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  • Office of Regulatory Affairs | Georgetown University
    Research Integrity Learn More Georgetown Howard Universities Center for Clinical and Translational Science GHUCCTS is a multi institutional consortium of medical research institutions forged from a desire to promote clinical research and translational science Learn More The Research Clinic An interactive training tool on protecting research subjects and avoiding research misconduct search HHS Office of Research Integrity Learn More Conflict of Interest COI File or Update Your Annual Disclosure Form Learn More About the Office of Regulatory Affairs The Georgetown University Office of Regulatory Affairs provides oversight and guidance in human subject research animal care and use biosafety chemical safety radiation safety occupational health export controls conflict of interest handling of hazardous controlled or regulated substances material transfers and research misconduct The mission of the Office of Regulatory Affairs working in cooperation with the University community is to facilitate research integrity in the design conduct review and reporting of research and to promote adherence to applicable laws regulations and professional and ethical standards Departmental Units Institutional Review Board IRB The Institutional Review Board s IRB primary role is to safeguard the rights and welfare of all human subjects who participate in research studies conducted by Georgetown Learn More Animal Care

    Original URL path: http://ora.georgetown.edu/ (2015-09-30)
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  • Staff | Office of Regulatory Affairs | Georgetown University
    Home Staff Share Office of Regulatory Affairs Staff Sheila Cohen Zimmet B S N J D Senior Associate Vice President 202 687 8437 zimmets georgetown edu Sheila Cohen Zimmet is the Georgetown University Senior Associate Vice President for Regulatory Affairs and also serves as the research integrity officer and conflicts officer for the Georgetown University Medical Center Ms Zimmet previously served as Associate Dean for Research Integrity for Weill Cornell Medical College until returning to Georgetown in her current role in which she has oversight responsibility for an array of research ethics and compliance matters She is a former neonatal intensive care nurse Senior Associate Counsel to the Georgetown University Medical Center and the University s first Director of Research Assurance and Compliance Ms Zimmet has been appointed to a three year term on the advisory council of the Eunice Kenndy Shriver National Institute of Child Health and Human Development NICHD She also sits on the elected Steering Committee for the AAMC Forum on Conflict of Interest in Academe She is a former two term member of the National Center for Research Resources NCRR Advisory Council 1996 2000 and 2004 2008 Ms Zimmet frequently speaks on issues related to research compliance matters at local national and international professional meetings Administration Patricia L Mazar Senior Administrator 202 687 8425 mazarp georgetown edu Nina F Angeles Financial Officer 202 687 5211 nfa georgetown edu Kenya T Carter Administrative Assistant 202 784 5313 ktc georgetown edu Conflict of Interest Sheila Cohen Zimmet B S N J D Conflict of Interest Officer 202 687 8437 zimmets georgetown edu Presh Johnson Arabitg M A Deputy Conflict of Interest Officer Regulatory Affairs Associate 202 687 3354 pj186 georgetown edu Occupational Health Dr Phil Witorsch Medical Director 202 687 0398 witorscp georgetown edu Simona Diggs Occupational Health

    Original URL path: http://ora.georgetown.edu/staff (2015-09-30)
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  • Financial Conflict of Interest (FCOI) | Office of Regulatory Affairs | Georgetown University
    months Investigators with financial conflicts of interest must enter into a management plan before expenditures can begin View list of Public Health Service agencies below Questions about policies procedures or training Contact Sheila Cohen Zimmet 202 687 8437 zimmets georgetown edu or Presh Johnson Arabitg 202 687 3354 pj186 georgetown edu Who is an investigator Anyone responsible for the design conduct or reporting of funded or proposed research regardless of title or position This includes Project directors Principal investigators Co investigators Key personnel May include research assistants postdocs collaborators or consultants If you have any doubts about whether you could be classified as in investigator you should contact your Campus Conflict of Interest Officer What is a financial interest A financial interest is anything of monetary value related to an investigator s University Responsibilities whether or not the value is readily ascertainable in any of these categories renumeration or compensation e g salary consulting fees honoraria etc from a public or private company equity e g stock stock options or other ownership interest in a public or private company intellectual property rights e g patents copyrights and any royalties and licensing income from such rights a position in an outside entity that gives rise to a fiduciary duty such as director officer partner trustee employee or any position of management and for investigators with PHS funding also any reimbursed or sponsored travel For the full definition of a significant financial interest visit Appendix B and Appendix C of the Georgetown University Financial Conflicts of Interest FCOI Policy What are University Responsibilities University Responsibilities include professional responsibilities on behalf of the University including but not limited to teaching research research consultation professional practice institutional committee membership and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards Where do I file a disclosure form Investigators Non Investigators Access the Disclosure System called TRACS NetID and password required For detailed instructions visit File General Disclosure Form What happens after I file a disclosure form The form is reviewed by the appropriate Conflict of Interest Officer who will determine whether or not it identifies an actual or potential conflict of interest and if so what action is required to manage the situation appropriately The Conflict of Interest Officer may request additional information from an employee in order to make these determinations In the case of an identified conflict the Conflict of Interest Officer may work with the faculty or staff member to put in place and to document an appropriate conflict management plan An employee who disagrees with the decision of the Conflict of Interest Officer may seek review by the University Conflict of Interest Committee How do I complete COI training Investigators who receive Public Health Service PHS funding must undergo conflict of interest FCOI training before engaging in the funded research To complete the training visit our FCOI training page for instructions What agencies are a part of the Public Health Service PHS Includes federal agencies and

