Purpose of the Research (return
• Describe the nature, purpose, and significance of
• Describe the specific objectives or aims of the research and
what outcomes are expected, both general and specific.
• What do expect to learn from this research that is not already
known in your field?
• How and where will the data be disseminated?
Subject Population Description (return
• Describe the anticipated number of subjects, age
ranges, and where appropriate, gender, ethnic background,
• Identify the use of vulnerable populations such as children
(under age 18), prisoners, mentally disabled persons, or
economically or educationally disadvantaged persons.
Research Procedures and Methods (return
Recruitment and Selection of Subjects (return
• Describe how participants will be recruited. Attach
a copy of any recruitment materials
• Attach, describe, and refer to advertisements and letters.
• Describe the subject inclusion and exclusion criteria
• Describe the nature of the relationship between the researcher(s)
and the subjects.
One of the biggest concerns of the IRB is that potential subjects
freely volunteer to participate in research projects. Examples
of past abuses include prisoners who ‘volunteered’ to
participate in medical studies, or students whose perception
is that they had to volunteer if they desired a passing grade
in a course. These are readily recognized as problems with
the ‘volunteer’ requirement. However, researchers
might not be sensitive enough to forms of implied pressure.
For example, having a teacher diestribute a survey for her
own research in her class and then having the students who
do not want to volunteer hand back the survey in front of her
and all the other students is an example of implicit compulsion
that is not allowed. A procedure in which a researcher asks
friends to do him a favor by volunteering could be another
example of pressure that is not allowed.
A class may have a requirement for research experience, but
participation as a subject in a particular project cannot be
required. Students must be given a choice of alternative ways
to satisfy the requirement. And these alternatives must be
reasonable and non-exploitive. For example, providing a student
the choice between participating in an hour long project or
writing a 10 page research paper is not reasonable.
Researchers may compensate subjects for participating, but
payments must be described in the proposal to the IRB. Payments
should be appropriate to the risks associated with the research
and not of an amount that would alone convince a person to
volunteer. Subjects must receive partial payment if they withdraw
from the study.
In some projects, once potential subjects are attracted to
the project, some type of screening or selection of appropriate
subjects is performed. Sometimes potential subjects must be
excluded from the study, for example, people with liver damage
may be excluded from a nutrition study, or people who are depressed
may be excluded from a memory study. The inclusion and exclusion
criteria must be described.
For the IRB to be able to determine whether the recruitment
process is reasonable and without coercion, a proposal should
include a description of the procedure for attracting potential
subjects to the projects, including copies of fliers, letters,
Research Location (return
• List all sites where the research will be conducted.
• When appropriate, provide letters granting permission to recruit
participants and conduct research at these locations.
It is Miami policy that all MU researchers have permission
to conduct research granted by the owner of the property or
leadership of an organization. This is not only courteous,
but it is a matter of maintaining research integrity and human
subjects protection. If the owner of a property or the leadership
of an organization discovers an unapproved research project
being conducted, they may stop the project midway through,
thereby placing the research at risk and rendering the subjects
already contacted to have been put at risk for no benefit.
Researchers are expected to obtain permission to conduct research
and maintain documentation from the appropriate authority.
Letters of permission must be provided to the IRB whenever
research projects involve vulnerable populations.
Consent Process (return
• Describe the process of informing the subjects/legal
representatives, obtaining consent, and documenting consent.
• Include provisions for gaining assent from subjects under age
• Describe the process for ensuring subjects are voluntarily
participating in the research activities throughout the study
(provisions for self-withdrawal)
Informed consent refers to a person's freely made decision
to participate in a research project based on knowledge of
relevant aspects of the project and its implications for the
participant's welfare. It is an ongoing process in which participants
are given an explanation of the research project in language
that they can understand.
In most cases, subjects are informed about proposed research
and the risks associated with the project via a written consent
form; in fact Federal regulations require written consent.
The consent form describes the project and its risks; it also
provides sources of additional information if the subject has
questions about the project or his or her rights. The investigator
must give the subject or the representative adequate opportunity
to read the consent form, or it may be read to them, and to
have any questions about the study answered before it is signed.
A copy of the form needs to be given to the person signing
the form. It is important that investigators include a copy
of this form with their IRB application so that the IRB can
determine if the form is adequate given the risk level and
I. Basic Elements of Consent. The written consent document
shall include information on the following basic elements written
in language readily understandable by the subjects.
a. Description of the Research: The nature, purpose, and significance
of the research.
b. Research Procedures: The procedures to be followed.
c. Time Required for Participation: The expected frequency
and duration of each procedure and total amount of time required
d. Risks: Any reasonably foreseeable risks or discomforts
to the subjects.
e. Benefits: Any benefits to the subject or others which may
reasonably be expected from the research.
f. Alternatives: If the potential subject or legal representative
declines to participate, how might this effect the opportunities
of the subject.
