Research Regulatory Requirements
Both federal and state law require a written informed consent form (ICF) be signed and dated by the subject or the subject’s legally authorized representative. California law also requires, in addition, that the subject or legal representative receive and sign a copy of the “Experimental Bill of Rights (PDF)”. FDA regulations require that documentation of the informed consent process be reflected in the case history report.
Per UC Davis Health Policy and Procedure (P&P) 2306: Legal Medical Record Content/Core Elements: All subjects who participate in clinical trials involving a drug or device must have their signed ICF and HIPAA Authorization uploaded to the media section in the patient/subject’s electronic medical record.
New Department of Health and Human Services (DHHS) regulations and National Institutes of Health (NIH) Policy have been issued addressing researchers’ obligations to register at ClinicalTrials.gov. The DHHS Final Rule and NIH Policy have an effective date of January 18, 2017.
Some of the significant changes under the new Final Rule & NIH Policy include:
- All clinical trials funded in whole or in part by NIH (including behavioral studies) are required to register and report on ClinicalTrials.gov.
- More frequent updating of data elements is required.
- Results information is required for all registered trials, including drug or device product that is not approved, licensed, or cleared by the FDA.
- The data elements required for registration and reporting have expanded.
They have implemented increased penalties for failing to properly register and report including financial penalties and the withholding of DHHS and NIH grant funds.
In compliance with the UCOP Business and Finance Bulletin IS-3 “Electronic Information Security,” UC Davis Health established the Information Technology (IT) Evaluation Process. University of California Office of the President (UCOP), UCD Health policies, and State and Federal law require all members of the UCD Health workforce to protect Protected Health Information (PHI) or Personally Identifiable Information (PII). PHI or PII without the proper safeguards can place our organization, and staff personally, at significant risk.
Clinical research that requires implementation or use of new applications, systems or devices requires an IT Evaluation prior to the start of the study. This is necessary to determine whether or not the new technology may inadvertently create technical instability or create security risks for UCD Health. It is recommended that the evaluation precede IRB submission, as it may take several weeks or months to complete. The IT Evaluation includes steps to determine if the new technology is secure and complies with applicable laws, regulations and policies. Some examples of research-related technologies that have been evaluated include:
- Mobile devices that are used to gather research data on human subjects
- Software that would be implemented on the UCD Health network or that would be used to access the UCD Health network
- Clinical devices that require network access or involve data transfer.
It is important to note that an IT evaluation is restricted to a review of the technical stability, security and feasibility of technology used at UCD Health. Approval of applications, systems or devices does not signify a commitment of IT resources, implementation costs or financial approval. To initiate an IT Evaluation, email the Information Technology Evaluation team.
All research and investigational equipment and equipment modifications brought into UC Davis Medical Center under a clinical trial approved by the Institutional Review Board and/or is non-FDA approved for use on human subjects must adhere to UCD Health P&P 2245, Research Equipment.
While clinical sites typically provide medical treatment to subjects sustaining injury/complication on a study, who will cover the costs may not always be a clear decision. Industry sponsor, insurance or even self-pay options are considered.
UC Office of the President (UCOP) Operating Requirement 95-05 (PDF) outlines the requirements for administration of agreements with private sponsors for drug and device testing using human subjects.
For more information or assistance with determination, email UCD Health’s Risk Management Department or call (916) 734-3883.