I. Introduction
To assure the protection
of human subjects and to comply with Federal law, Miami
University requires that prior to contacting potential study
participants; all research projects involving human subjects
must be reviewed and approved by the Institutional Review
Board for Human Subjects Research (IRB). The IRB has the
responsibility for protecting the rights and welfare of
human subjects in research.
Miami University has a Federal wide Assurance (FWA) with
the Office for Human Research Protections (OHRP) in the
Department of Health and Human Services. This agreement
assures that all human subjects research conducted under
the auspices of Miami University will comply with Title
45, Code 46 (Common Rule) of the federal regulations. The
Miami University IRB also adheres to other federal, state,
local and institutional guidelines as applicable on the
responsible conduct of research.
Institutional Review Board (IRB)
The Institutional Review Board for Human Subjects Research
(IRB) for Miami University has the responsibility to oversee
procedures for carrying out the University's commitment
to protect human subjects in research. This oversight includes
both internal and externally funded research. The IRB is
authorized to approve, require modifications in (to secure
approval), or disapprove all research activities using human
subjects covered by this policy.
The IRB has two designated subcommittees: (a) the Psychology
Subcommittee of the IRB (Departmental Review Board) and
(b) International Research Subcommittee. Both subcommittees
have delegated responsibility for expedited review and have
members who are full-board members of the IRB. Research
protocols in the area of psychology may be submitted to
the chairperson of the Psychology subcommittee (DRB) only
if the project is not funded and all international
research protocols should be submitted to the OARS for review
by the International Research Subcommittee.
II. What
Is Human Subjects Research?
Human Subject
means a living individual about whom an investigator (whether
professional or student) conducting research obtains (a)
data through intervention or interaction with the individual,
or (b) identifiable private information.
Research is defined as a systematic investigation,
inquiry or analysis-including critical analysis or inquiry-that
is designed to develop or contribute to generalizable knowledge.
This definition also expands to include if the results of
your work are to be published, presented or shared externally.
Minimal Risk means that the probability
and magnitude of harm or discomfort anticipated in the research
are not greater in and of themselves than those ordinarily
encountered in daily life or during the performance of routine
physical or psychological examinations or tests.
III. Do I have to submit an IRB application?
This policy applies to all
activities which, in whole or in part, involve research
with human subjects if: (a) The research is sponsored by
Miami University, or
(b) The research is conducted by or under the direction
of faculty, staff, or students of Miami University in connection
with their institutional responsibilities, or
(c) The research is conducted by or under the direction
of faculty, staff or students of Miami University using
any property or facility of the University, or
(d) The research involves the use of Miami University's
nonpublic information to identify or contact human research
subjects or prospective subjects. Graduate and undergraduate
student research projects which meet the definition of research
and are intended for dissemination beyond the classroom
are covered by this policy. Student projects designed to
provide research training which are not intended for dissemination
beyond the classroom are not treated as research projects
under this policy (Refer to Standard Operating Procedure
11.7 for further details).
IV. Required Ethics Training on Human Subjects Research
All researchers who interact
with human subjects to collect data must complete a required
educational program on ethics and procedures for the use
of human subjects in research before the Institutional Review
Board may approve a proposal.
Who Should Complete Ethics Training?
The CITI on-line training course must be completed by the
principal investigator (PI), co-principal investigators,
and other key personnel who are responsible for the design
and/or conduct of the study. The requirement applies to
subcontractors, consultants, individual fellowship applicants,
study coordinators, and persons who conduct invasive procedures,
or conduct health or opinion surveys or interviews. Research
assistants including graduate and undergraduate students
who are collecting data from human subjects including providing
explanations or answering questions about the research or
data gathering instruments are also required to complete
the training program.
Individuals providing technical services only such as setting
up a room, handing out and collecting survey instruments
without providing explanations or answering questions about
the research or data-gathering instruments, typing data
into a data base, transcribing audiotapes, or reviewing
videotapes to code behavior, are not covered by this requirement;
however, they should receive instruction on maintaining
privacy and confidentiality of data.
Ethical Principles: The Belmont Report
A vital component of all human subjects ethics training
are the ethical principles regarding all research involving
humans as subjects. These principles have been set forth
in the report published by the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral
Research entitled, "Belmont Report: Ethical Principles and
Guidelines for the Protection of Human Subjects of Research."
Some of these principles include respect for persons, beneficence
(including minimization of risks and maximization of benefits),
and justice. This report is addressed in the CITI on-line
training and may also be accessed at the following site:
Belmont Report
V. Submitting an IRB
Application for Review
Researchers who propose to
conduct research involving human subjects shall prepare
and submit an Application for Approval of Research Involving
Human Subjects to the IRB or to the DRB. Applications must
be approved prior to any subject recruitment or contact
with subjects. Researchers must complete the required education
program on research ethics for human subjects research prior
to approval of an application (see section IV).
