I-CARE NEWS Regulatory Compliance Office
APRIL 2016-SPECIAL EDITION
APRIL 2016– SPECIAL EDITION
In this Issue:
Regulatory Compliance Office
The Regulatory Compliance Office in the Ana G. Méndez University System (AGMUS) ensures the highest standards in complying with federal and local regulations in research and research related activities. As part of its mission, it develops policies and procedures that guide research activities as well as assists in their implementation in all of AGMUS’ academic components. The Office also houses three review boards which are the Institutional Biosafety Committee ( IBC ), Animal Care and Use Committee ( ACUC ) and the Institutional Review Board ( IRB ). These boards are self-regulated and governed by the National Institutes of Health (NIH), the Office of Biotechnology Activities (OBA) and the Animal Welfare Act to fully comply with the Responsible Conduct in Research established by the Office of Research Integrity at NIH. Members of the review boards include faculty from Universidad del Turabo, Universidad Metropolitana and Universidad del Este. They also have members from other university components in central administration and from the general community.
Changes on the NIH/OBA Guidelines Increase on IBC received studies Recent amendments on OLAW and PHS Policies Animal Resource Center Renovation Internet-based Research Continuous success at IRB Certificate Workshops
In addition, the Regulatory Compliance Office works closely with other departments in AGMUS to ensure compliance with other regulations that may impact the research arena. Two of such organizational units, is that of the Vice-presidency of Administrative Affairs and the Associate Vice-presidency of Planning. The Office associates have provided counseling in the design of research methodology, construction and remodeling of research facilities, health and safety concerns, among others. To optimize the efforts of compliance, the Office appointed as part of this team a new Systemic Compliance Coordinator, Mrs. María A. Arvelo Fernández, which specializes in Biosafety (IBC) and Animal Care, Use and Welfare (ACUC). With her experience in research and knowledge in Biology and Biomedical Sciences, Mrs. Arvelo represents a significant contribution to the AGMUS’ Regulatory Compliance Office. The Regulatory Compliance Office also works closely with the Institutional Compliance Office at the Institutions to provide guidance, training and certifications to staff, researchers and students. It is the desire of the Office to continue developing a solid and safe research environment where our talented researchers can have the support and sense of security in complying with the regulations and policies governing their activities. Thank you for your support!
VICEPRESIDENCY FOR PLANNING AND ACADEMIC AFFAIRS ASSOCIATE VICE PRESIDENCY FOR SPONSORED PROGRAMS AND COMPLIANCE
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National Institute of Health (NIH) / Office of Biotechnology Activities (OBA) Guidelines The purpose of the OBA guidelines is to specify the appropriate and correct way to build and work with recombinant nucleic acid molecules, synthetic nucleic acid molecules; including those that are chemically modified but can base pair with any nucleic acid molecule, organisms and viruses containing such molecules and naturally occurring ones. The Regulatory Compliance Office is continuously updating its processes to comply with new or amended guidelines as they occur. In continuation, the last reported amendments: I.
Additions to Appendix B- Classification of Human Etiologic Agents on the Basis of Hazard. i. Appendix B-II-A. Risk Group 2 (RG2) – Bacterial Agents Including Chlamydia ‒ Pseudomonas aeruginosa. ii. Appendix B-III-D. Risk Group 3 (RG3) – Virus and Prions Coronaviruses ‒ Middle East Respiratory Syndrome Coronavirus (MERS-CoV).
