Grants, Training and Regulatory Compliance

All FAU personnel (faculty, staff, post docs, students, volunteers) participating in research must complete specific training and obtain relevant regulatory project approvals prior to the start of any research activity.

Grants

Grant 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).

The COM guidelines do not replace the FAU Office of Sponsored Programs Proposal Guidelines, we must follow those as well.

Grant 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.

Grant Assistance

Contact Dr. Laura Van Voorhis, Sponsored Research Administrator.

Training

Faculty, staff, postdoctoral fellows, students and volunteers must complete all required trainings prior to conducting research and that this is the responsibility of the faculty/principal investigator to manage and track. Contact Dr. Joanne Krasnoff if you have questions.

COM Research Training Checklist
The COM Research Training Checklist form is required for all COM faculty, staff, postdoctoral fellows, students and volunteers who conduct research. The form is used to ensure those who are conducting research are adequately trained and that the trainings are properly documented.
Student/Volunteer Access and Training Form

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.

Regulatory Compliance

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

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 Compliance Websites listed on this page.

CITI Responsible Conduct of Research (RCR)

CITI Responsible Conduct of Research (RCR)

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.

FAU RCR Training

See below table outlining the FAU CITI RCR requirements for sponsored research as per the Office of Research Integrity.

FAU CITI RCR Requirements for Sponsored Research
Research Integrity Faculty/Staff * Student (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

COM Guidelines for IRB Pre-Review and IRBNet Submissions Signatures

COM Guidelines for IRB Pre-Review and IRBNet Submissions Signatures

Pre-Review

In an effort to assist faculty with their IRB submissions, the COM Office of Research will provide a submission pre-review for human subject research that is greater than minimal risk and may require full board review.

The risk level is compared to “minimal risk” as defined by the federal regulations:

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45.CFR.46.102(j))(Common Rule).

If your proposed research includes any of the following, it may be categorized as greater than minimum risk and require Full Board Review:

  • Prisoners
  • Individuals vulnerable to coercion or undue influence
  • Procedures that might cause physical harm
  • Procedures that might cause significant psychological/emotional distress
  • Collection of information about highly sensitive topics
  • Collection of information about illegal behavior
  • Collection of information that could seriously harm the participant legally, socially, financially etc. if other people could identify them

Examples of studies which may require full board review:

  • Randomized treatment studies
  • Studies using investigational drugs and/or devices
  • Behavioral studies involving risky interventions, observations of illegal behavior or very sensitive data/questions

If your research meets any of the above criteria, please share your IRBNet project with Joanne Krasnoff for a package submission pre-review and signature. This pre-review must take place once the package is complete and before the required approval by the Department Chair and Research Dean.

IRBNet Submission Signatures

Obtain all required signatures prior to IRBNet submission.

FAU IRB Requirements

For new projects and those requiring continuing review, this is the Principal Investigator (PI), and Department Chair. For amendments, this is PI only.

The College of Medicine requires additional signatures from the Dept Chair and the Sr. Associate Dean for:

  1. Initial submissions and amendments for which the proposed research is greater than minimal risk and may require full board review
  2. All adverse events and protocol violation reports
Frequently Asked Questions

Frequently Asked Questions

The following 3 categories are guidance for researchers:

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 Research Data Security ‐ Background & Guidance Purpose.

Non-PHI (de-identified) data may be considered Not Human Subjects Research (NHSR). The Human Subjects Research (HSR) determination form should be completed and submitted via IRBNet for both funded and non-funded studies and for 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.

Do I need IRB?

Research deemed Not Human Subjects Research (NHSR): Refer to Do I need IRB

If you are uncertain whether you need IRB review, submit a request for human subjects research determination into the IRBNet system. If you do not have an account, please register as a New User to access IRBNet.

If the project is secondary use research, secondary research, funded, or you need an official letter, Policy 10.3.3 "Human Subjects Research Determination" provides more information on these types of projects.

*Note: If using a de-identified data set or specimen samples, a letter of collaboration from the cooperating institution stating this must be included. A data use agreement (DUA) or Material Transfer Agreement (MTA) may be required.

If my research is Quality Improvement (QI) or Project Evaluation (PE), what should I do?

For Quality Improvement (QI) and Program Evaluation (PE) Projects it is recommended to obtain a formal determination letter from the Research Integrity Office as official record for future publications.

The Human Subjects Research (HSR) determination form should be completed and submitted via IRBNet to obtain a formal determination letter.

If you have any questions or need more information, please contact the Research Integrity office at researchintegrity@fau.edu or (561) 297-1383.

Additional Information
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