UCLA Perinatal Biospecimen Repository
Conditions: Pregnancy, High-Risk Pregnancy
Sponsor: Yalda Afshar, MD, PhD

Title: 
UCLA Perinatal Biospecimen Repository 
NCT05035160 
 
 
Protocol ID: 
Version No: 
IRB#21-001018 
5.0 
IRB Approval Date: 
11/13/2025 
Amendment 1 Date:  
Amendment 4 Date:  
 
 
 
 
 
Sponsor-Investigator / Principal Investigator: Yalda Afshar, MD, PhD,              
Lab Director, Assistant Professor, UCLA, Division of Maternal Fetal Medicine, 
Department of Obstetrics and Gynecology, University of California, Los Angeles 
Office Address: Afshar’s Lab, Dep.: Obstetrics & Gynecology, UCLA 
City, ST, ZIP: 200 Medical Plaza Driveway, Suite 430, Los Angeles, CA 90095 
Phone: 310-794-7274 
email: yafshar@mednet.ucla.edu 
 
Prepared by:   Yalda Afshar, MD, PhD, Lab Director, Assistant Professor 
                          Irina Gontschar, MD (BY), PhD, ACRP-CCRP, SRA I at the Afshar’s Lab  
 
Revision History 
Version 5.0 
Version 4.0 
11/13/2025 
09/14/2021 
Version 3.0 
08/20/2021 
Version 2.0 
07/30/2021 
Version 1.0 
04/21/2021 
 
 
  
 
 
 
 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 2 of 40 
 
Signature Page 
 
By signing and dating this clinical protocol, I provide the necessary assurance that this study 
will be conducted according to all stipulations of the clinical protocol, including all statements 
regarding confidentiality of information. 
• I agree to protect the privacy, health, and welfare of the research participants 
and to ensure the integrity of the data collected. 
• I agree to conduct the study in compliance with best practice guidelines, and 
applicable regulatory federal, state, and university requirements.  
• I agree to conduct the study in accordance with the current clinical protocol 
and will not make changes to the research conducting without obtaining UCLA 
IRB approval, except, when necessary, to protect the safety, rights, or welfare 
of the research participants. 
 
 
 
Sponsor-Investigator: 
 
 
Signature:                                                    Date: 
 
Name:  Yalda Afshar, MD, PhD 
 
UCLA, Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, 
University of California, Los Angeles 
 
 
 
 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 3 of 40 
 
 
Document Confidentiality Statement 
 
The information in this document contains the scientific and ethical issues providing 
significant intellectual contribution that are privileged or confidential and may not be 
disclosed unless such disclosure is required by applicable law or regulations. In any event, 
persons to whom the information is disclosed must be informed that the information is 
privileged or confidential and may not be further disclosed by them. These restrictions on 
disclosure will apply equally to all future information supplied to you that is indicated as 
privileged or confidential. 
 
 
Legal notice 
 
This document is protected by copyright and may be used, reproduced, incorporated into other 
works, adapted, modified, translated, or distributed under a written permission provided that 
Dr. Afshar’s Lab's copyright in the document is acknowledged at all times. In case of any 
adaption, modification or translation of the document, reasonable steps must be taken to 
clearly label, demarcate or otherwise identify those changes were made to or based on the 
original document.  
• Any impression that the adaption, modification, or translation of the original 
document is endorsed or sponsored by Dr. Afshar’s Lab must be avoided. 
• The document is provided "as is" without warranty of any kind. In no event 
shall the UCLA or the authors of the original document be liable for any claim, 
damages or other liability arising from the use of the document. 
• The above-mentioned permissions do not apply to content supplied by third 
parties. Therefore, for documents where the copyright vests in a third party, 
permission for reproduction must be obtained from this copyright holder. 
 
 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 4 of 40 
 
Table of Contents 
 
 
Signature Page 
2 
 
Document Confidentiality Statement 
3 
 
Legal notice 
3 
 
Table of Contents 
4 
 
Abbreviations 
6 
 
Abstract 
8 
1 
BACKGROUND INFORMATION AND RATIONALE 
9 
1.1 
Introduction 
9 
1.2 
Compliance Statement 
10 
2 
STUDY OBJECTIVES 
11 
2.1 
Primary Aims 
11 
2.2 
Secondary Aim 
11 
2.3 
Hypothesis 
11 
3 
INVESTIGATIONAL PLAN 
12 
3.1 
Study Design 
12 
3.1.1 
Description of the Collecting Site 
12 
3.1.2 
Institutional Review Board Information 
12 
3.1.3 
Overview of the Data Collection 
12 
3.2 
Study Duration, Enrollment and Number of Sites 
13 
3.2.1 
Duration of the Study 
13 
3.2.2 
Total Number of Study Sites/ Total Number of Participants Projected 
13 
3.3 
Study Population 
13 
3.3.1 
Inclusion criteria 
13 
3.3.2 
Exclusion criteria 
13 
4 
STUDY PROCEDURES 
14 
4.1 
Data Collection Procedures 
14 
4.1.1 
Data Collection 
14 
4.1.2 
Schedule of Events 
14 
4.1.3 
Data Elements 
17 
4.1.4 
PHI Elements Collected 
18 
4.1.5 
Screening 
21 
4.1.6 
Screen Failures 
21 
4.1.7 
Study Termination and Participants Withdrawal 
22 
4.2 
Biospecimens 
22 
4.2.1 
Procedures 
22 
5 
BANK ADMINISTRATION 
24 
5.1 
Study Organization 
24 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 5 of 40 
 
