IRB application, q. 16

Students often have problems with q. 16 of the IRB application, which asks about the level of risk for a series of categories. This section has several hidden landmines, that if you check them your study will be rejected. Having a minimal risk is not a deal breaker for your study, but you must recognize the possibility. Let's take a look at each section and look for the landmines. 

16A. Unintended disclosure of confidential information (such as educational or medical records). The key words here are "unintended disclosure", in other words someone telling you something not related to your study. If you are doing an interview this is always a minimal risk – you never know what people will say. How to minimize the risk? State that you will stop them if they go into confidential areas that you do not need to know about. 

16B. Psychological stress greater than what one would experience in daily life (e.g., materials or topics that could be considered sensitive, offensive, threatening, degrading). If you are asking questions that people may be embarrassed or uncomfortable about, such as about sex, alcohol use, loss of a job, loss of a spouse or child, etc. it is at least a minimal risk. If your entire study is about the sensitive topic than it probably is a substantial risk and you will need to provide a list of low cost counselors or have a counselor available. 

16C. landmine Attention to personal information that is irrelevant to the study (i.e., related to sexual practices, family history, substance use, illegal behavior, medical or mental health). You should only be asking about information absolutely necessary for your study. Be careful about including any of the topics listed unless required for your study. 

16D. landmine Unwanted solicitation, intrusion, or observation in public places. You are not allowed to recruit (i.e., solicit participants in public places). You are also not allowed to observe people for research unless they are aware of it. 

16E. Unwanted intrusion of privacy of others not involved in study (e.g. participant’s family). Will you be able to guarantee privacy for your study? If not, indicate that it will be a minimal risk. This is also applicable if you are doing the study online- you will have no way to know if someone is in the room.

16F. landmine Social or economic loss (i.e., collecting data that could be damaging to any participants’ or stakeholders’ financial standing, employability or reputation). This is a very serious issue and you will not be able to collect this type of data, unless you can guarantee anonymity. 

16G. landmine Perceived coercion to participate due to any existing or expected relationship between the participant and the researcher (or any entity that the researcher might be perceived to represent). Anytime you may know the participant, you run the risk of coercion (they feel obligated to participate). This is why you should not do research in your workplace. 

16H. landmine Misunderstanding as a result of experimental deception (such as placebo treatment or use of confederate research assistants posing as someone else). Any type of deception is strongly discouraged, this includes using a placebo or control group.  

16I. Minor negative effects on participants’ or stakeholders’ health (no risk of serious injury). An example of this one is when interviewing elderly or ill participants there is the risk of fatigue, so I would indicate a minimal risk. To minimize it, give frequent breaks.  

16J. landmine Major negative effects on participants’ or stakeholders’ health (risk of serious injury). You will not be allowed to do a study with any possibility of this. 

Next time we will continue examining the IRB application, with q. 17-19. Do you have an issue or a question that you would like me to discuss in a future post? Would you like to be a guest writer? Send me your ideas! leann.stadtlander@waldenu.edu