Appendix B-II-A. Risk Group 2 (RG2) - Bacterial Agents Including Chlamydia
Appendix B-III-D. Risk Group 3 (RG3) - Viruses and Prions Coronaviruses
--Acinetobacter baumannii (formerly Acinetobacter calcoaceticus)
--SARS-associated coronavirus (SARS-CoV)
--Actinobacillus --Middle East respiratory syndrome coronavirus (MERS-CoV)
Flaviviruses - Group B Arboviruses
--Actinomyces pyogenes (formerly Corynebacterium pyogenes) --Aeromonas hydrophila
--Archanobacterium haemolyticum (formerly Corynebacterium haemolyticum)
--Japanese encephalitis virus (except those strains listed in Appendix B-II-D Risk Group2 (RG2) - Viruses) --West Nile virus (WNV) --Yellow fever virus
--Arizona hinshawii - all serotypes
Orthomyxoviruses
--Amycolata autotrophica
--Bacillus anthracis
-- Influenza viruses 1918-1919 H1N1 (1918 H1N1), human H2N2 (1957-1968), and highly pathogenic avian influenza H5N1 strains within the Goose/ Guangdong/96-like H5 lineage (HPAI H5N1).
--Bartonella henselae, B. quintana, B. vinsonii --Bordetella including B. pertussis --Borrelia recurrentis, B. burgdorferi
Poxviruses
--Burkholderia (formerly Pseudomonas species) except those listed in Appendix B-III-A (RG3))
--Monkeypox virus
Prions
--Campylobacter coli, C. fetus, C. jejuni --Chlamydia psittaci, C. trachomatis, C. pneumoniae
--Transmissible spongiform encephalopathies (TSE) agents (Creutzfeldt-Jacob disease and kuru agents)
--Clostridium botulinum, C. chauvoei, C. haemolyticum, C. histolyticum, C. novyi, C. septicum, C. tetani
Retroviruses
--Coxiella burnetii – specifically the Phase II, Nine Mile strain, plaque purified, clone 4
--Human immunodeficiency virus (HIV) types 1 and 2 --Human T cell lymphotropic virus (HTLV) types 1 and 2
--Corynebacterium diphtheriae, C. pseudotuberculosis, C. renale
--Simian immunodeficiency virus (SIV)
Reminder: Projects involving synthetic or recombinant nucleic acid molecules must comply with NIH Guidelines. Noncompliance of these regulations can result in: suspension, limitation or termination of funds independently of their source. For more information, you may access the NIH Guidelines at the following link: http://osp.od.nih.gov/sites/default/files/NIH_Guidelines_0.pdf. V I C E P R E S I D E N C Y
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Institutional Biosafety Committee This Committee is responsible for ensuring that all research conducted at the Institutions are performed under responsible behavior. Its main objective is to ensure the health, safety and welfare of all the members working in a research inside our Institution. In the last four years, the Committee has had a significant increase in the studies submitted for review, indicating an increase in all the scientific research conducted at the Ana G. Mendez University. This fact suffuse us with pride and great satisfaction, as the field of science and research is one crucial part for the evolution and growth of the Institutions.
Significant increase on IBC studies received from Ana
G.
Méndez
University System Institutions from 2012-2015
Inspected Laboratories by the Regulatory Compliance Office On November 4, 2015, the Metropolitan University inaugurated the Biotesting Laboratory, better known as ChEMTox. It is an innovative laboratory in the science and technology field, as it is the first laboratory of this nature at a private university in Puerto Rico. This laboratory offer seminars to Environmental Science graduate students and to Science and Technology undergraduate students. These seminars cover the fields of Biology (anti-cancer drug developments), Physics (nano-particle developments), and Environmental Sciences (monitoring and detecting cellular damage by environmental pollutants); among others. Dr. Beatriz Zayas, director of the Biotesting Laboratory and Environmental Science School professor quoted: “This laboratory represents an important step towards the transformation of the Metropolitan University towards a teaching system with a broader focus on scientific research.”
Puerto Rico Photonics Institute, is an initiative of the School of Environmental Affairs of the Metropolitan University (UMET) and Ana G. Méndez University System (SUAGM) under the direction of Dr. Jonathan S. Friedman, academic coordinator and research professor Dr. Andrés Díaz and photonics technician Roger Saltares. It is the only institute in Puerto Rico and the Caribbean dedicated to teach, research, disseminate, and promote optics and photonics In the research field, at the PRPI, the members conduct research on remote sensors, aerospace photonics, nanophotonics and metamaterials. PRPI is supported by the Arecibo Observatory, the National Science Foundation ( NSF), PRIDCO, the Trust for Science, Technology and Research of Puerto Rico, the Charles Stark Draper Lab, the University of Arizona, the University of Central Florida, and SRI International.