    Original URL path: http://ora.georgetown.edu/coi (2015-09-30)
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  • Clinical Trials Registration | Office of Regulatory Affairs | Georgetown University
    Management System You are here Home Clinical Trials Registration Share Office of Regulatory Affairs Clinical Trials Registration IMPORTANT UPDATE New Medicare requirement for ClinicalTrials gov registration number on claims Click here to learn more GUMC Registration of Clinical Trials Dear User PI Georgetown University has adopted the National Library of Medicine s Clinical Trials Protocol Registration System PRS to enter clinical trial records into ClinicalTrials gov The program provides patients family members and members of the public current information about clinical research studies To create new records and to modify existing records you will need to use PRS Georgetown s Office of Regulatory Affairs will create an account under your name so that you can enter into the PRS Soon after this enrollment you will receive an automated e mail from ClinicalTrials gov providing you with login information to enter study specific information The Principal Investigator is responsible for ensuring that registration requirements are met Even though some sponsors will do the actual registration work for the PI it is still the PI s responsibility to ensure that the registration has been accomplished Below you will find the most frequently asked questions of ClinicalTrials gov Please read through the material A reference guide for the PRS can be found at http prsinfo clinicaltrials gov A short step by step process on how to apply for your ClinicalTrials gov login will follow the FAQ section below ClinicalTrials gov Background Results History Laws and Policies Media Press Resources FAQ Why Should I Register and Submit Results How to Apply for an Account Training Materials Support Materials Quick Reference available below and at this link GU Box Georgetown University 37th and O Streets N W Washington D C 20057 Phone 202 687 0100 Maps Directions Copyright Information Privacy Policy Connect with us via

    Original URL path: http://ora.georgetown.edu/ClinicalTrialsRegistration (2015-09-30)
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  • Institutional Animal Care and Use Committee (IACUC) | Office of Regulatory Affairs | Georgetown University
    methods of animal care to individuals who use animals in research teaching or demonstration programs at Georgetown University Announcments Policies Std Procedures that have been approved in 2015 see policy page IACUC Policy Euthanasia of Research Animals 8 18 15 IACUC Policy Prolonged Restraint 8 18 15 IACUC Policy Monitoring of Genetically Modified Animals 7 21 15 IACUC Policy Isoflurane Anesthesia 7 21 15 IACUC Standard Procedure Oral Gavage Rodents 5 19 15 IACUC Policy Acclimation Period in Laboratory Animals 5 19 15 IACUC Policy Rodent Surgery and Post Operative Care 2 23 15 IACUC Policy Testing of Biological Materials to be Introduced into Rodents 2 23 15 5 11 15 TOPAZ is currently not working in Google Chrome but should be working in all other web browers To access Topaz click the link below https topaz prod uis georgetown edu TOPAZEnterprise Note to TOPAZ users The IACUC office is working to migrate to using TOPAZ for electronic amendments significant and minor personnel amendments will remain on paper Before you or your lab staff start writing an amendment please contact the IACUC office to determine if you are required to submit amendments electronically Criteria for amending in TOPAZ Protocol on Paper No amendments in TOPAZ continue paper amendments Protocol in TOPAZ 14 section form No amendments in TOPAZ continue paper amendments Protocol in TOPAZ 23 section form w previous amendments on paper Required to submit amendments in TOPAZ PI will have to reference amendments already approved on paper date of approval in the text if they plan to amend information in their approved amendments Protocol in TOPAZ 23 section with no previous amendments Required to submit amendments in TOPAZ All new and 3 year renewal protocols submitted for IACUC review must be submitted in Topaz Please contact the IACUC Office

