Many honors psychology undergraduates work on research projects with their advisors or on their own, for classes or personal interest. For most, this is the first time they encounter and learn about an Institutional Review Board (IRB).
"Why do I need IRB approval of my project?" a student may ask. The good news is that there are specific answers to that question.
I have written elsewhere about the history and purpose of IRBs (Prieto, 2004), so I will refer the reader there for information on the genesis of the IRB. However, it may be helpful to know a bit about the events that brought about the creation of IRBs, and the human rights values that serve as evaluative criteria for IRBs.
After World War II, the heinous violations of basic human rights by medical and other researchers in prison camps led to the creation and adoption of the 1947 Nuremberg Code (see World Medical Organization, 1996 for recent affirmation). That code sought to spell out the fundamental right of voluntary consent on the part of participants and participants' right to withdraw from being a part of research; to ensure that qualified personnel conducted research using the lowest ratio of risk to participants and the highest gain for the common good; and to make it the full responsibility of the researcher to ensure that all participants' rights and protections have been observed. Other landmark codes of conduct for researchers were to follow including the 1964 Helsinki Declaration (see World Medical Organization, 1996 for recent affirmation), the 1979 Belmont Report (US Department of Health, Education, and Welfare, 1979), and of course, the APA Code of Ethics (see 2002 for most recent version).
These codes provide for the consideration of other basic human rights in research, including informed consent of participants; equitable selection of subjects (fair exposure to risks or benefits across the population); privacy of participants and the confidentiality of their data; monitoring of data and research procedures; the equitable handling of incentives for participation; and, the need for ongoing, external oversight of projects.
Aside from ethics, US federal laws (see Code of Federal Regulations [CFR] Title 45, Part 46: Protection of Human Subjects) are also in force that require IRB oversight and approval of research projects; particularly those projects that are conducted as a part of grants or funding from federal sources, or that occur within institutions that receive federal funding. I recommend that students turn to The Institutional Review Board Guidebook (US Department of Health and Human Services, 1993) for detailed information on the laws, structure, and function of IRBs.
In terms of oversight, IRBs generally follow similar guidelines, however, there is some variance among institutions. Most IRBs will ask researchers from the institution over which they preside to apply for approval of projects. Some projects, depending on the samples used, level of risk to participants, as well as methods and measures employed, may need closer scrutiny than others. IRBs have a hierarchy of statuses to which projects are assigned. A project may be exempt from the need for a full board review and continuing oversight; may require ongoing oversight but be able to receive an expedited approval through the IRB; or may need the review of the full IRB and require closer monitoring.
Many of the projects in which psychology students engage (e.g., paper- and-pencil surveys, class-based research activities) are likely to fall within the two former categories. However, students in some specialty areas in psychology (especially those with bio-medical bases) may engage in more invasive or risky research with participants and may be involved (often as part of a research team with faculty) with projects that require full board review. Projects that involve protected classes of participants (e.g., children, prisoners, pregnant women) or involve the deception of participants also tend to require full board review and more intensive oversight.
Advice for students
When you embark on a study and put together an application to an IRB for approval, you will find there are many things to account for and keep in mind. Because of this, it is always a good idea to consult with your advisor or coinvestigators who may already have experience in completing IRB applications. Also, your IRB will likely have materials either in print or online to help you successfully navigate the application process. IRB considerations should begin to enter the picture the moment you start to plan a research study. This is especially important as most researchers plan to present and/or publish their findings; an eventuality that calls for initial IRB approval of a project.
As you plan a study, try to think like an IRB member. Ask yourself, "If I were on the IRB and were in charge of making sure the rights of participants were appropriately observed, what would I want to see the researcher do to minimize participant risk and maximize participant protection?"
As researchers, we often think only in terms of how we want our study to proceed. As we plan, we tend not to think in terms of potential glitches or adverse events in our projects. However, a "how could this project go wrong?" perspective is exactly the one every smart researcher should take while planning a project.
Of course, no researcher can be aware of every eventuality she might encounter during the course of a study. However, the list in Figure 1 gives you an idea of the many ways in which research efforts can (and have) gone awry or need to be thought through. Fortunately, the overwhelming majority of projects that psychology students engage in are completed with no difficulties. One reason for this is that those researchers have given a good amount of thought to the broader context in which their research is being conducted and specifically have thought about minimizing participant risk and maximizing participant protection.
As psychology researchers, we must always remember that although we serve our profession and society through our scientific efforts, it is only through the gracious service that our research participants provide to us that we are able to advance our knowledge bases. To these fine participants who serve our profession in this way, we owe a staunch commitment to their welfare.
American Psychological Association (2002). Ethical Principles of psychologists and code of conduct. American Psychologist, 57, 1060-1073.
Prieto, L. R. (2004, Fall). The Institutional Review Board: History and purpose. Psychology Teacher Network: American Psychological Association Education Directorate Newsletter, 14(3), 6-8.
US Department of Health & Human Services (1993). Institutional Review Board Guidebook (Office for Human Research Protections). Washington DC: Author. Retrieved need February 9, 2005 from http://www.hhs.gov/ ohrp/irb/irb_guidebook.htm
US Department of Health, Education, and Welfare (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research). Washington, DC: Author. Retrieved February 9, 2005 from http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm
World Medical Organization (1996). Declaration of Helsinki (1964). British Medical Journal, 313, 1448-1449.
World Medical Organization (1996). The Nuremberg Code (1947). British Medical Journal, 313(7), 1448.
As you plan your project, ask yourself general questions like:
- What things could possibly go wrong with the way I plan to gather a sample, obtain informed consent, collect and store data, present and publish results? Take a worse case scenario approach.
- What will participants' experience of my project and data collection be like? Be empathic and put yourself in their shoes.
- What are the general benefits of doing my study? How do these stack up against the potential risks or inconvenience I am placing on participants? Make sure the benefits of your project far outweigh risks to participants.
As you plan your project, ask yourself more specific questions like:
- Am I sure that any participant I might have in my research project can read and fully understand my informed consent materials for the study?
- To what extent do my research materials solicit personally identifying features of participants so that there is a risk of them being known only through their research materials?
- If data were accidentally lost or made public, what risk of embarrassment or loss of privacy would a participant face?
- Have I checked with others to ascertain if items in my research materials might be perceived as embarrassing, culturally offensive, or overly-invasive to participants?
- If I collect data on sensitive topics (e.g., sexual abuse), include protected populations (e.g., minors), or become aware of a participant's potential harm to self or others (e.g., intent to commit suicide), do I know my obligations to act (if any) under institutional policies and state laws concerning the protection of minors or mentally ill persons?
- If a participant starts to experience discomfort because of some of the questions on my instruments, have I made arrangements and appropriate referral services available to the person if the discomfort continues or is severe?
- Can I make myself readily available to all participants during my research via an array of contact avenues (e.g., phone, fax, e-mail, fixed mailing address)?
- Can I safely store my data in a locked location away from any eyes except those qualified co-investigators approved by IRB?
- Can I make sure that incentives (e.g., extra credit, money, other valuables) are evenly and equitably available to all participants, and that any incentive I use does not unduly entice a disadvantaged group or protected population to accept an unreasonable risk in participating in order to gain the incentive?