PROTOCOL TITLE:
INSTRUCTIONS FOR RESEARCH INVOLVING
RECORD/DATA/SPECIMEN REVIEW:
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This template is for research that involves the review and data
collection/analysis of records, other data, and specimens that were collected for
purposes other than this research. If your proposed project involves any
activities other than the review and/or analysis of data/specimens, do not use
this form.
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Please take the time to read all italicized instructions and questions.
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Delete the italicized instructions before submitting to the IRB.
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Depending on the nature of what you are doing, some sections may not be
applicable to your research. If so, mark as “N/A” or delete.
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When you write a protocol, keep an electronic copy. You will need to modify
this copy when making changes.
1) Protocol Title
Title:
Protocol Version Date: Click here to enter text.
2) Author of Protocol
☐UC Davis Researcher
☐Researcher from other institution
☐Private Sponsor
☐Cooperative Group
☐Other: _________________
3) Objectives
Describe the purpose, specific aims, or objectives.
State the hypotheses to be tested.
4) Background
Describe the relevant prior experience and gaps in current knowledge.
Describe any relevant preliminary data.
Provide the scientific or scholarly background for, rationale for, and significance of
the research based on the existing literature and how will it add to existing
knowledge.
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5) Indicate if this is a retrospective and/or prospective
chart/data/specimen review
☐Retrospective Chart/Data/Specimen Review (Retrospective means the
data/specimen you will access are already in existence when the project is
submitted to the IRB for initial review)
When were these data collected by the source?
From Month/Year to Month/Year
☐Prospective Chart/Data/Specimen Review (Prospective means the
data/specimen you will access are not in existence when the project is submitted to
the IRB for initial review)
When will these data be collected by the source?
From Month/Year to Month/Year
6) Describe the data you will be accessing and the source(s) of the data.
☐Electronic Medical Records
☐Student Records Note – There are federally mandated requirements for consent
before some school records can be accessed (FERPA).
☐Publically available records
☐Other: Click here to enter text.
Will the data/specimen come from UC Davis? ☐Yes
☐No
If “No,” provide information on the source of the data/specimen: Click here to
enter text.
Does the institution supplying the data/specimen require IRB approval before
releasing the data? ☐Yes ☐No
Note – If you are obtaining human tissue/blood/other matter from a source outside
of UC Davis, you must obtain authorization from the UC Davis Biological Safety
Committee.
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7) Data Management and Confidentiality
Confidentiality
☐ The data (or data associated with the specimen) will be identifiable when the
investigator accesses it.
☐ The data recorded for this research will include direct and indirect
identifiers.
☐ The data recorded for this research will not include any direct or
indirect identifiers for this research.
☐ The data (or data associated with the specimen) will not include information that
identifies the individuals when the investigator accesses it.
☐ The data source/repository/provider will code the data and a link from the
code to the individual’s identity will be maintained but will not be provided to the
investigator or research team.
☐ The data source/repository/provider will not code the data and there will be no
link to the individual’s identity.
☐ The investigator will receive a limited dataset and the investigator will sign a data use
agreement.
☐ Other - Describe: Click here to enter text.
Management
Indicate how you will protect the data that you obtain and/or the information you
record while conducting this study from disclosure to any individual who does not
have a right or a need to access the information?
☐ The data/specimen received by the investigator/research team will be
anonymous or de-identified.
☐ The investigator/research team will remove all identifying information from the
data/specimen as soon as the data are received by the investigator
☐ The investigator/research team will code the data/specimen, remove all
identifying information except the code and a link to the individual’s identity will
be maintained in a separate secure location.
☐ All identifiable electronic data will be maintained on an encrypted device
requiring a password for access. Passwords will be not be shared and will be
protected from access.
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☐ If protected health information or personal information from the medical records will be
stored on an encrypted device, investigators will follow applicable university policies (UC
Davis Hospital Policy 1313, UCDHS P&P 2300-2499, and UC Business and Finance
Bulletin on Information Security (IS-3).
☐ All paper records will be stored in a locked room/file-cabinet with access limited to only
individuals who have a right and need for access.
☐ Other - Describe Click here to enter text.
