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Northwestern IRB PI

A Principal Investigator (PI) or Co-Investigator (Co-I) is defined as the project director or principal or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, reporting of research, or proposed for such funding, which may include, for example, collaborators or consultant Post-Approval Monitoring & For-Cause Audits. Corrective and Preventive Action (CAPA) Plans. Study Support Resources and Templates. Training. Principal Investigator Transfer of Responsibility Guidelines. FDA Site Inspection Guidance. Reliance. Reliance. Single IRB Planning Before Federal Grant Submission While the PI may delegate responsibility for some project activity to others, the PI is ultimately responsible for compliance with all applicable regulations and policies. Northwestern University researchers can use this chart to pre-determine Principal Investigator eligibility to serve on an IRB protocol, IACUC protocol or a Sponsored Research. Northwestern University researchers can utilize this chart to pre-determine whether they are eligible to serve in the role of Principal Investigator (PI) on an IRB protocol, IACUC protocol or a Sponsored Research proposal/award. If based on your University status/title you fall into the case-by-case category, please consult the website of the respective office for detailed instructions. Individuals who are named as Principal Investigator on NWHSU IRB applications must have sufficient authority, appropriate background, and accountability to oversee all aspects of the research, including assumption of fiscal responsibility. Note that PI eligibility for IRB submissions is different than for sponsored projects (see table below)

Principal Investigator Eligibility and Permissions

Institutional Review Board (IRB) Office - Northwestern

  1. imal support from REDCap ad
  2. ing how depression relates to movement and other aspects of motor behavior.If you or someone you know has experienced depression (either in the present or past) and would like to participate, please email p-sands@northwestern.edu or text/call us at 708.
  3. IACUC OFFICE FAQ. Click here for IACUC FAQs on Protocol Submissions, Grant-Protocol Congruency, Semi-Annual IACUC Inspections, and InfoEd Matching
  4. The application process to request Northwestern IRB to cede review to an External IRB is complete and an email will be sent to the PI to submit. Once the PI submits, the Sit
  5. Policies. Resources. Approved Animal Procedures (AAPs) Forms and Checklists. Frequently Asked Questions. IACUC Ongoing Training. Links Regarding the Ethical Treatment of Animals. PI Eligibility for IRB Protocols, IACUC Protocols, and Sponsored Research Proposals and Awards. Policies

From: Jay Walsh, Vice President for Research <vp-research@northwestern.edu> Reply-To: VP Research <VP-Research@northwestern.edu> Date: Friday, February 12, 2016 at 11:45 AM Subject: Revised Conflict of Interest in Research Policy- NU Research community: As you may have learned from recent communications, Northwestern is launching a new conflict of interest (COI) disclosure system on February. Study Tracker is a set of web-based clinical research tools help to improve efficiency, safety and security for subjects in scientific studies. Study Tracker has logged more than 6,000 studies with nearly 80,000 patient accruals. In 2013 alone, there were more than 1,500 studies initiated Location of study: Les Turner ALS Center at Northwestern Medicine, 259 E. Erie St., Lavin 19, Chicago, IL 60611. Principal Investigator Ajroud-Driss, Senda ClinicalTrials.gov Identifier NCT04259255 IRB number STU0021005

Resources. Some information on this website requires VPN connection. Policies AAPs Forms and Checklists Regulatory Agencies Links Regarding the Ethical Treatment of Animals frequently asked questions pi eligibility for protocols Investigator Manual . APPROVED BY EFFECTIVE DATE PAGE HRP-103 Executive Director, IRB Office Northwestern University 05/20/2020 Page 5 of 57 . W. hat is the Human Research Protection Program Visit Forms and Checklists here. Northwestern NetID and Password is required. Please use a VPN or campus network connection IRB Studies. All studies submitted to the IRB that involve human participants are subject to the Conflict of Interest in Research policy, which requires: All Investigators must complete COI training and complete a disclosure in eDisclosure prior to initiating a study. ( Note: COI training is different than CITI training, or GCP training Overall PI: Relying Site Investigator: Northwestern IRB Study Number: STU. IRB review will be ceded under the SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement (Version 1). Acknowledged by: Reviewing IRB: D

