Human Subjects Training (IRB)

On This Page:

Training Requirement
Obtaining Required Training
Accessing the Training through CITI
Alternatives to Online Training for Special Situations
Training for professional service providers (e.g., transcriptionists, translators, etc.)

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

For more information, please see Human Subjects - Persons Required to Obtain IRB Training.

Obtaining Required Training

Certification of training on the protection of human research participants at Iowa State University can be obtained by completing a free, 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 instructions below for accessing and completing training. After successful completion, certification of training will be automatically registered electronically with the Office for Responsible Research. 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.

Accessing the Training

In order to access the CITI Human Subjects Protection training course, you will need to create an account in the CITI program if you do not already have one.

Instructions for New CITI Account Registration:

  • Go to the CITI training website.
  • Click on the “Register” button located on the top right of the page.
  • Complete the steps in the registration form as follows:
    • Step 1: Enter “Iowa State University.”
    • Step 2: Enter your name and ISU email address. You MUST use your ISU email address as your primary email to facilitate automatic notification of training completion to IRB staff.
    • Step 3 through Step 6: Complete the requested information.
    • Step 7: There are two educational tracks for the Basic Human Research Course:Social and Behavioral Research or Biomedical Research. To receive maximal benefit, you should choose the track most closely related to the research in which you are involved.
  • If your registration is complete, click on “Finalize Registration.”

 

    Once your account is created, or if you already have an account, you may log in and select the training course most appropriate to your area of research. The following courses fulfill the human subjects training requirement:

    • Social/Behavioral Research Course -- best if you conduct primarily social/behavioral/educational research
    • Biomedical Research -- best if your research is primarily biomedical in nature

    Please Note: The Responsible Conduct of Research (RCR) course does not fulfill the training requirement for Human Subjects Protection, so please make sure you select the correct course.

    Click on the course name to begin the course. If you need to change your course registration, click “Add a Course or Update Learner Groups.”

    Please Note: If you have already registered with CITI at another institution, you may transfer CITI training records (even if it says they are expired) to Iowa State by completing the following steps:

    1. Access your CITI account and click on the “Affiliate with another institution” link. Choose Iowa State University from the drop-down menu. When prompted, choose the human subjects research course you completed previously.

    2. Click on “My Profiles” at the top of the page and select “Change my email address.” Enter your ISU email address where prompted for the primary email address.

    3. Click "Add a Course" and choose Human Subjects Protection, then follow the prompts and choose either "Social/Behavioral Research Course" or "Biomedical Research", as it says above. 

    Once you have added the course, the modules will autofill if you have taken any that are required by Iowa State University. You can click on the gradebook and see which ones you've taken, and which ones you still need to take.

    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.