What does Oakland City University’s
IRB do?
Oakland City University’s Institutional
Review Board (IRB) has as its mission and function to review and
approve all proposed research involving human subjects and animals
that is conducted under the University’s auspices through
its Schools. Approval is required regardless of whether the research
is funded status or sponsored status. The code of federal regulations
guiding IRB policy can be found here: 45 CFR 46.
Further, Oakland City University’s IRB fully
intends to follow the intent and purpose of the law. The IRB believes
that the law is designed to protect the rights and safeguard the
welfare of human research subjects and/or animals utilized in research
activities. Since the law provides guidelines for establishing a
local peer-review process, the IRB believes that this review process
will help student/researchers better understand the nature of research
and the importance of ethical approaches in conducting research.
What forms of research need to be reviewed?
The IRB must review any and all research that
will be conducted by students or faculty that involves human subjects
or animals. For the purposes of this review, the term “research”
is defined by federal law 45 CFR §46.102 as “a systematic
investigation, including research development, testing and evaluation,
designed to develop or contribute to generalizable knowledge.”
All activities that meet the foregoing definition of “research”
will need to be reviewed by the IRB, including activities that may
or may not be conducted or supported under a program which is considered
research for other purposes (please note that some demonstration
and/or service programs may include research activities). For the
purposes of this policy a “systematic investigation”
is any data collection method. This includes interviews, surveys,
tests, observations, or other experiments, regardless of content
area, including pilot studies.
As additional criteria, the IRB further defines
research as a project designed to “contribute to generalizable
knowledge,” when it adds to a field of knowledge (e.g., the
field of education, the field of religion, the field of management),
and when the research results become publicly available, either
through a presentation or publication.
For the purposes of this policy the IRB considers
a research project to “involve human subjects” if the
research activity involves “a living individual about whom
an investigator . . . obtains data through intervention or interaction
with the individual or identifiable private information” as
defined by 45 CFR §46.102. This definition is interpreted broadly,
therefore, even if a student/researcher is just “interviewing”
people or conducting a survey, human subjects are involved in the
research and the research must be reviewed by the IRB in accordance
to this policy.
The following research projects/activities are
subject to prior review and approval by Oakland City University’s
IRB: any documentation of information from an identifiable person
or any collection of information about an identifiable person that
is not publicly available or the results of the research activity
will be made public (for example, through oral presentations or
written articles for publication). Such research projects include
any qualitative and quantitative research that involves human participants.
If there is any doubt as to whether a proposed project should be
reviewed by the IRB, a member of the IRB board should be contacted
for assistance.
Which application form should the student/researcher
use to have his or her research proposal reviewed?
In order for a student/researcher to conduct any
type of research activity involving human subjects and/or animals,
the student/researcher must fill out the appropriate sections of
the Universal Research Application. The sections of the Universal
Research Application that will be required to be completed and the
documentation that will need to be included with the application
depend on the applicable review level for the application. There
are three tiers of IRB review into which research activities involving
human subjects and/or animals could fall. The three tiers are:
1. Exempt Status
2. Expedited Review Status; or
3. Full Review
The student/researcher is to initially determine
the type of IRB review for which his or her project would qualify
(The IRB will make the final determination). The student/researcher
needs to understand that irrespective of the level of review that
the student/researcher determines is appropriate for his or her
research activity, any research project may be submitted to the
IRB for full review at a regularly convened meeting upon the election
of the IRB. If the student/researcher has questions about the type
of review for which the research activity will qualify, he or she
should call the Chair of the IRB or any one of its members.
Full Review Status: All human subject research
activities are presumptively in this category (unless such activity
meets the qualifications of Expedited Review Status, or Exempt Status
as set forth below) and requires the student/researcher to complete
all the necessary sections and provide the specific documentation
set forth in the instructions of the Universal Research Application
for a Full Review Status. Upon completion of the necessary sections
of the Universal Research Application and compilation of the necessary
supporting documentation, as set forth in the instructions of the
Universal Research Application for Full Review Status, the student/researcher
should submit the completed Universal Research Application and the
necessary supporting documentation to the IRB whereby such Full
Review Status Universal Research Application will be reviewed by
the entire IRB. Please note, that all research activities involving
animals require a Full Review Status and that in addition to the
Universal Research Application the student/researcher shall also
complete and submit the Animal Care and Use Application.
Expedited Review Status: If the research activity
meets the criteria for an Expedited Review Status, the student/researcher
shall complete all the necessary sections and provide the specific
documentation set forth in the instructions of the Universal Research
Application for Expedited Review Status. Upon completion of the
necessary sections of the Universal Research Application and compilation
of the necessary supporting documentation, as set forth in the instructions
of the Universal Research Application for Expedited Review Status,
the student/researcher should submit the completed Universal Research
Application and the necessary supporting documentation to the IRB,
whereby the IRB will assign one (1) member of the IRB to review
the Expedited Review Status Universal Research Application. To determine
whether a research activity meets the criteria for Expedited Review
Status, the student/researcher should review the Expedited Review
Status Criteria.