5.1.1 
Request of the Repository Biospecimens and/ or Data by the 
Investigators or other Entities 
24 
5.1.2 
Distribution Rules 
24 
5.1.3 
The Structure of the Repository 
25 
5.1.4 
The Person Responsible for Maintaining the Repository 
25 
5.1.5 
Long-Term Storage of Biospecimens for Future Research 
25 
5.2 
Data Collection and Management 
25 
5.2.1 
Computer System 
26 
5.2.2 
Participants’ Privacy 
26 
5.2.3 
Participants’ Confidentiality 
27 
5.3 
Material Collection and Management 
27 
5.3.1 
Research Data Ownership and Transfer 
28 
5.3.2 
Missing Variables and Outliers 
29 
5.3.3 
Statistical Analysis Plan 
29 
5.3.4 
Providing Results to Participants 
29 
5.4 
Regulatory and Ethical Considerations 
29 
5.4.1 
Risks and Benefits 
29 
5.4.1.1 
Potential Benefits of Participation 
29 
5.4.1.2 
Potential Risks 
30 
5.4.1.3 
Risk/ Benefit Analysis 
31 
5.4.2 
Standard of Care 
31 
5.5 
Recruitment Strategy 
32 
5.6 
Informed Consent 
32 
5.6.1 
Vulnerable Population 
33 
5.6.2 
Additional Protection for Pregnant Birthing Person and Neonate/ Fetus 
35 
5.7 
Payment to Participant/ Families 
35 
5.8 
Confidentiality 
36 
5.9 
Ethical Considerations 
36 
6 
SAFETY MANAGEMENT 
37 
6.1 
Clinical Adverse Events 
37 
6.2 
Adverse Event Reporting 
37 
7 
PUBLICATION   POLICY 
38 
8 
REFERENCES 
39 
 
 
 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 6 of 40 
 
ABBREVIATIONS 
 
AE 
Adverse Event 
CFR 
United States Code of Federal Regulations  
CHD 
Prenatal Vascular Phenotype in Congenital Heart Disease 
Co-PIs 
Co-Investigators 
CRF 
Case Report/Record Form (paper or electronic) 
DMC 
Data Monitoring Committee 
DMP 
Data Management Plan 
DNA 
Deoxyribonucleic Acid 
DUA 
Data Use Agreement  
EC 
Endothelial Cell 
eCFR 
electronic Case Report Form 
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration  
FFPE 
Formalin-fixed Paraffin Embedded  
GCP 
Good Clinical Practice 
hESC 
Human Embryonic Stem Cell 
HIPAA 
Health Insurance Portability and Accountability Act  
HUVEC 
Human Umbilical Vein Cell 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization  
IP 
Internet Protocol address numbers 
IRB 
Institutional Review Board 
ISBER 
International Society for Biological and Environmental Repositories 
LEP 
Limited English Proficiency  
MTA 
Material Transfer Agreement  
NIH 
National Institutes of Health  
PAR 
Post-Approval Reporting Requirements  
PHI 
Protected Health Information  

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 7 of 40 
 
PI 
Principal Investigator  
PII 
Privately Identifiable Information 
POC 
Product of Conception 
RHI 
Research Health Information 
RI 
Restricted Information  
RNA 
Ribonucleic Acid 
SAE 
Serious Adverse Even 
SAP 
Statistical Analysis Plan  
TORCH 
Infections: toxoplasmosis, rubella virus, cytomegalovirus, and HIV 
UCLA 
University of California, Los Angeles 
URL 
Web Universal Resource Locator 
WHO 
World Health Organization 
 
 
 
