I am very concerned... Do I have to be a student to submit an IRB form???

[libraryismyhome]

I am an alumni working on a clinical research project. Currently my title is neither a student nor a employee but a volunteer.

Since I am just getting data from a FDA approved device and make my project as a data review, my PI's study coordinator informed me that I don't need patient consent and just fill out IRB Retrospective Data Review Studies form.

And I also had to work on the form's additional paperwork such as Informed Consent Waiver form, Expedited Review Request Form, Hospital Medical Record form, HIPPA Waver form, and Researcher Assurance form.

I did my best working on them and arranged an appointment with my PI's study coordinator this morning, her supervisor(the head study coordinator) abruptly canceled my appointment cause I am not a student. I spoke to the supervisor this morning and she said that she will have a conference call with my PI and try to find out what's all about. What is going on??

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[SBR249]

I am an alumni working on a clinical research project. Currently my title is neither a student nor a employee but a volunteer.

Since I am just getting data from a FDA approved device and make my project as a data review, my PI's study coordinator informed me that I don't need patient consent and just fill out IRB Retrospective Data Review Studies form.

And I also had to work on the form's additional paperwork such as Informed Consent Waiver form, Expedited Review Request Form, Hospital Medical Record form, HIPPA Waver form, and Researcher Assurance form.

I did my best working on them and arranged an appointment with my PI's study coordinator this morning, her supervisor(the head study coordinator) abruptly canceled my appointment cause I am not a student. I spoke to the supervisor this morning and she said that she will have a conference call with my PI and try to find out what's all about. What is going on??

I feel that this may be a very institution-specific issue...