Protection of Human Subjects in Research

US DHHS Proposes Changes to Human Research Subjects Protections Regulations

On September 8, 2015, the US Department of Health and Human Services (DHHS) issued proposed changes (Notice of Proposed Rule Making [NPRM]) to the regulations for the protection of human research subjects.

 

DHHS published the following list of the most significant changes proposed in the NPRM:

Time is Running Out to Register for PRIM&R's Nov 12 SBER Conference

Time is running out to register for Public Responsibility in Medicine & Research (PRIM&R)'s November 12 Social, Behavioral, and Educational Research (SBER) conference in Boston. PRIM&R is a non-profit organization based in Boston that advances ethical standards in the conduct of research, focusing on human subjects and vertebrate animal research.

PRIM&R’s November 12 Social, Behavioral, & Educational Research Conference in Boston

Public Responsibility in Medicine & Research (PRIM&R) is a non-profit organization based in Boston that advances ethical standards in the conduct of research, focusing on human subjects and vertebrate animal research.

Canadian 2nd Edition of Tri-Council Policy Statement (TCPS 2): Ethical Conduct for Research Involving Humans Released

The Canadian Panel on Research Ethics announced in December 2014 the revised version of the 2nd edition of the Tri-Council Policy Statement (TCPS 2): Ethical Conduct for Research Involving Humans. TCPS 2 (2014) replaces TCPS 2 (2010).

Researcher-Participant Confidentiality Privilege Changes in Canadian Law

The Canadian Medical Association Journal (CMAJ) reported on February 3, 2014 that researcher-participant confidentiality is now a formal concept in Canadian law.  The privilege will be applied on a case-by-case basis, according to the ruling from the Quebec Superior Court.    

World Medical Association's Declaration of Helsinki Revised in October 2013

The World Medical Association’s Declaration of Helsinki sets forth principles for the ethical conduct of biomedical research by physicians involving human subjects around the globe.  It was originally adopted in 1964 and has been updated periodically, most recently in October 2013.

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