Strasser, Jane (strassje)

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1 Strasser, Jane (strassje) From: Strasser, Jane (strassje) Sent: Tuesday, April 12, :35 AM To: Subject: [UC-COMP-MATTERS] Compliance Matters--April 2011 April 2011 Happy spring! As it warms up, remember work safely, and as your summer students and/or new personnel join your team, train them and add them to your protocols. If you have a suggestion that will help us to help you, please contact us at research.compliance@uc.edu. Jane Strasser, PhD Director, Office of Research Compliance and Regulatory Affairs (ORCRA) Research Compliance Officer Research Integrity Officer IN THIS ISSUE: Spotlight On: Mandatory Training for FDA-Regulated Research ORCRA News IACUC News IRB News/New or Updated HRP Policies and Procedures Quality Improvement Tips for Investigators Biosafety News SPOTLIGHT ON: MANDATORY TRAINING FOR FDA-REGULATED RESEARCH UC is a recognized leader in clinical trials. To maintain and grow this recognition, we must consistently demonstrate that we meet or exceed the high regulatory standards that our sponsors and funding agencies demand of us. In particular, we must meet any and all requirements laid out for Food and Drug Administration (FDA)-regulated studies. The FDA has determined that investigators performing these clinical trials are not always appropriately trained. The agency has requested that supplemental training resources be made available, and that all investigators conducting FDA-regulated research demonstrate that they have the necessary knowledge base to maintain the integrity of their studies. All PIs, Co-PIs and CRCs working on protocols at, or approved by, the University of Cincinnati with research that is associated with an IND or IDE are required to complete the 11 training modules and the associated quizzes. Retrospective chart reviews alone, examining the outcomes of patients on a given drug, biologic or device during the course of clinical practice are not subject to FDA regulations pertaining to clinical research and training is not required. If your research is FDA-regulated you must successfully complete knowledge assessments by Dec. 31, To help with training, the IND/IDE Assistance Program has prepared an informational booklet, available for download at A series of 1

2 lectures has also been scheduled and a list of sessions and registration may be accessed via Whether you choose to utilize the booklet or inperson training, you must complete your knowledge assessment through the UC continuous professional development (CPD) website at ( ORCRA NEWS New Process The Post-Approval Monitoring Program provides quality assurance review in order to improve the quality of research and to facilitate compliant research. The program has recently changed the procedure for following up on site visits. Summaries of quality assurance review observations and investigator responses to recommendations will be addressed directly with quality assurance monitors. The IRB will be notified after all issues have been resolved. Download revised Procedure 325. If you have questions, please research.compliance@uc.edu. IACUC NEWS New Guide Impacts IACUC Inspections in Fall 2011 With the release of the eighth edition of the Guide for the Care and Use of Laboratory Animals earlier this year, the Institutional Animal Care and Use Committee (IACUC) will modify the current inspection process for fall In the new version of the guide, the IACUC is required to monitor all controlled substance logs during semi-annual inspections. This means that all principal investigators and their research teams will now be asked to present up-to-date documentation of all controlled substances utilized in their labs. While there are multiple changes in the eighth edition of the guide, the change in the monitoring of controlled substances is the most pertinent for all principal investigators and research teams. We will keep you updated as other potential impacts are identified. A copy of the updated guide can be found here. A comparison of the seventh and eighth editions can be downloaded here. Please feel free to contact the IACUC office with any questions you may have regarding the new inspection process or the eighth edition of the guide. IRB NEWS/NEW OR UPDATED HRP POLICIES AND PROCEDURES New Required Element of Consent The Food and Drug Administration (FDA) Amendments Act of 2007 has added a new required element for the informed consent document and processes for all applicable drug, biologic and device clinical trials. No modifications are needed or required to add this to existing studies and no re-consenting is required for the new information. The required element includes language informing participants that clinical trial information will be entered onto the clinicaltrials.gov databank. The new element must be included by March 7, The required element of consent is as follows: What is the Clinical Trials Registry? [Insert if your study is using an investigational drug, device or biologic, otherwise please delete] A description of this clinical trial will be available on clinicaltrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time. 2

3 This new language is included in the updated medical Informed Consent Document template which can be downloaded from the Institutional Review Board (IRB) website If you have any questions please contact Julie Waltz Gerlach, IRB office director at or (513) Research at UC Health University Hospital Research Administration at UC Health University Hospital is charged with assuring the integrity of research conducted at University Hospital, while protecting the safety and welfare of patients, visitors and staff directly or indirectly associated with research endeavors. Secondarily, Research Administration assures that hospital patient charges and billing are compliant with prevailing public and/or private insurance regulations and relationships with investigators adhere to standards of propriety and transparency. The purview of Research Administration includes all funded and unfunded clinical or social-behavioral research conducted by any persons on the property of University Hospital, including all inpatient facilities at University Hospital and Deaconess Hospital and all hospital-based outpatient clinics or services at the Holmes Hospital, Hoxworth Building, Outpatient Building, Barrett Cancer Center, A or B Pavilions or other hospital-leased facilities. University Hospital holds a Federal-Wide Assurance (FWA) from the U.S. Office of Human Research Protection and recognizes the University of Cincinnati Institutional Review Board (IRB) as its primary IRB of record. In addition, the hospital will recognize research protocols reviewed and approved by Cincinnati Children's Hospital Medical Center, Western IRB and Schulman IRB, if allowed by the faculty member s primary institution. Investigators wishing to conduct research at University Hospital should contact Research Administration for guidance as to budget preparation, forms submission and credentialing. University Hospital-based research includes, but is not limited to, accessing hospital records including protected health information and direct and indirect contact with patients, their family members and the public for clinical or social-behavioral studies. All investigational drug and medical device use will require prior approval through Research Administration. To request information regarding approval for the conduct of research at University Hospital or for guidance regarding research conducted at other UC Health facilities, please contact Research Administration at (513) or paul.volek@uchealth.com. QUALITY IMPROVEMENT TIPS FOR INVESTIGATORS Tip #1 Prior to accepting the role of principal investigator, ensure that you have sufficient time and resources to properly conduct and supervise the study. When reviewing time and resources consider the experience of the study staff, current workload, study complexity, the proposed number of participants for enrollment as well as competition for the population sample from other ongoing studies. Tip #2 Ensure adequate training for all research personnel in the following areas: Purpose of the study and protocol Institutional policies and procedures Applicable regulations and other standards for the conduct of the study Delegated study-specific tasks and changes as they occur Tip #3 Ensure the completion of study duties and protocol adherence. This may be achieved through procedures for documenting completed study tasks such as checklists as well as routine meetings with study staff to review study progress, procedures and modifications. 3

