OHRS Updates to Study Staff Review and Approval Process

As of October 17, 2026, study staff will now be added and approved to research protocols in iRIS. The Institutional Review Board (IRB) must approve research staff working on all research studies. As such, we have launched a new form titled the Research Team Update Form (HCC member or staff login required to download). This form can be found linked in iRIS or the Office for Human Research Studies (OHRS) website and will be submitted to add or remove staff on all non-exempt research studies. This form will document staff members, whether they have met their institutionally required human subjects research training, and whether they need and have completed the Outside Interest Form. For all active studies, this form will be submitted as an administrative modification in iRIS for IRB review, and if necessary, the Office of Research Integrity and Compliance (ORIC) review whenever a disclosure indicates a potential conflict that requires review and management. For new studies, staff will be added to the iRIS shell at the time of the New Protocol Application submission and routed for IRB and ORIC review. OHRS and ORIC will be holding Office Hours to review this process. 

OHRS & ORIC Office Hours Session

Oct 20, 2026 | 11:00 AM - 12 PM

OHRS and ORIC will hold an HCC-wide Office Hours to discuss the new operational process to add staff into IRIS for IRB approval after the 10/17 iRIS release. OHRS will present the steps for updating iRIS with research staff and ORIC will discuss the financial disclosure part of this process. 
 

Study team members to be listed in iRIS:

•  Individuals are considered HCC study team members when they:
• Act as a Principal Investigator, Co-Investigator, Sub-Investigator, Study Coordinator, Research manager, or Protocol Statistician;
• Interact with human subjects (e.g., facilitating the informed consent process, manipulating a subject’s environment for research purposes, conducting research procedures);
• Collect, report, or analyze identifiable research data or specimens; Or conduct activities for research that is outside the scope of their regular work practice

Individuals who are required to complete an Outside Interests Form (OIF):

• Any individual who "participates" in research, which is defined as an individual designated as responsible for the design, conduct, or reporting (DCR) of the research, regardless of title or position (responsible for DCR). 
• Examples may include: Principal Investigators, Sub-Investigators/Co-Investigators, Research Nurses, Biostatisticians, any other individuals identified by the principal investigator as responsible for DCR, or individuals who will be making a direct and significant contribution to the research, including recruiting subjects, administering informed consent documents, determining subject eligibility, generating study data, assessing primary endpoints, evaluating efficacy data, etc. 
• It is the responsibility of the principal investigator to identify which individuals are responsible for DCR of the research  

Individuals who should not be listed in iRIS:

• Staff members are generally not considered research team members when they are functioning within their regular work responsibilities, and their involvement in the research is limited to those activities within their normal responsibilities, without further contribution to the research. For example, clinical nurses acting in their normal scope who do not need specific training on the research protocol. Pharmacists generally do not need to be included as study staff in iRIS, even those that have received some training on the protocol.

Please let us know if you have any questions