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US discuss revision to research ethics requirements.

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By Terry Anderson September 7, 2011 - 11:56am Comments (2)

I recieved the following from the president of the Amer. Educ Research Association. Seems they are proposing to change and redcue the requirements for Research Ethics Board approval for minimal risk research.

IMHO this is great news and a move I hope is followed in Canada. I note one quote from the discussion paper hits the nail on the head " We believe that annual continuing review of research studies involving only activities that are already well-documented to generally involve no more than minimal risk may provide little if any added protection to subjects, and that it may be preferable for IRB resources to be devoted to research that poses greater than minimal risk."

 

We should indeed use ERB time and resources for real ethics issues, not for mindless, gate keeping.

Changes for the U.S. Federal Regulations for the Protection of Human Research Participants 

As you may know, in late July, the U.S. Department of Health and Human Services (HHS), in coordination with the Office of Science and Technology Policy (OSTP), issued an advance notice of proposed rulemaking (ANPRM) changes to federal regulations governing human research protections (45CFR46, Subpart A). The ANPRM seeks to protect research participants while advancing essential research. The potential changes are far reaching ranging from seeking to remove low-risk research with adult populations from consideration by Institutional Review Boards (IRBs) to introducing a new category of excused research that would not require IRB review but where otherwise exempt research would be registered and where research that only involves informational risk would not be reviewed by IRBs but could be alternatively governed by mandatory standards of data security.

AERA along with the Federation of Associations in Behavioral and Brain Sciences (FABBS) and the Consortium of Social Science Associations (COSSA), is leading an effort across research associations and organizations to examine the many aspects of changes intended to improve practices for human research protection and promote research. On September 1, 2011, AERA hosted a full-day meeting of 21 representatives from relevant organizations, and work is underway to continue our analysis and the preparation of a joint response.

Via this e-mail, I encourage you to examine the ANPRM and related information (http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html) and send any comments you may have directly to me at ethics@aera.net. The AERA Ethics Committee will also discuss the proposed changes. Those of you wishing to comment to DHHS may do so online, as noted in the ANPRM. The deadline for comments is October 26, 2011 at 5:00pm, Eastern Daylight Time.

Comments

  • Richard Kenny September 13, 2011 - 4:22pm

    Hi, Terry. I'm a little slow on the uptake here as I only saw this today (Sept. 13th), but have you passed this information on to the AU REB?  I am wondering how this relates to the new Tricouncil policies? The latter essentially govern our REB's actions, right, i.e., not legislation as in the US? Rick

  • Terry Anderson September 13, 2011 - 6:49pm

    Thanks Rick

    - good idea re Athabasca REB, I will do that. Problem is that this is just proposed US regulations and as you state, we are 'governed' by the Tri -Council guidelines, but it does show that the 'tide is turning' allowing us to get out from the over resrictive medical model research when doing low risk social sceince research which is the normal at Athabasca.

    Terry