Changing rules of human research

[MeSci]

Interesting article in NEJM:

Perspective

Bringing the Common Rule into the 21st Century

Kathy L. Hudson, Ph.D., and Francis S. Collins, M.D., Ph.D.

October 28, 2015

On September 8, 2015, the Department of Health and Human Services (HHS) and 15 other federal departments and agencies issued a proposal to revise the regulations governing the ethical conduct of research involving humans.1 The current regulations were adopted by HHS in 1981 to implement the landmark 1979 Belmont Report. Adopted by other agencies throughout government in 1991, the regulations, informally known as the Common Rule, have changed little since their inception, while the research landscape has changed radically.

In addition to revolutionary advances in scientific knowledge and technologies, society has undergone tremendous shifts in recent decades that are highly relevant to the conduct of research. Today's studies are more likely to include multiple research sites and large numbers of participants. Research is moving toward a more participatory model, as volunteers increasingly expect to be partners in research — as exemplified by such studies as the President's Precision Medicine Initiative (www.nih.gov/precisionmedicine). Sharing data and biospecimens can accelerate discoveries, and increasingly sophisticated information can be obtained from biospecimens. The controversy that followed the 2013 publication of the genome sequence of the HeLa cell line (derived from tumor cells from Henrietta Lacks) underscores the need for greater involvement of and respect for research participants.2

Full article here.