New Chart Review Application

New Chart Review Application

North Shore-Long Island Jewish Health System Institutional Review Board

Application for a Chart Review (NRAP version)

THIS FORM MUST BE TYPED. THE IRB WILL NOTACCEPT HANDWRITTEN APPLICATIONS.

When to Use this Form

This form should be used to submit a research study involving human subjects for IRB review and approval when the proposed research falls under the expedited review category of research involving materials (data, documents, records) that have been collected, or will be collected solely for nonresearch purposes (prospective or retrospective)

Attachments Include:

Always submit these documents:

Application for a Chart Review (This form)

Conflict of Interest Questionnaire: for all staff involved in the design and/or conduct of this studyOR complete External Interest (COI) Disclosureelectronicallyatera.northshorelij.com/login.asp

Data Collection Form and Master Link Sheet

Consent/Authorization FormOR anApplication for Waiver of Informed Consent and/or HIPAA Authorization

NSLIJHS Research Approval Process (NRAP) Form

When applicable, submit these documents:

Any other information that is pertinent to the review of your project

Protocol, when one exists

Do not use this form to submit an exempt study. Exempt studies should be submitted to the IRB using the Application for Exemption. If you are unsure whether your study is exempt, refer to the exempt application or call the IRB office.

Submission Instructions – NSLIJ IRB and Staten Island University IRB

Applications may be submitted through email to the IRB: . Protocols and consent forms should be submitted in an editable format such as Word, Excel, etc. Please contact the IRB office at 516-562-3101 with any questions.

Submission Instructions – Huntington Hospital IRB

Applications may be submitted through email to the IRB:r in hard copy format to the Office of the IRB, Huntington Hospital, Dept. of Medical Affairs, 270 Park Avenue, Huntington, NY 11743.Protocols and consent forms submitted electronically should be submitted in an editable format such as Word, Excel, etc. Please contact the IRB Office at 631-351-2750 with any questions.

Principal Investigator

/ Study Coordinator
Name: / Phone #: / Name:
Dept/Div: /

Fax:

/ Phone #:
Affiliation: / Email: / Email:
(Hospital/Facility)
Person/Address to which correspondence should be mailed:

VersionDate:

Study Title

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:

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New Chart Review Application

North Shore-Long Island Jewish Health System Institutional Review Board

Version 12/16/13 page1 of 10

New Chart Review Application

North Shore-Long Island Jewish Health System Institutional Review Board

Section A Study Description

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 thescientific rationale, a hypothesis, a concise description of the methodology, with how the chart review will be conducted, and a discussion of the results. The length should be at least half of a page. You should not refer the reader to the attached protocol.

Proposed length of the study. In essence, how long will it take to complete the chart review, analyze data, etc.? State number of years or months:

Purpose and/or specific aims of the study:

Discuss the potential benefits to science and/or society which may accrue as a result of this research.

Are there any other risks of this study besides breach of confidentiality? If so, please detail:

The dates of the data to be used: to

Statistical Analysis: Briefly describe what statistical analysis(es) of which outcome will be applied in order to address each primary aim.

Examples of quantitativestatistical 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.

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

Provide literature references:

Section B Lead of Multi-Center StudyN/A

Complete this section when you are the lead site or lead investigator of a multi-center site

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]
Explain how protocol modifications will be managed

Section C 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.

This proposal will adhere to the NSLIJHS HRPP Policy for reportable event reporting:

Yes; No; explain:

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 D Study Subjects

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

How many chartsdo you plan to review? (This should be the estimated number of charts that must be reviewed in order to reach the goal for statistical analysis)

Age range of the subjects whose charts will be reviewed:

Does your review plan to target any charts ofthe following vulnerable subjects?

Yes; check all that apply: No

Childrenor viable Neonates (SUBMIT CHILDREN APPENDIX)

Children who are wards of the state(SUBMIT CHILDREN APPENDIX)

Cognitively Impaired(SUBMIT APPENDIX)

Pregnant Women, Fetuses, and/or Neonatesof uncertain viability or nonviable (SUBMIT APPENDIX)

Prisoners(SUBMIT APPENDIX)

If yes, 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). (If applying for a waiver of informed consent, indicate N/A)

If yes, please describe the safeguards afforded to all subjects to protect the vulnerable populations?

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

Indicate your estimated goal for the number of subjects per category:

Male / Female / total
Adults
Children
total

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

No Yes If yes, Justification is provided in the protocol on page: OR

Justification is:

Are there any particular populations (gender/racial/ethnic subgroups) that disproportionally bear the burden of the disease(s) under analysis in this study?

No Yes Ifyes, which populations?

Please describe how you will allow for adequate accrual of data for the aforementioned populations:

Section E Informed Consent

Informed consent will not be obtained. This includes studies which include deception and/or are withholding information from the subject. SUBMIT the: Application for Waiver of Consent/Authorization

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

Signed consent will be obtained from subjects and/or parents (if subjects are minors),

Signed 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)

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

Describe the circumstances under which consent will be obtained, including where the consent process will take place,

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:

Who will obtain consent? Describe their experience in obtaining consent from subjects.

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:

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

Discussion reviewing informed consent details and reminding subject of their right to withdraw at any timevia 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

Do you anticipate enrolling subjects withlimited English proficiency? Yes No

If Yes, for which language(s) will you require translation?
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:

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

Will more than one consent form be used for this study? Yes No; list each consent title:

Section F Privacy, Confidentiality, and Security

Provisions must be in place to protect the privacy and confidentiality 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.

Discuss how research records will be stored and protected:

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:

Indicate your study’s source of health information:

Physician/clinic records

Mental health records

Lab, pathology, and/or radiology results

Billing records

Hospital/medical records

Data previously collected for research purposes

Other; specify:

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 Nameor Initials
2. / 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 number
5. / Fax number
6. / Electronic mail (email) address
7. / Social security number (Note: SSNs should be collected only if necessary (e.g. tax requirements)
8. / Medical record numbers
9. / Health plan beneficiary numbers
10 / Account numbers
11. / Certificate/license numbers
12. / Vehicle ID numbers serial numbers including license plates
13. / Medical device identifiers
14. / Web URLs
15. / Internet protocol (IP) address
16. / Biometric identifiers (finger and voice prints)
17. / Full face photographic images
18. / Any unique identifying number, characteristic or code

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

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

Will it be possible for you to identify and access the source data again based solely on the information recorded in your data sheet/database (without the use of the link (code) to identifiers? Yes No

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.

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

Yes; describe data and justify collection:

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

Yes; describe:

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

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

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