Required Human Subjects Research Training (CITI)

Training Requirements PIs Must Complete Before Conducting Human Subjects Research

Training Requirement

All investigators and key personnel listed on forms submitted for IRB approval must complete training on the protection of human research participants before the research will be approved. Data collection and contact with human subjects cannot start until written approval is received by the PI from the ISU Institutional Review Board (IRB).

The following individuals must be included as personnel on IRB applications and are required to obtain human subjects training:

• All members of the research team, including the principal investigator and all personnel who have contact or interactions with research subjects or with their private, identifiable information
• Faculty supervisors of student research projects
• Non-ISU investigators or key personnel who are collaborating with ISU investigators on an ISU research study when ISU is serving as the IRB of record for the study as designated by a formal written agreement

Individuals who are not required to obtain human subjects training include:

• Technicians whose only role in the research is to perform standard clinical procedures (such as a blood draw) that are part of the approved research protocol
• Dietary personnel whose only role is to prepare and deliver food
• Non-ISU investigators who are collaborating with ISU investigators on an ISU research study and who will be under the review of their own IRB

Getting Started

Researchers affiliated with Iowa State University need to complete two steps in order to be added as personnel on IRB protocols:

1. Complete the required training through the Collaborative Institutional Training Initiative (CITI) and
2. Sign into IRBManager, ISU’s online protocol system.

The remainder of this page explains how to fulfill step 1.  To manage step 2, simply visit https://iastate.my.irbmanager.com and sign in using @iastate.edu credentials.  This will allow IRBManager to import training records from CITI when the two systems sync each night.

Training records for personnel who are not affiliated with Iowa State must be attached using the “Add New Non-ISU Contact” process described in the Key Personnel section of the IRB application.

Obtaining Required Training

Certification of training on the protection of human research participants at Iowa State University can be obtained by completing a no-cost, web-based training course offered by the Collaborative Institutional Training Initiative (CITI). This training will help you identify research activities that involve human participants and help you understand how to protect the rights and welfare of all human participants involved in research.

Please carefully follow the CITI Training Course Guidance for detailed instructions on accessing and completing training. After successful completion, certification of training will be automatically registered electronically with the Office of Research Ethics. To ensure this occurs, you must select Iowa State University as your affiliation in CITI and use your ISU email address as your primary email for your CITI account. You do not need to send a copy of your certificate to IRB staff, but you should save a copy for your records.

In limited situations, certification of training from other sources may be accepted. Documentation of training from the other source(s) must be submitted to IRB staff and will be evaluated on an individual basis.

Refresher Training

Iowa State University’s Human Subjects Training policy does not require investigators to renew or refresh human subjects research training – the training is considered non-expiring. However, funding agencies may require that training be renewed at regular intervals. Iowa State has worked with the Collaborative Institutional Training Initiative (CITI) to establish a Human Subjects Training Refresher Course to meet training recertification requirements imposed by some funding agencies.

For guidance related to enrollment and completion of this online refresher course, please see CITI Refresher Course Guidance.

Alternatives to Online Training for Special Situations

The IRB recognizes that completion of CITI training may not be appropriate or feasible for support staff in certain limited circumstances. In those instances, the IRB may approve an alternative human subjects training program. If approved, the principal investigator assumes responsibility for training of support staff.

The following are examples of staff and circumstances under which an investigator may request IRB approval of alternative training:

• Field workers in remote areas or foreign countries without internet access
• Support staff with limited literacy
• Support staff not fluent in any of the languages in which CITI training is available

Investigators are encouraged to consult with the IRB early in the application process if alternative training may be needed. A detailed description of plans for alternative training must be described in IRB applications, including the proposed content of the training, plans for delivery, and documenting completion by support staff.

Alternative training must provide sufficient information to promote ethical treatment of human research subjects, as appropriate for the design of the research project and role of support staff. At a minimum, the following components must be covered:

• Ethical considerations for recruitment and informed consent (including parental consent, child assent, and consent from legally authorized representatives)
• Protection of privacy of subjects and confidentiality of research data
• Adherence to IRB-approved protocols
• Procedures for reporting unanticipated problems or adverse events

Training for professional service providers (e.g., transcriptionists, translators, etc.)

Some research projects require assistance from professional service providers, such as transcriptionists, translators, phlebotomists, etc. To be considered a professional service provider, the individual’s involvement on the project is limited to a specific service that they otherwise routinely provide as part of a company or other professional setting. Professional service providers are not considered to be members of the research team as they are not involved in the design or conduct of the research. Accordingly, they do not need to complete human subjects training as long as they operate under established and acceptable practices or policies that address relevant human subjects protection requirements (e.g., safety, confidentiality, etc.).

For example, technicians providing routine clinical services (e.g., blood draws, x-rays, etc.) in an established clinical setting are generally professional service providers. A transcriptionist with an established business or transcription company that routinely provides professional transcription services would be considered a professional service provider.

The principal investigator is responsible for vetting professional service providers before allowing them to work with human subjects or with their information. For example, PIs should carefully review the adequacy of transcriptionists’ confidentiality policies before sharing any audio/video recordings.

Names of individual professional service providers need not be listed on IRB applications. Instead, the IRB application should include information about plans for engaging these services and ensuring adequate protection of subjects or their data.