Note - If the data or specimens you are obtaining for the research were collected
for a purpose other than this research and are de-identified and coded or
anonymous (in other words, you cannot ascertain the identity of the individual to
whom the data pertain, then this study is probably not human subject research
requiring IRB review and oversight Please contact the IRB if you have questions. If
you need unofficial correspondence (such as an email) indicating that the study is
not human subject research requiring IRB review and oversight, please contact the
IRB. If you need official correspondence, please submit the protocol through the
normal process.
8) Inclusion and Exclusion Criteria
Inclusion Criteria:
Click here to enter text.
Exclusion Criteria:
Click here to enter text.
Age Range:
Click here to enter text.
9) Number of Individual Records to Reviewed
Number of charts/records/specimen to be reviewed: Click here to enter text.
Provide a rationale (e.g. statistical justification) for the number of
charts/records/specimen to be reviewed: Click here to enter text.
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Note - Approval of this research will be limited to the number of charts/records you
indicate you need to review. If you find that you need to collect data from a larger
number of charts/records, you must request approval of this larger number before
you access the data. To obtain approval, submit FORM HRP 213 to the IRB before
you access any additional records.
10) Compensation to Subjects
☐ Participants will not be compensated or reimbursed.
☐ Participants will be compensated.
What is the total compensation participants will receive?
Click here to enter text.
When and how (form of payment) will participants be compensated?
Click here to enter text.
11) Recruitment Methods
Describe how the records or specimens to be reviewed will be identified.
Click here to enter text.
12) Study Timelines
The duration anticipated to enroll all study subjects for prospective chart/data
collection only:
☐ I do not plan to obtain consent from subjects.
☐ I will be obtaining consent and enrolling subjects until: Click here to enter text.
The duration anticipated to identify the records for chart/data review:
Click here to enter text.
The duration anticipated to conduct data review and analysis:
Click here to enter text.
The estimated date for the investigators to complete this study (complete primary
analyses):
Click here to enter text.
13) Procedures Involved
Describe and explain the study design.
14) Data/Specimen Banking
Will data/specimen be banked for future use? ☐ Yes ☐ No
If yes, will the data/specimen that are banked be identifiable?
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☐ Yes, the data/specimen will be identifiable
☐ No, the data/specimen will be completely anonymous.
☐ No, the data/specimen will be stripped of identifiers and coded. The link to the
individual’s identity will not be accessible by the research team.
Note - If data or specimens will be banked for future use, the aims of the study must
justify the retention of the data and you will need to address the additional
questions below.
Where will the data/specimen be stored?
Click here to enter text.
How long will the data/specimen be stored?
Click here to enter text.
Who will have access to the data/specimen?
Click here to enter text.
Describe the procedures to release data/specimen, including: the process to request
a release, approvals required for release, who can obtain data or specimens, and the
data to be provided with specimens.
Click here to enter text.
15) Risks to Subjects
☐ This record/data review poses the risk of loss of confidentiality. The risk will be
minimized through the processes described above. This study will abide by all
applicable law, regulations, and standard operating governing the protection of
human subjects, student information and protected health information.
☐ Other – Describe: Click here to enter text.
16) Potential Benefits to Subjects
☐ The subjects whose records and/or specimens that are reviewed are not likely to
receive any benefit from the proposed research but others may benefit from the
knowledge obtained.
☐ Other – Describe: Click here to enter text.
17) Sharing of Results with Subjects
☐ Results will not be shared with subjects.
☐ Results will be shared with subjects – Describe: Click here to enter text.
18) Setting
Describe the sites or locations where your research team will conduct the research.
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Identify where your research team will identify and recruit potential subjects.
Identify where research procedures will be performed.
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For research conducted outside of the organization and its affiliates describe:
o Site-specific regulations or customs affecting the research for research
outside the organization.
o Local scientific and ethical review structure outside the organization.
19) Resources Available
Describe your staff by roles (e.g. coordinator, research assistant, co-investigator,
or pharmacist). Describe the qualifications (e.g., training, experience, oversight)
required to perform each role. Provide enough information to convince the IRB that
you have qualified staff for the proposed research.
Describe other resources available to conduct the research: For example, as
appropriate:
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Justify the feasibility of recruiting the required number of suitable subjects
within the agreed recruitment period. For example, how many potential
subjects do you have access to? What percentage of those potential
subjects do you need to recruit?
