CMU RELYING INVESTIGATOR STUDY WORKSHEET

Complete this form whenan 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 toprovide the local context for the relying investigator(s)research activities at each site.

SECTION A: BRIEF STUDY INFORMATION

  1. Study Title:
  1. Protocol Author:
  1. Study Sponsor:

SECTION B: DESCRIPTION OF RESEARCH TEAM

Relying Investigator (RI) Information:

  1. RI Name:
  1. RI email address:
  1. Name of Institution:

Research Personnel:

  1. How many sub-investigators (co-researchers) do you have supporting you in conducting this research at the “relying” institution?
  1. How many research staff (e.g., nurses, clinical research coordinators, research personnel) do you have supporting you in conducting this research?
  1. 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?
  1. 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 and Degrees / Certifications / Licenses
  2. Specify institutional email address
/ Specify position / title and department / List research activities being performed and the individual’s qualifications(training, experience) relevant to the research; include licenses/medical privileges, including privileges at multiple sites. / Research Team Member will:
Interact / Intervene
with subjects / Access to Subject Identifiable Information
(e.g. PHI) / Obtain
Informed Consent
EX / Relying Investigator
John Doe, MD, MPH
/ Associate Professor, Neurology / Involved in all research activities except data abstraction; Board Certified in Neurology; Dr. Doe has physician privileges at both MHS and UC / x / x / x
1 / Relying Investigator
2 / Sub-Investigator
3 / Sub-Investigator
4 / Sub-Investigator
5 / Sub-Investigator
6 / Research Staff
7 / Research Staff
8 / Research Staff
9 / Research Staff

SECTION C: RESEARCH ACTIVITIES

Research Procedures:

  1. Provide a description of any research procedures that will differ from the IRB-approved protocol:

See IRB-approved protocol page numbers:

  1. 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:
  1. 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:

  1. Describe how potential study participants are identified and recruited to this study:

See IRB-approved protocol page numbers:

  1. Identify recruitment materials usually used:

Compensation/Incentives/Reimbursement to Study Participants:

  1. 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):

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.

  1. Where does the consent discussion take place?
  1. 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?
  1. Who provides consent?

If LAR, provide a description of how you assess a potential study participant’s ability to provide consent:

  1. How is the potential study participant’s understanding of consent assessed?
  1. Is the informed consent process conducted with non-English speaking potential study participants?
  1. For what languages will consent/assent translations be provided? How will the documents be translated?

Pharmacy Information:

  1. Will the drugs/agents used in the study be managed by a pharmacist?

If yes,provide the name and title of the pharmacist at each location where the RI will conduct the research:

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:

  1. 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).

  1. Check all measures that will be used to maintain the confidentiality of identifiable information.

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.

  1. Check all measures that will be used to maintain the study participant’s privacy.

Emergency Resources:

  1. Check all resources available at the site to treat emergencies resulting from study-related procedure.

SECTION D: VULNERABLE POPULATIONS:

  1. Check all vulnerable populations which you intend to enroll.
  1. For each vulnerable population checked above, indicate the safeguards.

Children

Pregnant Women

Economically disadvantaged

Educationally disabled

Physically disabled

Additional Confirmations When PI Intends to Enroll Pregnant Women [45 CFR 46.204 (h), (i), (j)]:

  1. Confirm the following statements by choosing ‘True’.
  1. No inducements will be offered to terminate a pregnancy.
  1. Research team will have no part in decisions related to the timing, method, or procedures used to terminate the pregnancy.
  1. Research team will have no part in determining the viability of a neonate.

CONTINUED: ROLES AND EXPERTISE OF THE RESEARCH TEAM – NOTE:Use this sheet to include addition Study Personnel.

  1. List Role, Name and Degrees / Certifications / Licenses
  2. Specify institutional email address
/ Specify position / title and department / List research activities being performed and the individual’s qualifications(training, experience) relevant to the research; include licenses/medical privileges / Research Team Member will:
Interact / Intervene
with subjects / Access to Subject Identifiable Information
(e.g. PHI) / Obtain
Informed Consent
EX / Sub-Investigator
John Doe, MD, MPH
/ Associate Professor, Neurology / Involved in all research activities except data abstraction; Board Certified in Neurology / x / x / x
10 / Sub-Investigator
11 / Sub-Investigator
12 / Sub-Investigator
13 / Sub-Investigator
14 / Sub-Investigator
15 / Sub-Investigator
16 / Sub-Investigator
17 / Sub-Investigator
18 / Sub-Investigator
19 / Sub-Investigator
20 / Research Staff
21 / Research Staff
22 / Research Staff
23 / Research Staff
24 / Research Staff
25 / Research Staff
26 / Research Staff
27 / Research Staff
28 / Research Staff
29 / Research Staff
30 / Research Staff

Version: August 2014Page 1 of 8 Relying Investigator Study Worksheet