are received, an application
is considered complete and it will be submitted to reviewers.
(d) Incomplete applications will be held in the OARS office
for a period of 30 days. If the required components are
not submitted after 30 days, the incomplete application
will be returned to the PI(s).
11.2 Procedure for Post-Hoc Review of
Although the federal and institutional
policy is very clear that research projects
involving human subjects are to be submitted and approved prior
to engaging in research activity, in rare cases The Institutional
Review Board for Human Subjects (IRB) will conduct a post-hoc
review on a case-by-case basis where research is in progress
without prior IRB review and approval.
In such cases, formal verification with the PI will be conducted
(i.e., project initiation dates will be checked) to ensure that
the research is in fact either in progress or has been completed
without prior IRB review and approval. Once this confirmation
is secured the following process will be followed:
(a) The PI is to immediately
stop all research activities that involve direct contact
with human subjects until further notice from the IRB.
(b) The PI is to submit a Human Subjects Research Application.
The application should provide information on all activities
that have occurred and decribe them as they did occur. Alon
with the application, a short letter requesting Post-Hoc Review
providing a rationale for submitting the application after the
research was begun.
(c) Since conducting research without IRB approval is a research
non-compliance issue, the application will be reviewed by the
IRB Chairperson and the Director of Research Compliance. If
warranted, a full committee review by the IRB may also be conducted.
(d) As part of the reviews mentioned above, the following issues
that will be considered may include, but are not limited to:
a. a review the methods that
were used or could be used for future activities to provide
for basic human subjects protections;
b. an identification of any problems with the research procedures
which were conducted and those areas which are still open
c. the risks and benefits of the study;
d. the procedures used to ensure informed consent, confidentiality
and safeguarding of data;
e. if the PI is a student, the level of faculty involvement
(e) Approval will not be
granted retroactively for the stages of the project that have
already been completed. However, for researchers whose projects
have been initiated and/or are currently in progress, the
IRB may provide approval for those segments
of the project which have not been initiated
at the time of review.
(f) Written comments will be provided to the PI regarding
the research activities that involved human subjects and the
degree of risk associated with the study. In the case of student
research, the written comments will also be given to his/her
faculty advisor and if warranted, the department chair will
also receive written notification.
(g) If the IRB finds that there were serious problems in the
human subjects protections during data collection and/or it
finds that the researcher(s) knowingly (i.e., he or she completed
human subjects ethics training which details the importance
of submitting an application) engaged in the research without
prior IRB approval, the Director of Research Compliance will
also conduct an investigation of non-compliance and the findings
of the investigation will be sent to the researcher in writing.
The focus and goal of the post-hoc review
process is to protect human subjects. The resolution of such
cases can take many forms, each resolution will depend on
the research project.
11.3 Procedure for Research Involving
Collaboration with Researchers External to Miami
These procedures apply in cases where
a Miami University (MU) faculty, staff or student is engaged
in a collaborative project with a researcher(s) from another
institution and research activities will occur on a Miami Campus
or involve Miami students as subjects:
(a) The MU researcher is required to
submit an IRB application if he or she is the lead researcher.
In this protocol application, the activities of the Miami
researchers should be distinguished from those of the external
(b) If it is a multi-institution study
with multiple collection sites. Miami may accept the IRB review
and approval of another institution. Contact the compliance
office for study specific information.
for Research Conducted by Researchers from Outside Miami
In cases where a researcher from another
institution is the principal investigator on a project and wishes
to conduct research at MU that involves human subjects:
(a) It is Miami Policy that all human
subjects research being conducted on a Miami campus be reviewed
by an Institutional Review Board. That IRB review or exemption
could be provided by the home institution of the researcher.
(b) If the outside researcher is collaborating
with a Miami employee and the Miami employee is functioning
as a researcher, the Miami researcher must be listed as personnel
on the external collaborator's IRB approved protocol or the
Miami IRB must conduct a review of the protocol using the
(c) If no Miami personnel will be obtaining
consent of subjects, collecting data or having access to data
with identifiers, then Miami is not engaged in research therefore
Miami IRB approval or Compliance Office exemption are not
required. However, we ask that external researchers send us
a copy of the protocol and approval letter because we may
be contacted about the project by potential subjects or the
university administration granting access. Copies of the research
description and the approval letter should be sent to the
Miami's Research Compliance
Office for our records.
