· Web viewInstitutional Biosafety Committee (IBC) Does this study involve the use of materials requiring approval from the IBC (e.g. biohazards, recombinant DNA)? No Yes If

New Protocol ApplicationNorth Shore-Long Island Jewish Health System Institutional Review Board

Application for a New Study

THIS FORM MUST BE TYPED. THE IRB WILL NOT ACCEPT HANDWRITTEN APPLICATIONS.When to Use this FormThis form should be used to submit a research study involving human subjects for IRB review and approval when the proposed research falls under either Full Board OR Expedited Review

Attachments Include:Always submit these documents:

Application for New Protocol (This form) Conflict of Interest Questionnaire: for all staff involved in the design and/or conduct of this study OR complete External Interest (COI) Disclosure electronically at era.northshorelij.com/login.asp Consent/Authorization Form Protocol

When applicable, submit these documents: Appendix: Drugs Appendix: Medical Devices Appendix: International Research

When your research subjects include vulnerable populations; attach the applicable appendices to this form: Appendix: Children Appendix: Cognitively Impaired Appendix: Pregnant Women, Fetuses, and Neonates Appendix: Prisoners

NIH Grant Investigator’s Brochure or Product/Device Information Questionnaires/Surveys Recruitment Materials Investigator’s medical license Any additional institutional approvals: e.g. IBC, CSRRC, EMRC, Radiation, TAP Any other information that is pertinent to the review of your project Required information for IND or IDE number Use of controlled substances in research form

Do not use this form to submit an exempt study. Exempt studies should be submitted to the IRB using the Application for Exemption.

If applying for the review of a Humanitarian Use Device, do not use this form. Instead, use the Application for Humanitarian Use Device.

Submission InstructionsOur website provides full instructions on submitting applications through email to the IRB: [email protected]. Protocols and consent forms should be submitted in an editable format such as Word, Excel, etc. Please contact the IRB office at 516-321-2100 with any questions.

Version Date: IRB NUMBER: _________________Title:

Principal Investigator Study CoordinatorName: Office Phone #: Name:

Dept/Div: Cell Phone #: Cell Phone #:

Affiliation: (Hospital/Facility) Fax: Office Phone #:

Email: Email:

Person/Address to which correspondence should be mailed:

Version 12/19/14 | email [email protected] | phone 516-321-2100 | page 1 of 18

mailto:[email protected]


Has this study ever been reviewed and rejected/disapproved by another IRB prior to submission to this IRB?

No Yes; If yes, explain why you are submitting for review again:

Section A. Institutional Approvals Required Prior to Initiating Conduct of Research

Please indicate if this research involves any of the following belowCommittee on Protection of Participants (COPP)1. Is this a Tissue Acquisition Program

(TAP) protocol?

No Yes

If YES, indicate COPP approval date and/or attach COPP approval letter.

Cancer Services Research Review Committee (CSRCC)2. Is this cancer research that requires

approval from CSRCC?

No Yes

If YES attach CSRRC approval letter/email.

ALL Adult & Pediatric Cancer Studies must be approved by the CSRRC prior to submission to the IRB*. *(Not relevant for Staten Island University Hospital or Huntington Hospital)

Emergency Medicine Research Committee (EMRC)3. Will this study involve Emergency

Medicine patients at NSUH or LIJMC?

No Yes

If you answered YES to any of these 3 questions, you are required to submit to the EMRC. ALL NSUH and LIJMC Emergency Medicine studies must be submitted to the EMRC and receive either approval or acknowledgement prior to submission to the IRB.

1. Indicate EMRC approval date: 2. Include EMRC approval letter with this application

submission.

4. Will this study involve Emergency Medicine faculty at NSUH or LIJMC??

No Yes

5. Will this study be conducted within the Emergency Medicine Department at NSUH or LIJMC?

No Yes

6. Is Radiation or Radioactive Material(s) being used for reasons other than clinical care?

No Yes

If YES, has Radiation Safety Officer approval been obtained? For a list of who to obtain approval from, click here. If NO, explain current state:

Institutional Biosafety Committee (IBC)7. Does this study involve the use of

materials requiring approval from the IBC (e.g. biohazards, recombinant DNA)?

No Yes

If YES, has IBC approval been obtained? For a list of who to obtain approval from, click here.

