Consent Forms and EMR Requirement
Both federal and California 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”. FDA regulations require that documentation of the informed consent process be reflected in the case history report.
Per UCD Health Policy and Procedure 2306: Legal Medical Record Content/Core Elements: All subjects who have signed a research consent and HIPAA Authorization form to participate in a research study must have their signed ICF and HIPAA Authorization uploaded to the media section in the patient/subject’s electronic medical record. References: http://intranet.ucdmc.ucdavis.edu/policies/hospital_policies_and_procedures/medical_records/2306.shtml
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.
For additional resources, see (1) Compliance memo on DHHS and NIH Policy & (2) CTSC website: http://www.ucdmc.ucdavis.edu/clinicaltrials/ClinicalTrialsGov/clinicaltrialsgov.html.
Subject Injury and Complications
While the clinical sites typically provide medical treatment to the subjects sustaining injury/complication on the study, who will cover the costs may not always be a clear decision. Industry sponsor, insurance or even self-pay options are considered.
For privately sponsored studies that are conducted pursuant to a private sponsor’s protocol (industry sponsor), the sponsor of the study is required to pay for the reasonable cost of treating injuries/complications directly resulting from participation in the study, including injuries/complications resulting from the study material or research procedures performed pursuant to the study protocol, to the extent that injuries/complications were not a result of negligence, willful misconduct or failure to reasonably act on the part of the study personnel (UC Operating Requirement 95-05, 13-01). Other costs that are incurred during conduct of the study but not directly resulting from the subject’s participation (i.e. typical for this type of disease or procedure) may be billed to private and government insurers, if consistent with their policies.
However, in the case of injuries resulting from the natural progression of a disease or illness, the sponsor would be responsible for any injuries if, and to the extent, the progression resulted from participation in the study. In some cases, determination of whether the complication was directly or indirectly related may not be clear.
Contact UC Davis Risk Management at email@example.com or (916) 734-3883 for help with determination.
When the trial is not conducted pursuant to a private industry sponsor protocol, the costs of treating study subjects for injuries/complications directly resulting from a study material or research procedures may be responsibility of the University or Medicare/private insurance plans, depending on whether the injury resulted from a research procedure designed to benefit the subject directly. Generally, Medicare and other health plans require proof of therapeutic intent and medical necessity for coverage of clinical trial costs and the University Subject Injury Policy will not pay or reimburse the participant for any injuries resulting from medical research procedures designed to benefit him or her directly.
For more information, contact Risk Management as directed above.
Private Support Research
The UC Davis policy on privately supported research can be located at http://manuals.ucdavis.edu/PPM/230/230-01.pdf. Of note, there have been several changes in the management of residual funds:
- Residual funds remaining at the close of the account after all costs, including F&A costs, have been recovered will be transferred to a departmental, unit, or dean's account designated to record and receive residual funds. These funds shall be expended in support of the teaching, research, and public service mission of the university, in accordance with established department or school practices.
- Residual funds in excess of 20 percent of each privately sponsored research activity budget will require a written explanation by the PI attesting to the nature and reason for the excess funds. Explanations shall be submitted to the unit head, dean, or Vice Chancellor, Research, as the next higher level of authority with confirmation that the residual funds have been deposited in the designated account.
- All residual funds in excess of 20 percent of project budget are subject to monitoring and potential audit review.
Information Technology (IT) Evaluations for Research
In compliance with the UCOP Business and Finance Bulletin IS-3 “Electronic Information Security,” UC Davis Health established the Information Technology (IT) Evaluation Process. UC and 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 UC policies as well as state and federal regulations. 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, contact the Information Technology Evaluation team via email at ITevaluation.newtechnology@ ucdmc.ucdavis.edu