federal_register: 2013-15160
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2013-15160 | Notice of a Department of Health and Human Services Public Meeting and Request for Comments on Matters Related to the Protection of Human Subjects and Research Studying Standard of Care Interventions | Notice | The Department of Health and Human Services (HHS) is announcing a public meeting to seek public input and comment on how certain provisions of the HHS requirements related to 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 is requesting 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. This 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. | 2013-06-26 | 2013 | 6 | https://www.federalregister.gov/documents/2013/06/26/2013-15160/notice-of-a-department-of-health-and-human-services-public-meeting-and-request-for-comments-on | https://www.govinfo.gov/content/pkg/FR-2013-06-26/pdf/2013-15160.pdf | Health and Human Services Department | 221 | The Department of Health and Human Services (HHS) is announcing a public meeting to seek public input and comment on how certain provisions of the HHS requirements related to the protection of human subjects should be applied to research studying one... |