North Shore LIJ Health System, Inc. Section: Research DEPARTMENT: Research Administration Last Revised/Reviewed: 5/2011

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1 North Shore LIJ Health System, Inc. POLICY TITLE: Visiting Scientists and Scholars for Research POLICY #: GRO81 Approval : 5/26/11; 9/22/11 Effective : Prepared by: Research Administration ADMINISTRATIVE POLICY AND PROCEDURE MANUAL Section: Research DEPARTMENT: Research Administration Last Revised/Reviewed: 5/2011 Superseded Policy(s)/#: n/a GENERAL STATEMENT of PURPOSE The Visiting Scientist and Scholars for Research policy is established to facilitate the interaction of North Shore-LIJ Health System ( Health System ) and Hofstra North Shore-LIJ School of Medicine ( School of Medicine ) faculty with other scientists, colleagues and students, who will have access to Health System and School of Medicine research resources, facilities and faculty, not otherwise available to the public. The purpose of the policy for Visiting Scientists and Scholars for Research is to provide faculty with guidelines to accomplish the following: Provide a mechanism for hands-on instruction and/or research collaboration capability using Health System and School of Medicine faculty, resources and laboratory facilities, to individuals who are not otherwise Health System or School of Medicine employees; Provide safeguards to ensure compliance with Health System and School of Medicine policies and procedures and contractual obligations to federal and industrial sponsors; Provide safeguards for the Health System and School of Medicine to require the Visiting scientist or scholar to maintain appropriate records (including lab notebooks and regulatory documents) and to submit any reports or other outstanding documents prior to leaving the Health System or School of Medicine to the appropriate designated individual. POLICY It is the policy of the North Shore-LIJ Health System and Hofstra North Shore-LIJ School of Medicine to allow Visiting Scientists and Scholars with prior institutional approval to interact with and conduct research at Health System and School of Medicine facilities. Research faculty are encouraged to seek collaboration opportunities with colleagues and scientists affiliated with other academic institutions and/or from the for-profit sector. Research faculty are also encouraged to provide training opportunities to students who receive financial support from their Page 1 of 10 GRO81 9/22/11

2 university, company, and/or foreign governments. These individuals may visit the Health System and have direct access to Health System or School of Medicine research facilities, resources and faculty only with appropriate approvals from administration. In order to facilitate these interactions, while protecting the Health System s and School of Medicine s rights, it is important to strike a balance. As a result, all Visiting Scientists and Scholars will be governed by a Visiting Scientist Agreement. Faculty members must, prior to arrival of the visitor on campus, require that a Visiting Scientist execute a Visiting Scientist Agreement. If the Visiting Scientist will be representing a Company or an Institution or if his/her activities as a Visiting Scientist will be subject to employment or contractual requirements at the Company or Institution, the Visiting Scientist Agreement must be co-signed by the appropriate representative who is authorized to execute agreements and bind the outside Company or Institution. Regardless of whether they are compensated, all individuals with visiting appointments conducting research at Health System or School of Medicine facilities must comply with Health System or School of Medicine human resource, research, and compliance policies and procedures. Visiting Scientists and Scholars retain responsibility for their actions and enjoy equally the rights, privileges and protections afforded Health System and School of Medicine employees with some exceptions. Those appointed without compensation do not participate in staff benefits programs and are not covered by general or professional liability insurance for claims and judgments arising out of their activities. In addition, those appointed without compensation and acting as representatives of a US based company or institution must provide a certificate of insurance showing general liability and worker s compensation coverage and if acting in a clinical capacity, medical malpractice coverage. All Visiting Scientists and Scholars will attend a general research orientation where they will be appropriately orientated to the Hospital or Facility. This orientation may include as appropriate to their role: HIPAA/ confidentiality, human subject protections, animal care, safety, infection control and fire safety. They may also receive additional specific department orientation as needed. Visiting Scientists and Scholars may be expected to submit to a background screening, and acceptable medical clearance must be received before they can begin working in any Health System or School of Medicine facility. Visiting Scientists and Scholars will be provided with an appropriate Health System or School of Medicine issued identification badge and must wear the badge while on campus. Visiting Scientists and Scholars (as applicable) involved in direct patient care must be appropriately licensed and privileged through Medical Staff Services and must provide a certificate of insurance and letter from their home institution stating the work performed is within the scope of their duties. Direct patient care is defined as involving any aspects of the health care of a patient, including but not limited to patient treatments, administration of medication, counseling and patient education. All Visiting Scientists and Scholars performing work as a physician must possess a valid NYS medical license and may be required to purchase their own medical malpractice insurance through a NYS carrier. Page 2 of 10 GRO81 9/22/11

