IRB application, q. 43

q. 43 of the IRB application asks you to recognize what vulnerable groups may be present in your study and how you will protect them. First, recognize that you may have some of these vulnerable people in your study and not be aware of it (and that is fine, as long as you recognize it). 

q. 43A Minors (17 and under). Generally, you will only have minors if you are targeting that age group. Protections are parental consent, child assent, and they will be told that they can stop being in the study at any time. 

q. 43B Residents of any facility (prison, treatment facility, nursing home, assisted living, group home for minors). Carefully think about this one, even if you aren’t targeting on of the groups. If you are doing some kind of general survey, is it possible that someone from a facility might be included? Some possible protections are they will be told that they can stop being in the study at any time, if appropriate, they can skip questions, and they will self-select whether to participate. 

q. 43C Mentally disabled individuals. Same issues as above, could they participate and you not know it? Protections are same as q. 43B. 

q. 43D Emotionally disabled individuals. This is possible for virtually all studies, there is no way to really know. Some possible protections are they will be told that they can stop being in the study at any time, if appropriate, they can skip questions, and they will self-select whether to participate. 

q. 43E. Pregnant women. If you are doing a study that may include women of childbearing age (13-50), this is always possible. Protections are the same as in q. 43D. 

q. 43F Subordinates of the researcher. Think this one through carefully – because it raises red flags. The best protection is anonymity. 

q. 43G Students of the researcher. Think this one through carefully – because it raises red flags. The best protection is anonymity. 

q. 43H Clients or potential clients of the researcher. Same issues as q. 43F & G. 

q. 43I Individuals who might be less than fluent in English. This is a tough one, if you require that they read, write or speak extensively you may want to make being a Native English speaker an inclusion criteria. If you are doing an anonymous survey, it is probable possible that they may e in the study. You may want to consider having alternate versions of written materials available in different languages if you are looking at say, an immigrant population, but check with the IRB as there very specific requirements for doing this. 

q. 43J Individuals who are in crisis (such as natural disaster victims or persons with an acute illness). This one is generally possible with any study. Some possible protections are they will be told that they can stop being in the study at any time, if appropriate, they can skip questions, and they will self-select whether to participate. It is also a good idea to provide frequent breaks and offer to come back if they are fatigued. 

q. 43K Economically disadvantaged individuals. Again usually possible in any study. See protections in q. 43D. 

q. 43 Elderly individuals (65+). Another one to carefully think about, is it possible that someone of this age group might participate? If so, protections such as those in q. 43J may be appropriate. 

Next time we will continue examining the IRB application, with q. 44-45. 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