Scope of Work: Northwestern University • Start-up o Obtain IRB approval (local IRB or via sIRB, depending on current cohort IRB approval) and other necessary approvals for Phase 1 protocol o Participate in staff training and certification • COVID-19 Questionnaires o Administer wave 1 questionnaire, plus QC o Administer wave 2 questionnaire. A PI Proxy can only be assigned by the PI on an approved, non-ceded study. Any initial study application that has not yet been approved will need to be granted IRB approval before a proxy can be assigned. Any study for which the review has been ceded to an External IRB, assigning a PI Proxy is not permitted Northwestern Oklahoma State University (NWOSU) is authorized by the federal government to determine whether studies thought by the principal investigator (PI) to be exempt from federal regulations actually qualify for exemption. Such determination is made on behalf of NWOSU by the IRB IRB's requirements, but may still be submitted at the PI or study team's discretion. UPIRSOs (Unanticipated Problems Involving Risk to Subjects or Others) If a sponsor issues a study-wide safety report, and the NU principal investigator determines that th

Principal Investigator (PI) - Northwestern Universit

Assist PI to prepare Institutional Review Board (IRB) protocol submissions; Assist the PI to protect the rights and welfare of human research participants through data security of consents and other protected records; Assist the PI to ensure all documents related to the research protocol and the IRB application and approval are up-to-dat However, for applications that are likely to be funded, the PI and Sponsored Research will receive an additional email directly from the specific Grants Management Specialist in the NIH Institute or Center requesting the JIT information. Questions for IRB? Email: irb@northwestern.edu IRB Studies. All studies submitted to the IRB that involve human participants are subject to the Conflict of Interest in Research policy, which requires: All Investigators must complete COI training and complete a disclosure in eDisclosure prior to initiating a study. ( Note: COI training is different than CITI training, or GCP training

PI Eligibility for IRB Protocols, IACUC Protocols, and

  1. istrator must be able to account for the total dolla
  2. IRB Number: STU00212069. ClinicalTrials.gov Identifier: NCT04245839. PI Name: Reem Karmalil. Eligibility Criteria: Age of at least 18 years. Diagnosis of Follicular or Marginal Zone Lymphoma, which has either returned or is not responding to your current treatment. Follicular Lymphoma and Marginal Zone Lymphoma are two types of non-Hodgkin.
  3. Principal Investigator (PI) The Principal Investigator is responsible for the design, conduct, and reporting of the research project. Northwestern University Conflict of Interest Office (COI) oversees and implements the University faculty and staff conflict of interest policies and procedures. The Institutional Review Board (IRB.
  4. istratively supports the IRB which is responsible for approving research protocols, informed consent documents, and other study material before a study can begin
  5. IRB Investigator Manual . NIH guidance on clinical trials. Northwestern Libraries Data Management Guide. Contacts . If you have any questions about this policy, you may contact: 1. Executive Director, Office for Sponsored Research - (312) 503-7955 or osr-chicago@northwestern.edu. 2
  6. IRB Institutional Review Board LCC IIT Lurie Cancer Center investigator-initiated trial NCI National Cancer Institute NIH National Institutes of Health NOTIS Northwestern Oncology Trial Information System NU Northwestern University PI Principal Investigator QA Quality Assurance QAM Quality Assurance Monito

Principal Investigator Eligibility Requirements for IRB

  1. istration Training. Responsible Conduct of Research (RCR) Training
  2. The Northeastern University Institutional Review Board (IRB) follows the basic ethical principles of respect for persons, beneficence, and justice as set forth in the Belmont Report. These principles are codified in 45 Code of Federal Regulations Part 46, subparts A-D - Protection of Human Subjects. It is the policy of Northeastern University that no activity involving human subjects be.
  3. Remembered Intimacies and the Bona Fide Marriage, funded by the Sexualities Project at Northwestern, IRB-approved study, Charles Clarke, co-principal investigator. Study compares rate and character of non-matching answers on spousal green card interviews with rate and character of non-matching answers on The Newlywed Game television show
  4. requirements the PI must fulfill to reinstate accrual privileges, or follow-up with any additional questions or requests for information. The NU PI will also be notified. In addition to the compliance policy detailed above, if sites use the NU IRB as the IRB of record, they must also follow th
  5. For Major Goal 1, Hines' IRB and R&D committee approved the study on 4/20/2015 and 5/26/2015, respectively. Northwestern's IRB approved a study revision on 5/22/2015. The study documents were submitted to Santa Clara Valley Medical Center's IRB and reviewed on 9/11/2015. Their IRB has requested clarifications and changes which will b
  6. ation 5.4.1 The Northwestern IRB Office considers study closure a change in status. Therefore, the Principal Investigator is required to submit the External IRB closure documentation to the Northwestern University IRB
  7. The IRB Office has launched an education initiative for new human participant researchers upon receipt of their first Northwestern IRB approval. Each month, the unit will randomly select one new principal investigator to engage in a brief self-assessment activity

