June 26, 2013
On June 26, 2013, the Department of Health and Human Services (HHS) announced in the Federal Register an August 28, 2013 public meeting to seek public input and comment on how certain provisions of the Federal policy for the protection of human subjects should be applied to research studying one or more interventions which are used as standard of care treatment in the non-research context. HHS specifically requests input regarding how an institutional review board (IRB) should assess the risks of research involving randomization to one or more treatments within the standard of care for particular interventions, and what reasonably foreseeable risks of the research should be disclosed to research subjects in the informed consent process.
HHS is seeking participation in the meeting and written comments from all interested parties, including, but not limited to, IRB members, IRB staff, institutional officials, research institutions, investigators, research subject advocacy groups, ethicists, and the regulated community at large. The meeting and the written comments are intended to assist HHS, through the Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health (OASH), in developing guidance regarding what constitutes reasonably foreseeable risk in research involving standard of care interventions such that the risk is required to be disclosed to research subjects. HHS is seeking input on a number of specific questions but is interested in any other pertinent information participants in the public meeting would like to share.
The public meeting will be held on August 28, 2013, from 9 a.m. to 5 p.m., in the Hubert H. Humphrey Building, 200 Independence Ave., SW, Great Hall, Washington, DC 20201; Metro: Federal Center SW station.
Deadline for Registering to Attend the Pubic Meeting:
While there is no registration fee, individuals planning to attend the public meeting in person must register to attend. Registration to attend the meeting will be accepted on a first-come, first-served basis and must be received no later than 5 p.m. on August 14, 2013. Due to space limitations, the number of registrants will be capped.
Deadline for Registering to Present at the Public Meeting:
Registration to present at the public meeting will be accepted on a first-come, first-served basis and must be received no later than 5 p.m. on August 7, 2013.
Deadline for Submitting Comments for the Public Meeting:
Written comments for discussion at the public meeting must be received no later than 5 p.m. on August 7, 2013.
Deadline for Submitting Comments after the Public Meeting:
In addition to materials submitted for discussion at the public meeting, individuals may submit other written comments after the public meeting. These comments must be received no later than 5 p.m. on September 9, 2013 for consideration by HHS.
An alternative to attending the meeting in person will be provided. Participants who cannot attend the public meeting in person will have an option to view it via live streaming technology. Information on that option will be posted at a later time on the OHRP website at http://www.hhs.gov/ohrp.
The Federal Register notice announcing the public meeting and details about the following: registering to attend, registering to present at the meeting, submitting written comments, viewing the public meeting via live streaming, issues for discussion, special accommodations, and, additional background information, can be accessed at: http://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/public-meeting-08-28-2013/index.html