4 BIOSAFETY NEWS Genetically Modified Animals: IBC Requirement Revised Thanks to revision of the National Institutes of Health (NIH) guidelines for research involving recombinant DNA (01/19/11), BSL1 research projects restricted to experiments involving genetically modified animals no longer require Institutional Biosafety Committee (IBC) registration. Exceptions include: Breeding experiments involving transgenic rodents that contain more than 50 percent of the genome of an exogenous eukaryotic virus from a single family (to prevent inadvertent reconstitution of an exogenous virus in the resultant transgenic rodent) Breeding experiments in which the transgenic rodent's transgene is under the control of a gamma retroviral long terminal repeat (LTR) (to address the small risk of recombination with endogenous retroviruses which could potentially result in mobilization of the transgene via a replication-competent mouse retrovirus). Already approved IBC protocols will; however, remain active until their three year expiration. Although no longer requiring IBC registration, should you choose to participate, the Biosafety Office will continue collecting basic data on those exempted experiments through the transgenic animals form ( which will serve as a resource for principal investigators to identify animal lines which may be available within the institution. Biological Toxins Even in minute quantities, some biological toxins can be extremely hazardous requiring strict safeguards. Principal investigators whose research projects involve the use of biological toxins must ensure that proper training is provided to all personnel working with and/or potentially exposed to the toxin, and emergency procedures for spill and exposure must be in place. Some biological toxins are classified by the federal government as Select Agents due to their potential for weaponization. Possession, use and transfer of select agent toxins is highly regulated. Failure to comply with these regulations can result in imprisonment as well as fines to both the individual and the institution. In federally regulated limited quantities, these toxins are exempt from the Select Agent registration. In order to ensure compliance with the Select Agent regulations, the biosafety office created the Biological Toxins Exempt Amounts Assurance form with the goal of collecting and maintaining information on the location and use on campuses of any potential select toxins. A list of select toxins and agents and the assurance is at Biosafety Cabinets (BSCs) When used properly, biological safety cabinets (BSCs) keep your work sterile, protecting your experiment and protecting you from the agents with which you are working. There are different types of BSCs. Recirculating BSCs should not be used with volatile chemicals and/or toxins. BSCs are not a substitute for good laboratory practice. General Procedures Before use Personnel should be properly trained in the use, care and maintenance of a BSC. Prior to use, the work surface must be wiped down with approved disinfectant followed by 70 percent ethanol if disinfectant is corrosive. Seat height must be adjusted in order to ensure that the operator s face is completely protected by the cabinet sash. Sash height must be kept at the position indicated by the manufacturer to maintain correct airflow. 4

5 Place enough absorbent pads to cover the work surface to contain any splatters or small spills that may occur during the procedure. Equipment which generates aerosols (e.g., micro-centrifuge, vortex) should be placed towards the rear of the cabinet. Plan ahead. Everything needed to complete a particular procedure should be placed inside the cabinet prior to beginning work, including bottles with disinfectants. Remember to provide a container for wastes on the inside of the cabinet. Arrange implements in a logical manner to segregate clean and dirty materials. During use Never place any items on the intake grills (front and back) as this will block the air flow. Every effort should be made to restrict the opening and closing of doors and walking traffic in the work area, as these activities will disturb the cabinet's airflow. Limit arm movements and do not make fast, pumping motions. Work must be conducted at least 4 inches back from the glass view panel. The middle third of the work surface is the ideal area to be used. After use Wait at least 5 minutes before unloading materials from the biosafety cabinet in order to purge airborne contaminants from the work area. All equipment must be enclosed or surface decontaminated before removal from the BSC. All materials and waste (liquid and solid) must have their surface decontaminated before removal. Decontaminate the interior work surface using approved disinfectant followed by 70 percent ethanol if disinfectant is corrosive. Hazard Communication Biohazard Symbol Different hazard symbols are designed to warn about the presence of various hazardous materials (biological, chemical, physical). The biohazard universal symbol is used to warn about hazard coming from a biological source (e.g., bacteria, viruses, fungi) and should be placed at locations and equipment used for processing, disposal or storage of infectious or potentially infectious materials (i.e., human derived materials). 5