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OVPRI Human Subject Research Protection Blog

The VCU Human Research Protection Program is dedicated to facilitating ethically and scientifically sound research through robust review of research projects and through effective education and outreach to the VCU research community.

Upcoming RAMS-IRB Patch – RAMS-IRB will be down 11/15/18, 9:00 pm through 11/16/18, 1:00 pwhile this update is being installed.

  1. This update includes new/revised questions within the smartform.
    • Protocols submitted following the update will require responses to applicable new questions. If responses remain outstanding at submission, investigators may encounter an error message. You can identify and view outstanding smartform responses prior to submission by Editing the submission and then clicking on the Hide/Show Errors link in the smartform header.
  2. This update also includes a reduction in the number of days a submission will remain in a PI Action Required state before the submission is auto-withdrawn.
    • Submissions in PI Action Required states currently auto-withdraw from review if not re-submitted within 90 days. Following this update, this will change to 60 days. To avoid auto-withdrawal, please ensure submissions in PI Action Required states are resubmitted prior to reaching 60 days in this state.
  3. PIs and Protocol Editors will receive reminder notifications every 3 days while a submission is in a PI Action Required. We request your assistance in ensuring submissions are addressed and re-submitted as quickly as possible. This is especially relevant over the next two months as we prepare for regulatory changes of the upcoming revised Common Rule, which will go into effect on 1/21/19.

 Thanksgiving Holiday Schedule

The Office of Research Subjects Protection will be closed beginning at noon on Wednesday, 11/21/18 and will reopen on Monday, 11/26/18.

Investigators remain responsible for reporting to the IRB any unanticipated problems involving risk to subjects or others that occur during this time.

  • For guidance on what constitutes an unanticipated problem involving risk to subjects or others, refer to the VCU IRB Written Policies and Procedure #VII-6 at  research.vcu.edu/human_research/irb_wpp/VII-6.htm. In addition, as always, investigators are responsible for taking any actions necessary to ensure the ongoing safety of research participants.
  • To report an unanticipated problem involving risk to subjects or others:
    • Follow the normal procedure for submitting the Report within RAMS-IRB.
  • To seek guidance regarding an unanticipated problem or any emergency situation during the Thanksgiving holiday:
    • Call 804- 827-1533 and leave a message including a phone number where you can be reached. Messages will be checked daily and your call will be returned.

Winter Closing Holiday Schedule

The Office of Research Subjects Protection will be closed December 21, 2018 – January 1, 2019.

Expedited studies that are due to expire during the Winter Closing period should be submitted for continuing review as soon as possible to allow for IRB review prior to the Winter Closing.Categories IRB Members, News and Updates
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