IRB application, q. 44-45

Questions 44-45 of the IRB application ask you to go into more detail on the issues that you listed in q. 43. 

q. 44 asks you to justify the inclusion of each vulnerable group you identified in q. 43. If you are targeting one of the vulnerable groups, then explain that they are essential for your study. For other groups that you have marked as possible, indicate that you won't know if they are members of the groups and/or that it would be unethical to exclude them. 

q. 45 asks that you consider whether competency might be an issue and how you will deal with consent with these individuals. Let's take a step back and consider who might have questionable competency: the elderly, homeless individuals, mentally handicapped, and people who are seriously ill are common groups of concern. While some of these individuals are competent, there is also a percentage that may not be. You need a way to make sure that your sample is competent to give consent; a common method is using the Mini Mental Status Exam (look it up in the library). You will also need to determine how you will tell volunteers that they do not qualify for the study if you determine they are not competent. A method that I have used is to have them complete a couple of questions from the study and then thank them for participating (not telling them that I feel that they are not competent, and not using their data). 

It is possible that you want to target one of the groups that I mention above; another option is to get consent from their guardian (if they have one). However, you will still need to get assent from the participant. 

If competency is not a possible issue in your study, then enter N/A. 

Next time I will have a Valentine's Day message for you. 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