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.
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).
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 we use.
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 was generalizable.
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 us at firstname.lastname@example.org. 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.
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 Research Mentor who certifies they will provide direct supervision and guidance and assume final responsibility for the conduct of this study in accordance with all University of Pittsburgh and/or UPMC policies and procedures regulating human research.
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. Detailed information about the required research courses is available on the Training section.
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.
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:
- Educational strategies, curricula, or classroom management methods
- Tests, surveys, interviews, or observations of public behavior
- Existing Data or Research Records (not applicable for medical record reviews)
- Retrospective Medical Record Review
- Research with biological specimens
- Request for an Exception to Informed Consent Requirements:Studies Using In Vitro Diagnostic Devices with Specimens that are NOT Individually Identifiable
- Determination that Research Does Not Involve Human Subjects or Is Not Research
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, an "informational script" is used
- Prior scientific review by a School or Departmental review committee is not required
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 ‘tests, 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 that application.
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 be included.
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 than minimal.
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 “Letter” 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 links above.
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.