Obama Administration Fast-Tracks Huge Rule On Patient Risks, According To Human Research Report

Worries arise over too-quick changes to patient safety

OMAHA, Neb., Sept. 24, 2015 /PRNewswire/ — Imagine you are about to take an experimental drug or get an experimental medical device implanted in you. Then you find out that your doctor only had 90 days of training on all the risks. And only part time at that. Still want it?

“That’s about what the federal government is doing now, with only a 90-day comment period on big changes to THE research rule that is supposed to protect people in experiments,” said Dr. Dennis Maloney of the Human Research Report.

The research rule is often called the Common Rule. It must be followed by most researchers being funded by the government. The Rule for protecting human subjects is complex, lengthy, and even followed differently by some federal agencies.

The recent proposed changes are explained in over 100 pages of small, 3-columned print in the government’s daily Federal Register publication. Maloney estimates that the research risk document is at least 100,000 words long (at http://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-21756.pdf).

“The government gives the American public only 90 days to read it, study it, and give feedback on it? In their spare time?” Maloney questioned. “These changes can affect hundreds of thousands of people who volunteer to be in experiments and their families too.”

“There is speculation that the Administration wants to ram these changes through before Obama’s term ends,” Maloney noted. “If it becomes a Final Rule before Obama leaves — good rule or bad rule — it will be very hard to fix later.”

The key ethics groups protecting human research subjects at hospitals and universities are called Institutional Review Boards, or IRBs. IRB members study local research proposals, approving or disapproving them based mainly on how safe the research is for research subjects.

“IRB members are scientists from many fields, members of the clergy, community citizens, etc. Many volunteer their IRB time, on top of their full-time jobs,” Maloney said. “It took the government four years to review public comments from an earlier 2011 proposal on the Common Rule,” he pointed out. “90 days is an unacceptably short time to study what the effects of these new changes might be on the safety and welfare of research subjects and their families,” Maloney added.

Anyone can request an extension of the short 90-day comment deadline on this vital rule on research risks (due by December 7). Requests can be sent on the Internet to http://www.regulations.gov, citing Docket Number HHS-OPHS-2015-0008.

Dr. Maloney earned his Ph.D. in Experimental Psychology in 1973 and is the founding writer and publisher of the monthly Human Research Report. Now in its 30th year, the Report (on the Web at HumanSubjects.com) is written mainly for IRBs. It contains updates on human research regulations, laws, lawsuits, and anything affecting the safety of people who agree to participate in experiments.

SOURCE Human Research Report