Patient Consent Waiver
This article was originally published in SRA
Executive Summary
Use of consent waiver in emergencies challenged in US
Use of consent waiver in emergencies challenged in US
In a letter to the acting commissioner of the US Food and Drug Administration (FDA), Charles Grassley (Republican - Iowa), the chairman of the US Senate Committee on Finance, has questioned why the FDA allowed a clinical trial of a blood substitute product to be carried out on trauma patients in 18 states, in some cases without there being patient consent. In doing so, Senator Grassley has drawn attention to Federal Regulation 21 CFR 50.24, which explains the circumstances under which the usual informed consent procedures governing clinical trials can be waived.
Senator Grassley reportedly first became aware of the trial from a story published in The Wall Street Journal1,2. The Phase III trial was being conducted under the waiver provision which allows consent to be bypassed in emergency settings3. Under the regulation, waivers can be granted if the subjects face life-threatening situations and if the sponsor informs the affected communities ahead of time and explains the risks and benefits4.
In his letter, Sen Grassley acknowledged that an unknown number of community meetings were held in the 18 states, but he questioned the attendance and therefore effectiveness of those meetings. Anyone who did attend would have been able to opt out of the scheme by requesting, and wearing at all times, a wristband stating that he/she had opted out of the trial. But Sen Grassley asked whether this was fair. “Why should Americans have to wear a bracelet at all times to protect themselves from a government-sanctioned medical experiment if they happen to get into a car accident?” he asked.
The blood substitute, PolyHeme, is a haemoglobin-based oxygen-carrying resuscitative fluid that is intended to be used on patients at the pre-hospital stage as well as during the early hospital period. Northfield Laboratories, the manufacturer, began the Phase III trial in approximately 25-30 level 1 trauma centres in 2003. The trial was approved by the FDA and by 32 institutional review boards at level 1 trauma centres after patients reviewed the protocol and the results of previous trials with PolyHeme, the company said. It added that the trial had passed four interim analyses of the mortality and serious adverse event data by the independent data monitoring committee charged with its oversight5.
Sen Grassley said: “The idea that the FDA would put the burden on the public to opt out of this mass experiment is outrageous.” A meeting was scheduled for 22 March 2006 so that FDA officials could brief finance committee staff on the trial. Sen Grassley is also asking for a detailed list and summary of all clinical trials conducted under the waiver of informed consent regulation that have taken place from 1 January 1996 to February 2006.
References
1. US Committee on Finance press release, 23 February 2006, http://finance.senate.gov/press/Gpress/2005/prg022306a.pdf
2. Reuters citing The Wall Street Journal, 24 February 2006, http://today.reuters.com
3. Northfield Laboratories press release, 22 February 2006, http://phx.corporate-ir.net/phoenix.zhtml?c=91374&p=irol-newsArticle&ID=820512&highlight=
4. Code of Federal Regulations, Title 21, Volume 1, Sec 50.24 Exception from informed consent requirements for emergency research, www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.24
5. Northfield Laboratories press release, 24 February, http://phx.corporate-ir.net/phoenix.zhtml?c=91374&p=irol-newsArticle&ID=821855&highlight=