Before a PI leaves the UI, they will need to inform the IRB and make changes to their project information in HawkIRB. The changes required will depend on several factors.  

These may include:  

Planning Ahead for HawkIRB Access 

When a PI leaves the UI, they will no longer have access to the HawkIRB system and are considered “deactivated” once their UI appointment has ended. This status is based on their UI employment status (HR records) or enrollment status (registrar records). If the PI has HawkIRB delegates, the delegates can complete limited submissions once the PI is deactivated, but only for the projects to which they have been assigned as a delegate. These submissions include submitting Project Close forms and Modification forms.  

As soon as the departure date is known, the PI should submit the appropriate forms to the IRB and others in the Human Research Protection Program (HRPP). These are a Project Closure Form (if the research will no longer be conducted at the UI) or a Modification Form to change the PI (if the study is not complete and research activity will continue at the UI under a new PI).  

Research Results 

The UI generally owns the primary research results generated from research conducted under its jurisdiction (see the Research Data Policy for more information). When a PI plans to leave the UI and would like to take the original data to a new institution, the transfer of the data/samples to the new institution must follow established guidelines. See Section II, Part 24 of the UI IRB Standard Operating Procedures and Researcher Guide and information about Data Use Agreements on the Division of Sponsored Programs website.  

Records Retention  

While the study is open and for a specified period after the study has closed, the University/VA Healthcare System and federal regulations require that the PI maintains the following records: 

Prior to departure, the PI should save copies of the completed application and IRB approval memos before they lose access to HawkIRB. All original, signed Informed Consent Documents must remain on the UI campus for the required time: 

The UI IRB record retention policy only applies to the documents listed above and not the data collected for the study. Study data must be stored according to confidentiality protections outlined in Section X of the HawkIRB application. Please note that study sponsors may require a longer retention period and/or broader definition of the records that need to be maintained. 

Ultimately, the PI is responsible for maintaining accurate files of IRB correspondence, approvals, and research records during and after completion of the study. Please see the UI IRB Standard Operating Procedure and Researcher Guide, Sec. II, Part 23 for additional details.  

To Submit a Project Close Form: 

When data collection is complete and the PI/research team will not work with identifiable research data/samples, they should submit a project closure. If the PI is planning to take data to the new institution, they should make sure that it is described in the HawkIRB application and approved by the IRB prior to closure. 

To create a Project Close form, log into your HawkIRB inbox. Under ‘Projects,’ click on the IRB number of the study you would like to close. 

• Under ‘Create Form,’ generate a Project Close Form. 

  

• Under ‘Create Form’ click on the Modification/Update Form 

After starting the modification, you will be routed to the Frequent Mods portion of the Modification Index. If you will be sharing data, please see the November 2023 IRB Connection article ‘Best Practices for Research Collaboration and Data Sharing’. 
 

Additional Information about Transfer/Departure/Change of Status Forms and Procedures is also available in this April 2023 article.  

AAHRPP Accreditation Review – Domain II. IRB 

The University of Iowa Human Research Protection Program (HRPP) is in the process of applying for reaccreditation to the Association for the Accreditation of Human Research Protection Programs (AAHRPP). This article is part of a series outlining the certification process and requirements.  

In previous articles, we introduced the three domains of the AAHRP accreditation review:  

This month we will focus on the IRB Domain. This area of the application and review process is focused on the requirements for the ethical oversight of research by an institutional review board (IRB) or ethics committee (EC). The supporting documents submitted with the AAHRPP application for this Domain will include HawkIRB application forms, workflow communications, and reviewer checklists; as well as meeting materials, internal standard operating procedures (SOPs) and policies in the UI Standard Operating Procedures and Researcher Guide. 

This article outlines the five Standards under the IRB Domain and the specific supporting documents for each standard 

STANDARD II-1:  

The federal regulations have specific requirements for the types of expertise and experience the board members must possess (e.g. scientific, non-scientific, and community/non-affiliated members). Additionally, the institution must manage potential conflicts of interest. To show that the UI IRB meets these requirements, the AAHRPP application will provide supporting documents, including the IRB rosters, disclosure forms, meeting agendas and meeting minutes.  

STANDARD II-2:  

The nine Elements under this Standard provide an outline for assessing whether the IRB members and staff participating in the review or research projects have protected the human participants utilizing the appropriate expertise, category of review (e.g., full board, expedited, limited review, or exempt), and the criteria for approval. The supporting documents for these Elements will include the HawkIRB application forms, reviewer checklists, and template letters to researchers.  

STANDARD II-3:  

This Standard addresses whether the IRB follows written policies and procedures for the approval of research. When assessing the application for this Standard, AAHRPP reviewers will rely on supporting documents that include the HawkIRB application forms, the primary reviewer checklists and the consent templates.  

STANDARD II-4:  

Focusing on how the IRB ensures protections for vulnerable populations, the supporting documents for this Standard will include HawkIRB application forms, reviewer checklists and informed consent templates.  

STANDARD II-5:  

This Standard contains two elements which address that the IRB has and follows policies and procedures for maintaining documents as proscribed by regulation and policies. The supporting documentation for the application under this Standard will include SOPs, HawkIRB, the IRB meeting minutes. 

In our next installment about AAHRP Accreditation, we will focus on the next Domain: Researchers and research staff members.