(d) Researchers must still obtain permission
to use Miami facilities from the appropriate official (e.g.
Dean of Student Affairs, Dean of a College, Department Chairs,
Provosts Office etc.). The IRB and compliance office do not
have the authority to grant or deny access to Miami facilities,
staff, or students. Rather, the IRB or Compliance office review
and approve procedures.
Unless the Miami IRB has conducted a review and
issued an approval letter, Miami University or the Miami
IRB cannot be referenced as approving of the research.
Compliance office acceptance of external review does not
constitute Miami IRB approval.
You can refer subjects to the Miami Compliance Office
for questions or concerns about the procedures (per our
policy, we will have a copy of the protocol on file)
Procedure for Oral History Projects
Oral history interviewing projects in
general do not involve the type of research as defined by Department
of Health and Human Services (DHHS) regulations and therefore
are excluded from IRB oversight *. If the project does not fall
within the guidelines below it does require IRB review and routine
application submission procedures apply.
For purposes of this SOP, if your project fulfills the following
criteria it is considered to be an oral history project and
does not require IRB review:
(a) Oral history projects involve interviews
that are explicitly intended for preservation as a historical
(b) Projects involving oral history interviews that are not
designed to contribute to generalizable knowledge as the 45
CFR part 46 regulations describe. The project does not seek
underlying principles or laws of nature that have predictive
value nor can it be applied to other circumstances for the
purposes of controlling outcomes.
(c) Projects involving oral history narrators that are not
anonymous individuals selected as part of a random sample
for the purposes of a survey. Individuals are selected due
to their unique relationship to the topic and the questions
are gradually developed and open-ended.
(d) Projects involving oral history interviews where the historian
(PI) follows the Oral History Associations Principles and
Standards and Evaluation Guidelines as part of his or her
(e) Oral history projects involve interviews
in which those being interviewed fully understand the purposes,
potential uses and their freedom not to answer questions.
In most cases, the narrators are required to sign a release
that addresses copyright and terms of access and reproduction
(for interviews deposited in a library or archives), identification
of narrators, and disposition of tapes and transcripts.
See the MU
FAQ's Entry on oral history for more information.
of Human Research Protections & Oral History Association
2003 joint policy-IRB http://www.dickinson.edu/organizations/oha/)
Procedure for Reviewing Research Involving the Internet or Electronic
In such cases where MU researchers use
email, listservs, and/or Internet-based mediums to conduct their
research, the following procedures will be used in reviewing
such protocols to ensure that ethical procedures are followed:
(a) The PI should submit to the IRB as part of his or her
application all materials that will be submitted to subjects
via email, listservs, and/or Internet-based mediums. These
materials may include, but are not limited to: (1) the studys
face page or information page explaining the study, (2) URL
website address, (3) the website address for web-based surveys,
(4) related materials that are part of the study and require
direct subject involvement.
(b) If the PI is studying an online group (e.g., listserv,
blog, etc.) the PI should provide evidence that the group
owner/host has given permission to recruit participants. If
this is not a feasible procedure, the PI should provide an
explanation as to why.
(c) All recruitment materials should clearly specify the age
limit for participation. If a PI is conducting research with
underage participants, then information should be provided
as to how consent will be obtained or a justification for
a waiver of parental permission must be provided.
(d) The PI should clearly state in his or her information
letter and/or consent form that although every effort will
be done to ensure confidentiality of your subjects responses,
that all Internet-based communication is subject to the remote
likelihood of tampering from an outside source.
(e) PIs should clearly state to his or her subjects what types
of confidentiality measures will be utilized (i.e., IP addresses
will not be investigated, responses will not remain on the
Internet server, all internet correspondence will only go
to the PI, etc.).
(f) If the research, particularly the initial recruiting,
is being conducted via an electronic mail listserv, the PI
should ask interested individuals to contact him or her by
a separate email and not directly to the listserv address
to protect confidentiality.
