What training do my staff and I need to conduct Human Research?
This section describes the training requirements required by the IRB. You may have additional training required by other federal or state oversight agencies, institutional policies, or those specific to a research protocol.
Northwestern University requires all individuals involved in human research activities to complete human participant protection training and re-certify their training every three years. The IRB will withhold approval if these training requirements are not met.
These requirements apply to all persons engaged in human research and who are included in the eIRB+ study application. Those individuals include, but are not limited to:
- Principal Investigator and Co-investigators,
- Individuals named on a study grant or contract proposal,
- Individuals listed on an FDA form 1572 for the conduct of the research at the institution or an affiliate institution,
- Individuals who are responsible for the informed consent process or recruitment of research participants, and
- Individuals who obtain individually identifiable health information under a Northwestern Business Associate Agreement.
The Collaborative Institutional Training Initiative (CITI) Program provides research ethics education to the research community. The CITI program offers both initial and refresher courses covering human research and HIPAA requirements. The CITI program is the primary option for completing the Northwestern University IRB human participant protection training requirement.
- The CITI site can be accessed at http://www.citiprogram.org/.
The following training options are also available for those unaffiliated with Northwestern and who do not have access to complete CITI training and are acceptable to satisfy the requirement:
- Protecting Human Research Participants (PHRP) Online Training*
- CIRTification: Community Involvement in Research Training*
- Office for Human Research Protections (OHRP): Human Research Protection Training*
* These additional training are recommended for those unaffiliated with Northwestern and who do not have access to complete CITI training.
Additional training may be required for individuals when conducting research funded by certain federal agencies (e.g., Department of Defense, Department of Navy, etc.).
Training is valid for three years, after which time the individual must recertify.
All members of the study team involved in the conduct of Human Research must complete training. Members of the study team who have not completed human research protections training may not participate in aspects of the research involving human participants or their identifying information. Study team members should also receive protocol-specific training before the study starts, when there are changes to study personnel or responsibilities, and whenever study expectations change.
For each new initial submission received in eIRB+, the IRB Office will verify that all study team members (including volunteers and interns) have met the training requirement. If they have not met the requirement, the IRB Office will return that submission to the study team. You may re-submit for review only after all training requirements have been met or after removing individuals who have not met requirements from your study team as appropriate.
After the initial submission, it is the responsibility of the PI to verify and maintain a record that the training of all study team members is current in eIRB+. The IRB will continue to monitor human participant protection training dates for all PIs, Co-Is, and study team members for all submissions.
For individuals from outside of the institution with whom there is an IRB Authorization Agreement (IAA), it is the responsibility of the home institution to monitor and maintain current human participant protection training. For all external collaborators for whom Northwestern covers research oversight through an Individual Investigator Agreement (IIA), the Northwestern IRB and Principal Investigator are responsible for ensuring the collaborators maintain active and valid human participant protection training.
Maintaining a Delegation of Authority (DOA) log allows you to track study team training, in addition to keeping copies of certificates of completion of human participant protection training. Please find DOA templates on IRB’s Study Support Resources and Templates page.