Reference no: EM133235713

You are collecting data on workers in a manufacturing plant in order to examine the association between job tasks and health outcomes. You will extract data from the employee personnel records on age, job tasks, average weight lifted daily, and exposure to noise in plant. 

Workers will also go through a health screening including:

• weight and height
• interview regarding chronic health conditions such as diabetes and heart disease
• blood draw to assay plasma lipid levels (plasma triglyceride and cholesterol)
• questionnaire to assess depressive symptoms 
• strength and flexibility testing
• screen to determine hearing loss

You originally planned to administer informed consent prior to collecting any data on each worker, but the employer says this can't be done because it would result in decreased productivity. The employer says they have told workers that participation is mandatory, so consent is not needed. 

You will enter data into an excel spreadsheet that will be saved on the hard drive of your laptop. During the hearing evaluation, you will write down the results on a piece of paper that includes the worker's name, age, and home address.  You will take these forms back to the lab at UC.

The employer wants copies of the data that you collect. The employer says anonymous data is OK, as long as you include age and gender of each subject.

Questions for Case Study

1. Do you need IRB approval? _____ Yes         _____ No        
   
   
   1. If you don't know, how do you find out?  

1. Is it reasonable to bypass the informed consent process in order to avoid decreasing worker productivity?
2. Describe why or why not:
3. Is it ethical for the employer to make participation in the study mandatory?
4. Describe why or why not:
5. Name at least 3 ways both the electronic and paper data be kept confidential and private:
6. Are there circumstances where you could ethically give the data to the employer? If no, why not? If yes, what are the biggest concerns with sharing the data and what could/couldn't be shared?
7. In your research you plan to ask a potentially sensitive question about depression and suicide. If one of your subjects responds by saying they are "severely depressed and suicidal," other than documenting their response in your dataset, do you have any further ethical or legal (e.g. IRB) responsibilities?
8. Name at least 2 potential risks/benefits for the worker regarding this study. [Remember: Each of these risks and benefits need to be in the informed consent.]