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					UCLA Office for the Human Research Protection Program

APPLICATION SUPPLEMENT FOR HUMAN SUBJECTS RESEARCH INVOLVING NO SUBJECT CONTACT
(For use only with the Social Behavioral, Education and Health Services Application)

For behavioral studies that include access to or study of data and/or human biological
specimens with identifiers
 Use this Application in conjunction with the (HS-1) Application for the Involvement of Human Participants in SBER &
  HSR if the study also involves any contact with subjects.

                                                 PART 1: STUDY DESIGN
INSTRUCTIONS:
 Please include in this supplement only information which is specific to the component(s) of your research that
   involve access to or study or data and/or human biological specimens with identifiers that involve no subject contact.

 1.A. RESEARCH DESIGN AND DATA ANALYSIS - Describe the study design and proposed data analyses for the
 component(s) of the research that involve access to or study of data and/or biological specimens with identifiers and
 involve no subject contact.



       PART 2: TYPES AND SOURCES OF DATA AND/OR HUMAN BIOLOGICAL SPECIMENS
2.A. DESCRIPTION OF DATA AND/OR SPECIMENS

2.A.1. Complete the table below for each different type of data and/or human biological specimen included in this study. If
you need additional space, add rows or attach another sheet.
 Data and/or           Source           Pre-existing              Description of        Approximate      Beginning and
 Specimens?           (If UCLA            at time of            Data/Specimens           Number of         end dates of
                 Bank/Repository or       study or         (e.g., academic records of   Data Records         collection
                   previous study,      Prospective          pupils 6 – 12 years old,      and/or         (If no end date,
                  also indicate the     Collection?         discarded blood samples      Specimens      indicate unknown
                        IRB#.)                               from UCLA Clinical lab)                       or continuing.)

   Data                                      Pre-Existing

   Specimens                                 Prospective


   Data                                      Pre-Existing

   Specimens                                 Prospective


   Data                                      Pre-Existing

   Specimens                                 Prospective

2.A.2. If any of the sources of the data and/or specimens are not at UCLA, check the box               Agree
to the right to indicate your agreement that the appropriate institutional approvals for               Not Applicable
release of the data and/or specimens will be obtained (e.g., IRB approval).
2.A.3. Attach the data abstraction tool, form, instrument, or a list that includes all of the data elements that will be collected.
2.A.4. If you indicated that you will be using human biological specimens, please answer the following items:
    a. Will the specimens be used in research with          No
    animals?                                                Yes If yes, indicate the UCLA IACUC approval number:
    b. Will you conduct genetic analyses with the           No
    specimens?                                              Yes If yes, provide your assurance that the results will not be
                                                            disclosed to subjects or used for clinical care.       Agree


                                                                                                                   Version 12/7/2009
UCLA OHRPP Application Supplement For Human Subjects Research Involving No Subject Contact                                                       page 2 of 5
For studies accessing or studying data and/or human biological specimens with identifiers

                                                             PART 3: CONFIDENTIALITY
INSTRUCTIONS:
 Please include below only information which is specific to the component(s) of your research that involve access to or
   study or data and/or human biological specimens with identifiers that involve no subject contact.

3.A. CONFIDENTIALITY
3.A.1. Identifiers: Please indicate all identifiers that may be collected and/or included in the research records for the
        study. Important Guidance: If the research includes more than one cohort of subjects and different identifiers are
        collected from different cohorts, please explain below from whom which identifiers will be collected.

Check all that apply.
[ ] Names                                                [   ] Social Security Numbers*                       [   ] Device identifiers/Serial numbers
[ ] Dates                                                [   ] Medical record numbers                         [   ] Web URLs
[ ] Postal address                                       [   ] Health plan numbers                            [   ] IP address numbers
                                                                                                                                          1
[ ] Phone numbers                                        [   ] Account numbers                                [   ] Biometric identifiers
[ ] Fax numbers                                          [   ] License/Certificate numbers                    [   ] Facial Photos/Images
[ ] E-mail address                                       [   ] Vehicle ID numbers                             [   ] Any other unique identifier
[ ] Financial account information                                                                                   (including student ID)
[ ] None of the identifiers listed above

* NOTE: If social security numbers will be collected, explain below why they are necessary and how they will be protected.



3.A.2. Determining whether the Health Insurance Portability and Accountability Act (HIPAA) Regulations apply to
       this study: Please answer the Questions below as they pertain to the identifiers marked in the above section.
       Check all that apply.

Note: See UCLA Policy 9440: Release of Personal Health Information for Research Purposes for additional details about
HIPAA “The Privacy Rule” requirements.

3.A.2.a. Are study data*:                                                 HIPAA regulations apply if:
                                                                              you check any of the boxes to the left and
[ ] Derived from a medical record?
                                                                              any of the identifiers are marked in Question 3.A.1 above
    Please identify source:
                                                                                 and
[ ] Added to the hospital or clinical medical record?
                                                                              the research is being conducted in the USA.
[ ] Created or collected as part of health care?
[ ] Used to make health care decisions?
                                                                          If HIPAA applies, the identifiers above are considered Personal
                                                                          Health Information (PHI). Please complete Part 6 of this
* This includes data that are accessed in order to
conduct eligibility screening.                                            application.