If NO, explain current state:

8. If other clinical services are required (i.e., laboratory, consults from other departments, etc.) list them and obtain chair approval for each:

9. Do you have all the resources you need to conduct the research? No YesIf NO, and any of the following services are needed, please contact the Clinical Research Service at 516-562-0340, as they may be able to assist you:

Nurse and/or coordinator time/ services

EKG Vital Signs

IRB Submissions Site visits with sponsor/monitor Database creation/data entry Drug or investigational agent

administration

Specimen collection, processing, storage, maintenance and/or shipment

Clinical procedures (e.g. finger stick, venipuncture)

Subject recruitment and/or consent (including electronic consent)


http://www.feinsteininstitute.org/professionals/resources-for-investigators/human-research-protection-program/submissions

http://www.feinsteininstitute.org/professionals/resources-for-investigators/human-research-protection-program/submissions


Section B Study Funding N/A (No funding)Specify all the funding sources for your study.

1. External Funding Sources:

Federal grant; Industry contract

Cooperative groups

Sub-contract Foundation grant

Other

Sponsor Name:

External Agency Grant Award #: N/A

NSLIJ HS Fund #:

NSLIJHS Funding Sources:

Departmental; specify:

PI funded; specify:

Other; specify:

Who authored the protocol? Investigator Sponsor

Section C Category of ReviewFor full details on categories of IRB review, visit our website. Select the category of review you believe your study falls under: (Please note that the final category will be determined by the IRB)

Full Board Review

Expedited Review; Expedited Review Category #

Exempt Review; STOP; use the Application for Exemption instead (don’t use or continue filling out this form)



Section D Study Personnel RequirementsRequired Education- These completion dates can be found online at www.feinsteininstitute.org/hrpp/training/dates.The Human Subjects Training CITI Date is the date of most recent completion of the CITI tutorial program for the basic or refresher human subjects’ research course. The Researcher Registration Date is the date the person signed the researcher registration form. If not complete, this form can be found online here. The COI Training CITI Date is the date of most recent completion of the Conflict of Interest Training Course.

External Interest (COI) Disclosures for ResearchAs of July 1, 2013, all NSLIJHS researchers with access to the eRA portal must complete their annual External Interest (COI) Disclosure electronically at era.northshorelij.com/login.asp. Those without access should complete the paper Conflict of Interest Questionnaire available online at www.feinsteininstitute.org/hrpp/forms The Date of Disclosure is the date of the most recent external interest disclosure for each individual on the project.

Obtaining Informed Consent? Study Personnel

Role on Project

Department & Hospital or Facility

Affiliation(e.g. Pediatrics/

NSUH)

REQUIRED EDUCATION External Interest (COI) Disclosures for Research

Human Subjects Training (CITI)Date

Researcher Registration

Date

COITraining(CITI)Date

Date of Disclosure

Management Plan

Required?

Disclosures for all personnel listed

have been reviewed & are

accurate as of the date of this

submission? Yes No Yes No

Yes No*

Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No

If additional space is needed, you can find a study personnel addendum at www.feinsteininstitute.org/hrpp/forms. *If an individual’s disclosure is not up to date, he/she should revise the disclosure using the appropriate method.


http://www.feinsteininstitute.org/hrpp/forms


http://www.feinsteininstitute.org/hrpp/training

http://www.feinsteininstitute.org/hrpp/training/dates


1. Are all investigators listed above employed by NS-LIJ Health System? Yes No.

If no, please indicate which investigators are employed elsewhere and where they are employed: 2. Confirm that all investigators on this study have the adequate resources to protect human subjects:

Yes No

3. Explain how staff is qualified; include any training and expertise specific to the conduct of this study. Include information about relevant licenses/medical privileges, as applicable:

4. Detail processes to inform staff of the protocol and their duties and functions for this study:

Section E Study Description

1. Summarize your study. The summary should be written in language intelligible to a moderately educated, non-scientific layperson. It should contain a clear statement of the rationale and hypothesis of your study, a concise description of the methodology, with an emphasis on what will happen to the subjects, and a discussion of the results. It should not be copied and pasted directly from the protocol, nor should the reader be directed to refer to the attached protocol. This section should be ½ page - 1 page in length.

2. Proposed length of the study including any follow-up period (i.e., time to complete recruitment, intervention, analyze data, etc.). State number of years or months:

3. Justify that the proposed period of time is sufficient to conduct and complete the study:

4. Purpose of the study:

5. Scientific rationale for conducting the study:

6. List the specific aims of the study:

7. Justify that adequate facilities have been allocated for this study and will be used in the conduct of the study:

8. Explain any medical or psychological resources available for subjects if needed as a consequence of their participation in this study, or indicate “N/A”: N/A

9. Describe psychological, social or medical monitoring, ancillary care, equipment needed to protect subjects, or indicate “N/A”: N/A

10. Describe other resources needed for the protection of subjects in the conduct of this research (e.g. participant communication needs language translation services, etc.) or indicate “N/A” N/A

