Can someone answer my questions about IRB approval?

[questiona]

So I have been working with two researchers for the past few years via a previously IRB approved research study. One of the researches graduated medical school and the other left to practice in a different state.
The IRB is no longer approved since it wasn't renewed before its deadline. So here are my questions:

1. I have a lot of data gathered from this research, if I want to use it on my own to create a manuscript for submission to journals, do I need to apply for IRB approval to use the data?
(I won't be needing to come in contact with patients anymore since I already have tons of data to look at)

2. Might be a stupid question, but how exactly does the process of writing and submitting a manuscript work?

3. If I do need to re apply for my IRB, do I have to list a research advisor on it through my university?

Thanks!

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[JoshSt]

So I have been working with two researchers for the past few years via a previously IRB approved research study. One of the researches graduated medical school and the other left to practice in a different state.
The IRB is no longer approved since it wasn't renewed before its deadline. So here are my questions:

1. I have a lot of data gathered from this research, if I want to use it on my own to create a manuscript for submission to journals, do I need to apply for IRB approval to use the data?
(I won't be needing to come in contact with patients anymore since I already have tons of data to look at)

2. Might be a stupid question, but how exactly does the process of writing and submitting a manuscript work?

3. If I do need to re apply for my IRB, do I have to list a research advisor on it through my university?

Thanks!

1. If it's patient data - if the data is depersonalized (i.e., it was already collected), no. As long as you don't collect new data and don't review new records, it was IRB-approved.

If it's animal / hazardous materials / something else data - it's fine as long as you don't collect new data.

Whoever wrote and is on the IRB-approval needs to be coauthor(s).

2. You need a mentor to help you through this. Varies from situation to situation, depends how involved/uninvolved your mentor is. Very long process, even with all data collected, it could take >>1 year to write a submittable manuscript, especially since you don't have prior experience. Get a PhD or physician to help you out, you're unlikely to succeed otherwise.

3. Again, the people who were on the IRB approval should be coauthors and involved in the manuscript.

Good luck.