HOSTING RESEARCH VOLUNTEERS AT MAIMONIDES MEDICAL CENTER Instructions and Forms Research volunteers provide important contributions to clinicians conducting research at Maimonides Medical Center. If you plan to host research volunteers to support your research activities, please review the instructions and forms in this packet. Please note that research volunteers are distinct from observers. Observerships are generally intended for foreign medical school graduates and are usually time-limited to one month. Observerships must first receive approval from Department Chairs or Training Program Directors and be screened through the Department of Volunteer and Student Services. If you have any questions, please contact: The Department of Volunteer and Student Services at 718.283.3980
Overview DEPARTMENT OF VOLUNTEER AND STUDENT SERVICES RESEARCH VOLUNTEER KEY RESPONSIBILITIES Research volunteers provide important contributions to clinicians conducting research at Maimonides Medical Center. While the specific duties of a research volunteer may vary by Department, the role of a research volunteer is to support non-clinical, clinical and/or laboratory research under the supervision of the principal investigator and her/his research team. Screening. Research volunteers are first screened and recruited by the Principal Investigators/ research staff and then referred to the Department of Volunteer and Student Services for processing. Orientation. After Research volunteers complete the requisite screening and application process and are approved, the Department of Volunteer and Student Services provides general orientation including Code of Conduct Corporate Compliance, Environment of Care Safety, Emergency Management, HIPAA Privacy and Security, Infection Control, Customer Service, Cultural Diversity and Sensitivity, MMC Mission, and other guidelines for volunteers at the Medical Center. Research Training. In addition, research volunteers must complete a variety of on-line trainings (please refer to Forms and Checklist) and submit certificates of completion to the Department of Volunteer and Student Services Office and their supervisor (access instructions noted on the Checklist form). Check-In and ID Badges. While on duty, research volunteers are required to wear a volunteer ID badge and a jacket (if needed) which are provided by the Department of Volunteer and Student Services. They also must sign in and out through computer kiosks on each day of duty. Functions / Responsibilities Duties of a research volunteer will vary according to the projects and needs of Investigators but may include: 1. Participation in non-clinical, clinical and/or laboratory research under the supervision of the Principal Investigator 2. Assisting staff with literature search/review, electronic and paper chart review, data collection and analysis (with supervision), and patient recruitment materials 3. Assisting with Institutional Review Board (IRB) application and reports 4. Attending meetings, conferences, and seminars as advised by their supervisors 5. Performing other related duties as assigned such as computer data entry (access to electronic patient information must be approved / authorized by MIS) 6. Maintaining confidentiality of all information acquired while on duty 7. Providing customer service: respect, flexibility, pleasant attitude, and helpfulness 1
SCREENING & APPROVAL PROCESS Responsibility Task Dept. of Volunteer and Student Services (DVS) / Clinical Dept. Screens volunteers (recruitment may originate from the DVS or the Dept.) Refers recommended volunteers to the DVS via email (please refer to template document in the packet) or by submitting original letter signed by supervisor The DVS provides application to volunteer Volunteer Completes application and submits to the DVS Submits completed medical forms to the DVS Dept. of Volunteer and Student Services Reviews and processes application Conducts background check Interviews applicant Schedules volunteer for orientation Volunteer Signs all requisite forms / Attends the DVS orientation Completes recommended online research training prior to commencement Provides hard copy of training completion certificates to the DVS and Supervisor Supervisor Submits Request for Access to Maimonides Network/Clinical Application form and MIS security form to the DVS, which is then submitted to Research Administration (if applicable) Research Administration Submits Request for Access to Maimonides Network/Clinical Applications form, MIS security form and any other required documents to MIS (if applicable) MIS Provides network / clinical system access for volunteer (if applicable) Dept. of Volunteer and Student Services Refers volunteer to Security for ID badge Provides volunteer with a volunteer blue jacket (if required) Provides volunteer with computer ID access number to sign in/out Supervisor Provides requisite hands-on training for the specific functions that the volunteer is responsible for performing Evaluates the volunteer and submits performance appraisal form to DVS 2
Acceptance Email Template Supervisors: once you have identified and screened a research volunteer, please send the following email or signed letter of acceptance in the format below to Alla Zats, Director, Volunteer and Student Services <Date> Alla Zats Director, Volunteer and Student Services Maimonides Medical Center 4802 Tenth Avenue Brooklyn, NY 11219 Dear Alla: This letter confirms my acceptance of <Insert Full Name> as a Research Volunteer in the Department of <Insert Name of Department>. <Insert First Name of Volunteer> will be under the supervision of <Insert Name of Attending Physician/Faculty>, primarily providing support on <her/his> research studies. <Insert First Name of Volunteer> will serve as a volunteer at Maimonides from approximately <Insert Start Date> to <Insert End Date>. If you have any questions, please feel free to contact me at <Insert Phone Number>. Sincerely, <Signature> <Name of Department / Division Head or Principal Investigator> <Title> 3