V I C E P R E S I D E N C Y F O R P L A N N I N G A N D A C A D E M I C A F F A I R S A S S O C I A T E V I C E P R E S I D E N C Y F O R S P O N S O R E D P R O G R A M S
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Animal Care and Use Committee (ACUC) New Federal requirements for the Animal Care and Use The Vertebrate Animals Section (VAS) requirements for the application proposals, cooperative agreements and contract proposals, have changed. Changes have been made to eliminate redundancy on ACUC, and at the same time, comply with the Public Health Service Policy and Use of Laboratory Animals.
It is important to include a clear description of the proposed procedures to be used involving vertebrate animals for the research referred in the application or proposal.
It must provide a justification that the animal model is appropriate for the proposed research.
Explain clearly why the research goal cannot be obtained through an alternate animal model.
Describe interventions with analgesia, anesthesia, sedation and palliative treatment to reduce discomfort and pain.
Indicate whether the method of euthanasia is consistent with the recommendations of the Guide to the American Veterinary Medical Association (AVMA), otherwise describe the method and provide a scientific justification.
A description of veterinary care is no longer required, justification for the number of animals has been eliminated and a description of the method of euthanasia is required only if the method is not consistent with AVMA guidelines.
These requirements will take effect for all applications for due dates on or after May 25, 2016 .” National Institutes of Health (NIH), October 13, 2015.
Animal Resource Center (ARC) - UNE Dr. Loyda Mendez, member of the Animal Care and Use Committee (ACUC), associate professor of the Department of Science and Technology at Universidad del Este and Director of the Animal Resource Center (ARC), was the recipient of a proposal issued by NIH on September 1st, 2015. The renovation process will begin next fiscal year. The ARC is for the use and benefit of all faculty and researchers at our institution and collaborating institutions. Dr. Mendez is currently in the drafting process of a new proposal which will be titled, "Air Pollution Toxicity: Interconnection between Lung and Brain Responses. " It will be submitted to NIEHS and intends to use mice as the animal model.
ACUC’s President Dr. Mariel Pérez Vélez One important aspect of the Compliance Office is to oversee the regulations of mandatory statutes related to the care and use of animals in research through the Animal Care and Use Committee ( ACUC ) which I chair since 2015. Our mission is to protect the welfare of animals used in teaching, research or biological tests, by reviewing and approving protocols involving the use of live or dead animals and inspect the facilities assigned to the care and maintenance of the institution. It is our duty as representatives of SUAGM and responsibility of every faculty, researcher, student and laboratory personnel to treat laboratory animals in a correctly and appropriate manner. With tenderness, compassion, sympathy and avoiding the most harm or suffering while being handled or maintained. Thank you for joining us in promoting the welfare of laboratory animals. Dr. Mariel E. Pérez Vélez
Human Research Protection Board (IRB) “Internet-based Research”
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In recent years, there has been an increase in the use of the
The Institutional Review Boards (IRB) have great challenges with on-line
Internet as a vehicle for searching information to conduct research.
research. To assist in this process, the "Secretary's Advisory Committee
This trend is due to the speed and ease with which they can obtain information and shorten the time to obtain data for studies that can take months or even years to complete. The massive scale to pre - identified individuals and groups is the major attraction
on Human Research (SACHRP)" advisor offer recommendations to the Secretary of HHS on matters related to human subjects research. They created a document addressed to the IRB's guide Committee for the
for researchers.
review and implementation of various processes which allow researchers
TheCaption most describing common studies using this research style are
interested in conducting research on the Internet, to meet the
investigations human behavior (cultural and social). This could be picture orofgraphic.
requirements of established federal regulations. It can be accessed
beneficial and of great exposure at the same time, especially to
through the following link: “Considerations for Research with the
comply with federal regulation 45 CFR 46 and the ethical principles of Belmont Report, which apply to: the participant’s privacy and confidentiality, security of data and the accuracy of identifying and
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Internet” http://www.hhs.gov/ohrp/sachrp/commsecbytopic/Internet% 20Research/may20,2013,attachmentb.html
qualifying a subject for the type of study to be performed.
