You must minimize risk associated with your research.
If you do research at the university level as a student or professor, you will most likely deal with your school's institutional review board, or IRB. Other entities that conduct research involving human subjects, such as hospitals, also have IRBs. As the Bard College IRB notes, if your work "involves people as participants," your organization's IRB will need to approve it before you proceed.
IRB Function
An IRB does not review research that does not involve human subjects. Its main concern is to safeguard the rights of people who give their consent to participate in research activities, according to Bard College's IRB website. The IRB acts to ensure that you follow the proper procedures for recruiting and working with human subjects throughout your study.
Risks and Benefits
When you petition an IRB for approval of your research, you are essentially attempting to acknowledge potential risks associated with your study, along with concrete details as to how you intend to mitigate them. This risk is "the probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study," according to the Office of Research Administration of the University of California, Irvine. If your study can benefit its participants or provide advantages to them, you must also make this clear to the IRB.
Minimal Risk Definition
Although universities use their own, similar definitions of risk, the U.S. Code of Federal Regulations defines "minimal risk." From the Department of Health and Human Services website: "Minimal risk means that 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."
In other words, if you are administering a depression inventory to human subjects, you generally must note the possibility that some questions on the survey could cause emotional harm to the subjects, since they will be asked about their mental states and potentially sensitive subjects. This risk is greater than what people expect to encounter in daily life, such as walking out of your front door and having a tree fall on you.
Minimizing Risk
In your IRB protocol, you will detail what you hope to accomplish with your study. This is a benefit. For instance, if you are studying how physical layout of a neighborhood affects its sense of community, you might note that a potential benefit is that your study can yield information useful to urban planners to help them create socially healthy and cohesive places. IRB members will weigh this, and other potential benefits, against the "magnitude" of the risks presented to study participants.
In this example, the chances of "physical, psychological, social, or economic" harm is small or even non-existent. However, to justify the risk as minor in relation to the potential benefits, you must address your plans for safeguarding your research participant's privacy.
Considerations
Several ways for researchers to minimize risk in their studies are described on the website of the University of California, Irvine. One way is to put together an experienced and well-qualified research team. If you are a student, even at the graduate level, you might be required to include a professor as part of your research team. Although this isn't required, it's a good idea because it lets the IRB know that somebody with more experience than you is monitoring your work.
Following a sound scientific basis for your work--for example, citing past studies, using the proper sample size to produce meaningful results--also gives the IRB confidence that you know competently execute research.
