3-16-2020

The Dickinson IRB is issuing an immediate temporary “pause” as of 3-16-2020 on active, approved IRB Protocols which involve any “in-person”/“face-to-face” contact with study participants. This includes those research studies which are/were a) determined to be exempt from review, b) expedited review, or c) full review.  This pause in “in-person”/“face-to-face” protocol activity will be in effect until further notice to ensure the health and safety of our researchers and research participants in our community. 

Given the current COVID-19 coronavirus outbreak, and the real or perceived risk of exposure, the risk/benefit ratio for research participation must be reassessed for each protocol. Ethical principles of research and federal regulations for the protection of human research participants require an acceptable risk/benefit ratio.

  • Studies for which there is little to no prospect of direct benefit to participants 

Study procedures involving in-person/face to face contact with participants at all locations, and participant travel for research purposes within that location must be paused, effective immediately or as soon as can be implemented.

Procedures such as telephone contact or monitoring or remote data collection if part of such studies may be approved and proceed only if an Amendment to your protocol is approved by the IRB. IRB will review your amendment and determine if your revised protocol may move forward without pause. See special instructions for filing an Amendment below.

  • Studies for which there is direct benefit to participants.

These studies must also be paused. If it is possible to conduct protocol activities remotely by telephone or electronically, you must first file an Amendment to your protocol. The IRB will review your amendment and determine if your revised protocol may move forward without pause. See special instructions for filing an Amendment below.

  • Studies for which data collection and contact with study participants has ceased, and only data analysis by the PI and associates is proceeding.

These type III studies need NOT be paused.

How to File a special Amendment to your Protocol:

See instructions regarding COVID-19 Amendments on IRB Mentor’s Info page

 

Students:  We understand fully the unfortunate consequences this situation may have on the completion of your studies. Please understand this is “pause” is intended to be temporary, and it will be lifted as soon as it is safe to do so for all concerned.  Please contact your professor/mentor to discuss alternate research plans.  The IRB will not officially terminate your protocol without input from you and/or your Protocol Supervisor.

Note that the IRB will not close operations. We will continue to attend to business as normal, and Mentor will be operating normally.

See the Dickinson IRB Website for updates and a notice of when the temporary “pause” is lifted. http://www.afrikaar.com/homepage/78/institutional_review_board.

IRB Chair: Dan Schubert

IRB Members

IRB Institutional Officer: Neil B. Weissman, Provost and Dean of the College

 

 

8/23/2017 Revisions to the Common Rule will require minor changes in IRB policy, protocol submission and review processes, effective Januay 1, 2018.  Oral history and similar research is specifically excluded from IRB review under the new Common Rule.  The Committee is working hrough the various changes in fall 2017, and will announce them at an appropriate time. We anticipate that the revised processes will appear much the same as the are now.

5/10/2013 Dickinson's IRB policy statement (standard operating procedures, or SOP) was approved by the IRB and the College on May 10, 2013. The SOP document replaces the original policy dated 2003.  What specifically does not change is that oral history research remains excluded from IRB review, because it does not meet the federal definition of research that is subject to regulation. The SOPs are now available here (use your Dickinson email and password to access) and as an indexed PDF on the IRB Mentor on-line submission system main page. The IRB intends to provide additional practical information - via FAQs and a Q&A - on IRB Mentor and on the IRB website, rather than integrating those in the SOP’s.  Note that the new SOP borrows substantially from that of the Fairfield University IRB where our IRB Mentor online protocol submission system was developed. FFU’s agreement to allow Dickinson's IRB to use their SOPs as a model is acknowledged with gratitude.