CIRB Annual Principal Investigator Worksheet About Local Context

Institutional Review Board Human Research Protections Appendix R – Single IRB (sIRB) Review Version 04-18-2017

Appendix R is to be completed when a UCI investigator is requesting to rely on a non- UCI IRB for a multi-site or collaborative research study OR when another HS#: site/institution will cede review to UCI IRB. A separate Appendix R must be completed for each site/institution requesting to cede review to UCI. Upload this (to be completed by the IRB) appendix and any supplemental documentation to the IRB APP.

SECTION A: GENERAL INFORMATION

Lead Researcher/Investigator Name:

Study Title: Indicate who will cede IRB Review:

[ ] Non-UCI Site/Institution will cede review:

[ ] UCI will cede review to non-UCI IRB:

Does the Sponsor / Funder of this research require Single IRB (sIRB) Review? [ ] Yes [ ] No To be completed by non-UCI sites/institutions only: Provide the name of your IRB Representative.

Email:

Phone:

[ ] Not applicable, site/institution does not have an IRB.

SECTION B: DESCRIPTION OF RESEARCH TEAM

 If UCI is ceding IRB oversight provide local UCI study team member information.

 If non-UCI site/institution will rely on UCI IRB provide information about the research team. Note: For UC Reliance, provide information only about the Lead Researcher/Investigator

Instructions:  List all research team members who will interact or intervene with human subjects or will have access to identifiable private information about human subjects. Add additional rows for Co- researchers and Research Personnel, as needed.  For each research team member, indicate all applicable research activities the individual will perform. Finalizing informed consent is defined as reviewing, answering/asking questions, confirming competency, as necessary, and signing/confirming informed consent.  UCI-specific: List the Faculty Sponsor as a Co-Researcher who will have research oversight

responsibilities.

Lead Researcher: UCI-specific, the Lead Researcher must meet the eligibility requirements or obtain a Faculty Sponsor. Name and Degree: Position/Title and Department: 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):

Co-Researcher: Name and Degree: Position/Title and Department: 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):

Co-Researcher: Name and Degree: Position/Title and Department: 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):

Research Personnel: Name and Degree: Position/Title and Department: 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):

For non-UCI sites/institutions only: 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?

[ ] Yes (Please attach the management plan for review) [ ] No

SECTION C: STUDY POPULATION

I. Subject Populations/Data Sources: Provide site/institution specific information. [ ] Site will interact/intervene with subjects. Provide the maximum number of subjects to be enrolled in the research. a. Overall Sample Size across all sites: b. Site/Institution-Specific Sample Size: OR

[ ] Site will not be recruiting own subset of subjects. Instead, site will be accessing identifiable data/records/biospecimens for analysis only. Provide the source and the maximum number of individual- level data/records/specimens to be accessed/analyzed:

[ ] Other: II. Vulnerable/Special Populations: For each vulnerable population involved in the study, indicate the safeguards to be implemented at site/institution. If the research does not include these Vulnerable/Special Populations skip to Section D, ‘Research Activities.’ 1. CHILDREN

[ ] Assent will be obtained with a Youth Information Sheet

[ ] Extra monitoring will be used in this population as follows:

[ ] Other (specify):

2. PREGNANT WOMEN1

[ ] Information is provided pertaining to how study intervention could impact the woman and the fetus

[ ] Inclusion is scientifically appropriate based on preclinical studies

[ ] No inducements will be offered to terminate a pregnancy REQUIRED SELECTION

[ ] The research team will have no part in decisions related to the timing, method or procedures used to terminate the pregnancy REQUIRED SELECTION

[ ] The research team will have no part in determining the viability of a neonate REQUIRED SELECTION

3. PRISONERS2

[ ] Consent specifies that participation in the research will have no effect on parole (required selection)

4. ECONOMICALLY DISADVANTAGED

[ ] Cost burden, if any, is fully explained

[ ] No financial incentives are provided

[ ] Social Services are available to assist the study subject

5. COGNITIVELY IMPAIRED AND/OR EDUCATIONALLY DISADVANTAGED

[ ] Verbal explanation of the research is provided

[ ] Extra time is provided to answer questions

[ ] Legally authorized representative will participate in the consent process if subject does not have the capacity to consent

[ ] Caregiver to assist with medications and identifying adverse events

[ ] Translations are available, if needed

1 Per 45 CFR 46.204 (b) – Any non-exempt research involving pregnant women without the prospect of direct benefit to the pregnant woman or fetus may only be approved when (1) the risk to the fetus is no greater than minimal AND (2) the purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means.

2 California Penal Code 3502 prohibits biomedical research involving prisoners. Page 4 of 9

6. PHYSICALLY DISABLED

[ ] Treatment facility is accessible

[ ] Assistance is available, as needed

[ ] Witness is available, as needed

[ ] Caregiver to assist with medications and identifying adverse events

[ ] Other (specify): 7. OTHER

[ ] Describe any other special populations not listed above and the additional safeguards in place for those subjects, if any (specify):

SECTION D: RESEARCH ACTIVITIES Provide site/institution-specific information for the following research activities.

