Wednesday, February 19, 2014

IRB application, q. 49-50


Questions 49-50 ask about whether you are including prisoners in your sample.  

q. 49. Will you be including prisoners? If yes indicate and go on q. 50. If no, indicate it and skip to q. 51. 

q. 50. Enrollment of prisoners requires that the IRB is able to document that the seven conditions under federal regulations 45 CFR 46 Subpart C are met.  If you plan to recruit individuals who are at high risk of becoming incarcerated in a penal institution during the research (e.g., participants with substance abuse history, repeat offenders, etc.), it is best that the IRB can address the Subpart C requirements at the time of initial review.  Otherwise, if a participant becomes incarcerated during the course of the research and the IRB has not previously reviewed and approved your research for enrollment of prisoners, all research activity must immediately cease for that individual until review and application of Subpart C regulations occurs by the IRB.

Understand that prisoners are a very protected population, if you want to do a study on them, there are many issues ahead. Start with reading the info provided on the IRB web site, talk to the warden of the facility and see what they require. There are a number of extra protections that can be done for prisoners, check the IRB site on this- look for info related to Federal certificate of confidentiality (to shield data from subpoena). 

Each of the following are yes/ no questions. 

q. 50a. asks whether the study will examine causes, effects, or processes of incarceration 

q. 50b. asks if this study examine the facility as an institutional structure? 

q. 50c. asks if this study specifically examine the experience of being incarcerated? 

q. 50d. asks if this study examine a condition(s) particularly affecting these prisoners? 

q. 50e asks if this study examine a procedure, innovative or accepted, that will have the intent or reasonable probability of improving the health or well-being of the participants? If yes, it asks that you describe if you will assign them to groups. 

Next time we will finish examining the IRB application, with q. 51-52. 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

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