3 Note: Due to special insurance requirements, Risk Management must be notified prior to any Visiting Scientist or Scholar performing work at Lenox Hill Hospital. SCOPE This policy applies to all members of the North Shore LIJ Health System workforce including, but not limited to, employees, medical staff, volunteers, students, physician office staff, and other persons performing work for or at North Shore LIJ Health System. DEFINITIONS Visiting Scientist/Visiting Scholar Visiting Scientist and Visiting Scholar titles designate visitors conducting research or similar scholarly activity for a specified period from one week to one year. The specific title, always preceded by "Visiting," should reflect the actual duties of the visitor. A Visiting Scientist is primarily occupied with research in the field indicated. A Visiting Scholar is a student and may or may not be associated with a formal academic program. Visiting appointments are academic appointments. Visiting appointees may be full or part time, salaried or unsalaried and, as individuals performing as agents of the institution, are subject to all employment responsibilities. Appointments are made to academic departments or laboratories/centers with approval of the department head or laboratory/center director and, if a School of Medicine faculty appointment is requested, approval of the Dean. If an appointee receives compensation paid through the Health System, funding responsibility resides with the department or laboratory/center that is the locus of the appointment regardless of whether the compensation is provided by operating funds or external sources. Since appointments to this rank are by definition temporary, visitors are typically not eligible for benefits, except for those with compensated appointments of 50 percent or more time and of at least three months' duration. Guests of the Institute A guest is usually a distinguished individual of considerable professional attainment to whom the Institute extends the prerogative of observing or participating informally in certain phases of its activities. Guest appointments are academic, receive no salary and are not considered employees of the Health System or the Medical School. Page 3 of 10 GRO81 9/22/11

4 PROCEDURE/GUIDELINES The faculty sponsor who will host the Visiting Scientist or Scholar is responsible for having the Visiting Scientist Agreement signed prior to the visit. The Visiting Scientist or Scholar should print and complete two originals. If the Visiting Scientist or Scholar is coming to the Health System or School of Medicine as an individual and is not subject to any contractual or employment constraints from an outside entity, both copies of the Visiting Scientist/Scholar Agreement should be signed by the Visiting Scientist/Scholar, as an individual and both signed originals returned to the sponsor. Visiting Scientist/Scholar(s) who are coming to the Health System or School of Medicine and are subject to any contractual or employment constraints from an outside entity are required to sign both copies and have both copies signed by the appropriate representative of the company or institution who is vested with the authority to sign such agreements. Both signed originals should be returned to the sponsor. The faculty sponsor will complete the questionnaire(s), and then forward the signed agreement and questionnaire(s) to Research Administration for review and for signature on behalf of the Health System or School of Medicine. The VSA Questions must be answered for ALL Visiting Scientist/Scholar Agreements. The section on Foreign Nationals must be completed for all foreign scientists/scholars unless the proposed visitor is a U.S. Citizen or a lawful permanent resident (holds a Green Card). Research Administration reserves the right to request additional information or clarification of the information provided in order to complete its review. If changes to either agreement are requested by the Visiting Scientist/Scholar or the Visiting Scientist/Scholar s organization, or if changes are deemed necessary by the Health System of School of Medicine, Research Administration will negotiate the changes with the Visiting Scientist/Scholar (for agreements with individuals) or with the organization (for Visiting Scientist/Scholars representing a company or institution). After signature of the agreement on behalf of the Health System or School of Medicine, a fully executed agreement will be provided to the Health System or School of Medicine faculty sponsor or designee. THE VISITING SCIENTIST IS PRECLUDED FROM CONDUCTING RESEARCH AT THE HEALTH SYSTEM or SCHOOL OF MEDICINE UNTIL A FULLY-EXECUTED VISITING SCIENTIST/SCHOLAR AGREEMENT IS OBTAINED. Page 4 of 10 GRO81 9/22/11

5 REFERENCES to REGULATIONS and/or OTHER RELATED POLICIES CLINICAL REFERENCES APPROVAL: To Include Committee Name / Approval System P&P Committee 5/10/11; 9/13/11 System PICG Committee 5/26/11; 9/22/11 Page 5 of 10 GRO81 9/22/11