3.A.2.b. Are study data:
                                                                          If you checked ONLY responses to 3.A.2.b, and NO responses
                                                                          to 3.A.2.a. are applicable, HIPAA regulations do not apply.
[ ] Obtained from a foreign country or countries
    only?
                                                                          The identifiers marked in Question 3.A.1 above are not Personal
[ ] Obtained from records open to the public?
                                                                          Health Information (PHI) if they are ONLY obtained through one
[ ] Obtained from existing research records?
                                                                          or more of these responses. Skip Part 6 of this application.
[ ] None of the above.


3.B. Disclosure of Personal or Private Identifiers: Indicate to whom or where you will disclose any of the identifiers listed
in Section 3.A.1. as part of the study process. Check all that apply.




1
  Biometric Identifiers are observable biological characteristics which could be used to identify an individual, e.g., fingerprints, iris/retina patterns, and
facial patterns.
                                                                                                                                            Version 12/18/2009
UCLA OHRPP Application Supplement For Human Subjects Research Involving No Subject Contact                           page 3 of 5
For studies accessing or studying data and/or human biological specimens with identifiers


[   ]   We do not plan to share any of the identifiers listed above outside the research team.
[   ]   The study sponsor (specify if more than one sponsor:          )
[   ]   Other (specify:         )
[   ]   A foreign country or countries (specify:       )

Note: Data and specimens shared with outside entities (e.g., sponsors) should be coded or de-identified.


                                             PART 4: RISKS AND BENEFITS
INSTRUCTION: Your response to these questions should relate ONLY to the component(s) of your research that involve
no subject contact.

4.A. RISKS AND DISCOMFORTS - The risks of studies that                      Yes
involve use of data and/or specimens without human subject                  No If no, describe the other risks associated
contact are often limited to the risks associated with the possible         with this study and the steps that you have taken
breaches of confidentiality. Is this true of this study?                    to minimize them.


4.B. BENEFITS - What are the potential benefits to society?


4.C. RISK/BENEFIT ANALYSIS - How do the benefits of the study outweigh the risks?


4.D. ADDITIONAL INFORMATION ABOUT RISKS AND BENEFITS TO SUBJECTS

INSTRUCTIONS: If the study is DHHS-funded and data or specimens which contain PII or PHI (see Part 3A) will be
prospectively collected, that is, collected as part of this study (see Part 3), or will not be obtained from a bank or repository
(See Part 3), check all that apply:

Important Note: The information in the Application Supplements listed below is required for studies funded by the
Department of Health and Human Services (DHHS) and other federal agencies who have adopted the related applicable
subparts of the regulations:
Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
Subpart D: Additional Protections for Children Involved as Subjects in Research

          Minors: If minors' data and/or specimens will be studied, please provide the required assurance below.
          Subpart D Risk Assessment: Provide your assurance that the study as designed meets the                 Agree
          definition of “Research not involving greater than minimal risk (45 CFR 46.404, 21 CFR 50.51),”
          with “minimal risk” defined as “the probability and magnitude of harm or discomfort anticipated in the
          research are no greater than those ordinarily encountered in daily life or during the performance of
          routine physical or psychological examinations or tests.”[45 CFR 46.102(i)].
          Pregnant Women, Fetuses and Fetal Tissue: Please attach Supplement for the Inclusion of Pregnant Women,
          Fetuses and Fetal Tissue.
          Neonates: Please attach Supplement for the Inclusion of Neonates.
          Prisoners: Please attach Supplement for the Inclusion of Prisoners.

                   PART 5: REQUEST TO WAIVE INFORMED CONSENT AND/OR ASSENT
INSTRUCTION: Your response to these questions should relate ONLY to the component(s) of your research that involve
no subject contact.

5.A.        Do the component(s) of your research that involve no subject contact pose more than minimal              Yes      No
            risk to participants?

5.B.        Would the participants’ rights and welfare be adversely affected by waiving consent?                     Yes      No

                                                                                                                 Version 12/18/2009
UCLA OHRPP Application Supplement For Human Subjects Research Involving No Subject Contact                                   page 4 of 5
For studies accessing or studying data and/or human biological specimens with identifiers


5.C.     Explain why the research could not practicably be carried out without the waiver of consent. Check all that apply.
           It would not be possible to contact all of the participants associated with the data or specimens
           The design of the study does not allow the possibility of obtaining consent
           The size of the potential study population is so large that it would not be feasible to obtain consent
           Requiring informed consent may introduce systematic bias into the data
           The risk of contacting the participants is greater than the risk of the study procedures
           Other (please describe)

5.D.     If you indicated that the study design does not allow the possibility of obtaining consent, that requiring consent may
         introduce systematic bias or checked “other”, provide any information that may assist the IRB in understanding
         why obtaining consent would not be feasible.