g. Confidentiality: The extent to which confidentiality of
records identifying the subject will be maintained. Note: Data
should not be described as anonymous if there are any identifying
names, or numbers, or information about the individual through
which individual subjects could be linked by the researcher
or anyone else to his or her responses.
h. Voluntary Participation: A statement that:
• participation is voluntary,
• refusal to participate will involve no penalty or loss of benefits
to which the subject is otherwise entitled,
• the subject may discontinue participation at any time or refuse
to answer specific questions without penalty
or loss of benefits to which the subject is otherwise entitled.
i. Questions About the Study: An offer to answer any questions
about the procedures and an explanation of who to contact (the
name, phone number and email address of the investigator and,
in the case of student investigators, the faculty advisor)
for answers to pertinent questions about the research. Where
applicable, provide the name of a contact in the event of a
research-related injury to the subject.
j. Questions About Rights of Subjects: A
statement that subjects may contact the Office
for the Advancement of Research
Scholarship (513-529-3600) or <email@example.com> for
questions or concerns about their rights as
k. Compensation for Injury: For research involving more than
minimal risk, an explanation as to whether any compensation
or medical treatment is available if injury occurs, and, if
so, what they consist of, or where additional information may
l. Recording: Plans to audiotape or videotape any sessions
or photograph participants need to be described and explicitly
agreed to on the consent form.
A short-form written consent document, stating that the
elements of informed consent have been presented orally
to the subject
or the subject’s legally authorized representative
may be used. When this method is used, there must be a
witness to the oral presentation. The IRB must review a
of what is to be said to the subject or representative.
A copy of the written statement about the research study
the short-form consent document must be given to the subject
Consent Form Example
Consent/Assent of Special Populations (return
Subjects Under Age 18. When the subjects are younger
than 18 years of age, including college students, a parent
guardian must sign a written consent form. In addition, the
child should be asked to ‘assent’ to participate.
For older children, e.g. older than 14, this assent should
be written. For younger children, this assent should be verbal.
Researchers need to provide a script of what will be said to
children to seek their agreement to participate.
Vulnerable Adults. When subjects include individuals who
are not legally or physically capable of giving documented
informed consent because of mental incapacity, or inability
to communicate, consent must be sought from a legal guardian
as well as assent from the subjects themselves. The subjects
should also be given an explanation of the procedures at a
level appropriate to their condition and asked for their assent
to participate in the research project. A written form to document
assent may also be appropriate for mildly impaired adults.
III. Waiver of Some Elements of the Consent Process (return
Although the use of a written informed consent form is highly
encouraged by the IRB, it is understood that there are situations
in which the use of such a form creates problems and therefore
the investigator may request a waiver to the requirement to
document informed consent in writing. In these cases, the researcher
should state in Section 6 of the application “I request
a waiver to the requirement to document informed consent in
writing” and provide the information the IRB needs to
justify waiving the requirement. Examples of situations that
the IRB will normally waive the written consent form requirement
1. Protecting the identity of participants. The requirement
for a signed consent form may be waived when the only record
linking the subject and the research would be the consent document
and the principal risk would be potential harm resulting from
a breach of confidentiality.
2. Cross cultural research. If the project involves people
in a culture where signed consent forms are not appropriate,
the researcher should propose alternative ways to assure that
participants fully understand and willingly participate in
the research. Usually, verbal consent is required by the IRB.
A script describing the procedure should be included in the
D. Research Activities (return
Include, as necessary, the following when relating your step-by-step
• If appropriate, clearly distinguish between the
normal activities subjects will engage in (would occur in
of the research) and the research activities. First describe
the normal activity in general terms and then describe the
activities that will be used for the research aspects of the
• Address the frequency and length of time involved in activities
added to the curriculum for the purpose of the research and
the overall length of research participation;
• Describe the training and experience of persons administering
the treatment, collecting data, or accessing the data and relevance
of this to human subjects protections.
• Describe the compensation, if any, to subjects for their participation.
Payment should be reasonable and prorated with partial payment
to those who withdraw before the completion of the research.
• Attach data gathering instruments, copies of questionnaires
or interview questions.
Confidentiality of the Information (return
• Indicate whether the data will be treated as confidential
How will participants’ privacy be protected and confidentiality
of data maintained;
• How long will confidential documents and information be retained
after the end of the study;
• Where and how will data be stored;
• Who will have access to data for which subject identity is
known or could be inferred?
There is a difference between confidentiality and anonymity.
Confidential treatment of data is required when a dataset and/or
research materials include personal identifiers, such as a
name, photograph, sound recording, or personal references such
as an address, phone number or identification number that may
be used to connect a particular subject with his or her data.
Even without collecting names along with responses, demographic
information such as (male/female, age, occupation, income category,
education level) can be used to identify individuals within
a group where the composition of the group members is known.
Although the researcher is allowed access to confidential
information, it is the responsibility of the researcher to
develop procedures that assure that no unauthorized/unapproved
person has access. At a minimum, the information should be
kept in an inaccessible place, e.g. a locked file cabinet.