6 Name of Visiting Scientist/Scholar: North Shore-LIJ Health System Feinstein Institute for Medical Research Hofstra North Shore-LIJ School of Medicine Visiting Scientist/Scholar Agreement (Template) Name of Visiting Scientist/Scholar s Home Institution: Name & address of Health System/School of Medicine facility where Visiting scientist/scholar will work: Anticipated period of time at Health System/School of Medicine: Name of Faculty Sponsor: Feinstein/Health System/School of Medicine Business Unit and Department/Lab: In consideration of being permitted to perform research at (check all that apply) North Shore-LIJ Health System Feinstein Institute for Medical Research Hofstra North Shore-LIJ School of Medicine And to use its facilities and resources I hereby agree as follows: Research work permitted is limited to:. When applicable, Intellectual property rights will be governed by the separate Intellectual Property Agreement attached hereto and executed by the Visiting Scientist/Scholar and by authorized officials of the Visiting Scientist/Scholar s home institution and as applicable the North Shore-LIJ Health System, Feinstein Institute for Medical Research, and/or Hofstra North Shore-LIJ School of Medicine (together the institution ). Publication of the results of research performed under this agreement is permitted after review by the Faculty Sponsor and by sponsor s representatives, when required by the terms and conditions of an award or other regulation. I understand that publication may be delayed in order comply with these requirements. In addition the following terms apply: I agree to maintain accurate and complete laboratory notebooks and/or other written documentation that is appropriate for the purpose of the visit. If conducting clinical research I agree to maintain records in compliance with the guidance provided in ICH Topic E6, Good Clinical Practice: Consolidated Guidance. At the close of this Agreement, I shall submit the original copy of all and such documentation including any reports and/or other outstanding items to the Faculty Sponsor or designee prior to the last day of my visit. I understand that I may retain a copy for my files. I agree to keep and maintain in confidence and not to use any information that I may observe while at the institution that relates to research programs without prior permission. I certify that I am qualified to perform the tasks that I will undertake at the institution and will comply with all necessary background checks, mandatory education programs, and credentialing procedures required by the institution and/or funding agencies. I understand that the research may involve risks such as exposure to potentially hazardous equipment, materials, chemicals, microbes, infectious organisms, medical waste, pathogens, laboratory animals, Page 6 of 10 GRO81 9/22/11

7 radioactive materials, and the risk of accidents or injuries. As a result I will comply with all applicable institutional safety plans. I agree to cooperate fully with the institution s Faculty Sponsor or designee to obtain any required training, approvals or authorizations for performance of the research tasks, in accordance with institutional policies and procedures, as well as applicable laws, regulations and standards. I agree to comply with export and sanction regulations of the United States of America. I understand that the institution may review all institution activities that may result in an export or sanctioned activity with a foreign national, entity, or country requiring an export license or other governmental approval. I agree to cooperate with any such review and to comply with any recordkeeping, certification, license, security measure or other action that may result from the review. I understand that I am not covered by general or professional liability insurance for claims and judgments arising out of my activities. I am responsible for any injuries to people or property resulting from my acts. (INCLUDE if applicable): My participation as a Visiting Scientist at the institution shall not create an employment relationship between the institution and me. I shall receive no stipend or benefit from the institution for my activities and I am not entitled to participate in the institution s benefit programs including, but not limited to, worker s compensation or health insurance. VISITING SCIENTIST/SCHOLAR AUTHORIZED OFFICIAL for HOME INSTITUTION/COMPANY Title FEINSTEIN/SOM DEPT CHAIR/CENTER HEAD AUTHORIZED OFFICIAL for FEINSTEIN/SOM Page 7 of 10 GRO81 9/22/11

8 Visiting Scientist/Scholar Agreement Questionnaire Complete the following questions for All Visiting Scientists/Scholars. Attach it to the signed agreement and submit to Research Administration for review and signature of behalf of the North Shore-LIJ Health System, Feinstein Institute for Medical Research, and/or the Hofstra North Shore-LIJ School of Medicine. Name of Visiting Scientist/Scholar: Address of Visiting Scientist/Scholar: SS#: NA Signed and dated CV attached Will the Visiting Scientist/Scholar be representing or affiliated with another company or institution? Yes No If, yes, name of Visiting Scientist/Scholar s Home Institution: Name & address of Health System/School of Medicine facility and specific Department/Center/Lab where Visiting scientist/scholar will work: Period of time at Health System/School of Medicine: Name of Faculty Sponsor: Will the Visiting scientist/scholar be receiving any compensation or salary from the Health System? Yes No If, yes, name of business unit and department where salary cost will be charged: Note, you still must complete a position data change form and submit to facility finance and human resources for approval to split an individual to specific cost centers, this questionnaire does not take the place of that process. 1. What is the purpose of the visit (provide a brief summary and overview of the project, including whether the Visiting scientist/scholar will work on any federally supported projects. If so, please provide PeopleSoft project ID and funding agency grant #) Note you may attach project descriptions or abstracts to this questionnaire 2. Will the Visiting scientist have access to other faculty members and their laboratories or other institutional facilities or resources not otherwise open to the public (for example cyclotron, center for comparative physiology, etc). Yes No If, yes, describe: Note special access approvals including fingerprinting and background checks may be required. 3. Will the Visiting scientist have access to existing or potential institutional intellectual property? Yes No If, yes, describe: 4. Will the Visiting scientist/scholar be bringing any research materials with him/her? Yes No If, yes, describe and include whether the research material would be co-mingled with any other materials developed at the institution: Complete the following additional questions for FOREIGN NATIONAL Visiting Scientists/Scholars. Page 8 of 10 GRO81 9/22/11

