This page has been designed to introduce students to the University of Pittsburgh
Institutional Review Board. We have attempted to assemble, in one place, basic information
relevant to most student research projects that involve human subjects. Please keep
in mind that this is a summary; more detailed information can be found by linking
to relevant sections of our online Policy and Procedures Manual.
What is an ‘IRB’?
How do I know whether my project requires IRB review and approval?
What Is Required For IRB Submission?
How Do I Determine Whether My Study Falls Into The “Exempt”
Or The “Expedited” Review Category?
Criteria for an Exempt Study
Criteria for an Expedited Study
“Question & Answer” Consent Form Style
“Letter” Consent Form Style
Conducting Research at Sites Other than the University / UPMC
Contact Information for the IRB Student Research Liaison
What is an ‘IRB’?
Institutional Review Boards (IRBs) have been established by the federal government
to protect the rights and welfare of human subjects participating in research activities.
The IRB ensures that physical, psychological, and social risks to research subjects
are minimized, and that the risks associated with the research are commensurate
with the importance of the research and/or the knowledge to be gained. Consistent
with the ethical principles of the
Belmont Report, the IRB also ensures that research subjects receive accurate,
complete, and comprehensible information about the nature of the research and any
associated risks, as well as their rights as research subjects. In addition, the
IRB reviews human research activities to ensure that the University, affiliate institutions,
and investigators are compliant with the ethical standards and the regulations governing
human subject research. These regulations are summarized in the Code of Federal
Regulations (45 CFR 46) from the
U.S. Department of Health and Human Services and from the
Food and Drug Administration (21 CFR 50; 56).
How do I know whether my project requires IRB review
The University of Pittsburgh IRB reviews all projects that meet two criteria: (1)
The project must be “research,” and (2) the project
must include “human subjects.” The federal regulations
provide definitions for each of these terms, and those are the definitions that
Researchis defined as “…a systematic investigation,
including research development, testing and evaluation, designed to develop or contribute
to generalizable knowledge” (45 CFR 46.102.d). Thus, a case report on a single
individual would not meet the definition because one could not generalize from that
single case. A completely unstructured discussion with several people (‘tell
me what it was like to be a feminist in Berkeley in the 1960s’) would not
meet the definition because the investigation is not ‘systematic.’ On
the other hand, an open-ended interview that includes a number of probing questions
to ensure that all interviewees address the same topics would be considered to be
systematic and would meet the definition of research – so long as sufficient
people were interviewed to provide some assurance that the resulting information
A Human Subjectis defined as “…a living individual
about whom an investigator (whether professional or student) conducting research
obtains (1) data through intervention or interaction with the individual, or
(2) identifiable private information” (45 CFR 46.102.f). Thus, individuals
are considered to be a human subject if the researcher interviews them or asks them
to complete an experiment, or if the researcher obtain private information about
them (e.g., medical information by reviewing their medical records).
IRB oversight is required only when a project meets the criteria for both
research and human subjects involvement. For example, a project
that only analyzes data from publically available databases would
not require IRB oversight because there is no interaction with the individuals whose
data are being studied, and the information being studied is not private (by definition;
it is publically available!).
Many classroom projects that are designed solely to instruct students about research
methods and data collection procedures would not require IRB oversight because they
would not result in generalizable knowledge. Nevertheless, such projects should
be supervised by a faculty member; in most instances, an ‘introductory script’ should be developed and used
to inform anyone who participates in such a project that this is a student project
and that they are not obligated to participate.
If you have any doubt as to whether a project requires IRB oversight, please contact,
Erin Holmes Grabowski, IRB Student
Research Liaison, or Michelle Lemenager,
Student Liaison for International Research. Also, because some
Schools and Departments mandate that all research projects obtain an IRB approval
letter, the IRB Office can review your project and make a formal determination that
your project does not meet the criteria for human subjects research. For this determination,
you must complete the relevant
form on the Exempt web page.
What Is Required For IRB Submission?
All studies are submitted electronically using OSIRIS. If you have any questions regarding the use of OSIRIS,
please email our support team at firstname.lastname@example.org.
The University of Pittsburgh permits (encourages!) students to serve as Principal
Investigators for research projects. However, when a student (and this includes
graduate and post-graduate fellows and medical residents who do not have faculty
status) is listed as the Principal Investigator, the IRB submission will require
the inclusion of a University of Pittsburgh Faculty Mentor who
completes a Faculty Mentor
All investigators and key personnel involved in Human Subject Research (including
Faculty Mentors) are required to complete specific research ethic courses using
the CITI training program. Only those individuals who have completed the required
training are permitted to conduct human subject research or to access OSIRIS (IRB
on-line application). The courses are designed for three user groups: biomedical
researcher (includes all health science students), social and behavioral researcher,
and undergraduate student researcher. At a minimum, all users must completed courses
in Human Subjects Protections and Responsible Conduct of Research. Go to
www.citi.pitt.edu for more information and to access the courses. If you
have any questions, email us at email@example.com.
At the University of Pittsburgh, the IRB makes a distinction between three types
of reviews. Minimal risk studies that meet certain requirements can be reviewed
administratively by members of the IRB office staff. These types of reviews are
known as ‘exempt’ or ‘expedited,’
depending on whether they meet certain other requirements, as described below. Most
student projects will fall into one of those two categories. Studies that are considered
to be more than minimal risk will require what is known as a ‘full board
review,’ where a committee of experts evaluates the project during
a monthly meeting and makes a determination as to whether subjects are adequately
protected from research risks.
