April 14, 2016 - As promised, the piloted submission forms released on 3.1.16 have been updated to incorporate feedback and requests we recieved from the research community members who started using the new forms early. The most up to date versions (ORA v.2016.4) will be available starting tomorrow (4.15.16) via the IRB Forms page or the How to Submit pages. The revisions to the forms are to formatting only for improved user friendliness. We encourage those of you who downloaded the original revised versions to replace them with these newest editions.
For those who are not yet familiar with the new forms or the new process, we encourage you to take the time either individually or as a team in your department to review the forms and the “How To Submit” pages in the menu above. The instructions have been tailored to each type of submission to ease the transition of using the forms.
As discussed at the recently offered trainings for the new continuing review form, and as noted in the 2016 Forms Update Overview (also available on the website- see “How to Submit” tabs), the changes to the electronic submission system (HSERA) system are still in process and have not yet been implemented. There is a potential that HSERA will not be revised to align with the new paper submission forms by the required use deadline of June 1st.
When you begin using the forms in June as required, HSERA may continue to have the input fields (smart forms) that you are used to completing. In order to work around the system (and hopefully make submission easier for you while we await the revisions to be completed), we are asking you to complete the paper form and attach it on the confirmation page and to only fill in the HSERA question fields with references to the attached form to avoid inconsistencies.
Please keep in mind that when submitting a modification or any other submission which makes changes to the sections of the original HSERA application sections (i.e. Basic info, personnel, sponsors, sites, protocol, populations, etc.) – the changes should still be made in HSERA to align the application with the any revisions proposed as it is the IRB’s expectation that the HSERA application be in alignment with your study documents.
Additionally, the submissions and associated documents will be expected to be complete and comprehensive (see guidance provided on the forms for expectations). The IRB staff has been instructed to return any submissions that are incomplete as it pertains to the requirements listed in each submission form.
In addition, any submissions created after the June 1, 2016 deadline that do not include the new form or the required documentation associated with that submission type will be returned prior to screening.
If you have questions about any of these processes, please send your questions to the IRB general email (firstname.lastname@example.org) and your question will be directed to the most appropriate staff member.
Thank you for your continued efforts for regulatory compliance while conducting your research.
Tracy Ziolek, Director, Human Research Protections and the IRB Administrative Staff
3624 Market Street, Suite 301 South
Philadelphia, PA 19104