Training

Human Subjects Education and Training

The University of South Alabama IRB requires Investigators, Co- investigators, coordinators, and key personnel involved (all persons who will be directly responsible for the study management, data collection, consent process, data analysis, transcription, participant recruitment, or follow up ) in research to complete required human subjects training.  The training curricula are as follows, according to your role:

▼   STUDENT RESEARCH

Initial Training

Human Participant Protections Education – Is a two hour web based training course that satisfies the NIH human subjects training requirement.  This course is required for all investigators and key personnel involved in the conduct of human subject’s research. The certificate of completion should be uploaded in your IRBNet user profile.  This course was developed and monitored by the NIH Office of Extramural Research.  Continuing Medical Education (CME) is available for successful course completion.

HIPAA for Research, if applicable

Investigators and key research personnel that obtain/maintain protected health information* (PHI) must complete the USA HIPAA in Research Training.  PHI obtained/maintained within the 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, Speech and Health Center, and Psychology Clinic.

* List of 18 PHI identifiers

▼   INVESTIGATORS- NON-BIOMEDICAL RESEARCH

Initial Training 

Human Participant Protections Education – Is a two hour web based training course that satisfies the NIH human subjects training requirement.  This course is required for all investigators and key personnel involved in the conduct of human subject’s research. The certificate of completion should be uploaded in your IRBNet user profile.  This course was developed and monitored by the NIH Office of Extramural Research.  Continuing Medical Education (CME) is available for successful course completion.

HIPAA for Research, if applicable

Investigators and key research personnel that obtain/maintain protected health information* (PHI) must complete the USA HIPAA in Research training.  PHI obtained/maintained within the 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, Speech and Health Center, and Psychology Clinic.

* List of 18 PHI identifiers

▼   INVESTIGATORS: CLINICAL RESEARCH

Initial Training

Human Participant Protections Education – Is a two hour web based training course that satisfies the NIH human subjects training requirement.  This course is required for all investigators and key personnel involved in the conduct of human subject’s research. The certificate of completion should be uploaded in your IRBNet user profile.  This course was developed and monitored by the NIH Office of Extramural Research.  Continuing Medical Education (CME) is available for successful course completion.

HIPAA for Research

Investigators and key research personnel that obtain/maintain protected health information* (PHI) must complete the USA HIPAA in Research training.  PHI obtained/maintained within the 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, Speech and Health Center, and Psychology Clinic.

* List of 18 PHI identifiers

GCP for the Experienced Investigator: Reducing Risks and Avoiding Common Inspection Findings

Clinical trial investigators are required to complete the online module entitled “GCP for the Experienced Investigator: Reducing Risks and Avoiding Common Inspection Findings”. The IRB requires completion and submission of the certificate provided for the above training course for clinical investigators prior to project approval. The certificate of completion should be uploaded in your IRBNet user profile.  This online course is accessible at:

Associates of Clinical Research Professionals (ACRP) – The USA ACRP training portal is only accessible by utilizing the ACRP generated login and password. Save the ACRP completion certificate, place it into your IRBNet user profile and submit for IRB acceptance.  NOTE:  The IRB must create an ACRP user account, please send a request to irb@southalabama.edu

Good Clinical Practice

All NIH-funded investigations/staff involved in the conduct, oversight, or management of clinical trials are required to complete GCP training, consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).  Training in GCP complements other NIH training requirements on protections for human subjects.

The FDA requires GCP compliance for studies conducted under an investigational new drug application or investigation device exemption.  GCP describes the responsibilities of investigators, sponsors, monitors, and IRBs in the conduct of clinical trials.  GCP training must be refreshed at least every three years in order remain current with regulations, standards and guidelines

Acceptable GCP online courses:

Collaborative Institutional Training Initiative (CITI)

Association for Clinical Research Professionals (ACRP)

▼   CLINICAL RESEARCH KEY PERSONNEL

Initial Training

Human Participant Protections Education – Is a two hour web based training course that satisfies the NIH human subjects training requirement.  This course is required for all investigators and key personnel involved in the conduct of human subject’s research. The certificate of completion should be uploaded in your IRBNet user profile.  This course was developed and monitored by the NIH Office of Extramural Research.  Continuing Medical Education (CME) is available for successful course completion.

HIPAA for Research

Investigators and key research personnel that obtain/maintain protected health information* (PHI) must complete the USA HIPAA in Research training.  PHI obtained/maintained within the 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, Speech and Health Center, and Psychology Clinic.

* List of 18 PHI identifiers

Good Clinical Practice

All NIH-funded investigations/staff involved in the conduct, oversight, or management of clinical trials are required to complete GCP training, consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).  Training in GCP complements other NIH training requirements on protections for human subjects.

The FDA requires GCP compliance for studies conducted under an investigational new drug application or investigation device exemption.  GCP describes the responsibilities of investigators, sponsors, monitors, and IRBs in the conduct of clinical trials.  GCP training must be refreshed at least every three years in order remain current with regulations, standards and guidelines

Acceptable GCP online courses:

Collaborative Institutional Training Initiative (CITI)

Association for Clinical Research Professionals (ACRP) 

Orientation on Clinical Research Fundamentals

Orientation 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 of and oversight of clinical research activities. 

Clinical Research Training Modules (SUPPLEMENTAL TRAINING)

Associates of Clinical Research Professionals (ACRP) – The ACRP training eLearning course catalog consists of 23 available courses, each providing CME/CEU credit.  The courses/links are located directly under the Welcome Screen – not through the course catalog tab at the top of the screen.

NOTE:  The IRB must create a ACRP user account, please send a request a irb@southalabama.edu

▼   ADDITIONAL TRAINING AND RESOURCES

Clinical Research Training Modules

Associates of Clinical Research Professionals (ACRP) – The ACRP training eLearning course catalog consists of 23 available courses, each providing CME/CEU credit.  The courses/links are located directly under the Welcome Screen – not through the course catalog tab at the top of the screen.

NOTE:  The IRB must create a ACRP user account, please send a request a irb@southalabama.edu

Seminar and Classroom Lectures

Contact Dusty Layton, Director, Research Compliance and Assurance at dlayton@southalabama.edu or 460-6625 if you would like to arrange a training session. 

DHHS Office of Research Integrity: The Research Clinic

This interactive training video educates clinical and social researchers on the importance of appropriately protecting research participants and avoiding research misconduct. The Research Clinic provides users to assume various roles in conducting research and determines the outcome of the storyline through selection of deciding on the course of action for each “playable” character. The video can be accessed HERE.

DHHS Office of Research Integrity

The Research Clinic (interactive training video)

Office of Human Research Protections: Educational Videos

These videos are listed on the OHRP YouTube playlist.

DHHS Office of Human Research Protections:
- Research use of human biological specimens

- Reviewing and reporting unanticipated problems and adverse events

- Research involving vulnerable populations

- General informed consent requirements

- Biobanking - When issues with tissues come a knockin'