(g) For online survey forms, the PI should provide a home
or face page containing an introductory message that describes
the project, how the data will be used and other relevant
information of informed consent. The bottom of the message
could contain a button that indicates that they volunteer
to participate and another one that indicates that they decline
for Reviewing Research Conducted in a Public or Private Educational
For purposes of this SOP, an educational
setting is defined as: (1) designated public school settings
(including after-school programs that are affiliated with a
public or private school), (2) designated private school settings,
and (3) educational training facilities (i.e., training centers,
day care settings). The following procedures will be followed
by the IRB in reviewing such research:
(1) Prior to submitting a protocol,
the PI should consult with the educational setting to determine
if the setting has a designated IRB or ethics review board.
In such cases where there is such a board, approval of the
project should be secured prior to engaging in the research
and written confirmation should be submitted with the MU application
(2) All research procedures and materials that will be submitted
to the subjects should be reviewed by the teacher and/or principal
where appropriate to ensure compliance with educational setting
(3) In cases where the research will pose an interference
with routine school activities, then it is effective research
practice to secure approval from a school official stating
that he or she is aware of the project and approves of it
being conducted in his or her school.
(4) MU applications should address issues of informed consent
(and assent where appropriate). In addition, the No Child
Left Behind Act of 2001 identified eight classifications of
protected information for surveys, questionnaires, interview
materials or testing measures used with students in the school
system. Research involving any of the following eight areas
requires written parental informed consent prior to the participation
of a student in research: (a) mental or psychological problems
of the student or the students family; (b) political affiliations
of the student or the student or the students parents; (c)
religious practices, affiliations or beliefs of the student
or the students parents; (d) income; (e) illegal, anti-social,
self-incriminating or demeaning behavior; (f) political affiliations
of the student or the students parents; (g) sexual behavior
or attitudes; and (h) critical appraisals of others with whom
students have close family relationships.
(5) In cases where the PI is using his or her own students
as part of his or her research project (i.e., his or her students
are the primary subjects), the PI should clearly describe
how issues of coercion and voluntariness will be addressed
with research subjects.
(6) In cases where the PI wishes to use education records
(printed, computer file, e-mail) and use those records as
part of his or her research, all guidelines under the Family
Educational Rights and Privacy Act (FERPA) must be adhered
to and compliance with these guidelines must be addressed
in the MU application materials.
*Refer to ed.gov
for details on the FERPA.
Procedure for Student and Course-Related Research
This student research is defined as any
observation or intervention by a student as part of a Miami
University (MU) course which is designed to develop or contribute
to student learning or to general knowledge. Course-related
research is any research that is being conducted as part of
an MU course.
This policy does not apply to
masters theses or doctoral dissertations - such protocols must
follow standard IRB/Exemption procedures.
There are two types of student and course-related research projects:
(A) student projects that are strictly for in-classroom exercises
and (B) student projects that will be used beyond the classroom
environment. For clarity, the IRB has established the following
(A) Student Projects That are
For student projects that are solely classroom directed exercises
(purpose of the student investigation is solely for the fulfillment
of a course requirement) these projects do not require IRB
review if they meet all of the following criteria:
(a) involve the learning of research
(b) involve no more than minimal risk; AND
(c) the data is recorded anonymously by the students (i.e.,
with no names, Social Security numbers, Banner Identification
numbers, email addresses, or any other codes that can be
linked to a list of names, or the recorded data will not
identify the subject through deduction); AND
(d) the data will not be used beyond the classroom environment
(i.e. will not be published, orally presented, presented
at a conference, seminar/workshop, departmental colloquium,
poster presentation or used in further research by the student,
other class members or the instructor).
* Projects must meet all of the
conditions stated above and instructors should consult
with the compliance office before assuming that their
class assignment does not fall under the purview of the
For activities utilizing the "In-Classroom
Research" status (11.8 (A), the onus of responsibility
for the ethical and safe conduct of students in
the class and the welfare of their subjects is placed
on the instructor.
In all cases, it is expected the activities will
meet the code of ethics associated with the professional
society(ies) of that field.