Describe the time that you will devote to conducting and completing the
research.
Describe your facilities.
Describe your process to ensure that all persons assisting with the research
are adequately informed about the protocol, the research procedures, and
their duties and functions.
20) Provisions to Protect the Privacy Interests of Subjects
If you are reviewing or collecting data from records or specimen that are not yet
existing, you will most likely need to have an interaction with the individuals to
obtain consent and authorization. Describe the steps that you will take to protect
subjects’ privacy interests. “Privacy interest” refers to a person’s desire to place
limits on with whom they interact or to whom they provide personal information:
☐ N/A this is a retrospective review of records/specimens or other data and we will
be requesting a waiver of consent.
Click here to enter text.
Describe what steps you will take to make the subjects feel at ease with the research
the research. “At ease” does not refer to physical discomfort, but the sense of
intrusiveness a subject might experience in because you are accessing information
about them.
☐ N/A this is a retrospective review of records or other data or we will be
requesting a waiver of consent.
or
Click here to enter text.
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21) Consent Process
Waiver of Informed Consent Process:
In order to waive consent, the IRB must make determinations required by
regulations or UC Davis policy.
The FDA regulates the research:
☐ Yes ☐ No Note – If the FDA regulates this research, you will need to obtain
informed consent.
This research cannot be conducted without this waiver because:
☐ This is a retrospective review of data/specimen and obtaining consent from the
individuals will be very difficult.
☐ Failure to include the data/specimen of even one individual due to lack of informed
consent will result in biased data. Please provide additional justification:
Click here to enter text.
☐ Other – Explain:
Click here to enter text.
Informed Consent Process (if you’re not requesting a waiver of
informed consent, check all that apply):
Note - If this study meets the requirements for an exemption, you may use an
abbreviated process for obtaining consent. Consent can be verbal, but you must
provide the following information to participants through an information sheet or
written script:
 The subject is being asked to participate in a research study involve access
to personal, data or specimens;
 Participation is voluntary; and
 The investigators name and contact information.
If this study is not exempt and you are not requesting a waiver of consent, you will
need to complete the consent form template and confirm that you will follow HRP
090 and HRP 091when obtaining and documenting consent from participants:
☐ I confirm I will follow the applicable SOPs.
HIPAA Authorization for Research
Note - If this study involves review of identifiable health information, you must
obtain an authorization from the individual to whom the information pertains. If
you cannot obtain an authorization, you will need a waiver of authorization to use
or share private health information for this research/recruitment.
For more information on HIPAA Authorization for Research visit the Compliance
Program website.
Do you want to request a waiver of authorization? ☐Yes ☐ No
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If you are not requesting a waiver of authorization, you have completed the
template. If you are requesting the waiver, answer the following questions so the
IRB can make the determinations required to approve this waiver.
☐ I confirm that you will destroy the identifiers at the earliest opportunity consistent with
the conduct of the research unless there is a health or research justification for retaining the
identifiers or as otherwise required by law.
Describe your plan to destroy the identifiers you collect at the earliest opportunity:
Click here to enter text.
☐ I confirm that only authorized persons will be granted access to the identifiers;
identifiers stored on a computers, electronic notebooks, mobile devices, datastorage devices will be encrypted and password protected; identifiers maintained in
paper format will be kept in a locked area with access limited to only research staff
who require access to conduct the study.
☐ I confirm that protected health information from this research will not be reused
or disclosed to another person or entity, except as required by law, for authorized
oversight of the research study, or other research for which the use or disclosure of
PHI would be permitted.
Explain why this research could not practicably be conducted without the waiver. In
other words, why can’t you obtain authorization from the individual before
accessing his/her information?
Click here to enter text.
Explain why the research could not practicably be conducted without access to and
use of the PHI. In other words, why do you need access to all of the chart/record
you are requesting?
Click here to enter text.
Explain why this waiver will not adversely affect the privacy rights of the
individual?
Click here to enter text.
22) Data Collection Form
Provide your data-collection form or a list of the data elements you will be
recording.
Click here to list the data elements or check “Yes” in the box below.
The data-collection form is attached. ☐Yes ☐ No
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