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Old 07-12-2007, 03:13 AM
augigi
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Default Research in practice

No researchers here? I am an aspiring researcher. Having worked at a medical device company for the past few years, I've had a massive learning curve about what is required for human research, designing and performing trials, ethical requirements, government regulations etc etc and now I'm fascinated!

I am just finishing up my coursework for my masters degree, and need to do my research and thesis next year. I am planning to compare wound care products for ventricular assist device wounds on infection and healing rates.

I am moving to the US, so plan to do my research over there. Anyone with any experience with US HRECs/IRBs?? Hard/easy/depends where you are? Any hints to make a submission go easier?

Cheers,
Gen
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Old 07-13-2007, 08:17 AM
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Hi Gen!

I'll be watching your responses closely, as I am thinking about going into research myself (after much more schooling - just now going back for BSN). Your project sounds very interesting. I'll keep my eyes open for research information! I wonder if the National Institute for Nursing Research would be of any help. Their website is great.
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Old 07-13-2007, 01:43 PM
Marachne
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Default IRBs

I've just returned from 4 days at the coast....no, not having fun, studying w/the rest of my cohort for my comprehensive exams--the last hurdle before I go into dissertation phase. So yeah, I'm a (budding) researcher. I'm also on one of the (4) IRB boards at the University/medical center/research center I'm a student at.

It is definitely a matter of "it depends." It depends on what kind of research, what kind of risks, and how well you cover your bases--most important are appropriate consent, ways to protect privacy, and level of risk (well, and that the project displays good science -- theoretically the board doesn't look at that, but if the research is iffy, they're not going to approve. I know at my institution, which has the best research integrity offices, they say contact early and contact often as you're working on your study design so that you get things set up correctly the first time and don't have to make a million revisions. If there is no/low risk (usually this is limited to chart reviews and surveys) you can possibly get either an expedited or exempt status, and don't have to go through a full board review.

If you are doing your research as part of a degree from a Uni, you'll need approval from that IRB/HREC as well as from any institution you plan on collecting your data from. Sometimes institutions will give courtesy approval based on approval from another institution, but if it's in another country, I don't know. Also know that a lot of hospitals, unless they're big, do not have their own IRBs but use regional ones. And be aware that it can cost big bucks to get approval if you are not affiliated with the institution.

I don't know about using NINR for info, I think they figure you're going to work with your institution.
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Old 07-14-2007, 08:08 AM
augigi
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Default Thanks

Thanks for the info, that's really helpful!! I will be working for the US hospital, so lack of affiliation shouldn't be a problem. I didn't know the IRB assessed the quality of the research methodology, so that's handy to know.
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Old 07-14-2007, 02:07 PM
Marachne
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Technically, no, the idea is not judging the quality of the research (and if it is funded by something like NIH one generally assumes it has gone through a rigorous enough process), however, if the science is bad, then the risk-benefit equation of human subjects is affected. Why would one allow people to give of their time and energy, not to mention any possible risks, if the study is worthless?

As for hospital affiliation, not all hospitals have IRBs--it depends on how much research they do.
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