11. What is the risk level of this study? Minimal; justify why this category is appropriate: Greater than minimal

12. Assess the potential benefits to science and/or society which may accrue as a result of this research. If the risk in this study is more than minimal, explain how the risks are reasonable in relation to the benefits

13. Describe the risks and discomforts of the research procedures (e.g., questionnaires, investigational or approved drugs, devices, etc.). Describe the expected frequency of particular side effects (if applicable). If subjects are restricted from receiving standard therapies during the study, please also describe the risks of those restrictions.

a. What precautions have been taken to minimize these risks and what is their likely effectiveness:



b. Describe other alternative and accepted procedures, if any, that were considered and why they will not be used:

14. Statistical AnalysisA. Briefly describe what quantitative statistical analysis(es) of which outcome will be applied in order to address

each primary aim.

Examples of quantitative statistical analyses include: Calculation of descriptive statistics such as mean, median, SD, range, tallies. Examination of graphs such as outcome vs. time, scatterplots of two variables, Kaplan-Meier curves. Estimation of differences between two groups with comparison by t-test or Mann-Whitney test. Estimation and testing of within-person changes by matched t-test or Wilcoxon signed-rank test. Multiple linear regression, logistic regression, or Cox proportional hazards regression. Repeated measures models.

B. For qualitative research, briefly describe how qualitative data will be analyzed.

C. The following question applies for investigator initiated studies submitted for FULL BOARD REVIEW:

Has a professional statistician played a significant role in the design of this study and the statistical analysis plan found in the protocol document? A professional statistician is someone who has received an advanced degree or certification in statistics (or equivalent), and has had at least 2 years of experience as a statistician after earning their advanced degree. Any statistician employed in the Biostatistics Unit within the Feinstein Institute is acceptable. Starting 11/15/2014, for investigator initiated protocols being submitted for full board review (greater than minimal risk protocols), it must be evident that a professional statistician was involved in the development of the statistical considerations.

Yes If yes, please identify the statistician (Name, Title, and Affiliation): No (It is highly recommended that you receive a professional consult before submission)

15. Please check off which of the following will be conducted for the purposes of this study. In essence: what procedures are being done for research purposes only (not standard care)?

Questionnaire/survey (electronic OR paper)- Submit copy for review Review of Medical Records Interviews- Submit copy for review Data/Samples/Specimens stored for future research (i.e., repository/registry)- Specify: Saliva or buccal samples Voice, video, digital, or image recordings Deception International research EKG EEG

Blood draw Venous Arterial

MRI with contrast without contrast

Physiological processes - Specify: Clinical tests - Specify: Surgical procedure Collection of clinical specimens

Biopsy Specimen removed during surgery

Radiological Procedures Other - Specify:

16. Describe the procedures performed that are already being performed for nonresearch purposes (i.e., for standard care, diagnostic, or treatment reasons):



Section F Study Location

1. Indicate the site(s) to be used in this study: Ambulatory Care Center Arthur Smith Urology Center CECR Center for Learning and Innovation (CLI) Chiari Institute Cohen Children’s Medical Center (CCMC) The Feinstein Institute for Medical Research (FIMR) Franklin Hospital Medical Center Huntington Hospital Lenox Hill Hospital LIJ Medical Center Manhattan Eye Ear and Throat Hospital Monter Cancer Center Nassau University Medical Center

North Shore University Hospital (Forest Hills) North Shore University Hospital (Glen Cove) North Shore University Hospital (Manhasset) North Shore University Hospital (Plainview) North Shore University Hospital (Syosset) NSUH Dentistry (400 Community Drive) Southside Hospital Staten Island University Hospital - North Staten Island University Hospital- South The Zucker Hillside Hospital Private Offices specify: Other; specify:

2. Indicate the building(s) and room number(s) of each location where the study will take place:

3. Study is: Single center (study will be conducted only at NSLIJ) Multi-center (study will be conducted at another institution besides NSLIJ)

I am the Lead Investigator of a multi-center study (if checked, complete section G)

Section G Lead of Multi-Center Study N/AComplete this section when you are the lead site or lead investigator of a multi-center site

1. Explain the management of unanticipated problems from other sites [Note: Unanticipated problems that involve risks to subjects or others must be reported to the IRB]

2. Explain how interim results will be evaluated and managed

3. Explain how protocol modifications will be managed

4. Complete the following section only if the study will be conducted at sites that are not affiliated with NSLIJHS:

a. Does the site(s) have an IRB? Yes Nob. Do you have the other site(s) IRB approval? Yes No

If yes, please submit with your application

c. Has the site (s) agreed to allow the research to be conducted there? Yes Nod. Contact Information of the IRB at each site:

Section H Medical Devices N/A1. Is a device being used for the purposes of the study (for research purposes)? Yes No