    Original URL path: http://ora.georgetown.edu/iacuc (2015-09-30)
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  • Institutional Review Board (IRB) | Office of Regulatory Affairs | Georgetown University
    Research Integrity Misconduct Resources Seminars Education Georgetown University Medical Center School of Medicine School of Nursing Health Studies Georgetown Lombardi Comprehensive Cancer Center Biomedical Graduate Research Organization Biomedical Graduate Education Dahlgren Memorial Library MedStar Georgetown University Hospital Georgetown University About Admissions Financial Aid Academics Our Schools Research Campus Life News Services Email Google Apps Blackboard Directory Campus Map Directions Events Libraries GOCard Services Georgetown Management System You are here Home Institutional Review Board IRB Share Office of Regulatory Affairs Institutional Review Board IRB On behalf of Georgetown University the Institutional Review Board s IRB primary role is to safeguard the rights and welfare of all human subjects who participate in research studies conducted by Georgetown In compliance with Federal law and institutional policy all research projects involving human subjects or human material must be reviewed and approved by the IRB All biomedical social and behavioral research projects conducted by the faculty the staff and students of the University are subject to the Policies and Procedures of the Institutional Review Board The Georgetown University IRB has the authority to disapprove modify or approve protocols based upon consideration of human subject protection It also requires progress reports from the investigators at least annually and oversees the conduct of the study The overall criteria for IRB approval are The risks to subjects are minimized as much as possible The risks to subjects are reasonable in relation to anticipated benefits The informed consent is adequate Where appropriate the research plan makes provisions for the safety of the subjects during the data collection process Where appropriate there are adequate provisions to protect the privacy of subjects and maintain confidentiality of data Appropriate safeguards are included within the study to protect the rights and welfare of the vulnerable subjects Address Hours Address First Floor SW104 Medical

    Original URL path: http://ora.georgetown.edu/irb (2015-09-30)
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  • Occupational Health | Office of Regulatory Affairs | Georgetown University
    employees working with nonhuman primates are required to receive this training to top Medical Clearance Procedures 1 Risk Assessment Health History Survery All Animal Research Personnel who are listed as participants on an approved IACUC protocol must complete a Health History Survey and medical evaluation and obtain medical clearance annually and prior to IACUC protocol renewal All Animal Research Personnel who will be listed as a participant and will work with animals on an IACUC protocol must obtain medical clearance through the Occupational Health Program before the IACUC protocol can be approved or renewed The Health History Survey is available here New Animal Research Personnel also receive the form during their required DCM orientation All completed surveys are sent directly to the Occupational Health Program Coordinator Coordinator who logs and forwards the form to the Medical Director The Medical Director reviews the survey and provides the appropriate risk assessment evaluating the following Tetanus Diphtheria Toxoid Td will be offered valid for 10 years otherwise a booster will be recommended unless medically contraindicated Personnel may decline vaccine by indicating this choice on the Td Tdap Vaccine Declination form TB screening Individuals working with nonhuman primates who do not have history of a prior positive PPD receive a PPD on enrollment If the PPD is positive further action will be as per CDC ATS ACCP guidelines If the participant has a history of a previous positive PPD further skin testing is not performed a TB Questionnaire is administered A chest x ray is obtained if the individual s response to the TB Questionnaire suggests active pulmonary tuberculosis or the individual cannot provide documentation of a normal chest x ray following the discovery of the positive PPD Hepatitis A 2 doses of vaccine will be offered Personnel may decline vaccine by indicating this choice on the Hep A Vaccine Declination form Hepatitis B 3 doses of vaccine will be offered unless an individual has had prior doses of the vaccine If prior doses of the vaccine were administered the vaccine series will resume from the last dose received the series does not need to be restarted Employees may decline vaccine by indicating this choice on the Hep B Vaccine Declination Form Measles MMR Personnel working with nonhuman primates who have not had previous exposure to measles e g had a natural case or been previously vaccinated and have laboratory evidence of immunity will be offered the vaccine Personnel may decline vaccine by indicating this choice on the Measles Vaccine Declination Form If measles vaccine is declined or medically contraindicated employee WILL NOT be cleared to work with nonhuman primates Allergy assessment and General health assessment to top 2 Medical Clearance If additional tests physical exams or health surveillance are needed the Medical Director completes a Medical Authorization and Order Form and forwards it to the Coordinator The Coordinator forwards an electronic copy of this form to the animal research personnel and assists in setting up appointments as necessary with the Clinical Research Unit

    Original URL path: http://ora.georgetown.edu/occupationalhealth (2015-09-30)
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  • RCR Training | Office of Regulatory Affairs | Georgetown University
    scientific process and to meet institutional obligations as a federal grantee institution Georgetown University has developed a program of instruction in the responsible conduct of research based on graduate levels of study and achievement throughout the scientist s professional life Mandatory programs for all undergraduates graduate students and pre doctoral trainees engaged in research include either a semester course focusing on RCR GUMC Phar 543 Ethical Issues in Scientific Research or the electronic CITI RCR course plus for some researchers no less than 8 hours of face to face instruction by way of small group discussions such as but not limited to lab meetings departmental journal clubs and seminars For further details please click on your specific campus plan in the table below Medical Center GUMC RCR Notice Training Plan Main Campus Law Center Qatar Campus RCR Notice Training Plan Completing the on line course from Collaborative Institutional Training Initiative CITI Log onto the CITI homepage with your username and password Select Georgetown University as your institution CME CEU credits for the required courses are available through the University of Miami Office of Continuing Medical Education They will provide up to 6 Category 1 CME credits for Physicians Physician s

    Original URL path: http://ora.georgetown.edu/training (2015-09-30)
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