The human subjects protections landscape will be changing somewhat in the near future, although not drastically, due to new legislation and a long-awaited revision of the Common Rule.
On December 13, 2016, the 21st Century Cures Act became law; specifically, this legislation contains provisions affecting research involving human subjects as follows:
Strengthening protections of human subjects’...
The 2017 edition of the International Compilation of Human Research Standards is available from the U.S. Department of Health and Human Services' Office for Human Research Protections (OHRP).
According to OHRP, this resource "features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 126 countries, as well as standards issued by a number of international...
The UNH Institutional Review Board for the Protection of Human Subjects in Research (IRB) has set its Spring 2017 meeting schedule, available at http://www.unh.edu/research/irb-meeting-schedule.
Please contact Julie Simpson (603/862-2003) or Theresa Cherouvis (603/862-3536) in Research Integrity Services with questions or visit http://www.unh.edu/research/human-subjects.
The National Institutes of Health (NIH) recently issued two policies that impact the conduct of clinical trials that the NIH funds, either partially or in full. They are as follows:
NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
NIH Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-Funded Clinical Trials
The first policy requires that all...
UNH Sponsored Programs Administration (SPA) recently released guidance on Payment of Incentives/Compensation to Research Participants (Human Subjects). According to Louise Griffin, Senior Director of Research and Sponsored Programs Administration, the guidance was developed to “…meet the increasing needs of the research community, minimize the administrative burden, and comply with federal...