Before you begin to set up an IRB, read and become familiar with the federal regulations that apply to research with human participants as specified in 45 CFR 46 and the "Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Researchopens in new window" (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). An essential resource is the 100-page "Institutional Review Board (IRB) Guidebook" published by the Office of Human Research Protectionsopens in new window (OHRP). This guidebook is available for purchase or free download from the OHRP website. The OHRP website has everything you need for creating your IRB.
Keep in mind that the basic job of the IRB is to protect the rights and welfare of human research participants and facilitate research by using the basic ethical principles from the Belmont Report.
The Nuts and Bolts
This section summarizes some of the key federal regulations for establishing an IRB. Please keep in mind that this is a brief summary; be sure to refer to 45 CFR 46 for complete and specific information about these regulations.
Size of the IRB
According to federal regulations, the minimum number of people required for an IRB is five; however, you can certainly have more than five members. The number of members will most likely depend on the size of the institution and the IRB workload. The availability of potential members will also affect the number of members you choose to have on your IRB.
Your institution may have more than one IRB. Many universities have multiple IRBs that specialize in particular types of research. If you are working for a community college or other undergraduate college that has multiple campuses, it may be advisable to have multiple IRBs so that each campus has its own review panel. This may help speed up the review process for each individual proposal.
Composition
As noted above, an IRB must consist of a minimum of five members of varied backgrounds to facilitate diversity in its composition. Accordingly, if you are doing federally funded research, you will need to make sure that your IRB is composed of members who represent the following characteristics:
Scientific area. At least one member must work in science (e.g., biology, psychology, chemistry).
Nonscientific area. At least one member must work in a nonscience area (e.g., history, English, philosophy).
External to the institution. One member must come from outside the institution and not be affiliated with the institution.
Diversity of representation. An effort must be made to achieve diversity of representation, particularly if members of a “vulnerable population,” such as children or people with intellectual disabilities, are frequently a subject of study (see Definitions). If such populations will be used, someone who has knowledge of or experience with those populations should participate as a member of the IRB.
Diversity of gender. The IRB should have both male and female representation.
Diversity of profession. The IRB should not have representation from just from one profession, such as psychology.
If you are not doing federally funded research, you have the freedom to choose alternative and sometimes more appropriate members for your IRB.
Other Considerations
- An IRB may not allow any member to participate in the review of any project in which the member has a conflicting interest. That would include researchers involved in the project and administrators involved in the grant applications.
- An IRB may invite individuals with expertise in specific areas to assist in the review of projects that require expertise that is not represented sufficiently on the IRB; however, they may not vote with the IRB.
- By definition, the IRB is a board, not a committee. As such, it means that members of an IRB are tasked with rendering decisions about research they review. In contrast, members of standing committees may or may not be tasked with rendering decisions—often, their purpose is to offer recommendations or organize information used to help others make decisions. The appointment process to an IRB often differs from the appointment process to other standing committees, as federal regulations include specific requirements about the membership of an IRB.
IRB Staff
Your institution will need to provide adequate staffing for the IRB. You may be able to designate a current employee as the IRB staff person, depending on the person’s current duties and the expected workload for the IRB. Depending on the number of research projects, you may need a full-time staff person for the IRB. Key tasks for staff include:
- Answering questions regarding the IRB process.
- Assisting researchers in completing their IRB proposals.
- Tracking when ongoing research projects are due for their annual review.
- Communicating with the IRB regarding incoming proposals and/or other board responsibilities.
- Maintaining documentation of completed training for IRB members and principal investigators (PIs).
IRB Members
The members of the IRB that come from current faculty and staff may need release time to perform the functions of the IRB. In particular, the chairperson of the IRB will likely have some administrative functions for the IRB and may need the time to perform them. This release time needs to be taken into consideration when considering cost. Additionally, you may choose to provide a stipend or reimburse travel time or mileage to your community representative.
Procedures for IRBs That Meet Federal Requirements
Your IRB will need to establish written procedures so that it is clear how the IRB will function. Before the IRB creates these procedures, considering how the IRB will fulfill its duties will be helpful. The questions below will likely need to be addressed; the answers to the questions will be based on your institutional organization and the anticipated volume of research conducted at your institution that requires IRB review.
Members of an IRB will determine the level of IRB review required for submitted research proposals (e.g., “exempt,” “expedited,” or “full” IRB review). Studies that meet the definition of “research” and that involve human participants may be considered exempt if they meet certain requirements.
A “full” IRB review is required when the research is defined as (a) a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (38 CFR 16.102d); (b) that involves human subjects (i.e., a living person about whom a researcher collects either identifiable private information OR data through an intervention or interaction); and (c) involves greater than minimal risk to those human subjects. A full IRB review usually requires attendance from a quorum of IRB-appointed members.
An “expedited” IRB review is selected when the research is defined as meeting the first two classifications noted above but involves no more than minimal risk to subjects OR is being reviewed strictly for minor changes to previously approved protocols in the research project. An expedited review procedure can be conducted by a subset of reviewers designated by the IRB chairperson from members of the IRB.
