In the upcoming months, the Yale Human Investigation Committee (HIC) will transition from accepting submissions of research protocols on paper to accepting submissions sent in via email. This transition only affects those researchers who would typically drop off physical copies of documents for review to the HIC office, and not those who routinely submit via Coeus. Anyone who currently submits in Coeus will continue to do so without change to the process. In order to allow for a smooth transition process, each department will submit protocol documents via email on a predetermined schedule. Please see below for the schedule and instructions on how to submit protocols via email. Please be advised that we cannot accept emailed submissions from departments before their scheduled deployment date; rather, such submissions will be rejected in their entirety. Paper submissions will no longer be accepted after 30 days from the transition date. If your department is not on the list or you are unsure when to start submitting via email, please send an email inquiry to firstname.lastname@example.org, or call the main HIC number at 203-785-4688.
Email for submissions: email@example.com Please be advised that emailing submissions to individual HIC staff members or other HIC email addresses will NOT be accepted.
Please be advised that electronic versions of the HIC forms (e-forms) are no longer available. For all electronic submissions use the WORD versions of the forms below. Signatures on the forms are not necessary if they are submitted via Coeus.
This section includes forms and templates that aid members of the Yale human research community in fulfilling their obligations to ensure that research is designed, conducted, and approved consistently and in compliance with applicable laws, regulations and Yale’s commitment to the protection of its research participants.
Persons conducting, supporting or reviewing research subjects for Yale IRB approval should familiarize themselves with these forms and templates. This section should be referenced regularly as forms and templates are revised to stay current with corresponding revisions and updates to human research-related policies, procedures and guidance.
New research protocols under RDRC: For new protocol submissions requiring RDRC approval, faculty researchers should use the paper application, which could be found by clicking here. At this time, completed applications should be submitted to the Yale RDRC (RDRC@yale.edu) as a PDF file for initial review and pre-approval prior to submission of the protocol to the IRB (HIC). However, final Yale RDRC approval cannot be granted, and PI’s cannot commence human subject research withoutofficial approval by the IRB.
Existing approved research protocols: Faculty researchers are not required to re-submit approved protocols to the Yale RDRC using the new application at this time. However, if there is an amendment to a currently approved research protocol the faculty researcher is required to submit the amendment using the paper forms, which can be found by clicking here. The completed amendment forms should be sent to Yale RDRC (RDRC@yale.edu) as a PDF file.
Adverse reactions associated with use of radioactive drugs in an RDRC approved research study: Faculty researchers are required to submit any adverse effects associated with a Yale RDRC protocol to the RDRC per the FDA regulations. These adverse effects should be immediately reported to the RDRC (RDRC@yale.edu and copied to Dr. Sinusas at firstname.lastname@example.org).
The first Yale University RDRC meeting will be held on January 22, 2015. All new or amended protocols to be reviewed during this meeting must be submitted by noon on January 19, 2015. Additional information regarding this newly formed committee will be forthcoming.
For questions regarding the application process, approvals and/or future committee meeting dates and deadlines, please contact Donna McMahon at RDRC_admin@yale.edu.
Last Revised January 16, 2015