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[slack]

Hi all,

Does anyone have any idea when the proposed changes in the Common Rule (IRB guidelines) will be announced?  I'm most interested in the rules affecting social scientists who conduct surveys/interviews/observation with consenting adults.

I know they closed the public comment period on Oct 26th, but I'm wondering how long the whole process will continue to play out.  Any guesses? 

Our local IRB needs some reforms, but I'm not eager to put a lot of work into the project if the common rule is going to be drastically changed anytime soon.

Thanks!

s

[prof_smartypants]

bookmarking.

[polly_mer]

I don't know, but I am interested to see the answers.

[slack]

I emailed Jerry Menikoff, head of the Office of Human Research Protections.  He replied in less than 30 minutes.

It is hard to say when the next steps might be taken with regard to what was announced in the ANPRM. It would be inappropriate for me to guess regarding that time period.

Best,

Jerry  Menikoff

[octoprof]

Posting to be updated.

[germaneriposte]

Those involved in the process are being cagey (e.g., Jerry Menikoff's response above) but the rule-making process often takes years, especially when a. the rule hasn’t been changed in decades and b. so many federal agencies are covered by the rule.

[slack]

Years?  Yikes. 

Okay, assuming this process "could" take years, would any you try to reform your local IRB now?

Here is one issue I'm concerned about: Basically, we've been handed down new rules that make any type of open-ended interviewing impossible.  That is, without providing a detailed list of questions (not to be altered) at the point of initial application.

And there are others.

[octoprof]

Years?  Yikes. 

Okay, assuming this process "could" take years, would any you try to reform your local IRB now?

Here is one issue I'm concerned about: Basically, we've been handed down new rules that make any type of open-ended interviewing impossible.  That is, without providing a detailed list of questions (not to be altered) at the point of initial application.

And there are others.

Are we at the same university?

[prof_smartypants]

Years?  Yikes. 

Okay, assuming this process "could" take years, would any you try to reform your local IRB now?

Here is one issue I'm concerned about: Basically, we've been handed down new rules that make any type of open-ended interviewing impossible.  That is, without providing a detailed list of questions (not to be altered) at the point of initial application.

And there are others.

Here's the thing. What are they going to do about it if you alter the questionnaire. I mean, most of this research isn't exactly harmful - who is being harmed by open ended questions??? As long as confidentiality is maintained, and there is a signed consent form, WHO CARES? What liability is the university trying to eliminate by making these changes?

What's the impetus for this?

[thenewyorker]

Posting to be updated.

Ditto.

Thanks for starting the thread.

[slack]

Here's the thing. What are they going to do about it if you alter the questionnaire. I mean, most of this research isn't exactly harmful - who is being harmed by open ended questions??? As long as confidentiality is maintained, and there is a signed consent form, WHO CARES? What liability is the university trying to eliminate by making these changes?

What's the impetus for this?

Well, the reasons for the changers are largely specific to our institution.  New chair, new interpretation of existing rules, old political battles still being fought, etc.

The reason I care is not about my research, but my students'.  For projects where they are the PI, this is causing them real headaches.  

[slack]

Got a call back from another person at OHRP (I left a message before I emailed Menikoff).  She said the office has "no idea when--if ever--changes will occur."  She suggested I go ahead and propose reforms if I think they are merited.


Although I wish they would move faster, I gotta say I'm impressed that they even get back to me. 

[germaneriposte]

Even if the changes were to take effect tomorrow, there’s nothing in them (so far, at least) that would actively prevent your IRB from going ‘above and beyond’ as they are now. Don’t know how that affects your calculation.