Institutional Review Boards (IRBs) play a critical role in the practical application of ethical research principles. The key responsibility of IRBs is to assure that investigators whose research involves human participants follow appropriate steps to protect project participants’ rights and welfare.
Not all scholarly work is subject to IRB review. However, all research projects that will involve human participants, directly or indirectly, must be submitted to one or more IRBs for their consideration before any interaction with participants (including recruitment and advertisement) takes place. Projects that entail the secondary analysis of data collected from human participants previously by another researcher involve human participants indirectly. While a researcher may anticipate that their project will be declared “exempt” from IRB oversight (and while the IRB may ultimately declare the project “exempt”), this is not a designation that an individual researcher may make.
This “Decision Tree” may assist you in determining whether your research project falls under an IRB’s purview. For the purposes of making this determination, the terms “research” and “human participants” have explicit definitions:
- Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge..
- Human subject [participant] means a living individual about whom an investigator (whether professional or student) conducting research obtains:
- Data through intervention or interaction with the individual, or
- Identifiable private information.
Structure and Legal Basis of IRBs
U.S.-based institutions that receive federal research funding establish IRBs to develop and enforce institutional policies governing research involving human participants and to review research projects in this category. IRBs include diverse groups of faculty and administrators with knowledge of the ethics and principles that guide particular scholarly communities and the conditions that can affect the conduct of research. Some institutions have more than one IRB to serve different disciplinary communities.
All U.S. IRBs operate according to the terms of the Federalwide Assurance for the Protection on Human Subjects from the Office for Human Research Protections at the U.S. Department of Health and Human Services. The Federal Policy for the Protection for Human Subjects (FPPHS) has several subparts. The most widely applicable section (subpart A) is colloquially known as the “Common Rule” (regulations commonly used by a number of federal agencies that fund scholarly work). Within that regulatory framework, IRBs have leeway to establish institution- and discipline-specific requirements that approved projects must meet.
In January 2017 the FPPHS underwent a major revision. The new terms are tentatively scheduled for implementation starting in January 2018. If you will be initiating your human participant research after that date, you should consult with the relevant IRB/s prior to filling out an application, to inquire about how the change in regulations may affect their forms or approval process. QDR continues to monitor developments on the topic and will offer updated guidance once there is more certainty about the implementation details.
You must consult and work with the IRB at your home institution, and any other IRBs relevant to your research, to secure approval for your project prior to any interaction with participants. It is your responsibility to identify all of the IRBs that have jurisdiction over your project.
Independent IRBs – review boards that are not affiliated with a university or research organization – can be contracted by researchers who are not affiliated with an institution, or are affiliated with an institution that lacks an IRB. Independent IRBs may be the “central” (coordinating) IRB in cases of multi-site research. Independent IRBs follow the same regulations and have the same objectives as other IRBs. As a recent practice, they may pursue accreditation by private accreditation agencies that ensure that they follow and enforce acceptable standards.
IRBs for Collaborative and International Research
For research that involves collaboration across institutions located within the United States, separate applications to each institution’s IRB are often required; sometimes arrangements can be made to establish a single, designated IRB. Research conducted overseas may need to be reviewed by ethics boards of varying types in the contexts where the research will occur (for instance, by a community leader or other expert), in addition to being reviewed by the IRB at the researcher’s home institution. Both the U.S. and the host country’s requirements for protecting human participants must be satisfied. Informed consent and other aspects of the research that ensure its ethical conduct must be meaningful by both U.S. and local cultural standards. If you contemplate needing the approval of multiple IRBs for your research, allow for more time for obtaining approval.
Categories of IRB Approval
Your project might be declared “exempt” from further review by your IRB, the review might be expedited, or the project might undergo full-board review depending on your substantive focus and research design (for example, the degree of risk that involvement in the project may pose for human participants). Unless the project is deemed exempt by your IRB, the project will need to undergo periodic review as it progresses.
If you are not planning to collect any identifying information from project participants, and your project meets additional restrictive criteria, it may be deemed exempt from continued oversight or review by the IRB. This is a decision that can only be made by the IRB once you submit your IRB protocol including a justified request for exemption. Researchers cannot self-exempt their work.
IRB guidelines typically project that application review will take three or four months. However, IRBs are often able to grant exemptions more quickly than they can issue other types of judgments on research projects.
The following types of research often qualify for an IRB exemption:
- research in educational settings involving educational practice
- research involving educational tests, surveys, interviews or observations of public behavior
- if the participants are elected public officials or candidates for office
- if the participants are not identified or disclosure of their responses would not involve more than reasonable (“everyday”) risk
- research involving the collection or study of existing data if they are publicly available and/or unidentifiable
- research designed to study public benefit or service programs.
Research among vulnerable populations as defined by federal regulations (e.g. children or prisoners) is typically not exempt even if it meets one of the above criteria.
Whether or not your research is exempt from continued IRB review, you might consider planning data collection so as to avoid gathering identifying information from human participants if the level of sensitivity of the personal information is high, and especially if you don’t anticipate needing to contact participants more than once. While it is common practice to record personal information, such information is often used only for administrative purposes; avoiding gathering such information makes the project and the collected data easier to manage from a legal and ethical perspective.
QDR urges researchers to allow ethical principles to guide their research far beyond what IRBs require of them. Ethical considerations and strong ethical standards should be a backdrop to everything you do while conducting research.