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I-CARE NEWS Research Integrity and Compliance Office

A pril 2020: Special Edition

Clinical Research: Trials, Quality Control and Assurance on Human Subject Research On this edition 

IRB: Clinical Rsearch: Trials, Quality Control and Assurance on Human Subject Research. ACUC: How can institutions and their IACUCs best prepare for a pandemic? IBC: Minimizing Risks Associated with Coronavirus Research.

Clinical research has been growing exponentially due to all these new mutations from viruses and new diseases with unknown treatments. Clinical trial is one of the key components of this journey to the encounter of the accurate treatment in which provides information on the safety and efficacy of drugs under study. Sponsors of the clinical trials ensure that the investigators are following the compliant protocol, collecting and reporting quality data. Quality, one of the core modules of the trial, assures that the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded. Quality management system in clinical research aims at establishing and consistently achieving compliance with ethical, regulatory standards and maintaining authenticity of the clinical data. Quality control and quality assurance are the standard components of the quality management system in clinical research. In clinical research, quality control processes assure internal consistency by conducting periodic operational checks at every stage of the trial process and data handling to verify the compliance of the trial process and reliability of the data. The steps involved in the quality control process include developing the trial protocol, data collection and pooling the data in the database, analysis of the data and preparing the trial report. Quality assurance refers to systemic and independent audit of all activities and documents related to a clinical trial. This is performed by quality assurance personnel who are not involved in the research to determine whether the trial was conducted and that the collection, analysis and reporting of data were in accordance with the protocol, standard operating procedures (SOP’s) and Good Clinical Practices (GCP). In short, this process assesses the efficiency of quality control processes carried out by the sponsors. One important aspect of quality assurance in clinical trials is good clinical practice (GCP) which can be defined as a set of ethical and scientific quality guidelines that must be observed globally for a standard of the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. All research studies on human subjects should have a level of quality and ethical standard assurance built into their operations to ensure that the rights and well-being of human subjects are protected and that the data is reliable maintaining accuracy and quality throughout a clinical study. As the International Council for Harmonization for Technical Requirements for Pharmaceuticals for Human Use and the Good Clinical Practices (ICH/GCP) states: “Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society, a trial should be initiated and continued only if the anticipated benefits justify the risks, the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society, the available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial, clinical trials should be scientifically sound, and described in a clear detailed protocol and a trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB) approval.”; among others. The importance of Clinical Research, Trials, Quality Control and Assurance on Human Subject Research will always be the perseverance of the protection of the human rights, the well-being of the human subject, the confidentiality of the processes and the recompilation of the research data to reassure the compliance and the protection of the safety of human subjects involved in a research and protocol revision. For more information on this regard, you can access the Puerto Rico Science, Technology and Research Trust website and the FDA: Good Clinical Practice: Integrated Addendum to ICH E6(R1).

VICEPRESIDENCY FOR ACADEMIC AFFAIRS

VICEPRESIDENCY FOR SPONSORED PROGRAMS AND RESEARCH COMPLIANCE


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How can institutions and their IACUCs best prepare for a pandemic? CDC is responding to an outbreak of respiratory disease caused by a novel (new) coronavirus that was first detected in China and which has now been detected in more than 100 locations internationally, including the United States. The virus has been named “SARS-CoV-2” and the disease it causes has been named “coronavirus disease 2019” (abbreviated “COVID-19”). On January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization declared the outbreak a “public health emergency of international concernexternal icon” (PHEIC). On January 31, 2020, Health and Human Services Secretary Alex M. Azar II declared a public health emergency (PHE) for the United States to aid the nation’s healthcare community in responding to COVID-19.

Due to this declared pandemic, health measures must be taken to prevent the transmition of the virus form one mammal to another. This is why it is very important to follow CDC’s prevention awareness tips. There is currently no vaccine to prevent coronavirus disease 2019 (COVID-19). The best way to prevent illness is to avoid being exposed to this virus. However, as a reminder, CDC always recommends everyday preventive actions to help prevent the spread of respiratory diseases, including:      

Avoid close contact with people who are sick. Avoid touching your eyes, nose, and mouth. Stay home when you are sick. Cover your cough or sneeze with a tissue, then throw the tissue in the trash. Clean and disinfect frequently touched objects and surfaces using a regular household cleaning spray or wipe. Wash your hands often with soap and water for at least 20 seconds. If soap and water are not readily available, use an alcohol-based hand sanitizer with at least 60% alcohol. Always wash hands with soap and water if hands are visibly dirty.