If YES, please complete the following additional form: Appendix—Medical Devices

Section I Drugs and Biologics N/A1. Is a drug or biologic being administered for the purposes of the study (for research purposes)? Yes No

If YES, please complete the following additional form: Appendix—Drugs and Biologics


http://www.feinsteininstitute.org/hrpp/forms/#New_Submissions



Section J Data and Safety Monitoring Plan N/AStudies involving greater than minimal risk are required to have a Data and Safety Monitoring Plan (DSMP) (or Board, Committee, etc.). The plan must be appropriate to the level of risk to subjects, study design, objectives and procedures

Risk Level GuideThis is a guide to help you understand how risk levels are determined and how the risk level affects the type of oversight or monitoring that is appropriate for your study.

Explanation Examples Suggested Guidance

Moderate Risk

Low risk intervention in a population at risk for serious clinical

events based on underlying disease; interventions of undefined risk or with low frequency risk for

Reportable Events.

Study drug, vaccine, x-ray or CT with contrast, phase I or II study with safety data in humans, population at risk for serious clinical events based on underlying disease, investigator initiated single center randomized

trials

Full Data and Safety Monitoring Plan is required. The plan may outline

either an Independent reviewer or a DSMB consisting of independent

reviewers.

High Risk

Interventions associated with risk of serious Reportable events at high or uncertain frequency; studies in populations associated with very

high risk of serious adverse clinical events based on underlying

disease or in whom assessment of treatment-associated adverse

events may be difficult; vulnerable populations requiring special

protection

Phase III studies, complex multi-center studies, high risk procedures, gene transfer studies, interventional

studies involving vulnerable populations (e.g. children, pregnant

women, elderly, cognitively impaired) require additional

protections, interventions associated with very high risk of serious clinical events based on underlying disease

DSMB consisting of independent reviewers recommended.

1. Who will perform the data and safety monitoring for this study? (Check whichever apply.) Principal investigator Principal investigator’s designee: Other; describe:

For industry sponsored or Cooperative Group study, does the sponsor have a DSMB in place for this study?

No; explain how data safety will be monitored (provide attachment detailing this process) Yes; a copy of its membership and charter including a description of the planned meeting frequency and how

information will be distributed to investigators is provided Other, describe:

2. Explain how data and safety will be monitored (if this information is provided in the protocol, you can refer to the page of the protocol here):

3. Primary Data and Safety Monitor Contact Information: Provide name, phone, email and qualifications:

4. Describe in detail any potential conflict of interest that the DSM contact may have:

5. Describe the frequency of monitoring:

6. Will interim analysis take place? Yes; describe: No; explain:

Data Safety Monitor DetailsA DSMP (Data Safety Monitoring Plan) must be included in the protocol detailing the information stated above and below, and providing a clear description of the DSMP for this study. The description must detail: Types of data or events


New Protocol ApplicationNorth Shore-Long Island Jewish Health System Institutional Review Board that will be captured under the DSMP, responsibilities and roles for gathering, evaluating and monitoring data, information about the monitoring entity, reportable events that will be reported to the monitoring entity and when the events will be reported, assessments for the frequency of monitoring, stopping rules and criteria for safe withdrawal of subjects, communication and dissemination of information. Guidance for designing a DSMP can be found online here: www.feinsteininstitute.org/hrpp/guidance

Section K Reportable Events A plan for reporting unanticipated events that cause risk of harm to subjects or others must be reported to the IRB in accordance with IRB policy.

1. This proposal will adhere to the NSLIJHS HRPP Policy for reportable event reporting: Yes; No; explain:

2. All other entities to which reportable events will be reported: No other entities Sponsor; specify: NIH; specify institute: FDA (if working under 1572 or IDE) Other; specify:

Section L Study Subjects

For purposes of this form, the term “subjects” should be read to refer to all participants, patients, etc.

1. How many subjects do you plan to enroll at this site? Indicate the estimated goal of subjects per category below. (This should be the estimated number of subjects to sign consent, including screen failures.)

Male Female totalAdults

Children total

2. If this is a multi-institutional study, how many subjects will be enrolled studywide? or N/A

3. Subject age range (if study includes more than one group of subjects, e.g., mothers and children, please give the age range of both groups):

4. Provide the total time involved for subject participation and how often the subjects will require study visits:

5. Is compensation being provided to participants? Yes Noa. If yes, describe the nature of the compensation. Indicate amounts and schedule of payments as well as

conditions for subject receiving compensation for participating in the research:

b. If yes, Is the compensation fair and appropriate? Yes No , explain

6. Will subjects or their insurance be charged for any study procedures? Yes, No

If “Yes,” describe those costs below, and compare subjects’ costs to the costs associated with alternative care off-study. Finally, explain why it is appropriate to charge those costs to the subjects.

