Human Research Protection Program

HITECH Act

Forms & Templates Biomedical & Social and Behavioral

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.

Yale University Radioactive Drug Research Committee (Yale RDRC)

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 albert.sinusas@yale.edu). 

Upcoming Meetings:

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