Exempt Application

North Shore-Long Island Jewish Health SystemInstitutional Review Board

Application for Exemption (NRAP version)

THIS FORM MUST BE TYPED. THE IRB WILL NOT ACCEPT HANDWRITTEN APPLICATIONS.

When to Use This Form:

Use this application to verify that your study qualifies for exempt status. If it does not, you must submit an Application for a New Study or an Application for a Chart Review.

Screening questions:

This study is greater than minimal risk

This research is subject to FDA regulation (and is not a taste and food quality evaluation or consumer acceptance study)

This research involves prisoners as subjects

This research involves the collection (i.e., recording) of PHI (see Section D, #4 for more information)

If you checked any of the above boxes, then your protocol does not qualify for exemption. Stop filling out this form. Instead, submit the Application for New Study Review.

With this form you should submit:

Investigator Conflict of Interest Questionnaire for each staff member involved in the design and/or conduct of this study.

Data Collection Sheets, Surveys, Questionnaires, Recruitment Materials, tests or other instruments

NSLIJHS Research Approval Process (NRAP) Form

Submission Instructions – NSLIJ IRB and Staten Island University IRB

Applicationsmay 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 516-321-2100 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.

Version:

IRB Protocol # (OIRB use only)

Principal Investigator
/ Study Coordinator
Name: / Phone #: / Name:
Dept/Div: /
Fax:
/ Phone #:
Affiliation: / Email: / Email:
(Hospital/Facility)
Person/Address to which correspondence should be mailed:

PROTOCOL TITLE:

Potential Funding Source(if any): Note: If this is to be funded by a federal grant, attach a complete copy of the grant application.

Section AExemption Checklist

If you believe that your study constitutes one of the types of research which is exempt from review, please indicate below the specific category(ies) under which your study should be considered exempt.

  1. 45 CFR 46.101(b)(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
  1. 45 CFR 46.101(b)(2) Research involving the use of educational tests(cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
    (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

Research qualifies for exempt review under this category only if:

The research does not involve children.

The research involves children but only educational testing or observation of public behavior.*

*Note: research under category 45 CFR 46.101(b)(2) may include children only when the research involves observation of public behavior and when the investigators do not participate in the activities being observed.

  1. 45 CFR 46.101(b)(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
  1. 45 CFR 46.101(b)(4) Research involving the collection of or study of existing*data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

*Existing means that the materials exist at the time the research is proposed.

Answer additional question in Section C Question 11 below.

  1. 45 CFR 46.101(b)(5) Research and demonstration projects that are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

Research qualifies for exempt review under this category only if:

The research will be conducted pursuant to specific federal statutory authority.

The research does not involve significant physical invasions or intrusions upon the privacy interests of subjects.

The research has authorization or concurrence by the funding agency.

  1. 45 CFR 46.101(b)(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Section BStudy Details
  1. Use this section to describe your project. You may submit an attachment to describe your study. If you do, please write, “Attached” for the answer here.. Otherwise please answer all the below items.
  1. What are objectives of your study?
  1. What methods will be used for this research?
  1. Please provide a detailed description of the data, records or samples that will be studied in the course of this project.
  1. What will happen to the research subjects in this study; how will they be affected?
  1. Describe the instruments, if any, to be used to collect data in this study. Attach copies of all questionnaires, surveys, interview questions, etc.
  1. Proposed length (time period) for the study. Please provide expected number of years, months or weeks that it will take you to conduct this study:
  1. Justify that the proposed period of time is sufficient to conduct and complete this study:
  1. Choose a risk category:

Minimal; Describe why this category is appropriate:

Greater than minimal – STOP; if the study is greater than minimal risk, it is not eligible for exemption.

  1. How many subjects do you plan to include in this study, at this site?
  1. If this study is multi-site, how many total subjects will be enrolled study-wide?
  1. Data Use: Data that you generate will be used for (check all that apply):

Oral presentation

Publication

Other: Explain

  1. If your study qualified for category 4 exempt,
  1. Are you using data or samples that already exist (data and samples have already been collected at the time that this study is proposed to the IRB)?

Yes No

  1. Is the data being recorded without any of the 18 HIPAA identifiers (see next page for a listing of the 18 identifiers)?

Yes No

  1. Vulnerable Populations:Check off any/all of the populations listed that might be subjects in this study:

Children
Pregnant Women/Fetuses/Neonates
Cognitively Impaired
Senior Citizens
Institutionalized Persons / Prisoners*
Non-English Speaking
Students
Employees
* If prisoners are involved, this study is not eligible for exempt determination
  1. Consent: Is consent being obtained from subjects?

Yesdescribe consent/documentation process:

Nojustify

Section CHIPAA COMPLIANCE

Complete this section if you plan to use PHI (such as collecting data from a medical record).

  1. Describe the risks to privacy involved in this study and explain why the study involves no more than minimal risk to privacy:
  1. 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:

  1. Will anyone from outside the workforce of North Shore-LIJ Health System be accessing the PHI?

Yes No

If yes, HIPPA Authorization or a waiver of HIPAA Authorization will be needed and you should continue to complete the rest of the application. If the answer to this question is no, please proceed to signature page (questions 4-10 do not need to be completed). Because we are an organized healthcare arrangement, this is only needed when someone from outside the NS-LIJ Health System workforce has access to the PHI.

  1. 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 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 identification numbers and 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.

  1. How will information be recorded?

Paper Form - Data Collection Sheet

Electronically

  1. 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

  1. List any outside entities (i.e., sponsor, insurance company, regulatory agencies, data management, etc.) to whom PHI will be disclosed:
  1. Will data be stored in a secure location, accessible only to the investigators?

Yes No

  1. Describe how PHI will be kept confidential so that only those involved in the study will be able to view or record this information?
  1. Waiver of HIPAA Authorization: If a waiver of HIPAA Authorization is needed, please answer the following questions:
  2. Explain why it is not possible to seek subjects’ authorization for use or disclosure of the PHI.
  1. Explain why the research cannot be done without use or disclosure of the PHI.

Revised: 3/12/14Page 1 of 6

Exempt Application

Revised: 12/16/13Page 1 of 6