Grants, Training and Regulatory Compliance

• College of Medicine Proposal Guidelines
  Proposal submissions for grants, contracts, subcontracts, and all other externally funded proposals must comply with the College of Medicine proposal guidelines. This timeline is necessary to ensure adequate review and timely approval of proposals by the College of Medicine (COM) prior to submission to the Office of Sponsored Programs (OSP). Click here to view the complete document. Contact Angelina Grimm, Assistant Director of Research Administration, if you have questions. The COM guidelines do not replace the FAU Office of Sponsored Programs Proposal Guidelines, we must follow those as well, and their policy can be found here.
  
  
• College of Medicine Proposal Routing Form
  The COM Proposal Routing form is used internally to collect important information regarding grant submissions. Please complete the form as soon as you know you will be submitting a grant so our team can provide you with assistance. Click here to complete the routing form. Contact Angelina Grimm if you have questions.
   
• Grant Resources 
  • NIH Biosketch
  • Facilities, Resources, Equipment – Contact Angelina Grimm
  • Sample budget justification
  • R01 Checklist

Student/Volunteer Access and Training Form

The student/volunteer access and training form is required for every student or volunteer participating in research, whether in a research laboratory or laboratory classroom. The form is used to grant access to facilities, verify that trainings have been completed and register students if taking DIS/DIR. Volunteers will have additional paperwork.

It is the responsibility of each faculty (PI) conducting research to maintain compliance for themselves, staff and trainees, following all FAU and College of Medicine guidelines.

College of Medicine: All faculty who engage in and mentor trainees in research and/or scholarship must complete and maintain the CITI Responsible Conduct of Research (RCR) online training. This training is good for 3 years and can be found at www.citiprogram.org.

FAU:

RCR Training - See below table outlining the FAU CITI RCR requirements for sponsored research as per the FAU Office of Research Integrity at https://www.fau.edu/research-admin/research-integrity.

RESEARCH INTEGRITY	FACULTY/STAFF*	STUDENTS (undergraduate, graduate)*	POSTDOCTORAL FELLOWS*
NIH funded	CITI RCR required 8 contact hours required of RCR live instruction (as applicable to grant requirements) see below*	CITI RCR required 8 contact hours of RCR live instruction required	CITI RCR required 8 contact hours of RCR live instruction (required for training and career development awards)
NSF funded	As stipulated in award terms and conditions, and/or as described in scope of work	CITI RCR required	CITI RCR required
Other federal awards including flow through	As stipulated in award terms and conditions, and/or as described in scope of work	CITI RCR required	CITI RCR required
All other sponsored research	As stipulated in award terms and conditions, and/or as described in scope of work	As stipulated in award terms and conditions, and/or as described in scope of work	As stipulated in award terms and conditions, and/or as described in scope of work

*Additional requirements as stipulated in the funding opportunity announcement and/or in the proposal. As stipulated in award terms and conditions and/or as described in scope of work.

References:

NIH https://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html 

NSF https://www.nsf.gov/bfa/dias/policy/rcr.jsp

Review Boards - There are multiple training and compliance requirements for research involving human subjects, animals and recombinant/synthetic nucleic acid molecules and biological materials, agents and toxins. Please visit the Research Integrity webpages below for details.

• Institutional Review Board (IRB): http://www.fau.edu/research-admin/research-integrity/human-subjects-irb/

See below table outlining the COM required approvals/signatures for human subjects research/IRBNet.

COM GUIDELINES FOR IRB APPROVALS
Updated 5/20/2021

Type	Required Approvals/Signatures
Category A (exempt minimal risk) Initial Submissions	PI and Dept Chair
Category B (expedited review minimal risk) Initial Submissions	PI and Dept Chair
Category C (greater than minimal risk/full board review) Initial Submissions	PI, Dept Chair and Research Dean
Category B Amendments (any change to original protocol)	PI and Dept Chair
Category C Amendments (any change to original protocol)	PI, Dept Chair and Research Dean
Response to Modifications/Information Required	PI
Continuing Reviews/Annual Renewals	PI and Dept Chair
Adverse events and protocol violation reports	PI, Dept Chair and Research Dean
Closures	PI

 

The following 3 categories are guidance for researchers: 

1. If my research involves data, what should I do?
   
   PI must add COM IT Director in IRBNet to review protocol procedures and provide guidance to the researcher in the development, approval and implementation of data security.  Refer to https://www.fau.edu/research-admin/research-integrity/research-data/.
   
   Non-PHI (de-identified) data may be considered Not Human Subjects Research (NHSR). The Human Subjects Research (HSR) determination form should be completed and sent by email to researchintegrity@fau.edu for non-funded studies, or submitted via IRBNet for funded studies and studies requiring a formal determination letter.
   
   College IT input should be sought for all research involving collection, use, storage and the transfer of data. The level of risk of the data will determine how that data is ‘managed’ and thus, we encourage investigators to involve the IT unit early on.
   
   
2. Do I need IRB?
   
   Research deemed Not Human Subjects Research (NHSR): Refer https://www.fau.edu/research-admin/research-integrity/human-subjects-irb/do-i-need-irb/
   
   Funded projects must be submitted through IRBNet using the HSR determination form.  Unfunded projects should be sent by email to researchintegrity@fau.edu for administrative review. If a formal determination letter is requested, also submit through IRBNet.
   
   
3. If my research is Quality Improvement (QI) or Project Evaluation (PE), what should I do?
   
   Quality Improvement (QI) and Program Evaluation (PE) Projects should be cleared, in writing, by the Research Integrity Office researchintegrity@fau.edu to have on record for future publications.
   
   The Human Subjects Research (HSR) determination form should be completed for non-funded studies and sent by email to researchintegrity@fau.edu.  For funded studies or to obtain a formal determination letter, the HSR form should be submitted via IRBNet.  Refer to https://www.fau.edu/research-admin/research-integrity/human-subjects-irb/do-i-need-irb/ .
   
   

• Institutional Animal Care and Use Committee (IACUC): http://www.fau.edu/research-admin/research-integrity/animal-subjects-iacuc/
  
  
• Institutional Biosafety Committee (IBC): http://www.fau.edu/research/research-integrity/Institutional-Biosafety-Committee.php
  
  

EHS - It is the responsibility of each faculty (PI) to make sure all EHS required trainings are completed and maintained for themselves, their staff and trainees https://www.fau.edu/ehs/.