Protection of Human Subjects in Research

2017 Edition of International Compilation of Human Research Standards Now Available

The 2017 edition of the International Compilation of Human Research Standards is available from the U.S. Department of Health and Human Services' Office for Human Research Protections (OHRP).

Conducting Clinical Trials Funded by NIH?   Read about new requirements taking effect in January 2017

The National Institutes of Health (NIH) recently issued two policies that impact the conduct of clinical trials that the NIH funds, either partially or in full.  They are as follows:

50th Anniversary of Henry Beecher’s Ground-Breaking Article about Ethics in Clinical Research Involving Human Subjects

June 16, 1966 was the date that the New England Journal of Medicine (NEJM) published Dr. Henry Beecher’s ground-breaking Special Article on ethics in clinical research.  At the time, Dr. Beecher had been the world’s leading anesthesiologist for 30 years. The Special Article was aptly titled, “Ethics and Clinical Research.”  In his article, Dr.

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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