Starting July 1, 2017 we will be located in the Richard A. and Susan F. Smith Campus Center, Suite 935, 1350 Massachusetts Avenue, Cambridge, MA 01238. We look forward to seeing you in our new location!
ESTR will be offline for a configuration update on Thursday, April 27 from 6:00pm ET to approximately 7:00pm ET. With this release, Harvard is adding some configurations to support IRB review, along with policy-based updates. Release highlights include:
SmartForm revisions to clarify prompts and requirements around interest reporting and listing study team members.
Activity and workpsace updates to support IRB staff in the review process.
Updated PI and Faculty Sponsor assurance to further clairify requirements assocaited with interest reporting and...
The Committee on the Use of Human Subjects (CUHS) office, staff, and IRB will be moving from the Faculty of Arts and Sciences (FAS), Research Administration Services (RAS) to the Office of the Vice Provost for Research (OVPR) in Central Administration (CADM), effective as of July 1st, 2017.
Historically, the CUHS was constituted as a standing faculty committee of the FAS, and the CUHS staff have remained embedded in FAS despite the growth in volume of human subject research from other university area schools (currently, half of the volume of research studies reviewed by CUHS are from...
White House Chief of Staff Reince Priebus issued a memorandum to all executive departments and agencies to freeze new or pending regulations -- giving the new administration time to review them. Any regulations that have yet to be sent for publishing in the Federal Register, the memo asks the agency to not send any regulation to the Federal Register until reviewed by someone selected by the President.
For those that have been sent but not published, the White House ordered the regulations withdrawn.
NIH's Office of Behavioral and Social Sciences Research announced that the Good Clinical Practice (GCP) training modules they have developed that are specifically tailored to social and behavioral science researchers conducting clinical trials are now available through the Society of Behavioral Medicine, including for non-members of the Society of Behavioral Medicine.
The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies have announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.
These revisions are an effort to modernize, simplify, and enhance the current system of oversight. ...
The National Institutes of Heath (NIH) policy on Good Clinical Practice (GCP) training takes effect January 1, 2017.
This policy establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).
The National Institutes of Health (NIH) is extending the effective date of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research from May 25, 2017, to September 25, 2017.
A copy of the NIH Policy was published in the Federal Register on June 21, 2016 (81 FR 40325). See https://www.gpo.gov/fdsys/pkg/FR-2016-06-21/pdf/2016-14513.pdf
Guidance and Frequently Asked Questions to assist in the implementation of the policy will soon be available at http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinicalresearch-policy/models...