College of Medicine / Research / Training and Regulatory Compliance


       

Charles E. Schmidt College of Medicine
Florida Atlantic University
777 Glades Road
Boca Raton, FL 33431

561-297-4828
COMinfo@health.fau.edu

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.

Select an area to read more:

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. Click here to download the form. Volunteers will have additional paperwork.  Please note: faculty, staff and post docs must also complete required trainings prior to conducting research and this is the responsibility of the faculty (PI). Contact Melanie Weiss at mweiss@health.fau.edu if you have questions.

Required Trainings

The trainings below are required for all research laboratory/laboratory classroom personnel:

  • Laboratory Safety Training
  • Hazardous Waste Training

These two trainings can be completed online via Canvas and must be renewed annually. Visit http://www.fau.edu/facilities/ehs/training/selfenroll.php to self-enroll. Save a copy of your training certificates. Note: the courses say Refresher but you can take for your original training.

  • CITI Responsible Conduct of Research (RCR) Training

To access the course, follow these steps:

  1. Go to www.citiprogram.org
  2. As a new user, you will need to click Register Here to register for the training course.
  3. Select “Florida Atlantic University" from the Participating Institutions and click submit.
  4. Create a unique username and password and click “submit".
  5. Enter your personal information (first name, last name, e-mail) and click submit.
  6. Continue entering additional information (gender, degree, etc.) and click submit.
  7. Choose RCR module to complete.

Save a copy of your training certificate; this training must be renewed every three years.

  • FAU HIPAA Training
  • Module 1 - HIPAA - Security Rule for Covered Entities
  • Module 2 - HIPAA Privacy Essentials       

Visit http://www.fau.edu/hipaa/training.php to initiate HIPAA training. Screenshot your completion certificates.


Additional Trainings

Requirements will differ depending upon the type of research conducted.  Additional trainings may be required.  Each faculty member/mentor is responsible for keeping their lab in compliance and for indicating the proper training required for anyone under their supervision.

  • Bloodborne Pathogens Training -if anticipate exposure to human blood or other potentially infections materials
  • Radiation Safety Training-if using radioactive materials
  • Animal Training- There are multiple steps for personnel to work with animals including online and in person trainings. Visit http://www.fau.edu/research/research-integrity/animal-research-mandatory-training.php#collapseTwo for a complete list of requirements, including the CITI program animal module.
  • IACUC mandatory training: Contact Helen Munchow at amunchow@fau.edu
  • Vivarium mandatory training: Contact Carrie List at clist@fau.edu
  • Protocol amendment: Office of Research Integrity Dana Mulvaney at dmulvane@fau.edu The PI must process an amendment and add the student/volunteer/staff onto the protocol
    • Human Subjects Training- In addition to the CITI RCR module mentioned above, you will need to complete additional modules if working with human subjects.  You will select the most relevant module to your research discipline. The choices are: 1) Biomedical Research Investigators, 2) Social & Behavioral Research Investigators or 3) Data or Specimens Only Research. Keep a copy of your training certificate; this training must be renewed every three years.
  • Other trainings not listed here but may be required dependent on your role, such as Biological Shipping (can be done via CITI Program).
  • Institutional Review Board (IRB)- If your research meets the following two definitions then you are involved in research with human subjects: "Research" means a systematic investigation designed to develop or contribute to generalizable knowledge. "Human subject" means a living individual about whom an investigator conducting research obtains: 1.) data through intervention or interaction with the individual, or 2.) identifiable private information.

Please visit http://www.fau.edu/research/research-integrity/do-i-need-irb.php for more information.

  • Institutional Animal Care and Use Committee (IACUC)- The IACUCprovides oversight and assistance in ensuring compliance to all laws, regulations, and policies governing the care and use of research and teaching animals.

Please visit http://www.fau.edu/research/research-integrity/about-iacuc.php for more information.

  • Institutional Biosafety Committee (IBC)- Research experiments involving the use of human-derived substances (e.g. blood or blood components, tissues, cells, secretions, established human cell lines) require IBC review, and BSL2 guidelines must be followed while working with them. The following activities do not normally require IBC review:
    • Activities using only commercially available deregulated transgenic crops
    • Activities that involve only the in vitro use of nucleic acids (e.g., PCR, synthetic double stranded RNA) and does not involve the cloning and propagation of recombinant DNA in cells

Please visit http://www.fau.edu/facilities/ehs/safety/biological-safety-programs.php for additional information.



Last Modified 10/15/18