Northwestern University's Expectations for Visitors to Campus reviewed and approved in accordance with the relevant department, school and or center procedures. In addition, the Principal Investigator (PI), initiating school or center is responsible for: Notifying the Institutional Review Board Office and Institutional Committee on. Subcontracts. A subcontract (or subaward) is a formal agreement between Northwestern University (serving as a Pass-through Entity) and a subrecipient under a sponsored program. The information below applies to outgoing subawards (from Northwestern). Incoming subawards (to Northwestern) are categorized and handled as funded agreements

Welcome to Northwestern University. You are now a member of a vibrant, cutting-edge research community. Each member of our community is dedicated to furthering our mission of research excellence and improving human health. In your role as a clinical research staff member, you are a frontline. Northwestern's Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), and Center for Comparative Medicine (CCM) services are for Northwestern research activities (i.e. research projects awarded or contracted to Northwestern University or its affiliates (NMH, Lurie's, and RIC) directly or through subcontract.

Principal Investigator (PI) Institutional Official or designee. Key Tips. IRB. Key Tip 1. Create a template specific to your institution Northwestern University, IRB Office. 312-503-6071. m-oliver2@northwestern.edu irbreliance@northwestern.edu Eileen Yates. IRB Compliance Manager Northwestern University IRB: STU 00200069 Principal Investigator:Suena Massey, MD. Principal Investigator: Suena Massey, MD, Northwestern University is conducting a research study supported by the National Institutes of Health to understand how and why women who smoke may change their smoking habits during pregnancy Northwestern University faculty or staff (without a Lurie Children's appointment) will be engaged in the research conducting study procedures or interacting with participants at Northwestern University and/or its Affiliates (Ensure that these individuals are included on the abbreviated submission to Northwestern IRB

eIRB+ - Institutional Review Board (IRB) Offic

Northwestern University Feinberg School of Medicine. Department of Medicine. ClinicalTrials.gov Identifier NCT02986984 IRB number STU00204808. Principal Investigator Aggarwal, Vikram. IRB number STU00212602. More Info . Keywords immune checkpoint inhibitors acute kidney injury The main reason for the study is to determine whether aortic valve replacement with the Edwards SAPIEN 3 THV (the Study Device) is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms

After the changes have been instituted, the principal investigator should submit an RNI via eIRB+ within five days to inform the Northwestern University IRB. The RNI should include sufficient detail on the temporary changes being made and the harm being mitigated Northwestern State University This application must be completed by the Investigator and sent to the Office of Sponsored Programs by email to irb@nsula.edu All correspondence will be sent to the principal investigator and sponsor unless otherwise specified. 1 The Institutional Review Board (IRB) of Northwestern University is a committee that reviews research involving human subjects in order to ensure that the rights and welfare of human subjects are protected. Federal law and NU policy mandates that all biomedical and social/behavioral research involving human subjects must receive IRB approval. The Positive Affect Regulation sKills (PARK) Course is an online program that teaches positive emotion skills for individuals experiencing stress as a result of the COVID-19 outbreak, recommended/mandatory social distancing, and other related stressors (e.g., loss of income, shortages of daily essentials, etc.)

Reliance Agreements - Institutional Review Board (IRB) Offic

As a gateway for a clinician-scientist career, this T35 Summer Program (The Northwestern Summer Research Program for Medical Students), aims to offer academically promising medical students from five medical schools in the greater Chicago area (FSM, Loyola, Chicago, Illinois at Chicago, and Rosalind Franklin) a rich and didactic summer research basic science or outcomes research. Northwestern University IRB:STU00201386 Principal Investigator: Jacqueline Gollan, PhD (Psychiatry), Co-Investigator:Thorston Kahnt, PhD (Neurology). Why is this research important? Depression and anxiety are the largest contributors to disease and disability, affecting around 300 million people For studies that involve Lurie Children's and Northwestern University, a Master IRB Authorization Agreement is in place for Lurie Children's to serve as the IRB of record. Please refer to the . Studies involving Lurie Children's and Northwestern page for instructions on how to submit these studies for review category is called exempt, at Northwestern University the determination of exemption must be made by the IRB office. Exempt projects are different from Expedited or Full Board Review in that they are not assigned an expiration date, do not have to undergo continuing review, and are able to undergo alterations without IRB approval

