The Policies, Procedures, Guidance, and Documents that are part of the Human Research Protection Program at Harvard University Area IRB are collectively known as the “Toolkit”. The Toolkit consists of “living” documents that will be updated as our regulatory landscape changes. We will also provide additional guidance and IRB decision aids to assist the research community through the IRB review process. Here is an overview of the components of the Toolkit:
A notice of an unpublished document was filed on Thursday, January 17, 2018 at 4:15 pm to announce the January 22, 2018 publication of a “Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects”. As stated in the document:
“This interim final rule delays the effective date and general compliance date of the 2018 Requirements to July 19, 2018. The federal departments and agencies listed in this document are in the process of developing a proposed rule to further delay implementation of the 2018...
Conducting research in international locations is challenging in a number of ways: working with foreign governments, additional regulations and policies, and lack of infrastructure (such as internet accessibility) to name just a few. Based on your feedback we recognize that the human subject training requirements for foreign enumerators, who are part of the study team, have been challenging and that the content of the current training is not practical or easily understood by those who are not familiar with U.S. federal regulations.
Harvard IRB staff Tonya Ferraro featured in the PRIM&R blog, Ampersand, and explains how our IRB office leverages the Socratic Method to communicate the best way to handle difficult questions. Read more here -
Soon, the system that supports IRB reliance (under the Harvard Catalyst Master IRB Reliance Agreement) will undergo a phased shutdown. The last day to start a new request in the Harvard Catalyst system will be Monday, July 31....
NIH is extending the effective date of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research to January 25, 2018. The policy will apply to all competing grant applications for due dates on or after January 25, 2018. For R&D contracts, the policy will apply to all solicitations issued on or after this effective date.
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!