Institutional Review Board
Human Research Protections
RELYING INVESTIGATOR (RI) STUDY WORKSHEET
Complete this form when the UCI IRB is requested to serve as the Relying IRB (i.e. accept IRB approval from a
non-UCI IRB). This document provides the local context for the research activities at UCI. OR
Complete this form when the UCI IRB is requested to serve as the Reviewing IRB (i.e. IRB of record) for a nonUCI entity. This document must be completed separately for each relying institution/site as it is intended to
provide the local context for the 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:
a. List all research team members who will interact or intervene with human subjects or will have
access to identifiable private information about human subjects. Include additional rows for Coresearchers and Research Personnel, as needed.
b. For each research team member, indicate all applicable research activities the individual will
perform. Finalizing informed consent is reviewing, answering/asking questions, confirming
competency, as necessary, and signing/confirming the informed consent.
c. If applicable, list the Faculty Sponsor as a Co-Researcher who will have research oversight
responsibilities.
Lead Researcher:
Name and Degree: <Type here>
Position/Title and Department: <Type here>
Team Member will: [ ] Screen/Recruit [ ] Finalize Informed Consent
[ ] Perform Research Activities (describe below) [ ] Access subject identifiable data
List the research activities/procedures to be performed and the individual’s relevant qualifications (training,
experience): <Type here>
Co-Researcher:
Name and Degree: <Type here>
Position/Title and Department: <Type here>
Team Member will: [ ] serve as Faculty Sponsor with research oversight responsibilities
[ ] Screen/Recruit [ ] Finalize Informed Consent
[ ] Perform Research Activities (describe below) [ ] Access subject identifiable data
List the research activities/procedures to be performed and the individual’s relevant qualifications (training,
experience): <Type here>
Co-Researcher:
Name and Degree: <Type here>
Position/Title and Department: <Type here>
Team Member will: [ ] Screen/Recruit [ ] Finalize Informed Consent
[ ] Perform Research Activities (describe below) [ ] Access subject identifiable data
List the research activities/procedures to be performed and the individual’s relevant qualifications (training,
experience): <Type here>
Co-Researcher:
Name and Degree: <Type here>
Position/Title and Department: <Type here>
Team Member will: [ ] Screen/Recruit [ ] Finalize Informed Consent
[ ] Perform Research Activities (describe below) [ ] Access subject identifiable data
List the research activities/procedures to be performed and the individual’s relevant qualifications (training,
experience): <Type here>
Research Personnel:
Name and Degree: <Type here>
Position/Title and Department: <Type here>
Team Member will: [ ] Screen/Recruit [ ] Finalize Informed Consent
[ ] Perform Research Activities (describe below) [ ] Access subject identifiable data
List the research activities/procedures to be performed and the individual’s relevant qualifications (training,
experience): <Type here>
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Research Personnel:
Name and Degree: <Type here>
Position/Title and Department: <Type here>
Team Member will: [ ] Screen/Recruit [ ] Finalize Informed Consent
[ ] Perform Research Activities (describe below) [ ] Access subject identifiable data
List the research activities/procedures to be performed and the individual’s relevant qualifications (training,
experience): <Type here>
Research Personnel:
Name and Degree: <Type here>
Position/Title and Department: <Type here>
Team Member will: [ ] Screen/Recruit [ ] Finalize Informed Consent
[ ] Perform Research Activities (describe below) [ ] Access subject identifiable data
List the research activities/procedures to be performed and the individual’s relevant qualifications (training,
experience): <Type here>
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.
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:
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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
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?
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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.
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:
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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
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:
Additional Confirmations When PI Intends to Enroll Pregnant Women [45 CFR 46.204 (h), (i), (j)]:
Confirm the following statements by choosing ‘True’.
a. No inducements will be offered to terminate a pregnancy.
True
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
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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:
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