Northwestern Medicine Hot Flash Study. Participants are invited to join a research study involving hot flashes for postmenopausal women aged 40 to 70 years old who have moderate to severe hot flashes. This study is being done to determine whether a non-hormonal intervention utilizing a numbing injection can reduce the number and severity of hot. If you are the PI, it is your responsibility to make sure that there is a well understood line of communication at the local site. You are also responsible for ensuring compliance with IRB regulations, ensuring that the protocol is followed, promptly reporting adverse events, and staying abreast of changes to the study. 5. Stay organized Northwestern Faculty: PI Stephanie J. Kielb, MD. Due to obstructed labor, or attempts to relieve this labor via cesarean section, fistulas cause devastating injuries for women, like total urinary and/or fecal incontinence. Women are often ostracized from their families and communities and unable to access safe, affordable surgical care OHRP-40 Lost to Follow-up Notification. West Virginia University OHRP . PO Box 6845 Morgantown, WV 26506-6845. Phone: 304-2. 93-7073 Fax 304-293-3098 Email Human Subjects Office / IRB Hardin Library, Office 105 600 Newton Rd Iowa City, IA 52242-1098. Voice: 319-335-6564 Fax: 319-335-7310 irb@uiowa.ed

Templates & Forms - Institutional Review Board (IRB) Offic

Principal Investigator Borja-Cacho, Daniel. ClinicalTrials.gov Identifier NCT01897688 IRB number The Laboratory for Human Neuroscience at the Northwestern University Feinberg School of Medicine is seeking participants for research studies on how the brain develops across the lifespan. ClinicalTrials.gov Identifier NCT03344757 IRB number. The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain additional opinions Eligibility Criteria Genetic Cohort-PD Subjects • Have at least two of the following: resting tremor, slowness of movement, muscle rigidity • Parkinson disease diagnosis for 7 years or less • Male or female 18 years or older • Confirmation of LRRK2, GBA, or SNCA genetic mutation • Willing to undergo genetic testing Genetic Cohort-Unaffected Subjects • 50 years or older with LRRK2.

Institutional Review Board Northwestern Health Sciences

REDCap: Northwestern University Clinical and Translational

University Recruiting 175 Sam Sibley Drive Student Services Center Natchitoches, LA 71497 Phone: 318.357.4503 recruiting@nsula.edu Office of Admissions 175 Sam Sibley Driv All submissions must include a LCC member who is either the project PI, co or sub-investigator or mentor for a trainee project. All projects requiring IRB approval must be submitted to the LCC's Clinical Trials Office (submit to SRC.CCSG@northwestern.edu).Approval of applications will be on hold until confirmation of this submission is obtained The following searchable list includes all the Division of Pulmonary and Critical Care - Department of Medicine clinical trials currently looking for participants. Please feel free to contact us with inquiries about any of our ongoing research NOTE: Please submit completed form with attached copies of your Informed Consent Form and Letter of IRB approval to: Changiz Geula, Ph.D., Director, Tissue Distribution, Northwestern University CNADC, 320 East Superior Street, Searle 11-465, Chicago, IL 60611; phone: 312-503-7210; fax: 312-908-8789; email: c-geula@northwestern.edu

Paid Research Opportunities: Department of Psychology

PRINCIPAL INVESTIGATOR: Theresa Pape, DrPH . CONTRACTING ORGANIZATION: Chicago Association for Research and Education in Science Hines, IL 60141 . REPORT DATE: October 2016 . TYPE OF REPORT: Annual . PREPARED FOR: U.S. Army Medical Research and Materiel Command . Fort Detrick, Maryland 21702-501 projects with a Northwestern PI, the NU IRB will likely require proof of approval by your host institution. 14 27 Resource library - room 4219 in Jacobs Documentation (user guides, related books) about the statistical / mathematical software and datasets available at the schoo

Northwestern University Pi Beta Phi. March 1, 2019 ·. SAM LOVE OF MY LIFE - forever thankful for you being my first friend and NU and one of my very best forever since I'm sorry I can't be there to celebrate with you today but I love you so very much have an amazing day! -- Abby Richardson Make sure you have a faculty as Principal Investigator • IRB considerations when using Kellogg subject pools: Do not collect any identifiable information from participants (e.g. Principal Investigator Rogalski, Emily. ClinicalTrials.gov Identifier NCT03371706 IRB number STU00206086. More Info . Join our Registry . Email Rogers, Elizabeth Ann Phone 312 503 4012. Follow Mesulam Center on . Northwestern University Feinberg School of Medicine. Giving. Social Media Center Office for the Protection of Research Subjects, Northwestern University: E-IRB workgroup 2005 - 2008: Division of Student Affairs, Learning Beyond the Classroom, First Year Experience at Northwestern University, Residential Housing, etc. Collaborator 2003 - 2018: Searle Center for Advancing Teaching and Learning, Northwestern Universit