Exempt Status: If the research activity meets
the criteria for Exempt Status, the student/researcher is to complete
all the necessary sections and provide the specific documentation
set forth in the instructions of the Universal Research Application
for Exempt Status. Upon completion of the necessary sections of
the Universal Research Application and compilation of the necessary
supporting documentation, as set forth in the instructions of the
Universal Research Application for Exempt Status, the student/researcher
should submit the completed Universal Research Application and the
necessary supporting documentation to the IRB, whereby the IRB will
assign one (1) member of the IRB to review the Exempt Status Universal
Research Application. To determine whether a research activity meets
the criteria for exempt status, the student/researcher should review
the Exempt Status Criteria.
What if the student/researcher plans to
use animals?
If a student/researcher desires to conduct research
activities that involve animals, then in addition to the policies
and procedures outlined in this policy the student/researcher should
be familiar with and prepared to follow the Oakland City University
polices and guidelines and the Federal regulations with regard to
care and use of animals. The Animal Welfare Act of 1966 (P.L. 89-544,
as amended) and the Health Research Extension Act of 1985 (P.L.
99-158) provide guidelines and requirements for the care and husbandry
of animals utilized in research activities. In addition to the Universal
Research Application (completed for Full Review Status) required
for research activities involving human subjects and animals the
student/researcher will be required to fill out an Animal Care and
Use Application. The Animal Care and Use Application must be submitted
at that same time as the Universal Research Application so that
the IRB can conduct a Full Review of both applications.
Where does the student/researcher send
the application form?
The appropriately completed Universal Research
Application and the necessary supporting documentation, must be
submitted electronically to bmarley@oak.edu as an attachment along
with any necessary other attachments. After the Universal Research
Application form has been reviewed and approved by the appropriate
level of the IRB, the student/researcher must submit an original,
signed Universal Research Application to Dr. Bernard Marley
in Murray Administration Center prior to commencing any activities.
A current copy of the curriculum vita of the Primary
Researcher (PR) (faculty member) must be on file in the Academic
Affairs office. If the PR has submitted a current vita during the
current academic year, he or she will not need to include it with
his or her research application.
How long will the IRB process take?
An Exempt Status Universal Research Application
may be submitted at any time. Only one (1) member of the IRB needs
and/or will be assigned to review this level/type of application.
In the event the IRB member assigned to review the Exempt Status
Universal Research Application has questions with regard the Universal
Research Application that need to be answered prior to approving
or disapproving the research activity, the student/researcher will
be contacted for clarification. A response by the IRB will generally
be given within ten (10) working days (for the purposes of this
policy, holidays and weekend dates are not considered “working
days”).
An Expedited Review Status Universal Research
Application may be submitted at any time. Only one (1) member of
the IRB needs and/or will be assigned to review this level/type
of application. In the event the IRB member assigned to review the
Expedited Review Status Universal Research Application has questions
with regard the Universal Research Application that need to be answered
prior to approving or disapproving the research activity, the student/researcher
will be contacted for clarification. A response by the IRB will
generally be given within ten (10) working days (for the purposes
of this policy, holidays and weekend dates are not considered “working
days”).
A Full Review Status Universal Research Application
may be submitted any time. The entire IRB must review a Full Review
Status Universal Research Application. The IRB will generally meet
within ten (10) working days (for the purposes of this policy, holidays
and weekend dates are not considered “working days”)
after the Full Review Status Universal Research Application has
been submitted. In the event that the IRB has questions with regard
to the Universal Research Application that need to be answered prior
to approving or disapproving the research activity, the student/researcher
will be contacted for clarification. A response by the IRB will
generally be given within ten (10) working days after the IRB meets
to discuss the Full Review Status Application. Please note that
the IRB may require that a student/researcher provide written clarifications
to questions the IRB may have with regard to the Full Review Status
Universal Research Application prior to approving or disapproving
a research activity.
In addition to the forgoing outline of the application
process, Federal Certification forms will need to be provided if
the research proposal is being submitted for federal or state funding
that requires such forms. Please note that while Oakland City University
and the IRB are committed to expediting the application process
for all research involving human/animal subjects the foregoing outline
and time line is an estimate only and particular circumstances may
require more or less time to render a decision on whether research
activities are approved or disapproved.
When can the student/researcher start
collecting data?
No data or research on or with human subjects
or animals may be collected or commenced until approval is received
from the IRB.
What are the main ethical considerations
used in reviewing research?
Federal law requires that the IRB make certain
that the student/researcher understands each of these ethical issues:
* Potential research-related risks to human subjects
are minimized in the areas of physical, psychological, social, legal,
and economic status.
* The risks to human subjects are reasonable in relationship to
the anticipated benefits to the subject.
* The selection of human subjects is equitable and no group is excluded
without justifiable reason based on gender, race, religion, or economic
status.