Institutions must adhere to provisions of the PHS Policy, the Guide, and the commitments detailed in their Animal Welfare Assurance with OLAW. This includes advance planning for conditions that could arise as a result of a human pandemic (e.g., influenza) or outbreaks of novel infections (e.g., coronavirus disease 2019) that could jeopardize the health and wellbeing of animals because of a lack of personnel to care for the animals and/or to conduct IACUC official business. Pandemic plans developed by institutions and IACUCs should include consideration of the following: Animal facilities must be maintained at a high standard regulatory level to ensure animal welfare. Plans should consider appropriate staffing levels, cross-training to cover critical operations, and adequate inventories of essential supplies (e.g., feed, bedding, personal protective equipment, cagewash supplies). The IACUC should develop a plan for conducting official business during a pandemic event, taking into account the following:  The IACUC must continue to be properly constituted.  A quorum is required to conduct official business at a convened meeting.  The IACUC must ensure that protocol approvals are not allowed to expire or if they do expire, that no further animal activities (e.g., data collection) are

conducted.  Appointment and training of IACUC members (including nonscientific members and alternates) should be considered as a part of the plan. In devising a pandemic plan, the institution may consider using options provided in the PHS Policy that it does not choose to use in the normal operation of its animal care and use program. Social distancing means focused measures to reduce contact among people. The PHS Policy contains some provisions that can be instituted as social distancing measures to prevent the spread of disease, including:  The IACUC may institute alternatives to face-to-face meetings such as teleconference or video conferencing.  The number of IACUC meetings may be reduced to as few as one every six months, the minimum allowed by the Guide.  The IACUC may choose to expand their use of designated member review.

For additional information on this regard, search the following websites: National Center for Immunization and Respiratory Diseases (NCIRD), Division of Viral Diseases, olaw.nih.gov V I C E P R E S I D E N C Y

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Minimizing Risks Associated with Coronavirus Research The scientific community from public and private agencies around the world united efforts to develop a treatment that can inhibit the coronavirus replication. The research involves the use of active viral particles in the laboratories, which by itself implies a risk of infection for the researchers, physicians, and other health department employees. Therefore, the clinical and research laboratories, as well as the human resources, must comply with the Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19) published by the Centers for Disease Control and Prevention (CDC). The guidelines cover two major areas: clinical samples testing and laboratory research. First, the guidelines establish that each laboratory should perform a site-specific and activity -specific risk assessment and mitigation measures. These factors are dependent on the laboratory equipment & facility, the hazards involved in the procedures, the level of personnel competency and the resources available. The standard precautions include hand hygiene and the use of personal protective equipment (PPE), such as gloves, laboratory coats, and eye goggles. Currently, unless the laboratory is Biosafety Level 3 (BSL-3) the virus isolation in cell culture and initial characterization of viral agents are not recommended (Figure 1). The routine diagnostic testing of specimens can be performed in Biosafety Level 2 (BSL-2) laboratory. Some examples of the allowed testing are staining and microscopic analysis of fixed smears, molecular analysis of extracted nucleic acid preparations and pathologic examination and processing of formalin-fixed or otherwise inactive tissues.

Figure 1: Schematic of a Biosafety Level 3 Laboratory. The laboratory is separated from general traffic flow and accessed through an anteroom (double door entry or basic laboratory – Biosafety Level 2) or an airlock. An autoclave is available within the facility for decontamination of wastes prior to disposal. A sink with hands-free operation is available. Inward directional airflow is established and all work with infectious materials is conducted within a biological safety cabinet. (WHO Biosafety Manual, 3rd edition, 2004)