If the data is maintained in a computer system, then the system
should be protected from outsiders. Researchers should be aware
that there are legal means (e.g.subpoena) by which confidential
information can be made public.
Anonymity refers to the situation in which the dataset and/or
research materials contain no personal identifiers through
which anyone, including the investigator, could connect individual
responses with a specific subject. Data collected through face-to-face
interviews, and video, audio or photographic records are not
Usually, for as long as personal identifiers are present in
a dataset, the researcher is responsible for maintaining the
confidentiality of the dataset, and therefore, the research
project will receive periodic review (at least annually) to
insure that the procedures used to guarantee confidentiality
The IRB recognizes that in some research projects, the identity
of the subjects is integral to the study and therefore the
research material will contain the identity of the person;
research oral histories and qualitative clinical studies are
examples of this type of research. In these cases, the researcher
may petition the IRB to close the project without making the
dataset anonymous. The IRB will only consider petitions for
projects in which the procedure for obtaining informed consent
included explicit documentation that the subject consents to
maintaining identity in the dataset.
Deception and Debriefing (return
• Provide a rationale and justification for deceiving
subjects regarding the research activities
• Describe debriefing procedures.
A special problem of consent arises where informing subjects
of some aspects of the research is likely to impair the validity
of the research. Deception in research is justified only if
it is clear that (1) incomplete disclosure is necessary to
accomplish the goals of the research, (2) there are no undisclosed
risks to subjects that are more than minimal, and (3) there
is an adequate plan for debriefing the subjects. Information
about risks should never be withheld for the purpose of eliciting
the cooperation of subjects and truthful answers should always
be given to direct questions about the research.
In preparing material for IRB review, researchers must clearly
identify any deception in the research. The rationale for deception,
and plans for after-the-fact debriefing of subjects must be
provided for review by the committee.
Potential Modifications (return
Often in research it is difficult or impossible to design
all aspects of the research at the outset. For example, a project
may start with a pre-activity survey, the research activity,
perhaps using a variety of assignments in a class that would
provide research data, and interaction with subjects ends with
a post-activity survey. The nature and questions on the post-activity
survey may depend greatly on the response of the subjects to
the previous research activities. Another example would be
when a study takes place over many years and the researchers
will need to respond to changes over time. When these types
of circumstances exit, rather than attempt to anticipate or
limit activities, in Section 3G justify the deferment in planning
and likely timing of the submission of a protocol modification
Potential Risks and Discomforts (return
• In the process of writing the previous materials (Methods),
you should note the potential risks and discomforts associated
with each research procedure. This includes physical, psychological,
social, legal, economic, or other risk. Describe these risks
in this section.
• Evaluate the likelihood of occurrence and the degree of seriousness
of adverse events.
• Describe procedures for minimizing risks.
• Describe provisions for insuring necessary medical or professional
intervention in the event of adverse effects on the subjects.
Risks to human subjects posed by participation in research
should be justified by the anticipated benefits to the subjects
or society. The central charge of the IRB is to assess the
anticipated benefits to be gained from the research in relation
to the risks. The IRB needs to determine whether or not the
investigator has properly assessed the level and magnitude
of risk present in his or her project; minimized risks to the
extent possible; and communicated the nature of the risks and
anticipated benefits to the subject prior to seeking agreement
to participate in the project.
Participation in any research project carries with it a level
of risk of distress or harm that ranges from low to significant.
Low or minimal risk means that the probability and magnitude
of harm or discomfort is no more than engaging in everyday
activities or during the performance of routine physical or
psychological examinations or tests (e.g., drawing a small
amount of blood from a healthy person, or sitting through an
hour of tests). Some studies may involve a middle level of
risk in which there is expectation of some temporary distress
on the part of the subject (e.g. being asked to justify immoral
decisions). High or significant risk means that the subjects
may experience serious or lasting harm, (e.g. suffer a heart
attack while participating in an exercise training program
or be exposed to legal, financial or personal repercussions
if their responses become known outside the research). A high
level of risk is not a sufficient reason to disapprove a proposal;
if the anticipated benefits of performing the research are
high, and subjects are fully informed of the risks, then a
proposal with a high level of risk can be approved.
Potential Benefits (return
• Describe the potential benefits to
subjects as a result of their participation in this research.
• Describe any potential benefits to society that may be expected
from this research.
Benefits of research fall into
two major categories: benefits to the subjects and benefits
Subjects who are experiencing
a new teaching method or examination may benefit directly
from research involving evaluation of a procedure or understanding
of a learning disorder. Frequently, however, research projects
have no immediate therapeutic intent for the subject. However,
there may be benefits to society as a whole from the increased
knowledge, improved safety, better technology, or improved
practice in a field. Direct payments to subjects as an
or reward for participation should not be considered a “benefit” to
be gained from research.