9 Visiting Scientist/Scholar has been granted a visa by the US Department of State Will the Visiting Scientist/Scholar attend external meetings or conferences? Yes No If yes, where? Is the Visiting Scientist/Scholar from a country (Cuba, Syria, Iran, Sudan, North Korea) or institution sanctioned by the US Treasury Office of Foreign Assets Control? Yes No Note, if yes an export control license may be required. You must contact Research Administration immediately as the Visiting scientist/scholar will not be allowed access to the institution and may not begin working on any project without the appropriate license in place. For a full list of sanctioned countries, individuals and institutions: Is the Visiting Scientist/Scholar from Cuba? Yes No If no, proceed to the signature page If yes, specific exemptions may apply: General license authorizing accredited U.S. graduate and undergraduate degree-granting academic institutions to engage in Cuba travel-related transactions incident to certain educational activities 31 CFR Part (a). Therefore proceed to the following question: Is the purpose of the visit: (1) Participation in a structured educational program as part of a course offered for credit by the sponsoring U.S. academic institution. An individual traveling to engage in such transactions must carry a letter on official letterhead, signed by a designated representative of the sponsoring U.S. academic institution, stating that the Cuba-related travel is part of a structured educational program of the sponsoring U.S. academic institution, and stating that the individual is a member of the faculty or staff of that institution or is a student currently enrolled in a graduate or undergraduate degree program at an accredited U.S. academic institution and that the study will be accepted for credit toward that degree; (2) Noncommercial academic research specifically related to Cuba and for the purpose of obtaining a graduate degree. A student traveling to engage in such transactions must carry a letter on official letterhead, signed by a designated representative of the sponsoring U.S. academic institution, stating that the individual is a student currently enrolled in a graduate degree program at an accredited U.S. academic institution, and stating that the research will be accepted for credit toward that degree; (3) Participation in a formal course of study at an academic institution provided the formal course of study will be accepted for credit toward the student's graduate or undergraduate degree. An individual traveling to engage in such transactions must carry a letter on official letterhead, signed by a designated representative of the sponsoring U.S. academic institution, stating that the individual is a student currently enrolled in a graduate or undergraduate degree program at an accredited U.S. academic institution and that the study will be accepted for credit toward that degree; (4) Teaching at a academic institution by an individual regularly employed in a teaching capacity at the sponsoring U.S. academic institution, provided the teaching activities are related to an academic program at the Cuban institution and provided that the duration of the teaching will be no shorter than 10 weeks. An individual traveling to engage in such transactions must carry a letter on official letterhead, signed by a designated representative of the sponsoring U.S. academic institution, stating that the individual is regularly employed in a teaching capacity at that institution; Page 9 of 10 GRO81 9/22/11

10 (5) Sponsorship, including the payment of a stipend or salary, of a Cuban scholar to teach or engage in other scholarly activity at the sponsoring U.S. academic institution (in addition to those transactions authorized by the general license contained in ). Such earnings may be remitted to Cuba as provided in or carried on the person of the Cuban scholar returning to Cuba as provided in (d)(3); or (6) The organization of, and preparation for, activities described in paragraphs (a)(1) through (a)(5) of this section by members of the faculty and staff of the sponsoring U.S. academic institution. An individual engaging in such transactions must carry a letter on official letterhead, signed by a designated representative of the sponsoring U.S. academic institution, stating that the individual is a member of the faculty or staff of that institution, and is traveling to engage in the transactions authorized by this paragraph on behalf of that institution. Faculty Sponsor Department/Center Head Approval Research Office Use Only: check and provide dates Visiting Scientist/Scholar has: been screened for compliance with export controls: been cleared by employee health and human resources: met applicable insurance requirements: been cleared for performance of research: of Research Administration Page 10 of 10 GRO81 9/22/11

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