PROTOCOL #: __________________
PI: __________________________
EXISTING DATA
Second review by: _______________________________ for
 International*(see export control)
 Review level
 Other:
Human Subjects [45 CFR 46.102(f)]
YES NO



 Private information? (not publicly available)
 Individual-level information? (not aggregate only)
 Identifying Information (use chart below):












Student Researcher:  Faculty Assurance Form
Unaffiliated investigators
Department of Defense
UCSD joint review:  Coversheet
CGU joint review:  CGU Co-Chair email address
Funding
 Each grant/contract provided
 Procedures match protocol
 Adheres to subparts B, C, D (if required)
YES NO
  No identifiers, no links to identifiers AND deductive disclosure (or triangulation) of
identity not possible
  No identifiers BUT links to identifiers and a master list exists. Disclosure of identity
IS restricted. Investigator(s) is not the data owner and there is documentation of
agreement to restrict the receipt of or access to the master list or other identifying
information.
 No identifiers or links to identifiers BUT deductive disclosure of identity POSSIBLE
(choose one)
Not Human Subjects (no review)
Exempt [45 CFR 46.101(b)(4)]
(Quote from http://healthcare.partners.org/phsirb/deidinfo.htm)

“All geographic subdivisions smaller than a State, including: street, city, county, precinct, zip code - the
first three digits of the zip code can be used if this geocode includes more than 20,000 people. If such
geocode is less than 20,000 persons, "000" must be used as the zip code.”

“All elements of dates (except year) related to an individual, including birth date, admission date,
discharge date, date of death. For individuals > 89 years of age, year of birth cannot be used - all
elements must be aggregated into a category of 90 and older.”






Use of State Death Data Records CALAW (Sections 102231–102232): IRB review is
Expedited 45 CFR 46
required (not exempt) for research using California-Produced death data files containing
personal identifying information (i.e., state issued death certificates and indices.)
Hereditary Disorders, Confidentiality of Records involving. CA LAW, (Section 124980): All
testing results and personal information from hereditary disorders programs obtained from
any individual, or from specimens from any individual, shall be held confidential and be
considered a confidential medical record except for information that the individual, parent,
or guardian consents to be released. Data compiled for research purposes without reference
to the identity of any individual requires expedited or convened IRB review and approval
with a waiver of consent (116.d). – CONTACT AMY/DENA
 110(b)(1), 5 materials collected
for non-research reasons
 110(b)(1), 6 voice, video, digital,
or image made for research
 110(b)(1), 7 individual/group
characteristics or behaviors OR
survey, interview, oral history, focus
group, program evaluation, human
factors evaluation, or quality
assurance methodologies
 110(b)(2), MR minor mod.
 110(b)(1)(8)(a), long term f-up
 110(b)(1)(8)(b), no ppl enrolled
 110(b)(1)(8)(c), data analysis
 110(b)(1)(9), MR ROP, continue
Disclosure of identity IS NOT restricted. Investigator(s) is not the data owner BUT
there is no documentation of agreement to restrict the receipt of or access to the
master list or other identifying information
Investigator(s) is data owner.
Identifiers.
If Expedited or Full Committee, 45 CFR 46.111(a)
 Risks to subjects are minimized
 Risks to subjects are reasonable in relation to
anticipated benefits
 Selection of subjects is equitable
 When appropriate, there are adequate provisions to
protect the privacy of subjects and to maintain the
confidentiality of data
 Informed consent will be sought from each
prospective subject or the subject's legally
authorized representative
 116(d)(1-4) - Waiver of Consent
1 minimal risk;
2 won’t adversely affect rights & welfare of subjects;
3 could not practically be carried out w/out it;
4 subjects provided add’l info after participation if necessary
Letters of authorization required
 To access/use data
 From site of performance
 From other IRB
Other DRA review required
 Institutional (112)
 COI
 Risk Management
 IACUC
 IBC
 Export Control- 2/19/13
international AND UGP or unfunded) and any new, mod or rop
involving Cuba, Iran, North Korea, Sudan, Syria.
========OUTCOME===========

FC review required
 Insuff.Info/resubmit
 Conditional-Expedited
 Approved- Expedited

Verified Exempt
PROTOCOL #: __________________
PI: __________________________
IDENTIFYING INFORMATION
1. names
2. addresses other than state, and first three digits of the zip code (provided that this geographic unit contains more
than 20,000 people)
3. all elements of date other than year, and all specific ages over 89 years
4. telephone numbers
5. fax numbers
6. electronic mail addresses
7. social security numbers
8. medical record numbers
9. health plan beneficiary numbers
10. account numbers
11. certificate/license numbers
12. vehicle identifiers and serial numbers
13. device identifiers and serial numbers
14. web universal resource locators (URLs; web site addresses)
15. internet protocol (IP) addresses
16. biometric identifiers, including finger and voice prints
17. full face photographic images and any comparable images
18. any other unique identifying number, characteristic, or code