Besides, the guidelines regulate the experimental procedure, decontamination, laboratory waste management, and specimen packing and shipping.  Experimental procedure – in the case of the experimental procedures that generate droplets or aerosols a certified Class II Biological Safety Cabinet (BSC) (Figure 2) and PPE are recommended. Some of the PPE precautions that provide a barrier between the specimen and personnel are a surgical mask, centrifuge safety cups, and sealed centrifuge rotors.  Decontamination – the work surfaces and equipment should be decontaminated with EPA-registered hospital disinfectant that claims to be effective against SAR-CoV-2.  Laboratory Waste Management – the waste can be handled as other biohazardous waste in the laboratory.  Specimen Packing and Shipping – specimens of SARS-CoV2 from patients, cultures or isolates should be shipped following the current edition of the International Air Transport Association (IATA) Dangerous Good Regulations. Personnel must be trained to pack and ship according to the regulations. The Biosafety Committee at Universidad Ana G. Méndez ensures that our researchers perform investigation following the appropriate federal, state and local agencies guidelines, which warranty our students and personnel safety. Our university has 3 laboratories BSL-2 equipped, which can potentially work with SARS-CoV2 or other similar pathogens. The Biosafety Committee members and researchers are engaged in a variety of research projects to provide the community with solutions to common problems or with new treatments for outbreaks such as COVID-19.

Figure 2: Class II Biological Safety Cabinet. Provides personnel, environment and product protection. Used when working with low to moderate risk biological. agents. (cdc.gov)

For additional information on this regard, search the following websites: National Center for Immunization and Respiratory Diseases (NCIRD), Division of Viral Diseases, nih.gov V I C E P R E S I D E N C Y V I C E P R E S I D E N C Y

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Change of Chairpersons at ACUC and IBC Committees

Dr. Loyda Méndez on the left and Dr. Mariel Pérez on the right.

Beginning the 2019-2020 academic year, Dr. Mariel Pérez signed away her position as Animal Care and Use Committee (ACUC) Chair, leading to Dra. Loyda Méndez, as new ACUC Chair. Dr. Méndez, Carolina Campus Animal Resource Center Director, received a scholarship from the National Science Foundation (NSF) to pursue her PhD in Environmental Toxicology at the University of California, Irvine. In 2006, completed her Ph.D. and continued her post doctoral studies in the areas of Biochemistry, Microbiology and Aerosol Dosimetry. Upon completion of her studies, Dr. Méndez served as associate director of the "Air Pollution Health Effects Laboratory" at the University of California, Irvine. Dr. Méndez, is an Associate Professor and Research Professor at the Ana G. Méndez University System, Carolina Campus. She is currently the principal investigator of a proposal subsidized by the National Institutes of Health (NIH) that studies the effects of atmospheric pollutants on the respiratory and cognitive health of children in Puerto Rico.

Dr. Noemi Soto Nieves

Effective February, 27, 2020, Dr. Noemí Soto Nieves, was assigned as the new IBC Chair. Dr. Soto, Assistant Professor at the School of Science and Technology at the Cupey Campus, is an active IBC member since October 2013. She teaches courses in genetics, developmental biology, cellular and molecular biology, methods in molecular biology, general biology; among others at the School of Sciences and Technology. Her PhD is in biomedical sciences with an immunology, genetics, and molecular cell biology major from Albert Einstein College of Medicine in New York. In addition to teaching, her research aim focuses on cancer research. Her research in new chemotherapeutic therapies with azapodophyllotoxin derivatives to treat colon cancer in collaboration with Dr. Ajay Kumar is funded by INBRE/National Health Institute. She also actively collaborates in projects on autoimmune diseases and with the bioluminescence bay in Fajardo, PR. For more information: Evelyn Rivera Sobrado, RN, MPH Compliance Director Ext. 7196 Wanda Vázquez Solá, MBA Systemic Compliance Officer (IRB), Ext. 7195 María A. Arvelo Fernández, M.A. Systemic Compliance Officer (IBC/ACUC), Ext. 7197

Institutional Compliance Officers: Carmen Crespo, MBA Cupey Campus, Ext. 6366 Griseila M. Cruz Román, Ph.D. Carolina Campus, Ext. 2279 Josefina Melgar, MS, Gurabo Campus, Ext. 4126

Universidad Ana G. Méndez Amilcar A. Jiménez, MBA Assistant Professor Tampa Bay Campus, Office: 813-466-5181 E-mail: jimenezal@suagm.edu

Author Rights © 2020. Universidad Ana G. Méndez

Contacts: Office: 787-751-0178 Fax: 787-759-6411 Postal Address: Universidad Ana G. Méndez Research Integrity and Compliance Office P.O. Box 21345 San Juan, Puerto Rico 00928-1345

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