Any study that is not exempt – that is, requires either expedited or full
board review – must first undergo a formal scientific review. All departments
or research units should have a system in place for this review. Students conducting
their thesis or dissertation research can submit a letter from the committee chair,
or from their faculty mentor; that will meet this IRB requirement.
How Do I Determine Whether My Study Falls Into The
“Exempt” Or The “Expedited” Review Category?
Criteria for an Exempt Study:
The code of federal regulations identifies several different categories of research
as being exempt from Federal Policy for the Protection of Human Research Subjects.
Clicking on each of the categories below will bring up a table listing basic criteria,
as well as the appropriate IRB exempt application form.
“Exempt” Research Categories:
General characteristics of all exempt research include the following:
- With very few exceptions, private identifiable information cannot
be recorded by the investigator or members of the research team
- Research participants do not sign a consent form, but in most instances,
script" is used
- Prior scientific review by a School or Departmental review committee is
Most student projects that are exempt will fall into one of three categories: A
relatively small number will qualify for the ‘education’ exemption; many more will qualify for the
surveys, interviews, or observations of public behavior’ exemption.
A third category that is often used by student researchers is the one for secondary data analyses, although many of those may meet
the criteria for
no human subjects involvement and the investigator may wish to complete
Please note that the ‘education’ exemption only applies if the research
is actually conducted with students (children or adults) in a classroom or analogous
educational setting, where the primary purpose of the study is either to study normal
educational practices or to evaluate instructional techniques. Interviews with educational
administrators, for example, would fall into the second exempt category (‘tests,
surveys, interviews, or observations of public behavior’).
Also note that the exempt category for ‘tests, surveys, interviews, or observations
of public behavior’ is limited to research subjects who are adults –
18 years of age or older. The only exception to that is when observations of public
behavior are being conducted; in only that very limited instance can children can
Criteria for an Expedited Study:
Studies that don’t fall into the exempt categories may be expedited if two
criteria are met: first, the study must be ‘minimal risk’ (i.e., “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”);
second, the study must fall into one of several specific categories. Most student projects that are not
exempt fall into what is known as expedited category 7:
“Research on individual or group characteristics or behavior (including, but
not limited to, research on perception, cognition, motivation, identity, language,
communication, cultural beliefs or practices, and social behavior) or research employing
survey, interview, oral history, focus group, program evaluation, human factors
evaluation, or quality assurance methodologies.”
Please note that a project cannot be expedited if identification of the subjects
and/or their responses would reasonably place them at risk for criminal or civil
liability or would be damaging to their financial standing, employability, insurability,
or reputation, or would be stigmatizing. Thus, whenever this type of sensitive information
is to be collected, the researcher must ensure that reasonable and appropriate protections
are implemented so that risks related to invasion of privacy and breach of confidentiality
are no greater
Note that all expedited studies require signed informed consent from each subject,
unless the IRB has granted a waiver
of documentation of informed consent.
All investigators have an ethical (and legal!) responsibility to obtain a research
subject’s voluntary consent to participate in a study. For studies that do
not fall into one of the exempt categories, this process is facilitated by using
a written ‘consent form’ which must be reviewed by the potential research
subject and then signed by him or her. No research activity can begin until the
subject’s written informed consent can be obtained.
According to the Federal Regulations, a consent form must include the following
elements (note that this listing has been edited to apply specifically to minimal
risk student projects):
- A statement that the study involves research [the term ‘research study’
must be included in this description!], an explanation of the purposes of the research,
the procedures that will be followed, and the approximate amount of time required
by the subject
- A description of any reasonably foreseeable risks or discomforts to the subject;
the possibility of a breach of confidentiality is a risk, and must be included
- A description of any benefits the subject might expect; if there are none, that
should be stated
- A description of how the confidentiality of research records will be maintained
- Contact information for an individual who can answer questions about the research
study (usually, this is one of the investigators or the faculty mentor), as well
as the number of the phone number of the Human Subjects Protection Advocate
- A statement that participate is voluntary, refusal to participate will not result
in any penalty or loss of benefits to which the subject is entitled, and the fact
that the subject can discontinue participation at any time without any penalty
If there is a possibility that the subject may be charged for some or all of the
procedures (unusual in student research), or that the investigator may terminate
the subject from participation during the study, or that significant new findings
which emerge during the study may affect the subject’s willingness to participate,
these issues should also be addressed in the consent form – if applicable.
The University of Pittsburgh IRB permits several different consent form ‘styles.’
The most common form today is the so-called “Question and Answer”
format. Many student researchers prefer to use the simpler
format. Regardless of which style is used, all consent forms should be on Departmental
or School letterhead. An example of each format can be access by clicking on the
Conducting Research at Sites Other than the University
When research is conducting at sites outside of the University of Pittsburgh or
UPMC, the IRB requires the investigator to obtain documentation that he or she has
permission to conduct the study at that site. In some instances (e.g., when research
is conducted in certain school districts), the permission of an additional IRB may
be required. Please be aware that obtaining these permissions may prolong the time
needed for the University of Pittsburgh IRB to review and approve a protocol.
Contact Information for the IRB Student Research Liaison
Erin Holmes Grabowski, BS, CIP
Senior Coordinator, Exempt and Expedited Studies
Student Research Liaison