Forms and Training Checklist Supervisors and volunteers: The forms and activities listed below are required to be completed by research volunteers, in coordination with their supervisors and the Department of Volunteer and Student Services (DVS), prior to their commencement as a volunteer. FORMS Confidentiality Acknowledgement submit to DVS (Volunteer and Student Services) Acknowledgement of Participation submit to DVS Description of Volunteer Work submit to DVS who will then submit this form to Research Administration Request for Access to Maimonides Network / Clinical Applications (if applicable) submit to DVS who will then submit this form to Research Administration Maimonides Non-Employee Access Form (if applicable) submit to DVS who will then submit this form to Research Administration ORIENTATION / TRAINING Volunteer and Student Services Orientation (on site, in-person) CITI Training Modules: Human Subject Research Basic Course for Biomedical Research Investigators or Basic Course for Social-Behavioral-Educational Research Investigators (SBE) (course to be determined as per instructions from the supervisor). Date Completed: Go to www.citiprogram.org. Under Participating Institutions, choose Maimonides Medical Center. Set up username and password. Follow instructions below (or access instructions and the link on the MMC Intranet at http://intranet.mmc/main/educationalrequirementsforresearch.aspx) Besides written approval of Director of Clinical and Translational Research Laboratories to work in the Research Labs, volunteers shall complete the required CITI Biosafety Training, Hands-on Lab Biohazard and Safety Training, as well as laboratory-specific training for chemical safety, instrumentation use, etc., as may be needed. CITI BIOSAFETY COMPLETE TRAINING SERIES is designed to provide individuals working in a laboratory setting with a solid foundation in the principles of the containment and preventing exposure of biohazards. Date Completed: Go to www.citiprogram.org (same as for other CITI training modules) and choose the course Biosafety Complete Training Series and complete all associated modules. Modules are categorized as required, elective and optional. Required modules must be completed to earn a completion report. HANDS-ON LAB BIOHAZARD AND SAFETY TRAINING (on site, in-person) Date Completed: This training is mandatory for volunteers working in the laboratory setting and will be available in the Research Labs by appointment with the supervisor. 4
Acknowledgement of Participation Supervisors: Once a Volunteer has been screened and accepted by a Principal Investigator, the Volunteer must complete and submit the following signed letter to Alla Zats, Director, Volunteer and Student Services I acknowledge that I am being accepted as a (First and Last Name) research volunteer in the Department / Division of at Maimonides Medical Center for the period of to. (Start Date) (End Date) During this period, my responsibilities will include: If my volunteer position ends early or is extended, I will let the Department of Volunteer and Student Services Office know immediately. Date Volunteer Signature Volunteer Name (Printed) Supervisor Signature Supervisor Name (Printed) 1
Confidentiality Acknowledgement As a volunteer of Maimonides Medical Center participating in research studies, I understand that I may have access to sensitive patient information. I have generally been informed and understand that the information concerning treatment of patients is confidential and not to be disclosed to any person or entity without appropriate patient authorization, subpoena, or court order. As a condition of my volunteer position here, I agree not to directly or indirectly disclose said information without proper authority and specifically agree to the following requirements: 1. I will avoid any action that will provide confidential information to any unauthorized individual or agency. 2. I will not inquire about or review any medical records or files for which I have no authorization. 3. I will not make copies of any medical records or patient data except as specifically authorized. 4. I will not discuss in any manner, with any unauthorized person, information that would lead to the identification of individuals described in the medical record. 5. I will not provide my computer password or file access code to any unauthorized person. 6. If I observe unauthorized access to divulgence of confidential patient records or data to other persons, I will report it immediately to my supervisor; I understand that failure to report violations of confidentiality by others is just as serious as my own violation. 7. I will follow Maimonides Medical Center s guidelines, policies, and procedures for releasing confidential information and request guidance should I have any questions about the action to be taken. 8. I will not discard copies or originals of patient information without expressed authority from my supervisor and then such discarding will only be done in recyclable containers. 9. I recognize that medical records generated in an Ambulatory unit are confidential to the same extent as those records generated in the Hospital as a whole and therefore are subject to the same rules and procedures. I understand that confidential information or data is defined as any information where the patient, hospital, nurse(s), or physician(s), is named or otherwise identifiable. I understand that, as a volunteer, breach of confidentiality may be cause for immediate termination of my volunteer position. I have read this acknowledgement and the confidentiality policies of the facility to which I have been assigned and will demonstrate my understanding and willingness to abide by these policies and procedures by affixing my signature and the date below. Date Volunteer Signature Volunteer Name (Printed) Supervisor Signature Supervisor Name (Printed) 2
Description of Research Work This section should be filled by the person supervising the work of this volunteer. Return this form to azats@maimonidesmed.org and asegal@maimonidesmed.org Date of Request: Research Volunteer Name: Approximate Start Date of Work at Maimonides: Approximate End Date of Work at Maimonides: Department: Primary Location of Work (Address): Phone: Supervisor Name: Title / Department: Phone: Describe Research 1. Describe the nature of the work this volunteer will be asked to do. You must include whether the volunteer will have access to PHI, direct contact with patients and their family, exposure to procedures. 2. If the volunteer is working on an IRB approved project, please provide the IRB number, title, and name of the Principal Investigator. 3. Will this work involve working in a Laboratory? If so, describe the nature of the work and expertise of the volunteer in this area. 4. Describe the training you will provide to the volunteer to perform his/her research work. 3