CMU RELYING INVESTIGATOR STUDY WORKSHEET
Complete this form when an IRB is requested to serve as the Reviewing IRB (i.e. IRB of record) or is
requested to serve as the Relying IRB (i.e. accept IRB approval from another IRB) under the terms of
the Children's Hospital of Orange County (CHOC), MemorialCare Health System (MHS), University of
California, Irvine (CMU) IRB Reliance.
This worksheet must be completed as a separate document for each relying institution/site. This
document is intended to provide the local context for the relying investigator(s) research activities at
each site.
SECTION A: BRIEF STUDY INFORMATION
1. Study Title:
2. Protocol Author:
3. Study Sponsor:
SECTION B: DESCRIPTION OF RESEARCH TEAM
Relying Investigator (RI) Information:
4. RI Name:
5. RI email address:
6. Name of Institution:
Research Personnel:
7. How many sub-investigators (co-researchers) do you have supporting you in conducting this
research at the “relying” institution?
8. How many research staff (e.g., nurses, clinical research coordinators, research personnel) do you
have supporting you in conducting this research?
9. Have you or any of your research staff reported a financial conflict of interest related to this study
that has resulted in a management plan?
No
Yes, attach the FCOI management plan
10. Role and Expertise of Research Team (To list additional research team members use the form at
the end of this worksheet):
1.
List Role, Name
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Specify position / title
List research activities
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Research Team Member will:
Relying Investigator Study Worksheet
2.
and Degrees /
Certifications /
Licenses
Specify
institutional
email address
Relying Investigator
John Doe, MD, MPH
johndoe@uci.edu
and department
Associate Professor,
Neurology
EX
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2
3
4
5
6
7
8
9
being performed and the
individual’s qualifications
(training, experience)
relevant to the research;
include licenses/medical
privileges, including
privileges at multiple sites.
Involved in all research
activities except data
abstraction; Board
Certified in Neurology; Dr.
Doe has physician
privileges at both MHS and
UC
Interact /
Intervene
with
subjects
Access to
Subject
Identifiable
Information
(e.g. PHI)
x
x
Obtain
Informed
Consent
x
Relying Investigator
Sub-Investigator
Sub-Investigator
Sub-Investigator
Sub-Investigator
Research Staff
Research Staff
Research Staff
Research Staff
SECTION C: RESEARCH ACTIVITIES
Research Procedures:
11. Provide a description of any research procedures that will differ from the IRB-approved protocol:
Not Applicable: The research procedures do NOT differ from the IRB-approved protocol.
See IRB-approved protocol page numbers:
12. Maximum number of subjects to be recruited / screened. This number includes potential screen
failures. For records review studies, specify the maximum number of records that will be
reviewed/screened to compile the dataset:
13. Target Sample Size. This is the number of subjects expected to complete the study or the number
necessary to answer the research question. For records review studies, this is the number of
records necessary to answer the research question:
Recruitment:
14. Describe how potential study participants are identified and recruited to this study:
Not applicable: This study does not invovle recruitment. SKIP to Question #16.
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Relying Investigator Study Worksheet
The recruitment methods do NOT differ from the IRB-approved protocol.
See IRB-approved protocol page numbers:
15. Identify recruitment materials usually used:
Not applicable: No recruitment materials will be used.
Cooperative Group/sponsor-supplied handouts
Locally developed educational materials - Study-specific material requires IRB approval
Other - Describe:
Compensation/Incentives/Reimbursement to Study Participants:
16. Describe any compensation/ incentives/reimbursements provided by the RI or others?
Include amounts and method/terms of payment (e.g., money; check; extra credit; gift certificate,
parking validation cafeteria voucher):
Not applicable: This study does not provide compensation/incentives/reimbursement.
The compensation/incentives/reimbursements do NOT differ from the IRB-approved protocol.
See IRB-approved protocol page numbers:
Informed Consent Process:
Answer the following questions regarding the process used to introduce a trial to a potential study
participant and obtain their informed consent.
Not applicable: Waiver of informed consent granted. SKIP to Question #23.
17. Where does the consent discussion take place?
18. How long does the potential study participant have to review the consent document before a
response is required, including time to take the consent document home?
19. Who provides consent?
Potential study participant
Parent for potential pediatric study participant
Other - Explain:
Legally Authorized Representative (LAR)
If LAR, provide a description of how you assess a potential study participant’s ability to provide
consent:
20. How is the potential study participant’s understanding of consent assessed?
21. Is the informed consent process conducted with non-English speaking potential study participants?
Yes
No
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Relying Investigator Study Worksheet
22. For what languages will consent/assent translations be provided? How will the documents be
translated?
Pharmacy Information:
23. Will the drugs/agents used in the study be managed by a pharmacist?
Not applicable: No drugs/agents used in this study. SKIP to Question #25.