7. Justify that the study will be able to access a population that will allow recruitment of the necessary subjects proposed in this section, within the proposed timeframe:


http://www.feinsteininstitute.org/hrpp/guidance


8. Do you plan to target any of the following vulnerable populations as subjects in your study? No Yes; If yes, check all that apply:

Children OR viable Neonates (SUBMIT CHILDREN APPENDIX) Children who are wards of the state (SUBMIT CHILDREN APPENDIX) Cognitively Impaired (SUBMIT APPENDIX) Pregnant Women, Fetuses, and/or Neonates of uncertain viability or nonviable (SUBMIT APPENDIX) Prisoners (SUBMIT APPENDIX)

Indicate any other population types you will be targeting in this study:

NSLIJ Employees, Residents, Fellows, etc. Students Poor/Uninsured Aborted fetuses Patients with HIV Institutionalized (not prisoners)

Healthy volunteers Persons with limited English proficiency Minorities Elderly Physically disabled in-vitro fertilization

a. If you checked any of the above , provide a rationale for use of special groups or subjects whose ability to give voluntary informed consent may be in question (e.g., cognitively impaired).

b. If you checked any of the above , Please describe the safeguards afforded to all subjects to protect the vulnerable populations:

9. Will any subjects be excluded from the research? No Yes; If yes, explain:

10. Explain how the subject selection process in this research is fair and equitable, taking into account eligibility criteria, vulnerability and recruitment process

11. Provide the eligibility criteria (inclusion and exclusion). You may refer to the protocol page # if one exists:

12. How will you determine if a potential subject is eligible for the study? (e.g. screening examination, medical record/history review)

13. Are women or racial/ethnic minorities excluded in this non-gender/racial/ethnic-specific protocol? Yes;

Justification is provided in the protocol on page(s): Justification is:

No

14. Are there any particular populations (gender/racial/ethnic subgroups) that disproportionally bear the burden of the disease(s) under analysis in this study? Yes No

a. If yes, which populations? If yes, please provide an enrollment breakdown along with this submission (targeted Enrollment Report form is available on the IRB website).

b. Do the outlined recruitment methods allow for adequate accrual of the aforementioned populations? Yes No

15. Are AIDS/HIV patients involved in this study? Yes; consent to release HIV information form and informed consent form to perform an HIV test will be used.

No









Section M Recruitment Methods 1. How do you intend to recruit research subjects? Check all that apply

My own patient population/database Research database obtained from a 3rd party Flyers, posters, brochures: Please submit to the IRB Clinical patient population at my institution

Physician referrals Advertising: Please submit to the IRB Recruitment Registry Other (please specify):

2. Will there be any web postings? No Yes: Please give URL or submit text to the IRB:

3. Will letters be sent to potential subjects? No Yes: Please submit to the IRB

4. What procedure will be provided for participants to ask questions and voice concerns or complaints to the investigators?

Informed consent will include contact information for the research team If no consent form will be used, how will subjects be instructed to contact the investigator for this purpose?

Note: Ensure all recruitment materials are submitted to the IRB for review. For guidance, click here.

Section N Informed Consent Indicate how the required information is being presented to subjects (check all that apply):

1. Informed consent will not be obtained. This includes deception and withholding of information. SUBMIT the: Application for Waiver of Consent/Authorization

2. Written consent will be obtained from subjects, and/or parents (if subjects are minors) Written assent of children Informed consent will be obtained from subjects, but no signed consent form will be used. This includes oral

consent and implied consent (e.g. survey completion). SUBMIT the: Application for Waiver of Consent/Authorization

Written consent will be obtained from surrogates (e.g. Legally Authorized Reprezentative (LAR))

A. Describe the circumstances under which consent will be obtained, including where the consent process will take place, and the nature of the information to be provided to subjects during the consent discussion:

B. What opportunity will be afforded to the prospective subject (or the subject’s LAR) to consider whether or not to participate? (Check all that apply)

Schedule screening visits that allow for adequate discussion of the research and alternatives Review informed consent form in detail with potential subject Provide opportunity for subject to digest the information and come back with questions at a later time Mail consent document in advance of visit to allow extra time for review Other, specify:

C. How will it be determined that the subject (or the subject’s LAR) understands what has been explained? (Check all that apply)

N/A (if consent waiver is requested) Conversation with the subject to assess understanding and documentation of this conversation in the

subject’s research record/medical record as applicable Research review questionnaire Other, specify:

D. For long term studies (participation is longer than 1 year), how will you determine the ongoing consent of subjects?


http://www.research.ucsf.edu/chr/Forms/chrNewAppUnable.asp

http://www.feinsteininstitute.org/resources-for-investigators/human-research-protection-program/forms/


http://www.research.ucsf.edu/chr/forms/chrNewAppVerbal.asp


http://www.research.ucsf.edu/chr/HIPAA/app-waiver-MinRisk.doc

http://www.feinsteininstitute.org/hrpp/guidance/recruitment


Discussion reviewing informed consent details and reminding subject of their right to withdraw at any time via telephone or in person discussion at scheduled study visit.