(B) Student Projects That will
be Used Beyond the Classroom
For student projects that are part of a course requirement,
but the student and/or instructor, plans to either publish,
and/or present at a conference, seminar/workshop, departmental
colloquium, poster presentation, or any other public dissemination,
the following guidelines should be followed:
Management, Training for and
Review of Class Projects
(a) If the research protocol
is generic (i.e., all student researchers will
use the same instruments, methods and consent procedures),
the course instructor may submit an IRB Application form
or Exemption Application form. Information should be provided
regarding the training students will receive. The faculty
advisor would be listed as the Principal Investigator (PI)
and a listing of the students in the course will be provided
as part of the application. The instructors should emphasize
the importance of human subjects protection with their students
and the students should complete the online CITI training.
Once approved by the IRB, the generic
protocol may continue to be used by student researchers
for that course in any future semester by the IRB unless:
is a complaint and/or adverse reaction from a subject,
b) the PI, instruments, methods and/or consent procedures
have changed, or;
d) there is a change in the research environment or new
information that would indicate greater risk to human
subjects than that assumed when the protocol was initially
reviewed and approved, or;
e) the instructor fails to renew the protocol through
the annual status report.
If utilizing the approved protocol
for multiple semesters, the list of students for subsequent
terms can be updated via a protocol modification form
as can minor changes in procedures and consent forms.
Instructors using this method should
use the "General Research" form or
Exemption Screening form but include information about
the course, e.g. title, number, syllabus.
(b) If the research protocol
is not generic (i.e., each student/group will utilize
different instruments, methods and consent procedures),
then each student/group, with the support of a faculty advisor
(i.e., the course instructor or other faculty member if
appropriate) will submit an IRB Application or Exemption
Suggested method of managing
Description of procedures:
- All of the students complete
Part I of the training
program: the CITI online training for research using
- The faculty member must complete
all training and be familiar with the class projects
policy (Parts I and II, and discuss the class project
with the IRB Administrator).
- The students may or may not (faculty
member choice) be required to complete Part
II of the training application writing training
(we may be able to send someone to the class to conduct
- The students must submit their
applications to the faculty member for pre-review. The
advisor pre-review should address risk assessment, the
consent process, methods etc. as well as address whether
the activitiy meets the definition of regulated research.
- The faculty member is responsible
for submitting all of the applications (sender MU email
address serves as the advisor signature).
- ALL of the applications should
be submitted at once. (The faculty might consider including
the IRB application as an assignment for which there
is a late penalty).
- The IRB chair distributes all
of these protocols to a sub-committee that will act
as the reviewers for all of these projects.
Faculty advisors are expected to pre-review
and approve all applications before submitting
them for institutional review to ensure that
the applications are complete and the project
is understandable and can be accomplished safely
and ethically by the students.
With multiple projects per class, this can be
time-consuming and challenging. However, the
pre-review responsibilites cannot be transferred
to the IRB/Compliance Office. Applications may
be rejected or review/approval will be delayed.
It is wise for instructors to set bounds on
the types of research that can be proposed by
students for these assignments or set aside
sufficient time to pre-review all applications.
contact the IRB administrator before distributing the
class assignment for details regarding this procedure
and for scheduling in-class training. One of the primary
advantages of heeding the advice offered here and adopting
these methods is timely review of protocols.
If you are a PC user, here is
a way that works well:
1. For each student/project, the
application documents (there could be several documents)
are traiaged and stored in a Zip file by the faculty
advisor (FA) and given a unique name (e.g. including
a students uniqueid). Word documents and other files
(including zips) can simply be dragged into the zip
2. The FA emails many of the resulting
zips in one or a few submissions (gmail can handle attachments
totaling up to 25 MB). It may or may not be easy to
attach multiple files to an email message. That is,
it depends on your browser and email software. For Outlook
and Gmail, you can drag zip files into the message.
In fact, you could create a zip file for each student
as well as one zip file for the class and drag the individual
project zips into the class zip and then just send the
class zip to us.
We like to work with zip collections
because they behave like a single file and can be moved
around very easily.