Yes
If yes, provide the name and title of the pharmacist at each location where the RI will conduct the
research:
No
If no, provide the name and title of the responsible person for the drugs/agents at each location
where the RI will conduct the research:
24. How is the pharmacist / responsible person provided with a copy of the protocol?
Measures to Protect Confidentiality:
Confidentiality is defined as the study participant’s understanding of, and agreement to, the ways
identifiable information pertaining to them will be stored and shared. Identifiable information can be
printed, electronic, or visual (such as photographs).
25. Check all measures that will be used to maintain the confidentiality of identifiable information.
Paper-based records will be kept in a secure location and only be accessible to personnel
involved in the study.
Computer-based files will be available to research personnel through the use of access
privileges and passwords.
Prior to obtaining access to identifiable information, study personnel will be required to
sign statements agreeing to protect the security and confidentiality of identifiable
information.
Whenever feasible, identifiers will be removed from study-related information.
Other - Describe:
Measures to Protect Privacy:
Privacy is defined as the study participant’s ability to control how other people see, touch, or obtain
information about them. Violations of privacy can involve circumstances such as being seen without
clothing or partially clothed, being photographed without consent, being asked personal questions in a
public setting, etc.
26. Check all measures that will be used to maintain the study participant’s privacy.
Use of drapes or other barriers to vision for subjects who are required to disrobe.
Consent is obtained prior to collecting photographs involving study participants.
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Sensitive information is collected and used with respect to maintaining privacy.
Individuals are not identified publicly without their consent.
Other - Describe:
Emergency Resources:
27. Check all resources available at the site to treat emergencies resulting from study-related
procedure.
Not Applicable: Emergency resources NOT required to conduct this study.
ACLS trained personnel and crash cart
BCLS trained personnel
Emergency response team within facility
Emergency drugs and supplies to stabilize study participant until emergency personnel
arrive
Staff available to call 911
Other - Describe:
SECTION D: VULNERABLE POPULATIONS:
28. Check all vulnerable populations which you intend to enroll.
Not Applicable: No vulnerable populations will be enrolled. SKIP the remaining questions.
Children
Pregnant Women
Economically disadvantaged
Educationally disabled
Physically disabled
Other - Describe:
29. For each vulnerable population checked above, indicate the safeguards.
Children
Youth Information Sheets
Assent
Extra monitoring
Researchers credentialed in pediatrics
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Other health professionals with pediatrics experience
Other - Describe:
Pregnant Women
Inclusion is scientifically appropriate based on preclinical studies

Information is provided pertaining to how study intervention could impact the woman
and the fetus
Other - Describe:
Economically disadvantaged
Cost burden is fully explained

No financial incentives are provided
Social services are available to assist study participant
Other - Describe:
Educationally disabled
Verbal explanation of the research is provided in lay language
Extra time is available to answer questions
At the potential study participant's request, family members/significant others can
participate in informed consent process
Caregiver to assist with medications and identifying adverse events
Translations are available, if needed
Other - Describe:
Physically disabled
Treatment facility is accessible
Assistance is available, as needed
Witness to consent is available, as needed
Other - Describe:
Other - Describe any safeguards you will use for 'Other' vulnerable populations:
Additional Confirmations When PI Intends to Enroll Pregnant Women [45 CFR 46.204 (h), (i), (j)]:
30. Confirm the following statements by choosing ‘True’.
a. No inducements will be offered to terminate a pregnancy.
True
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False
b. Research team will have no part in decisions related to the timing, method, or procedures
used to terminate the pregnancy.
True
False
c. Research team will have no part in determining the viability of a neonate.
True
False
CONTINUED: ROLES AND EXPERTISE OF THE RESEARCH TEAM – NOTE: Use this sheet to
include addition Study Personnel.
Research Team Member will:
1.
2.
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23
List Role, Name
and Degrees /
Certifications /
Licenses
Specify
institutional
email address
Sub-Investigator
John Doe, MD, MPH
johndoe@uci.edu
Specify position / title
and department
Associate Professor,
Neurology
List research activities
being performed and the
individual’s qualifications
(training, experience)
relevant to the research;
include licenses/medical
privileges
Involved in all research
activities except data
abstraction; Board
Certified in Neurology
Interact /
Intervene
with
subjects
Access to
Subject
Identifiable
Information
(e.g. PHI)
x
x
Obtain
Informed
Consent
x
Sub-Investigator
Sub-Investigator
Sub-Investigator
Sub-Investigator
Sub-Investigator
Sub-Investigator
Sub-Investigator
Sub-Investigator
Sub-Investigator
Sub-Investigator
Research Staff
Research Staff
Research Staff
Research Staff
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Relying Investigator Study Worksheet
24
25
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27
28
29
30
Research Staff
Research Staff
Research Staff
Research Staff
Research Staff
Research Staff
Research Staff
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Relying Investigator Study Worksheet