Continuous success at IRB Certificate Workshops SUAGM’s Human Research Protection Board (IRB) and the Regulatory Compliance Office were given the task of facilitating the IRB certification process for the research community. This is accomplished by offering workshops which cover three certifications required by the IRB (Responsible Conduct of Research (RCR), Research with human subjects, Confidentiality and Privacy (HIPS)). These workshops initiated in October 2009 and are directed to faculty and Caption describing students. Each group participates in parallel sessions. picture or graphic.
The increased attendance of students and faculty in certificate workshops has demonstrated a commitment of everyone in the research community to comply with research regulations. Great Job! The workshops are offered once per semester alternating the Principal Campuses (UMET, UT and UNE). Please contact the Compliance Office of the institutions: UMET ext. 6366, UNE ext.. 2279 and UT ext. 4126 for further information. On the other hand, if you prefer to complete the online certificate, access the following link (compliance.suagm.edu) and search for instructions through CITI program’s website.
IRB workshop offered at
Universidad del Este, Carolina. February 2016
Institutional Biosafety Committee President Dr. Nydia M. Rodríguez Bonano
Dr. Nydia M. Rodríguez Bonano
AGMUS’s IBC was created in 2004 to promote biosafety and compliance among all researchers at Ana G. Méndez University System. The Committee supervises the use of recombinant DNA, infectious agents and biological hazardous materials during the research process. Our purpose is to maintain a safe environment through the development of specific policies and procedures which reduce targeted risks to SUAGM’s personnel and to the general community in accordance with established guidelines by the National Institute of Health, OSHA and state authorities. The members that conform the IBC, possess a diverse scientific expertise to ensure the correct protocol and project revision in a right and impartial process. My appreciation for the members of the Committee and by these means I reassure my commitment to serve as the IBC Chair during the academic year 2015-2016.
Policy Revision: Fraud and Responsible Conduct Executive order #08-2006 was amended in January 2016. The Policy is available on the Regulatory Compliance Office web site. For more information you may access the following link: http://compliance.suagm.edu
Future activities: Next IRB workshop: September 16, 2016 at Muñiz Souffront and Morales Carrión Amphitheater- UMET, Cupey. Ana G. Méndez University System Regulatory Compliance Office PO Box 21345 San Juan, Puerto Rico 00928-1345 Contacts: Phone: 787-751-0178 Fax: 787-759-6411 E-mail: cumplimiento@suagm.edu Website: http://compliance.suagm.edu For more information: Evelyn Rivera Sobrado, RN, MPH Compliance Director Ext. 7196 Wanda Vázquez Solá, MBA Systemic Compliance Coordinator (IRB), Ext. 7195 María A. Arvelo Fernández, M.A. Systemic Compliance Coordinator (IBC/ACUC), Ext. 7197 Institutional Compliance Coordinators: Carmen Crespo, MBA Universidad Metropolitana ext. 6366 Natalia Torres Berríos, MS Universidad del Este, ext. 2279 Josefina Melgar, MS, Universidad del Turabo, ext. 4126 Sistema Universitario Ana G. Méndez University System Amilcar A. Jiménez, MBA Assistant Professor Tampa Bay Campus, teléfono: 813-466-5181 E-mail: jimenezal@suagm.edu
Derechos de Autor © 2016. Sistema Universitario Ana G. Méndez