Obama Administration Releases Final Rule Relaxing Patient Consent Requirements For Research
The revised regulation lifts a proposal that would have required scientists to get written consent before using patient samples, DNA or other “biospecimens” obtained during medical procedures.
Stat:
New Rules Ease Consent Requirements For Scientists Using Patient Specimens
With only two days left in office, the Obama administration on Wednesday issued new rules intended to protect people who participate in scientific research, stepping back from proposals that would have imposed significant new regulatory requirements on scientists. In particular, the administration abandoned a proposal that would have required researchers to obtain written consent before using cells, blood, tumor samples, DNA, or other “biospecimens” obtained during medical procedures, even when the samples were stripped of the person’s name and other identifying information, or obtained from earlier studies the person had participated in. That was intended to prevent outrages such as the unauthorized use of cancer cells from patients like Henrietta Lacks, the African-American tobacco farmer whose tissue was taken in the 1950s without her permission or even her (or her family’s) knowledge. (Begley, 1/18)
Modern Healthcare:
Patient Advocacy Groups Worry About Lax Consent Requirements In Common Rule
Patient privacy advocates are not pleased with the Obama administration's decision to release a final rule that lifts a burden on scientists working with human subjects. The revised Common Rule, as it's known, dials back a proposal requiring researchers to get written consent from patients before using any biospecimens obtained during medical procedures. The HHS issued the proposal in 2015. The draft drew more than 2,100 comments, mostly negative. (Conn, 1/18)
CQ HealthBeat:
HHS Releases Final Update To Medical Research Rule
The Obama administration on Wednesday released a sweeping final rule that will update many long-standing federal protection measures for people who participate in medical research trials. The regulation, known as the Common Rule, has not been revised since 1991. Several contentious provisions were dropped or scaled back from a draft rule released in September 2015, including a measure that was vigorously opposed by academic medical interest groups pertaining to the use of blood, urine and other samples from the human body in research. Lobbyists say the exclusion of the provision will likely reduce any opposition to the rule from congressional leaders who were concerned about the impact it would have on medical research institutions. (Williams, 1/18)
