Updated Compliance Oversight for Clinical Trials

New NIH Biospecimens Security Policy

 

Updated Compliance Oversight for Clinical Trials 

By Catherine Branham, MBA, CHRC and Alyssa Conrad, MS, CCRC  

A cornerstone of responsible human subjects research, compliance monitoring maintains data integrity by identifying issues early,  safeguards participant well-being by ensuring adherence to approved protocols, and reinforces ethical standards through consistent regulatory review. 

In addition to protecting participants, monitoring supports continuous improvement and education for research teams. Monitoring also helps fulfill the UI human research protection program (HRPP) accreditation standards which require annual review of a minimum of 3–5% of active studies. 

The University of Iowa (UI) Human Subjects Office (HSO) and Institutional Review Board (IRB) have introduced an updated approach to clinical trial monitoring practices. The new clinical trials monitoring program will be similar to our current post-approval monitoring process and will include review of the  

  • IRB application and protocol,  

  • recruitment and consent materials, ,  

  • adverse event reporting, and  

  • investigational drug or device documentation.  

The clinical trials monitoring program will now include a review of case report forms. Data will be verified against source documents using EPIC. For studies utilizing OnCore and/or eReg, monitors will access subject registration, case report forms, and regulatory documents through those systems to establish protocol compliance. Access to EPIC, OnCore, and eReg is granted by the systems administrators following training and confidentiality agreements, coordinated with HCIS and study teams. The proactive, risk-based monitoring changes have been put into place to provide additional review of good clinical practice ethical standards that ensure participant safety. 

Monitoring Criteria and Risk Levels  

Studies will be selected for monitoring based on HawkIRB and Oncore Clinical Trial Management System (CTMS) usage. The depth of review is determined by risk level: 

  • Level 1: Minimal risk – 10% of records will be reviewed.  

  • Level 2: Low risk – 20% of records will be reviewed. 

  • Level 3: Moderate risk – 50% of records will be reviewed. 

  • Level 4: High risk – 100% of records will be reviewed. 

After monitoring, a report is drafted and reviewed by the IRB Chair, before being sent to the PI. The PI has 14 days to respond. If noncompliance is identified and could be considered serious and\or continuing noncompliance, the report will be referred to the convened IRB. 

Benefits of Monitoring 

Research teams may also request a clinical trial monitoring visit by contacting the HSO Compliance Team.  The benefits of a monitoring review include: 

  • Prompt identification of protocol deviations. 

  • Strengthened compliance culture. 

  • Enhanced research integrity. 

The at-request visit can help the research team prepare for an FDA audit and/or provide confidence that all materials are in compliance. 

For more information, visit the HSO Compliance Monitoring page or contact: irb-monitors@uiowa.edu 

New NIH Biospecimen Security Policy

Effective October 24, 2025, the National Institutes of Health (NIH) established additional policies and standard practices for ensuring the security of human biospecimens. The NIH Biospecimens Security Policy applies to all human clinical and research biospecimens obtained from U.S. persons that are collected, obtained, stored, used, or distributed and that are supported or funded by any on-going or new NIH funding mechanisms regardless of NIH funding level. 

The Policy does not apply to cell derivative products or cell lines derived from human biospecimens of U.S. persons collected, obtained, stored, used, or distributed using on-going or new NIH funds that were commercially or publicly available prior to October 24, 2025. 

Requirements 

Entities (e.g., biorepository, institution, investigator) that hold human biospecimens within the scope defined above are prohibited from directly or indirectly distributing the human biospecimens to institutions or parties located in countries of concern, as of November 6, 2025, China, Cuba, Iran, North Korea, Russia, and Venezuela.  

In limited circumstances, the human biospecimens may be shared or distributed to countries of concern only if use of the human biospecimens is: 

  • to meet transactions required or authorized by Federal law or international agreements, including Global health, or necessary for compliance with Federal law; or 

  • needed in rare and compelling circumstances where the facility and personnel in the country of concern possess needed capabilities and/or expertise not available elsewhere, the use of the biospecimen cannot be delayed to a time when capability and/or expertise is available elsewhere, and done with the consent of the individual from whom the biospecimen was collected; or 

  • at the request of the individual whose biospecimen was collected, obtained, or stored using NIH-funds; for purposes of diagnosis, prevention or treatment of that individual; and in compliance with applicable Federal laws, regulations, and policies.  

As a reminder, the export of human biospecimens must follow all applicable export administration regulations. 

NIH requires all entities to retain documentation related to sharing or distributing biospecimens to countries of concern under one of the allowable limited circumstances and further document the quantity and content of the biospecimen material that was shared or distributed. Documentation must be retained and provided to NIH upon request. It is the UI Principal Investigator's responsibility to create and retain the required documentation and provide it to the NIH upon request.   

HawkIRB requirements 

  • Appropriate informed consent of subjects and IRB approval are required for collecting, obtaining, and using biospecimens. (Section VII.E.6 and Section X.4) 

  • Appropriate informed consent of subjects and IRB approval are required for storing biospecimens in a biorepository (Section XII).  

  • If the study of biospecimens includes genetic testing and/or any type of whole or partial genome sequencing, it also requires disclosure in the informed consent and IRB application (Section VII.C). 

  • If the study includes external sharing of the biospecimens, this also requires disclosure in the informed consent and the IRB application (Section X.5-6). 

Additional Principal Investigator Responsibilities  

  • Create and retain required documentation related to sharing or distributing biospecimens to countries of concern and provide documentation to NIH upon request. 

  • Notify DSP if you or your lab hosts a biorepository. 

  • When transferring tangible research materials (including human biospecimens) to an organization outside the UI, route a Material Transfer Agreement to DSP using a Non-Monetary Routing Form. 

  • If human biospecimens will be transferred to another institution under a subaward agreement, the University will ensure that the subrecipient institution is made aware of and agrees to comply with the NIH Biospecimens Security Policy requirements. This includes confirming that any human biospecimens obtained, used, or stored under the subaward will not be shared or distributed to institutions or parties located in countries of concern, except as permitted under the policy. These obligations will be incorporated into the subaward agreement through appropriate flow-down terms. 

If you have questions regarding IRB approval, please contact the HSO.  Questions regarding Material Transfer Agreements may be directed to DSP.  

Full policy details are available on the NIH webpage. 

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