If you are a mac user,we do not
know enough about macs to advise you how to accomplish
the same thing, but 7it can be done (from : google search
"mac and zip files"). http://macs.about.com/od/faq1/f/How-To-Zip-And-Unzip-Files-And-Folders-On-A-Mac.htm
As with all IRB approved protocols,
such protocols still must be reviewed annually through continuing
review and submitted for revision if warranted in case of
a change in PI, instruments, methods and/or consent procedures.
Projects approved as Exempt, do not have to be renewed annually.
If you are unsure if your course content
is in compliance with this procedure, please contact the
IRB at (513) 529-3600 or via email at (firstname.lastname@example.org).
Procedure for Reviewing Research Involving
University-Collected Student Information*
In cases where a researcher
wishes to utilize University-collected information (i.e., data
that is given to and maintained by the University such as SAT/ACT
scores, student GPA, and/or related academic data) for purposes
of human subjects research, the following guidelines have been
(a) Use of the Miami University
Banner system to obtain such information is not allowed. Faculty/staff
access to student information via Banner is for academic advisement
and guidance purposes only and is not to be used to facilitate
research in any manner. IRB applications that indicate the
use of Banner for this purpose will be returned. For guidance
on the purpose of and access information, refer to (www.muohio.edu/mcs).
(b) Since some students have requested that such records be
kept confidential, University-collected student information
may be obtained from the Office of Institutional Research
(OIR) at email@example.com.
OIR will provide you with requested information in a confidential
format and will only release information from those students
who have not placed a restriction on their data. In this case,
the researcher should develop a consent form that specifically
allows the researcher to obtain the requested information
from OIR for the project.
*This procedure only applies
in cases where the researcher wishes to obtain University-collected
information. If the researcher wishes to obtain such information
directly from the subject, then normal consent procedures
IRB Procedures Regarding:
Quality Improvement Programs,
and Accreditation Assessments
There are two major issues to address
with these activities:
1. Distinguishing between activities
that would occur regardless of the research activities and
those activities that comprise the research. The IRB does
not have purview over any activities that are adopted by
some entity including Miami. The IRB only has purview over
activities that meet the federal definition of regulated
2. If data is to be collected to evaluate
the activity, then the way that data is to be used determines
if the evaluation is regulated human subjects research.
If the data is to be used by the entity for improving the
program without public reporting, then it is not regulated
human subjects research. If the data is going to be used
by Miami personnel for public presentation/publication,
then the activity requires IRB oversight or IRB Exemption.
However, since methods used in program
evaluation, quality improvement, or assessment employ methods
typically used in research, it may be challenging to determine
whether or not the evaluation is considered research under
the purview of the IRB.
If your project fulfills
the following criteria the project does not require IRB
1) The data collection
and analysis activities are not intended to generate scientific
knowledge, but rather are used as a management tool to
improve the provision of services to a specific population,
organization or program; AND
2) The activities that are examined are not intended to
have any application beyond the organization or program
that is the target or source of the evaluation. This may
include external reviewers and program evaluators; AND
3) The purpose of the activity is to assess the success
of an established program in achieving its objectives
and the information gained from the evaluation will be
used to provide feedback, monitor and/or improve the program.
Some federal agencies and private research
organizations may require IRB review and approval of program
evaluation or quality assurance projects. In such cases, the
IRB should be notified of this requirement and the project
should meet the criteria for IRB review as noted above.
In some instances, evaluations may gather data from human
subjects through direct or indirect interaction for purposes
of evaluation. Even in cases where the project does not fall
under the purview of the IRB, projects must be conducted with
the highest level of regard for ethical standards and policies.
Procedure for Using University-Provided Survey Tools
The following SOP
is designed to provide guidance to inform researchers of IRB
related issues when using the university-provided survey tools.
The Prezza Checkbox Web
and Snap Surveys tools are available to faculty and staff
for conducting surveys at Miami University. The Prezza Checkbox
Web survey tool provides the ability to create and deploy
online surveys using either a Windows or Macintosh computer.
The Snap Surveys tool provides the ability to create and deploy
both online and paper surveys and requires a Windows computer.
Attending the Survey Tools
and Data Protection workshop is required in order to obtain
an account for either of the University-provided survey tools.