The objective of committee review is to ensure that the
rights and welfare of the subjects are adequately protected
and that all activities involving human subjects are in
compliance with University policies and Federal regulations
to assure that:
(a) Selection of research
subjects is equitable
(b) Informed consent is obtained and documented where
appropriate
(c) Risks to subjects are minimized
(d) Risks are reasonable in relation to anticipated benefits
to subjects and others
(e) Privacy and confidentiality are protected
(f) Data handling and safety monitoring provisions are
adequate
(g) Vulnerable subjects are provided special safeguards
against undue influence or coercion to participate in
the research
Types of Protocol Review
A. New Protocol
Review -- All new research projects involving human
subjects shall be reviewed by the IRB or the DRB prior to
beginning the project. For initial review by the IRB, investigators
shall submit to the OARS office a signed original Application
for Approval of Research Involving Human Subjects, including
the cover page, research description and supporting materials
as specified in the Instructions for Completing an Application
for New Protocol Review AND one electronic
copy of the above either in ONE word document or ONE pdf
file to humansubjects@muohio.edu.
If the protocol is referred to the full IRB for review by
the initial reviewers, the investigator will be contacted
to submit additional copies of the protocol with any requested
changes.
B. Revisions to an Approved Protocol -- Any changes
in an approved protocol, including subject population, study
location, procedures, or project personnel must be reviewed
and approved by the IRB prior to initiating changes. Investigators
shall submit the signed original of the Revisions/Modification
Application Cover Page, a description of the proposed
changes, and the revised protocol that incorporates the
proposed changes.
C. Continuing Project Review -- All research
involving human subjects must be re-reviewed periodically,
at least every twelve months or more frequently as specified
in the original approval notification. This applies to studies
for which data are continuing to be collected or for which
research data are being maintained with personal identifiers
that can be linked to individual subject responses. For
review of continuing projects, investigators shall submit
a signed original of the Continuing Review Application
for Approval of Research Involving Human Subjects including
a status report and supporting materials as specified in
the Instructions for Completing an Application for Continuing
Project Review. Research projects are not eligible for continuing
review if the projects approval has expired. A new protocol
application needs to be filed in this situation.
VI. Researchers Responsibilities
for Responsible Conduct of Research
Researchers shall obtain
approval for proposed human subjects research prior to recruiting
subjects or collecting data from subjects. This applies
to preliminary and pilot studies which are developing or
testing instruments and procedures, as well as the full
study.
Researchers shall explain to subjects, prior to their decision
about whether or not to participate, the objectives of the
research, the procedures to be followed and the potential
risks and benefits. Researchers shall not use individuals
as subjects unless satisfied that they, and/or others legally
responsible for their well-being, fully understand the consequence
of participation and freely consent to participate in the
research. The IRB may waive these requirements for written
informed consent only when persuaded that the research cannot
otherwise be done, that its potential value outweighs the
indignity to the subject, and that the subject runs no further
risk or harm in participating. Researchers shall seek consent
from subjects to participate only under circumstances that
provide the prospective subject sufficient opportunity to
consider and decide freely whether or not to participate.
Subjects shall be given a copy of the informed consent materials
to keep.
Researchers shall make clear to subjects that participation
is voluntary and that they are free to withdraw from active
participation in the research at any time. Subjects who
indicate a desire to withdraw shall be allowed to do so
promptly and without penalty or loss of benefits to which
the subject is otherwise entitled. Any payment to subjects
must be reasonable and prorated with partial payment in
the event subjects discontinue participation during the
course of the study.
Researchers shall respect the privacy of subjects. They
shall protect confidential information given them, advising
subjects in advance of any limits upon their ability to
ensure that the information will remain confidential.
Researchers shall obtain approval from the IRB or DRB prior
to making any changes in the research procedures. This approval
shall be done in a timely manner.
Student Researchers
A. Student Research Projects
designed to add to generalizable knowledge through dissemination
of results in publications or presentations beyond the classroom
are covered by this policy on human subjects research. Faculty
members who assign or supervise research conducted by students
are responsible for ensuring that the proposed research
is reviewed and conducted in accordance with University
policy and the student is qualified to safeguard adequately
the well-being of the subjects.
B. Class Projects designed to provide hands-on experience
or research training to students are not treated as research
projects in this policy and do not require formal IRB or
DRB review. Projects in this category are expected to be
confined to the specific class and end at the termination
of that class. If it is anticipated that the research project
will be used in other classes or published or presented
beyond the classroom, the project should be submitted to
the IRB for review. Faculty members who assign research
learning experiences are responsible for assuring that people
used in such projects are treated ethically. Faculty members
must provide information to students on University policies
and guidelines on human subjects research and develop class
procedures in a manner that protects the privacy, dignity,
and welfare of participants. If you are planning
to conduct student or course-related research as part of
your work, please refer to SOP 11.7 for further guidance.
Research Subjects Under Age 18
Consent from parent(s) or legal guardian(s) is required
for children under age 18. College students who are under
age 18 must have parental or guardian consent to participate
as research subjects. In addition to parental or guardian
consent, children should also be asked for their assent
to participate in the research project in language appropriate
to the subject's age and maturity.
Surveys, interview procedures, or participant observations
are not eligible for exempt status when persons under age
18 are involved as subjects. If you are planning
to conduct research in a public or private educational setting
with students, please refer to Standard Operating Procedure
11.6 for guidance on this type of research.
If you have any further questions about the IRB application
materials, training requirements, review procedure or other
issues, please contact the Office for the Advancement of Research
and Scholarship at 529-3600 or email us at (humansubjects@muohio.edu).