Repeat the informed consent process N/A – this study does not entail long term participation from the subject

E. Do you expect to enroll subjects with limited English proficiency? Please consider your patient population and/or the population you are targeting for the study participation. If you do not expect to enroll subjects with limited English proficiency, but simply do not want to exclude someone based on this criteria, your answer should be No.

Yes No i. If Yes , for which language(s) will you require translation? ii. If Yes , describe plan for conducting the consent discussion and ongoing communication with subjects:

Staff member fluent in foreign language Telephone medical interpreter Other, specify:

F. If subjects cannot read the consent form, due to illiteracy or visual impairments, how will consent be documented?

G. Will more than one consent form be used for this study? Yes No; If yes, list each consent title:

Section O Privacy, Confidentiality, and Security 1. Describe the provisions in place to protect the privacy of subjects. The IRB will assess the methods used to identify

potential research subjects or to gather information about subjects to ensure that the privacy of individuals is not invaded. (e.g. private interviews, use of barriers when subject is required to disrobe, private room for performing research interventions):

2. Describe provisions in place to maintain the confidentiality of the data (Check all that apply): Paper based records will be kept in a secured location and only accessible to personnel involved in the study Computer based records will only be made available to personnel involved in the study through use of access

privileges and passwords. Whenever feasible, identifiers will be removed from the study-related information Other, specify:

3. Indicate your study’s source of health information: Physician/clinic records Interviews/questionnaires Mental health records Lab, pathology, and/or radiology results Biological samples obtained from the subject Billing records Hospital/medical records Data previously collected for research purposes Other; specify:

4. Check off any PHI identifiers you will be accessing (i.e., using), recording (i.e., collecting), or disclosing (i.e., sharing

outside of NSLIJ) among the following:

PHI Identifiers Accessing Recording Disclosing

1. Patient/Subject Name or Initials2. Elements of dates (except year) related to person**

Examples include but are not limited to: date of birth/death, admission or discharge dates, date of surgery

3. Address street location



Address town or city**Address state**Address zip code**

4. Telephone number5. Fax number6. Electronic mail (email) address7. Social security number (Note: SSNs should be collected

only if necessary (e.g. tax requirements) 8. Medical record numbers9. Health plan beneficiary numbers10 Account numbers11. Certificate/license numbers12. Vehicle identification numbers and serial numbers

including license plates13. Medical device identifiers14. Web URLs15. Internet protocol (IP) address16. Biometric identifiers (finger and voice prints)17. Full face photographic images18. Any unique identifying number, characteristic or code

**Items in red can be recorded/disclosed in a limited dataset. For a dataset to be de-identified, all of the above 18 identifiers must be removed.

5. Will there be a link (code) to identifiers (so that your study data can be connected back to the identity of the subject)? Yes No

6. List any outside entities (i.e., sponsor, insurance company, regulatory agencies, data management, and/or storage company etc.) to whom PHI will be disclosed: Note: A Business Associate Agreement must be in place with any external individual or organization providing services that will receive and/or use PHI.

7. Does the data collected in the course of the study contain sensitive data (e.g. mental health, HIV status, SSN, etc)?

No Yes; describe data and justify collection:

A. If yes, could any of this data, if disclosed have adverse consequences for subjects or damage their financial standing, employability insurability or reputation?

No Yes; describe:

B. If yes, will a Certificate of Confidentiality (COC) be obtained?

No Yes

Once obtained a COC needs to be submitted to the IRB.


http://privacyruleandresearch.nih.gov/pr_08.asp


Section P HIPAA Security Compliance for N/A Electronic Media Containing PHI

The HIPAA Security Rule requires protection of ePHI that is created, received, used, or maintained by a covered entity. Please indicate the protections planned for the security of electronic research data containing PHI.

A NSLIJHS HIPAA Questionnaire is required to be completed if you plan to use any application that the Health System has never used before or if you plan to use a new version of an application. If you plan to use an application hosted by another provider (such as at another institution, 3rd party vendor, or in the cloud) an Application Service Provider (ASP) Questionnaire must be completed as well. For help, please contact Joe Baskin at [email protected] or 516-562-0305.