1. RESEARCH PROCEDURES

[ ] Research procedures do NOT differ from the Master or IRB-approved research protocol.

Skip to Recruitment.

Provide a description of any research procedures that will differ from the Master or IRB-approved protocol: (Reference the relevant protocol page numbers) 2. RECRUITMENT

Choose one of the following:

[ ] Not applicable: Study does not involve recruitment at any site.

[ ] Not applicable: Study does not involve recruitment at UCI.

[ ] Not applicable: Study does not involve recruitment at non-UCI Site/Institution.

Skip to Measures to Protect Confidentiality.

Provide a description of how the site will identify and recruit subjects: (Reference relevant Master or IRB Approved protocol page numbers- if applicable)

Identify recruitment materials (either site-specific or sponsor-generated) to be used. If sponsor generated, be sure to include local site contact information on materials:

Recruitment Method Required Materials

[ ] Flyers Submit flyer(s)

[ ] Newspaper Advertisement Submit ad

[ ] Radio / Television Advertisement Submit script

[ ] Web-Based Advertisements – Including Submit text, page mock up or description of Social Media posting including any images.

[ ] Letters or Emails Submit template letter(s) or email(s)

[ ] Phone Call Submit phone script

[ ] Other Specify:

3. INFORMED CONSENT PROCESS:

[ ] Not applicable: Study does not involve an Informed Consent Process at any site.

[ ] Not applicable: Study does not involve an Informed Consent Process at UCI.

[ ] Not applicable: Study does not involve an Informed Consent Process at non-UCI Site/Institution.

a. Describe the setting where the consent discussion will take place?

b. How much time will the potential study subject have to review the consent document before a response is required, including time to take the consent document home?

c. Who provides consent?

[ ] Subject

[ ] Parent of Subject

[ ] Legally Authorized Representative (LAR)

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

e. How is the potential study subject’s understanding of consent assessed?

f. Is the informed consent process conducted with non-English speaking potential study subjects?

[ ] Yes

[ ] No, only individuals who can read and speak English are eligible for this study.

g. For what languages will consent/assent translations be provided? How will the documents be translated?

Compensation/Reimbursement to Study Subjects:

[ ] Not applicable: Study does not provide Compensation/Reimbursement at any site.

[ ] Not applicable: Study does not provide Compensation/Reimbursement at UCI.

[ ] Not applicable: Study does not provide Compensation/Reimbursement at non-UCI Site/Institution.

h. Will subjects be compensated?

[ ] Yes

[ ] No

[ ] Compensation / Reimbursement will NOT differ from the Master or IRB-approved protocol.

i. If yes and not otherwise stated as follows in the Master or IRB-approved protocol, specify:

Amount of Payment:

Method of Payment:

[ ] Cash

[ ] Check

[ ] Extra credit

[ ] Gift certificate:

Schedule of Payment:

[ ] After each study visit

[ ] At the end of study

[ ] Other :

4. MEASURES TO PROTECT CONFIDENTIALITY:

Check all measures that will be used to maintain the confidentiality of identifiable information. Confidentiality is defined as the study subject’s understanding of, and agreement to, the ways their identifiable information will be stored and shared. Identifiable information can be maintained in many ways including on paper, in a computer file, in an audio recording, or visually such as a video or photographs.

[ ] 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

5. MEASURES TO PROTECT PRIVACY:

Check all measures that will be used to maintain the study subject’s privacy. Privacy is defined as the study subject’s ability to control how other people hear, 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.

[ ] Research procedures (including recruitment and consent) are conducted in a private room.

[ ] Use of drapes or other barriers for subjects who are required to disrobe.

[ ] Only sensitive information directly related to the research is collected about subjects.

[ ] When information is collected from internet sources, the internet site’s privacy statement will be reviewed and followed.

6. PHARMACY INFORMATION:

[ ] Not applicable: Study does not involve drugs or agents.

Skip to Emergency Resources.

a. 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 research location:

If no, provide the name and title of the responsible person for the drugs/agents at each research location:

b. How is the pharmacist / responsible person provided with a copy of the protocol?

7. EMERGENCY RESOURCES:

[ ] Not applicable: Study does not require emergency resources.

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

[ ] Advanced Cardiovascular Life Support (ACLS) Trained Personnel and crash cart

[ ] Basic Cardiac Life Support (BCLS) trained personnel

[ ] Emergency response team within facility

[ ] Emergency drugs and supplies to stabilize study subject until emergency personnel arrive

[ ] Staff available to call 911

Please review your responses for accuracy and completeness.

Be sure to upload this appendix and any supplemental documentation to the IRB APP. Supplemental documentation could include Master Protocol, Investigator Brochure, Master Informed Consent template, UCI or site-specific consent, Recruitment Materials, IRB Authorization Agreements, Other Committee Approvals, etc.