Washington State IRB conversation

After wading through conversation with EWU's IRB with Ruth Galm last week, and they indicated that my work on gender-bias questionnaires in the gaming community did NOT fall under their responsibilities since I did the work independently of the university, but she said I would need to talk to the WA state IRB and/or pay the Spokane IRB to see, and that I might be in federal trouble, and/or have to worry about HIPAA, the WA State IRB representative assuaged those concerns.

Just off the phone with the WA IRB. The Washington State IRB is only if subjects, agencies, or data are affiliated with any Washington state entities. However, he was kind enough to walk me through my situation and make suggestions. Very short version of the 12 minutes conversation: He seemed to think I was neither at risk from federal or state regulations on human research, nor at risk from HIPAA, because of the nature of myself as an entity (not associated), and the nature of the data. The "journalistic" approach you suggested he thought appropriate and basically helps, but I definitely want to be careful in the future (And have learned a lot from this process alone), and I will want to find an IRB in the future if I want my work to be recognized as "scientific". He does think I walked a little bit of a thin line, but based on his seeming detailed knowledge of the regulations, but that I was in his opinion outside the scope of the regulations. He thought it would be okay publishing the information from the questionnaires. I am not able to get anything in writing, because that would engage a more formal process, but he seemed fairly certain I was not at any risk thankfully. He was glad that I erred on the side of caution to find all this out first. I will just be sure to also state in my disclaimers when I do release the results, that it was not part of any IRB process, etc.  Did not undergo peer review, etc. In the future I should be safe using anonymous questionnaires without requiring IRB approval, from a journalistic report, but if I want to get any academic acceptance or published by similar journals, I will need to wade through the whole IRB process in advance, in the future.  Phew!

T. Howard Stone

August 26th, 3:36 to 3:48 pm Pacific.

Telephone: 360.902.8075

http://www1.dshs.wa.gov/rda/hrrs/

The WSIRB is moving to a Web-based electronic protocol management system, ProIRB®. With ProIRB® research staff will be able to submit and track their WSIRB submissions entirely online. Interface and review forms will employ business logic to reduce time completing forms.

T. Howard Stone, J.D., LL.M., C.I.P., IRB Administrator

Maggie Frederick, M.P.H., C.I.P., Review Coordinator

Lilly Moneer, C.I.P., Compliance and Training Coordinator

Department of Social and Health Services

Human Research Review Section

1115 Washington Street SE,

P.O. Box 45205

Olympia, Washington 98504-5205

Telephone: 360.902.8075

FAX: 360.902.0705

Email: wsirb@dshs.wa.gov

State not interested. Only if state agency.

Find an IRB interested in review. Federal regulations, have to provide the provide the review in advance.

Can't do it retrospective.

Other options. find an affiliation. especially for publications that require IRB documentation.

Establish that the activity was not

generizable knowledge, trying to establish a hypothesis or challengeone. And this could be replicated in other populations.

Might have IRB decide that it doesn't require the review.

Not research defined by federal regulation, so not submitted for IRB review. Many activityies not researfh of that term. Not research that is systematicor developing to generlized knowledge. Not systematic, not sufficiently randomized.

related to 45cfr46

Federal regulation applies to institutions that undertake human research.

Separate HIPAA, applies to only covered entities, healthcare providers, clearing houses, and plans.

I am not these entities. this is not about their health.