1. Indicate the type of electronic program(s) you plan to use that will contain research data with PHI (check all that apply):

REDCap Databases or programs (commercial or in-house software, internet/web-based, etc.), Specify: Other, Specify:

2. Indicate where electronic programs containing PHI or ePHI will be stored, backed up or maintained (check all that apply):

Health System’s server Outside of the health system (e.g. cloud based server by vendor, other institution or entity, etc.), Specify: Note: A Business Associate Agreement, and a completed ASP questionnaire must be in place with any external individual or organization providing services that will receive and/or use PHI. Other (specify):

3. Indicate protections that are in place below - (please note: all of these are required). For more information: please see online guidance for additional information on maintaining security and compliance of ePHI.a) Access to data is controlled (e.g. password protection, designating levels of access, termination of access,

automatic log-off after inactivity)b) Plan for tracking/monitoring access to any data containing PHI is in place.c) Plans for emergency access, disaster recovery or preventing improper alteration/destruction (e.g.

restoration of data loss in event of natural/ manmade disasters, system failure or outages)d) Access to data is limited to authorized personnel dedicated by the PI (e.g. unique user ID, temporary

access to external monitors/auditors) e) Physical access is controlled to prevent unauthorized access, tampering or theft (e.g. locked doors, access

badges, laptops stored in locked cabinet/office, etc.)f) Workstation is secured (e.g. protected from public areas/ view using privacy screens, placement of

monitors, etc.)g) Data backed up on health system server or secure external serverh) Plans for secure disposition/disposal/ re-use of data/hardwarei) Encrypt data when transmitted (e.g. via email/web, cloud, etc.).

OR N/A, if you are not transmitting any dataj) Encryption of removable media/portable electronic devices containing data (e.g. laptops, portable hard

drives, CD/DVDs, CD/DVD, flash/ thumb drives, tablets, phones, etc.)OR N/A, if you are not using any of the above devices/media.

Section Q Clinicaltrials.gov


http://www.feinsteininstitute.org/cs/Satellite?blobcol=urldata&blobheader=application%2Fpdf&blobkey=id&blobtable=MungoBlobs&blobwhere=1247152186335&ssbinary=true



Public Law 110-85 requires registration of clinical trials. The International Committee of Medical Journal Editors (ICMJE) also requires registration of clinical trials in order for results to be published in member biomedical journals. Clinical trials are required to be registered before the enrollment of the first subject, but not prior to IRB approval.

Please select one of the following: This is not a clinical trial; registration not required Registration Pending ClinicalTrials.gov “NCT” number for this trial:

Section R Sponsor Investigators N/ANSLIJ Investigators holding an IND or IDE should complete this section. All NSLIJ study personnel involved in this study need to complete a HRPP approved GCP training, such as the CITI Program GCP Curse, 2-day Navigating Clinical Research class, or a Transcelerate accredited course. If personnel have taken a course other than CITI or Navigating Clinical Research, please submit the certificate with the training completion date.

Study Personnel GCP Training Date

Name of GCP Training Course



Section S Investigator’s Responsibilities Checklist The following are the minimum responsibilities of Principal Investigators conducting research at NSLIJ Health System.

Investigators conducting research subject to FDA jurisdiction and who are also the sponsors of the research (“Sponsor-investigators”) have additional responsibilities and should look at the guidance on Investigator Initiated Multi-Center research at: www.nslij.com/orc Sponsor-investigators must comply with these additional requirements.

Check off each item to indicate that you have carefully read and understand your responsibilities.

I, the Principal Investigator, acknowledge and accept my responsibility for protecting the rights and welfare of human research subjects and for complying with all applicable provisions of the Assurance.

I am responsible for providing a copy of the IRB-approved and signed informed consent document to each subject at the time of consent, unless the IRB has specifically waived this requirement or the study is determined by the IRB to be exempt.

All signed consent documents will be retained in a manner approved by the IRB.

Unless otherwise authorized by the IRB, I am responsible for obtaining and documenting informed consent in accord with applicable federal regulations at 45 CFR §46.116 and 45 CFR §46.117.

I shall be responsible for promptly reporting proposed changes in previously approved human subject research activities to the IRB. My proposed changes may not be initiated without IRB review and approval, except where necessary to eliminate apparent immediate hazards to my subjects.

I will report to the IRB any problems that require prompt reporting to the IRB within 5 calendar days of my first discovering it.

I will submit a progress report (Request for Continuation or Final Study Closure) at least four weeks prior to the date at which the IRB has determined continuing review is required. If the progress report is not received by the due date, I understand that it cannot be guaranteed that my study will be reviewed before the expiration of the IRB approval date. If my study is not reviewed prior to the expiration date, all enrollment is suspended and I may not continue with the study for previously enrolled subjects except as approved by the IRB.

