Training and Regulatory Compliance

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.

*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 - Update on the Requirement for Instruction in the Responsible Conduct of Research
• NSF - America COMPETES Act RECR Training Requirements

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 contact the Research Office for a submission pre-review. This pre-review must take place before the required approval by the Department Chair and Research Dean.

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

The goal of EHS at FAU is to provide and ensure a safe and healthy environment for students, faculty, staff, and visitors through comprehensive service programs and trainings. It is the responsibility of each faculty (PI) to make sure all EHS trainings are completed and maintained for themselves and their staff and trainees prior to engaging in research.

EHS Compliance Trainings

To identify the training(s) you need, please access the EHS Course Matrix for the most common course listings based on type of work/involvement and the associated required trainings.

To request specific EHS training(s), utilize the "OIT TICKET LINK" to submit a request for trainings. The request form will require additional information, including contact information, department, description of the ticket, place of work, and what type of laboratory or fieldwork. Based on the selected answers, pre-populated EHS trainings will be available for selection (more than one training may be selected in the request ticket). It is the responsibility of the trainee to request their own required EHS trainings; however managers/supervisors may also select trainings for their employees and will need the employee's FAUNet ID, name, and Znumber.

Many of the required trainings are conducted and managed/tracked through skillsoft's Precipio. Each faculty member will have a personalized Precipio profile that will enable them to view assigned trainings and access their past history of trainings. To access Precipio, please click on the "Precipio Training Link" and utilize your FAU Single-Sign On username and password.

Not all trainings will be listed on the EHS Course Matrix. To find other training courses you may want to take, please access the Precipio Course Library for a comprehensive list of available trainings. To access these resources, please visit the EHS Training Website.

• General
• NIH
• Basic Science
• Clinical Trial
• Social Science
• Human Genomic

The following 3 categories are guidance for researchers:

If my research involves data, what should I do?

PI must consult with COM IT Director 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 Novelution 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 Novelution system. Login to Novelution using your FAUNet ID and password.

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 Novelution to obtain a formal determination letter.

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