5.E.     Indicate your agreement that no information from this study will be provided to the subjects.                      Agree

                        PART 6: REQUEST TO WAIVE HIPAA RESEARCH AUTHORIZATION

INSTRUCTIONS:
 Complete this section ONLY if your response to question 3.A.2.a. indicates it is required.
 Your response to this question should relate ONLY to the component(s) of your research that involve no subject
   contact.


The HIPAA Privacy Rule requires, when you will access data and/or specimens with PHI, that you obtain (1) a) individual
UCLA Healthcare Authorization for Release of Health Information and/or b) UCLA IRB-approved waiver of
authorization, or (c) that the data/specimens be de-identified by one of two methods.

The applicable alternatives for the component(s) of your study that involve no subject contact are listed below.
Indicate which applies.


        Request for waiver of HIPAA authorization. I assure that the PHI collected for this study will not be reused or
         disclosed, except as indicated in this application.
                                                           2
        Limited Data Set with a Data Use Agreement. I assure that I will follow the data security plan outlined in this
         application to protect the identifiers from improper use or disclosure.
                                                                                    3
        Specimens/Data will be De-Identified Data using the “Safe Harbor Method. ”
                                                                                  4
        Specimens/Data will be De-Identified Data using the “Statistical Standard. ”




2
 Limited Data Set - PHI that excludes all categories of direct identifiers except for the following: a unique number code, or
characteristic that does not include any of the above listed identifiers, geographic data (without street address), and/or dates.
Data Use Agreement - An agreement into which the covered entity enters with the intended recipient of a limited data set that
establishes the ways in which the information in the limited data set may be used and how it will be protected. (For a copy of the UCLA
Healthcare Data Use Agreement, see Appendix 2 of the UCLA Policy HS 9440.)
3
 “Safe Harbor Method” – Identifiers are stripped from the specimens/data
4
 “Statistical Method” - The Statistical Standard requires documentation from a qualified statistician specializing in de-identification of
data demonstrating that the proposed methods and analysis will effectively de-identify the data. Attach the following to this application:
   o Information about the statistician certifying her/his expertise in de-identification methods and analysis.
   o Documentation from the statistician that the proposed methods and analysis for the research will result in the risk being very
      small that the information can be used to identify an individual.
                                                                                                                        Version 12/18/2009
UCLA OHRPP Application Supplement For Human Subjects Research Involving No Subject Contact                           page 5 of 5
For studies accessing or studying data and/or human biological specimens with identifiers

      Checklist for Application Supplement for Human Subjects Research Involving No Subject Contact
           (For use only with the Social Behavioral, Education and Health Services Application)

INSTRUCTIONS:
 Please use the checklists below to confirm that you have provided the requested information - as it relates to the
   component(s) of your research that involve no subject contact - in the (HS-1) Application for the Involvement of
   Human Participants in SBER & HSR.

STUDY DESIGN

[ ]     Describe the overall study design

[ ]     Lay language summary or synopsis: Summarize or provide a brief abstract of the proposed access to or
        study of data and/or biological specimens (SBER-HSR HS-1 Question 3.A.)

[ ]     Specific aims: Indicate the purpose of the proposed access to or study of data and/or biological specimens,
        specifying the problems and/or hypotheses to be addressed. (SBER-HSR HS-1 Question 3.C)


DATA SECURITY (SBER-HSR Part 8)

[ ]     Specify how data will be collected and recorded.

[ ]     Indicate the type of identifiers that will be linked to the research data (directly or indirectly via a code).

[ ]     Indicate how data will be stored and secured including paper records, electronic files, audio/video tapes,
        specimens, etc. Specify how the code key will be securely maintained, as applicable.

[ ]     Data on portable devices (e.g., laptops, PDAs, iPods, external hard drives): Specify whether personal or
        private identifiable data will be stored on portable devices. If so, provide the rationale for storing the
        identifiers on the device. Note: only the “minimum data necessary” should be stored on portable devices.

[ ]     Describe any additional steps taken to assure that identities of participants and any personal or private
        information are kept confidential. If video or audio recordings will be made as part of the study, disposition of
        these recordings should be addressed here and in the consent document(s).

[ ]     Internet Research: If data will be collected, transmitted, and/or stored via the internet, indicate the measures
        that will be taken to ensure security of data transmitted over the internet.

[ ]     After the Study Is Completed: If the personal or private information will either be kept with the data and/or
        specimens, or data or specimens will be coded, please provide the following information.


FUTURE USE OF DATA AND/OR SPECIMENS (SBER-HSR Part 8.B.)

[ ]     Indicate the current plans for use of the data and/or specimens collected for this study.

[ ]     Describe how and where data and/or specimens will be stored, including the security measures for preventing un-
        authorized access.

[ ]     If personal or private information and/or codes will be maintained, explain how the information will be handled and
        stored to assure confidentiality. For example, who will have access to the data and/or specimens, and how will the
        data and/or specimens be securely stored?
.
[ ]     If the data and/or specimens have direct identifiers, explain whether the materials will be de-identified, and if so,
        when.




                                                                                                                Version 12/18/2009