Required Human Subjects Research Training (CITI)

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

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

The remainder of this page explains how to fulfill step 1. To manage step 2, simply visit OneAegis and sign in using @iastate.edu credentials. This will allow OneAegis 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.

See the OneAegis How-To Guide for instructions on listing study personnel on IRB protocols.

Certification of human subjects protection training at Iowa State University is 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 (SSO) 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.

Iowa State University does not require researchers 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. Researchers can complete a Human Subjects Training Refresher Course to meet these training recertification requirements.

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

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 support staff and documenting their completion. These support staff do not need to be added to the IRB protocol.

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, as applicable to the study)
• Protection of privacy of subjects and confidentiality of research data
• Adherence to IRB-approved protocols
• Procedures for reporting unanticipated problems or adverse events

Some research projects require assistance from professional service providers, such as transcriptionists, translators, phlebotomists, clinical technicians, dietary staff, etc. To be considered a professional service provider, the individual’s involvement on the project must be 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.

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.

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.