IRB Case Studies

Case Study 1 

The Institutional Review Board (IRB) works to review the proposed methodology for research studies, assess their ethics, and approve or disapprove the studies. The IRB does this by assessing  the risks and potential benefits of the proposed study. Risks include any form of physical, psychological, social, or economic harm. The IRB favors studies designed with minimal risk, and with benefits that outweigh the risks. In Case Study 1, there are minimal risks for the participants. The study is proposing to analyze race differences in HIV positive test results, by evaluating the participants’ HIV positive status and demographic data (race, ethnicity, gender, socioeconomic status, age group and education level). This data is retrospective because it was collected between 2010 to 2011 at government-funded clinics, while the patients were being tested for HIV. This data was anonymous , so the patients cannot be identified from their data. Because of these reasons, the patients did not need to provide informed consent for their data to be used. Furthermore, the participants are not at risk of the researchers or the public learning of their HIV status or demographic information. However, there are also minimal benefits for the participants- they already know their HIV status and they are not receiving any compensation for their data. The researchers are also at minimal risk, yet would benefit from a successful study. The main benefits of this study would be to society. This research would examine the intersection between race and HIV status, allowing public health and medical professionals a better understanding of the population HIV impacts. However, because the data came only from government-funded clinics in the Midwest from 2010-2011, the results would be most representative of that area of the U.S., during that time period. Therefore, this study would benefit from using more recent data, collected nationally. These risks and benefits will be used to determine which of the three levels of  IRB review this study would be categorized as. The three levels of IRB Review are Exempt, Expedited and Full. This study would need an Exempt Level Review because it presents minimal risks to the participants, researchers and society, while ultimately benefiting society.  

 

https://www.unh.edu/research/irb-review-levels

https://research.uci.edu/compliance/human-research-protections/irb-members/assessing-risks-and-benefits.html

5 Responses

  1. ardavis8 at |

    I agree with you on the type of review board this falls under. I also feel it would be exempt since it is dealing with anonymous participants that are at minimal risk. I think to do a study with data from this many years ago would be obsolete. I would like to see them do the study with more current information (within the past 5 years) and have it in areas that are more diverse so they can get a more true picture of the nation. Otherwise, I truly don’t see the point of doing the study.

    Qiao, H. (3/2018). A Brief Introduction to Institutional Review Boards in the United States. Pediatric Investigation; 2(1):46-51.

    1. Katie Gabel (Instructor) at |

      So this is actually how information is collected in free clinic testing sites. Knowing this, what you think the “point of the study” might be?

  2. Katie Gabel (Instructor) at |

    Don’t get too stuck on the timeframe here; consider the implications of simply retrospective (which you did in the original post). What other reasons would be present to support knowing demographics in relationship to preventable communicable diseases, and how could support come from ethical guidelines?

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