Section T Submission Checklist


http://www.nslij.com/orc

New Protocol ApplicationNorth Shore-Long Island Jewish Health System Institutional Review Board Instructions:

Please complete the below checklist before submitting this application to the IRB.

*This checklist is a required element of this application.*

If any of the below items have not yet been completed, do not submit this application to the IRB until they are resolved . A complete application allows the IRB approval to be granted faster, the research to start sooner, and also decreases inefficiencies in the IRB process that result from communications back and forth between the study team and IRB staff.

Yes N/A ITEMPlease confirm that vital study documents (protocol, consent form, questionnaires, and advertisements) will be sent to the IRB in editable format (such as .doc, .docx, .xls, or .xlsx attachments). Note: If these documents are locked by your Sponsor, check “N/A.”

If you are applying for a waiver of informed consent, a waiver of documentation of consent, or a waiver of HIPAA authorization, please confirm that you have completed and attached the “Application for Waiver of Informed Consent and/or HIPAA authorization.”

If your study involves any of the following, please confirm that you have filled out the appropriate Application APPENDIX: Children, Cognitively Impaired, Pregnant Women/Fetuses/Neonates, Prisoners, Devices, Drugs/Biologics, and projects that involve Department of Defense funding.

If you are obtaining consent, please confirm that the consent form includes these sections: Description of Procedures, Study Purpose, and Potential Risks to Subjects.

Must be Yes Please confirm that the protocol includes these sections: Statistical Analysis, Eligibility criteria (inclusion/exclusion), Potential Risks to Subjects, and References.

Must be YesPlease confirm every member of the study team completed and listed all the required education dates on page 4 of this form (this includes 3 dates for each person: CITI basic human subjects training, researcher registration form, and CITI COI training). Required education dates can be found at this website: www.feinsteininstitute.org/hrpp/training/dates.

Must be Yes

Please confirm every member of the study team completed and listed the eRA Electronic Conflict of Interest (COI) Disclosure completion dates on page 4 of this form, including applicable management plans and confirmation that the disclosure has been reviewed and is accurate as of the submission date? If you do not have this information, it can be found here: www.feinsteininstitute.org/hrpp/training/dates.Alternatively, contact [email protected] for assistance.

Must be YesPlease confirm that the department chair of each study member listed has signed the last page of this form. (Example: If your study team includes personnel from oncology, pharmacy, and geriatrics, the department chair signature is needed from the chair of each of those departments). Dept. Chairs can be found at the bottom of this page: www.feinsteininstitute.org/hrpp/submissions

Must be YesPlease confirm the facility approver for each facility used for this research has signed the last page of this form. (Example: If your study will perform study activities at NSUH and ZHH, then a facility approval signature is needed for both sites. A list of facility approvers can be found at the bottom of this page: www.feinsteininstitute.org/hrpp/submissions

Must be Yes Please confirm that you have answered each question on the form and no question has been left blank (as applicable).

Must be Yes Please confirm that the principal investigator has signed the last page of this form.


http://www.feinsteininstitute.org/hrpp/submissions

http://www.feinsteininstitute.org/hrpp/submissions





PRINCIPAL INVESTIGATOR STATEMENTI attest that the information contained herein is a true and accurate representation of my proposed study, including any appendices submitted. I attest that I have not been disbarred, suspended or restricted by any federal or state agency from conducting this research study. I will abide by the requirements of NSLIJ Health System and the IRB as per the above investigator’s responsibilities checklist, federal and New York state laws and regulations, and the agreement with the sponsor in the conduct of this research study’s protocol.

___________________________ _______________________ ____________________Printed name of PI Signature of PI Date

DEPARTMENT CHAIR STATEMENTBy signing below, I acknowledge that I have reviewed this protocol for scientific validity, and confirm that the investigators have the appropriate credentials and resources to perform the research procedures. The execution of the project has my endorsement.

___________________________ _______________________ ____________________Printed name of Dept. Chair Signature of Dept. Chair Date




FACILITY APPROVAL

By signing below, I acknowledge that the facility is aware of the conduct of this research study at the site and I approve implementation at my facility.

______________________ __________________________ _____________________________ _____________Site Name of Executive Director or designee Signature of Executive Director or designee Date



SUBJECTS’ DEPARTMENT CHAIR STATEMENTIf subjects covered under this research protocol are under the administrative responsibility of a different department than the investigators on this study, approval of the subject’s department chair is required.



Documents

· Web viewInstitutional Biosafety Committee (IBC) Does this study involve the use of materials requiring approval from the IBC (e.g. biohazards, recombinant DNA)? No Yes If