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Training

All persons engaged in Human Subjects Research at USA must complete adequate training before becoming involved in either a new or existing study. This applies to anyone directly responsible for study management, data collection, data analysis, the consenting process, transcription, participant recruitment (or follow-up), etc. The USA IRB required training, according to your role, is as follows:

  1. All students are required to complete Human Subjects Protection training for IRB submission purposes. The Collaborative Institutional Training Initiative (CITI) online platform is utilized to meet this requirement. This training does not expire.

    For instructions on how to access and complete this training, click here. If you have completed an equivalent CITI module at a previous institution, this certificate will suffice at USA.
    Note: If you have an existing CITI account but have not completed this particular training, please reference the above guidance document and begin at Step 5. You may need to add an affiliation with USA if your account originated at an outside institution.

  2. Protected health information (PHI) obtained/maintained within a USA Health Systems Covered Entity must comply with HIPAA privacy and security training requirements. USA Covered Entities include USA Hospitals, USA Physician’s Group Clinics, Mitchell Cancer Institute, the Speech Pathology and Audiology Clinic, Physical Therapy Clinic and Psychology Clinic.

    Any student accessing, recording or maintaining protected health information (PHI) within one of these HIPAA Covered Entities for research purposes must complete USA HIPAA in Research training. This training can also be located in the USA IRB Documents for Researchers library within IRBNet Forms and Templates. This training does not expire.

    Full list of HIPAA PHI identifiers.

  1. All DNP students are required to complete Human Subjects Protection training for IRB submission purposes. The Collaborative Institutional Training Initiative (CITI) online platform is utilized to meet this requirement. This training does not expire.
    For instructions on how to access and complete this training, click here.

  2. All DNP students are required to complete USA HIPAA in Research training. This training can also be located in the USA IRB Documents for Researchers library within IRBNet Forms and Templates. This training does not expire.
  1. All personnel engaged with human subjects (e.g., obtaining consent, interacting with participants, etc.) are required to complete Human Subjects Protection training for IRB submission purposes. The Collaborative Institutional Training Initiative (CITI) online platform is utilized to meet this requirement. This training does not expire.

    For instructions on how to access and complete this training, click here. If you have completed an equivalent CITI module at a previous institution, this certificate will suffice at USA.

    Note: If you have an existing CITI account but have not completed this particular training, please reference the above guidance document and begin at Step 5. You may need to add an affiliation with USA if your account originated at an outside institution.

  2. Protected health information (PHI) obtained/maintained within a USA Health Systems Covered Entity must comply with HIPAA privacy and security training requirements. USA Covered Entities include USA Hospitals, USA Physician’s Group Clinics, Mitchell Cancer Institute, the Speech Pathology and Audiology Clinic, Physical Therapy Clinic and Psychology Clinic.

    Any personnel accessing, recording or maintaining protected health information (PHI) within one of these HIPAA Covered Entities for research purposes must complete USA HIPAA in Research training. This training can also be located in the USA IRB Documents for Researchers library within IRBNet Forms and Templates. This training does not expire.

    A full list of HIPAA PHI identifiers can be seen here.
  1. All personnel engaged with human subjects (e.g., obtaining consent, interacting with participants, etc.) are required to complete Human Subjects Protection training for IRB submission purposes. The Collaborative Institutional Training Initiative (CITI) online platform is utilized to meet this requirement. This training does not expire.

    For instructions on how to access and complete this training, click here. If you have completed an equivalent CITI module at a previous institution, this certificate will suffice at USA.

    Note: If you have an existing CITI account but have not completed this particular training, please reference the above guidance document and begin at Step 5. You may need to add an affiliation with USA if your account originated at an outside institution.

  2. Protected health information (PHI) obtained/maintained within a USA Health Systems Covered Entity must comply with HIPAA privacy and security training requirements. USA Covered Entities include USA Hospitals, USA Physician’s Group Clinics, Mitchell Cancer Institute, the Speech Pathology and Audiology Clinic, Physical Therapy Clinic and Psychology Clinic.

    Any personnel accessing, recording or maintaining protected health information (PHI) within one of these HIPAA Covered Entities for research purposes must complete USA HIPAA in Research training. This training can also be located in the USA IRB Documents for Researchers library within IRBNet Forms and Templates. This training does not expire.

    A full list of HIPAA PHI identifiers can be seen here.

  3. Good Clinical Practice (GCP) training is required for all NIH-funded investigations/staff involved in the conduct, oversight, or management of clinical trials. The FDA requires GCP compliance for studies conducted under an investigational new drug application or investigational device exemption.

    Acceptable GCP online courses include:
  4. All study personnel responsible for the transport or shipping of biospecimens/biohazards must complete CITI Shipping and Transport of Regulated Biological Materials training. To access this training, please click here.

    This training is valid for one year and must be refreshed annually.

    If you have completed an equivalent module from a reputable source, this will suffice for USA IRB purposes. Please note that if no expiration date is listed on the current certificate one will be given in order to ensure annual training.

  5. Orientation on Clinical Research Fundamentals sessions are periodically scheduled to provide instruction on the basic fundamentals of clinical trial management. These sessions are designed for the novice clinical research coordinator and affiliated key research personnel involved in the coordination and oversight of clinical research activities.

All unaffiliated personnel are required to provide proof of Human Subjects Protection training from their institution. Additional training may be required depending on the type of research being conducted.

Please refer to the Research Education and Learning Matrix for additional information regarding training that may be required according to your field of study and/or type of research.

The Office of Research Compliance & Assurance offers in-person and virtual training, lectures, demonstrations and educational sessions for faculty and students.

For information on educational sessions or classroom lectures conducted by the IRB Administrative Office, please contact Dusty Layton, Director of Research Compliance and Assurance at dlayton@southalabama.edu or 251-460-6625.

For information on IRBNet presentations or demonstrations, please contact the IRB Administrator at irb@southalabama.edu or 251-460-6308.