As community colleges establish IRBs, many of the decision makers at those institutions are turning to psychology faculty members to offer guidance on the process. Many working in the field of psychology are aware of negative reports concerning IRBs in journals and on electronic Listservs over the years. In those reports, complaints have been lodged about the restrictiveness of IRBs (Salzinger, 2006), infringement of academic freedom (Hamburger, 2007), the ever-increasing reach of these boards (Gunsalus, et al., 2006), and the lack of evidence to show that the entire IRB process has actually improved the safety of the research enterprise (Mueller & Furady, 2001a & 2001b). Many reports show that IRBs can hinder research productivity. These reports may lead some who are considering starting an IRB at their own institution to believe that the task is too great or too difficult or that having an IRB will make conducting research not worth the effort. The truth is that the task of starting, and using, an IRB may not be as onerous as it appears, and IRBs do not have to be an obstacle to research (O’Brien, 2006).

An Additional Note About the Value of Establishing an IRB

It is important to note that the creation of an IRB does not address all of researchers’ ethical issues. Researchers must be professional and adhere to the ethical codes of conduct that govern scientific research in general (i.e., The Belmont Principles) and their specific disciplines. For example, the American Psychological Association has an ethical code of conduct that includes standards for research with human participants (APA, 2002). This ethical code governs research conducted by people in the field of psychology, whether or not an IRB exists at their institution. The fact that an institution did not previously have an IRB does not mean that researchers at that institution have been unethical; it means that the institution has not formally documented whether the research adheres to all regulatory requirements found in 45 CFR 46. Having an IRB allows an institution to formally document that the institution is following the generally accepted method of assuring that human research participants are protected.

The pedagogical implications of having an IRB are enormous. Having an IRB allows faculty not only to talk firsthand about IRBs in their classes, but it also may allow students to participate by having them practice writing research proposals using the IRB’s official forms. It also may open doors for students to conduct IRB-approved research and potentially present their research at local, regional, or national professional meetings. However, students will also profit from exposure to the views of those who oppose the IRB process and the lack of empirical data to support it.

Having a properly composed IRB also makes research eligible for federal grants. Behavioral, social science and education research that uses human participants requires a review by a properly composed IRB to be eligible for federal grant monies. By starting your own IRB, you have the potential to open up more possibilities for research projects, giving faculty more opportunities for professional development and collaboration with faculty at other institutions.

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 district 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 in Appendix A). 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. The appointment process to an IRB is likely different than the appointment process to standing committees at your institution, as is the IRB’s obligations to your institution’s administration. The role of the faculty in developing the guidelines for the operation of your IRB will depend on the faculty’s role in your college’s institutional governance.

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, and

• 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.

Accordingly, one of the first questions to consider is who on the IRB makes the determination that a proposed study is exempt (see Appendix B, 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 Report. 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 Appendix C 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 Institutional Review Boards Guidebook 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, and

• 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 OHRP),

• 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 e-mail, 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 and

• Evidence of training completion.

Getting Started

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 Research (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 Protections. 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.

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. If the volume of research is relatively low and/or most of the research qualifies as exempt (see Appendix B), 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.

What is a Federalwide Assurance (FWA) and Does My Institution Need One?
A Federalwide Assurance (FWA) is a way that institutions can let federal agencies know that they intend to comply with the regulations for the protection of human research participants. An FWA is required of institutions engaged in nonexempt research with human participants that is conducted or supported by the DHHS. Because it is federal wide, it is accepted by other federal agencies and departments that have adopted the Common Rule and that support research with human participants.

What this means in practice is that, if you have a current FWA, a federal agency that is providing funding for research at your institution will not have to request information from the institution concerning the make up, policies, or procedures of the IRB. They will already have all the information they need in the FWA. It can streamline the process of obtaining grant money for research. The downside of an FWA is the amount of documentation required. Filing the paperwork and maintaining the FWA may require more work than choosing not to have an FWA.

You can compose an IRB that meets the federal guidelines described in 45 CFR 46 without an FWA. You can also, if you choose, use an IRB from another institution that has an FWA if you need it because of your request for funding from the DHHS (which requires an FWA). An FWA is not currently required for funding from other federal sources; however, other agencies may require their own assurance in the absence of an FWA.

There are significant advantages to having an FWA, but institutions need to be aware of both the requirements and the terms of such an assurance. For additional information, your IRB and/or your institution’s legal department should review the materials in the Assurances section of the OHRP website.

Does All Data Collection at Our Institution Require 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. If (a) the data collection meets the regulatory definition of research and (b) the research is done using human participants (see Appendix A, Definitions), it does require an IRB review. This is particularly important if the data collection is intended for dissemination outside of the institution, such as in a publication or in a conference presentation. 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.

What Else Do We Need To know?
It’s difficult to convey everything you need to know to start an IRB at your institution in one document. Things will undoubtedly come up as you go along, some of which will be unique to your institution. However, here are a few of the more common IRB issues you should know:

• Information gathered exclusively for educational purposes (i.e., not for outside dissemination), such as in-class student surveys or class projects, do not meet the regulatory definition of research and, therefore, do not require IRB approval. Even if the faculty or students do not submit an IRB proposal for these educational activities, faculty are still responsible for demonstrating appropriate and ethical conduct in research and for ensuring that their students do the same.

• If someone from another institution wants to use your institution’s employees or students in a research project, that individual’s home institution must first provide documentation of its IRB approval. For example, if graduate students from University X (UX) would like to use students from Community College Y (CCY) in their dissertation study, the graduate students must provide CCY with documentation that UX has already approved the IRB proposal.

• Similarly, if you want to use another institution’s or agency’s employees or students in a research project, you must provide evidence of IRB approval to the other institution. For example, if someone from CCY would like research access to students at Elementary School Z (ESZ), he or she must provide documentation to ESZ that CCY has already approved the IRB proposal.

• Again, the purpose of the IRB is to ensure protection of human subjects. It is not to judge the merits of a research proposal. If a proposal seems poorly conceived or incomplete, the IRB should not withhold approval if the proposal meets the regulatory guidelines for ethical treatment of its human participants. Just because you might do the study differently does not mean the proposal should not be approved. Relatedly, IRB members should not decline a proposal on the basis of political, religious, or moral perspectives that may be in conflict with the ideas presented in the research proposal.

Are There Some Basic Forms That Can Help Us Get Started?
Appendix D includes sample forms to help you get started. Feel free to use these as a framework from which to build forms for your institution. These are the forms used by the Maricopa County Community College District in Arizona. Your institution may want to add or delete content as appropriate.