This workshop introduces the University-provided survey tools
to ensure that faculty, staff and students are familiar with
the University data confidentiality requirements and how to
meet these requirements when using the survey tools.
For more information about this workshop, please visit:
Faculty and staff can request an account for a graduate
student, a student employee or faculty may elect to request
student accounts for a class project. These accounts are
referred to as 'sponsored' accounts and remain active on
a per semester basis.
Survey Data Protection and Storage:
The Institutional Review Board (IRB) and the IT Services
Information Security Office highly recommends that all survey
results, public and confidential, be stored in a secure
location. A dedicated survey data storage location is available
to faculty and staff who use either the Prezza Checkbox
Web or Snap Surveys tools. If you store data that should
be protected in an unsecured storage space, you may assume
risk associated with it being breached. To learn more about
saving your survey results to a secure location, please
see the MU
Important Information to Include in Your IRB Application:
Informed Consent-When using either Prezza
or Snap, participants will be able to provide consent in
one of two ways: (a) Through an electronic consent form
(e.g., an information page with all of the consent guidelines)
that participants will read and then notify the researcher
that they authorize consent to participate in the study;
or (b) Through reading the consent form and then completing
the survey (receipt of the survey will serve as informed
consent). These are only two examples of how consent may
be secured. It is important that whatever method that
is chosen, the process should be clearly outlined in your
Procedure for Safeguarding Confidentiality-Since
both Prezza and Snap utilize a firewall protected server,
your IRB application should state this and also provide
information regarding who in your research team will also
have permission/access to the data.
If you have any questions regarding
the survey tools, please visit the Survey Tools Web site
or contact IT Services, Learning & Information Services
Permission to Conduct Research On or Off Campus
The IRB reviews applications
based on anticipated risks and benefits and the protections
afforded to the subjects, however, the IRB cannot grant permission
to researchers to use any location to conduct research. Researchers
must seek and obtain permission to conduct research from the
owner or appropriate official at that location.
a) Miami Researchers conducting
research at off-campus locations:
It is the policy of Miami University
that personnel conducting research as Miami employees or
students obtain permission from the appropriate official
to conduct research at any off-campus location. With the
exception of research involving a vulnerable population
(pregnant women and fetuses, prisoners, children, and economically
or educationally disadvantaged persons), it is the responsibility
of Miami PI’s to obtain permission and maintain documentation
of that permission.
When vulnerable populations are the
subjects of research, documents granting permission must
be submitted to the IRB before research can be initiated.
Accepted documentation includes: original signed paper copies
on letterhead from the appropriate official OR email messages
sent directly from the authorized official to the IRB email
address (firstname.lastname@example.org). Electronic messages
not originating from the official or forwarded by researchers
through their email account are not acceptable. If the application
is being reviewed by the Psychology Department Review Board
(DRB), researchers should arrange to have the permission
documents sent to the chair of that board.
b) Non-Miami Researchers
conducting research on a Miami Campus:
It is Miami Policy that
all human subjects research being conducted on a Miami campus
be reviewed by an Institutional Review Board. If the home
institution of the researcher has an IRB, that review process
may be accepted by MU. A copy of the approved protocol and
a copy of the approval letter must be sent to the Miami's
Research Compliance Office prior to initiating research.
If the home institution of the researcher does not have
an IRB, the Miami IRB may be used for the review process.
If the outside researcher is collaborating with a Miami
employee and the Miami employee is functioning as a researcher,
the Miami IRB must conduct a review of the protocol using
the Miami procedure. Researchers must still obtain permission
from the appropriate official (e.g. Dean of Student Affairs,
Dean of a College, Department Chairs, Provosts Office etc.)
Protocol Application Submission and Signature Policy
An original signed
paper copy of your application is not required. However, applications
will not be accepted directly from undergraduate or graduate
1. All protocols must
be submitted electronically to
by a faculty researcher or the faculty advisor of a student
researcher (or submitted by an authorized non-faculty staff
2. Submissions must be emailed from faculty using their
MU email account.
the FAQ / Guidance for further
information regarding this policy