* Confidentiality of human subjects is protected as required by
law.
* Informed consent of human subjects in the research study is demonstrateable.
* Evidence of understanding of any special problems that may potentially
exist in the research is explored.
* Treatment and care of animals is appropriate.
The IRB acknowledges that the above list is not
complete and that it is to serve as a basis for the student/researcher
to understand the ethical issues involved in research that must
be addressed and their importance.
For further understanding of ethical issues involved
in ethics and human subject research, the IRB recommends the following
resources:
Online resources:
Student/researcher’s are encouraged to use
on-line resources that provide critical information in regard to
Human Subjects Research.
Books on Ethics available in OCU’s
Library:
Title: How good people make tough choices
Author: Kidder, Rushworth M.
Year/Format: 1995 / Book
Oakland City Univ. Library / Main: 658.4 K533
Title: Constructing a life philosophy: opposing
viewpoints
Author: Bender, David L., 1936-
Year/Format: 1993 / Book
Oakland City Univ. Library / Main: 140 C713
Title: Plato. Ethics, politics, religion, and
the soul
Author: Fine, Gail.
Year/Format: 1999 / E- BK
Oakland City Univ. Library / EBooks:
Title: Ethics: selections from classical and contemporary
writers
Author: Johnson, Oliver A.
Year/Format: 2004 / Book
Oakland City Univ. Library / Main: 170.22 J64e
Title: Ethics, the heart of leadership
Author: Ciulla, Joanne B.
Year/Format: 1998 / E- BK
Oakland City Univ. Library / EBooks:
Title: Public sector ethics finding and implementing
values
Author: Sampford, C. J. G. (Charles J. G.)
Year/Format: 2002 / E- BK
Oakland City Univ. Library / EBooks:
Title: An inquiry concerning human understanding
Author: Hume, David, 1711-1776.
Year/Format: 199u / E- BK
Oakland City Univ. Library / EBooks:
Title: Codes of conduct race, ethics, and the
color of our character
Author: Holloway, Karla F. C., 1949-
Year/Format: 1995 / E- BK
Oakland City Univ. Library / EBooks:
Title: Ethics in plain English: an illustrative
casebook for psychologists
Author: Nagy, Thomas F.
Year/Format: 2000 / Book
Oakland City Univ. Library / Main: 174.915 N39e
Title: Ethics & organizations
Author: Parker, Martin.
Year/Format: 1998 / Book
Oakland City Univ. Library / Main: 174.4 E855
Title: Ethics and the professions
Author: Appelbaum, David.
Year/Format: 1990 / Book
Oakland City Univ. Library / Main: 174 E835
Title: Ethics and social concern
Author: Serafini, Anthony.
Year/Format: 1989 / Book
Oakland City Univ. Library / Main: 170 E864
Title: Ethics
Author: Wekesser, Carol, 1963-
Year/Format: 1995 / Book
Oakland City Univ. Library / Main: 174.4 E845
What does the law require about informed
consent forms?
The Federal regulations and University policies
concerning human subject involvement in research activities exist
to ensure, among other items, that each human subject enters into
the research voluntarily and with adequate information. Therefore
consent must be obtained from all human subjects and such consent
must be informed and voluntarily. The requirement and circumstances
for obtaining informed consent are specific and must be followed
by all students/researchers. Federal regulations require that all
informed consent forms contain certain elements. The elements of
informed consent and a template for informed consent forms are available
from IRB members. IRB members can provide the Basic Elements For
Informed Consent and they can provide the student/researcher with
a Template For Informed Consent Students/Researchers should be aware
that the elements and circumstances for informed consent can be
complicated and that the drafting and formation of an appropriate
Informed Consent Form should be accomplished with the consultation
of an IRB member. For more information on the elements of informed
consent see 45 CFR §46.116.
Who does the student/researcher contact
if he or she has questions?
Any member of the IRB is able to answer questions
with regard to the application process and application requirements.
Questions may be directed to Dr. Bernard Marley at 812-749-1404 or bmarley@oak.edu.
Who are the OCU IRB members?
The IRB is composed of Oakland City University
faculty members as well as
one external member of the community. The law requires that IRB
have at least five members. The law also requires that each IRB
must include both males and females, people from varying cultural
backgrounds, people from varying professions, at least one member
whose primary concerns are scientific, at least one member whose
primary concerns are nonscientific, and at least one member who
is not affiliated with the institution. The Oakland City University
IRB has a self-imposed goal of having a representative from each
of the schools that conduct or may conduct human subject research.
Members are appointed by the Vice President of Research and Planning or designee for two-year
terms.
Currently the committee consists of the
following individuals:
Linda Marley, Education lmarley@oak.edu
Michael Atkinson, Life Sciences matkinson@oak.edu
Mary Perdue, Special Education mperdue@oak.edu
Norman Reynolds, Busines nreynolds@oak.edu
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