Michigan Lupus Epidemiology and Surveillance Program

Phone: 800-742-2300 : Category 9560

Fax: 734-998-7318

 

Frequently Asked Questions

 

Q: Why isn’t this project approved by my institution’s IRB?

This is a public health surveillance project. Reporting disease information to a state health department for surveillance is not considered research. This means that neither you nor your institution needs permission from your IRB before submitting data related to this request. For more information see the Office of Human Subjects Research Guidelines for Defining Public Health Research and Public Health Non-Research at the following website:

http://www.hhs.gov/ocr/hipaa/publichealth.pdf.pdf

Q: Don’t I have to get written authorization from my patients before giving out information?

No. HIPAA protects the privacy of individuals. But the law also recognizes that important public health activities must continue. HIPAA specifically authorizes you to give protected health information to the State when it is requested for public health surveillance purposes. Section 164.512 (b) of the privacy rule ensures that you are authorized to disclose to us information needed to report disease, including names and other identifiers, without obtaining prior consent. The information being requested is the minimum necessary to complete the project.

Q: My patients would be upset if a state official contacted them. If I report, will you contact my patients?

No. We will never directly contact persons you report to us. As the project progresses, we will give health care providers an opportunity to ask their patients if they would like to participate in future research, but any communication would come from the patient’s own health care provider.

Q: I have some patients who may have Lupus, but the diagnosis is not definitive. Should I report them?

Yes. In order to ensure the surveillance is complete, you should report all cases of suspected lupus. Project staff will review records in full and only those who meet project criteria will be included in the final prevalence and incidence estimates.

Q: I have lots of lupus patients – looking up all their names would be a hassle for me. Do I have to do this myself?

No. If you have a large number of lupus patient records at your facility, contact our project staff. Project staff members can come directly to your facility and work with you to find an effective way to identify lupus patients without taking too much of your time.

Q: Many of the patients I see may have other physicians. Do I report patients if I am not their only physician?

Yes. We expect that there will be some overlap of reporting as patients may be seen by a number of physicians. Our database validation and quality control will ensure that individuals are counted only once. When a Project staff member reviews the records they will determine the primary care physician.

Q: How do I report my cases?

We will help you determine the easiest way to report. This is based on the information you provide to us using the attached Physician Information Form. Currently, there are 3 ways for you to provide us with this information.

1) Complete the attached Physician Information Form and FAX to the secure MiLES FAX line at 734-998-7318.

2) Call 1-800-742-2300, enter category 9560 and leave a message with your contact information. A MiLES project team member will be in contact with you within 3 working days.

3) Complete the attached Physician Information Form (PDF file). Once complete, click the 'Submit' button located at the bottom of the form. This will electronically submit the completed form via email to miles-project@med.umich.edu

Remember, you only need to respond that you have patients to report, and the best way to contact you directly. If you have questions, contact 1-800-742-2300 and enter Category 9560 to leave your contact information. A member of the MiLES team will get back to you within 3 business days.

 

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