Protections for Research Subjects and Data-Sharing

[Brian MacWhinney]

Dear Info-CHILDES,

    Some of you may have already received a message from NIH regarding a request for comments on proposed changes in their policies regarding Human Subjects protection.  Recently Peggy McCardle, Chief of the Child Development and Behavior Branch, sent out a copy of this announcement and I am copying it here.  Earlier, I had provided comments and they did in fact reply to my input.  I said that, in the interest of scientific progress,  it would be important not to impose excessive restrictions on the sharing of data, particularly in the context of this segment of the proposed changes:

"4. Establishment of mandatory data security and information protection standards for all studies that involve identifiable or 
potentially identifiable data (Section V);"

Peggy pointed out to me that the more letters they receive on this issue, the more likely that they will respond positively.  Instructions on how to provide input are given in Peggy's letter which is attached.

-- Brian MacWhinney

On Oct 6, 2011, at 3:09 PM, McCardle, Peggy (NIH/NICHD) [E] wrote:



Dear Colleague:

HHS has announced a proposal to change Human Subject Research rules & policies and thereby improve the protection of human research subjects.

Your comments are sought.

Changes under consideration would ensure the highest standards of protections for human subjects involved in research, while enhancing effectiveness of oversight

The U.S. Department of Health and Human Services announced that the federal government is contemplating various ways of enhancing the regulations overseeing research on human subjects. Before making changes to the regulations – which have been in place since 1991 and are often referred to as the Common Rule – the government is seeking the public’s input on an array of issues related to the ethics, safety, and oversight of human research. The changes under consideration can be found in an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, published in the July 25 Federal Register. The proposed changes are designed to strengthen protections for human research subjects, but may also impact the conduct and design of your future research.

See http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html for ANPRM details and
http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html for how to comment.
 
 
 
Peggy                                
Peggy McCardle, Ph.D., MPH
Chief, Child Development & Behavior Branch, Center for Research for Mothers & Children

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