An “exempt” IRB review (see Criteria for Exempt Status) is selected when the research falls into one of the six approved categories of exempt research (45 CFR 46.101 [b]) and is not applicable to research in a covered research category (e.g., FDA regulation - 21 CFR 50.20). Exempt research does not mean that a research project has no review. Rather, for studies that are determined to be exempt, it means that the exemption (and its corresponding category) is documented in the IRB records and that the decision is communicated in writing to the investigator.
Accordingly, one of the first questions to consider is who on the IRB makes the determination that a proposed study is exempt (see Criteria for Exempt Status). Is the IRB chairperson solely responsible for that determination, or will a subcommittee screen all proposals for exemption?
- How will expedited or administrative review be conducted? Studies that pose minimal risk or proposals that are minor changes to studies that were previously approved by the IRB may not need to undergo a full IRB review.
- How will the IRB conduct initial and continuing review of research proposals? Studies that are ongoing (lasting more than 12 months) should have a follow-up review process at least once every 12 months.
- How will the IRB’s decision be communicated to the PI?
- How will changes in proposed research activity be communicated to the IRB? If the IRB has already approved a proposal, will changes to that proposal require new review?
- How will unanticipated problems that pose subsequent risks to human participants be reported to institutional officials?
- What are the deadlines for submissions, and how often will the IRB meet?
Be sure that you give these kinds of questions some thought up front and then solicit input from those people who are interested in either serving on the IRB or helping with the formation of the IRB. Most likely, you will also need to educate administrators at your institution about IRB regulations and procedures.
Educating IRB Members and Principal Investigators
IRB members and PIs need training and education in research ethics and current research regulations if they are going to be applying for federal funds. Most IRBs will choose to have some record of training, but it can be as innocuous as having researchers affirm that they have read the Belmont Reportopens in new window. If more extensive training is deemed necessary, it may be delivered a number of ways (e.g., a face-to-face class, an online class, a self-paced tutorial). The cost of providing training can vary widely. If you choose to have IRB members and PIs attend a face-to-face class, they need to have the time to participate, and you will need to provide a trainer. Online training costs also vary. There are online training modules that your institution can use for free or purchase and customize (see References and Resources for a list of inexpensive training options). As a psychologist, you may wish to review these training modules, as they are often quite naïve in their treatment of research methodology.
Setting up your own online training also has costs, such as the time of the person designing the website and the time of the experts needed to write the training modules. For institutions with limited time and/or budgets, the OHRP’s "Institutional Review Board Guidebookopens in new window" is a good place to begin in terms of deciding what material to include in a training course. The key information that needs to be delivered includes:
- The basic ethical principles underlying research with human participants as elucidated in the Belmont Report.
- The federal regulations for the protection of research participants.
- The history and ethics of research with human participants.
Completion of training requirements should be documented and kept on file so that the institution can demonstrate that IRB members and PIs have been provided the relevant information. Although probably not necessary, this documentation can be acquired by requiring that IRB members and PIs take a test after reading all of the material that is provided to them.
Record Keeping
Federal records, whether in hard copy or electronic form, need to be maintained and easily accessible for at least 3 years after the research is completed. You may choose a significantly less cumbersome system for research that is not federally funded. Office space or computer space will need to be allocated for storage. These records include:
- Research proposals, sample consent documents, updates from the researchers, and documentation of unanticipated problems (as described by OHRPopens in new window).
- Minutes of IRB meetings that document who attended; a record of voting; rationale for accepting, rejecting, or requiring changes to research proposals; and, where there is conflict among the IRB members, a summary of the issue and its resolution.
- Copies of communication, including email, between the IRB and researchers.
- List of IRB members, including their degrees, area they represent, relevant experience, and association with the college.
- IRB procedures and forms.
- Evidence of training completion.
How Much Will An IRB Cost?
The cost of the IRB depends on how much research the faculty, staff, and students at your institution are conducting and the nature of the research being conducted. Generally, faculty members serve on IRBs as part of their college service without additional compensation. If the volume of research is relatively low and/or most of the research qualifies as exempt (see Criteria for Exempt Status), the cost may be minimal. If the volume of research is high and/or the research involves more than minimal risk to participants, the additional record keeping may create greater costs.
Does All Data Collection at Our Institution Require an IRB Review?
Much of the data collected within or on behalf of an institution does not meet the regulatory definition of “research” and, thus, would likely not require IRB review. For example, many institutions often engage in projects that are best defined as quality improvement initiatives or program evaluation. Such projects usually do not meet the regulatory definition of research and thus would not need IRB review. However, if (a) the data being collected meet the regulatory definition of research and (b) the research is done using human participants (see Definitions), the study does require an IRB review. In addition, if one of the anticipated activities following the study is to disseminate the information, such as in a publication or conference presentation, the study may require an IRB review. When in doubt, the PI should submit an IRB proposal. Remember that the IRB is the institutional authority on research requirements, not the researcher or the institutional administration.