Northwestern University - IACUC - Northwestern RESEARC

Must complete Northwestern's IRB CITI training before interacting with any participants & must re-certify every 3 years. Preferred Competencies: (Skills, knowledge, and abilities IRB (CWRU) Short Form IC Guidance on the use of a Short Form: A Short Form may be used for non-English speaking individuals or for individuals who struggle with literacy. A Short Form consent form is a document that contains a brief paragraph that affirms all the elements of informed consent (as required by the federal regulations) were. As part of an academic medical center, the Division of Neurophysiology & Epilepsy at Northwestern University Feinberg School of Medicine aims to improve human health through scientific research. Clinical trials test or study drugs, surgical procedures, medical devices or interventions with human subjects Acts as liaison between research staff (PI, faculty, nurses, technicians, etc.), and internal/external regulatory and oversight groups (NU's IRB, sponsors (NIH, industry), government agencies (FDA), etc.) to resolve issues and problems, negotiate compromises, and offer alternatives and recommendations to facilitate and expedite research while. IRB determination. If the study involves human subjects research, include IRB determination. 6. Letters of support (2 required, up to 5) It is required that an institutional letter of support come from the LMIC institution where the research will be conducted as well as from the NU PI's division chief and/or department chair. 7

Paid Research Opportunities - Northwestern Universit

Must complete Northwestern's IRB CITI training before interacting with any participants & must re-certify every 3 years Preferred Qualifications Master's degree in a social or health science + 1. Change of PI Notification . OHRP - 6. West Virginia Univ. ersity. OHRP . PO Box 6845 . Morgantown, WV . 26506-6845. Phone: 304-293-7073. Fax: 304-293-309

Policies - Northwestern RESEARC

Your adviser, a Northwestern Faculty member should serve as your principal investigator. Please visit Northwestern's IRB website. For a more in-depth look at the IRB application process, also look at the Office of Undergraduate Research's IRB-Human Subjects Research webpage VI. PI Must Provide and Adhere to a Data and Safety Monitoring Plan. The PI has the responsibility to ensure that a study has an adequate data and safety monitoring plan (DSMP) appropriate for the risk level of the study (see Organization Policy 103.6(c)). Either the eIRB application or the protocol submitted to the IRB must explain the DSMP to. If the study involves human subjects research, include IRB determination. 6. Letters of support (2 required, up to 5) It is required that an institutional letter of support come from the LMIC institution where the research will be conducted as well as from the NU PI's division chief and/or department chair. 7. NIH style biosketches for key.

PRINCIPAL INVESTIGATOR: Tanya Simuni, MD Northwestern Parkinson's Disease and Movement Disorders Center (675 N St Clair St, Suite 20-100) and will take approximately 20 minutes. During this visit you will also fill out other Institutional Review Board (IRB) Office. You can call them at 312-503-9338 The IRB will notify the PI and research team of approval status in Cayuse IRB. The IRB approval letters (.pdf file) will be located on the Study Details page, under the tab titled Letters. For Initial applications and Renewals, the approval period expires on the last day of the month prior to the anniversary of approval The George Washington University Investigator Guidance and IRB Policies and Procedures. IRB Basics for GW Researchers. Institutional Review Board (IRB) Basics for GW Researchers (PDF) Current Investigator Guidance. Investigator Obligations (HRP-800) Prompt Reporting Requirements (HRP-801) Informed Consent (HRP-802) Documentation of Informed.

Video: Study Tracker: Northwestern University Clinical and

Supervisory or project management experience required.* Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years.Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities IRB Protocol Review Process. NOTE: The IRB no longer requires review and approval of classroom-based projects.See classroom-based projects for more information.. The IRB review process is initiated by the submission of an IRB application along with all necessary supporting materials (see how to prepare your application.)The IRB assesses the application materials to ensure, among other things. obligations of the Principal Investigator, organization or research team. Institutional Review Board (IRB) protocol and This project is within the authority of Northwestern's IRB since I am a PhD student in the Economics department of Northwestern University