 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 8 of 40 
 
Abstract 
 
The purpose of this investigator-initiated prospective observational cohort study is to 
establish the new UCLA Perinatal Biospecimen Repository (Perinatal Repository) for 
collection, storage, and distribution the human data and biospecimens of the participants with 
perinatal pathology. The secure and shared high-quality resource of clinical data and 
biological specimens (Repository Materials), across pregnancy pathology related to research 
protocols at the Afshar`s Lab will be created. Core variables of interest include clinical 
characteristics and relevant biological samples. Intention to collect perinatal data is aiding the 
efficiency and effectiveness of de-identified biorepository for pregnancy-at-risk outcome 
research. 
The primary aims of the project are: 
• 
To design the Case Report Forms (CRFs) for the clinical and biospecimen data. 
• 
To create and update the project-specific policies, agreements, and Standard 
Operating Procedures (SOPs). 
• 
To develop the data management system to assure personal health information 
de-identification, data integrity, participants welfare, and protocol compliance. 
• 
To develop and implement a quality management system for the Repository. 
• 
To collect and record in the Repository protocol-related clinical information. 
• 
To organize consistent system to bank high-quality biospecimens while 
protecting participant-donor safety and privacy. 
• 
To establish the policies and procedures for Repository Materials 
dissemination and research collaboration. 
• 
To analyze the scientific results of the Repository creation. 
The secondary aim of the study is to provide a mechanism to store and share for the 
research purposes the de-identified biospecimen and information about participants at risk for 
adverse pregnancy outcomes. 
Inclusion criteria: 1. Pregnant and postpartum birthing persons aged 18 and over with 
perinatal pathology; 2. Pregnant and postpartum birthing persons; 3. Non-pregnant birthing 
persons (volunteers). 
Exclusion criteria: Pregnant and postpartum birthing person unwilling to give written 
informed consent to participate in the study. 
Duration of the project – 5 years. Approximate number of participants – 1000. The 
number of visits – from one to 6. Duration of the subject’s participation in the study - from 1 
day to 10 months. Follow-up period: from enrollment to postpartum visit. Core variables of 
interest comprise of the birthing person’s/ fetus’/ neonate’s clinical characteristics and 
relevant biological samples: maternal blood, cord blood, plasma, serum, urine, breastmilk, 
placenta, umbilical cord, amniotic fluid, product of conception (POC), and cell lines. 
Collection and retaining of the biospecimens will be performed by study team across perinatal 
pathology cases at the UCLA Health Medical Centers for up to 15 years. Study medical 
procedures (blood drawing, assessment, physical examinations, medical record, etc.) will be 
conducted by appropriately licensed/ credentialed personnel working within the scope of their 
licenses and credentials. Dataset entry and specimens processing will be performed by the 
Afshar’s Lab personnel at the University of California, Los Angeles. 
 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 9 of 40 
 
Key words: Biospecimen, Perinatal, Pregnancy, Repository, Obstetrics 
1   BACKGROUND INFORMATION AND RATIONALE 
 
1.1 
Introduction 
 
According to the US Centers for Disease Control and Prevention, complications of 
pregnancy involve the mother’s health, the neonate’s / fetus’ health, or both. Some birthing 
persons can have perinatal disorders that arise during or after pregnancy. Other patients have 
health problems before they become pregnant that could lead to pregnancy complications. It 
is very important to know the risk factors of perinatal disorders to prevent non-favorable 
pregnancy outcomes. For pregnant and postpartum persons and also for their neonates/ fetuses 
implementation the results of scientific study into clinical care mean to decrease the risk of 
pregnancy complications. 
At the present time, Dr. Afshar is conducting and oversighting the series of scientific 
projects in the field of perinatal pathology, including the following:  
• 
PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY). It is the 
nationwide study of pregnant or recently pregnant persons who are either under investigation 
for Coronavirus infection (COVID-19) or have been confirmed to have COVID-19. This 
research is being performed to help patients and healthcare providers better understand how 
COVID-19 impacts pregnant persons and the newborns.  
• 
Prenatal Vascular Phenotype in Congenital Heart Disease (CHD). This project 
targets the mechanisms underlying the single heart ventricle vascular phenotype by linking 
molecular data and environmental clues. Single ventricle accounts for 25% of infant CHD 
deaths; only 50-70% babies with this disease survive beyond 5 years. Research results may 
improve treatment that arises from loss of vascular integrity.  
• 
Endothelial Cells: Conduits of Translational Medicine. Evaluation of the 
umbilical cord vessels provides data to identify the biomarkers responsible for the underlying 
etiologies of preeclampsia, growth restriction, and other pregnancy-related disorders.  
• 
The Umbilical Cord as a Model System. The project identifies a patient 
population with an unmet clinical need because of an underlying chronic dysfunction of 
hemodynamics related to endothelial cell dysfunction. The study analyses downstream 
complications and interventions that can improve quality of life in these patients with lifelong 
sequel related to an abnormal endothelial cell and vascular phenotype.  The project focuses 
on altered flow acting as a modifier in development and contributing to CHD. Flow is a well-
defined mechanism and provides a platform to study physical forces that alter hemodynamics 
and of critical importance of gene expression in prenatally diagnosed CHD with postnatal 
sequel related to the vascular phenotype.  
Creation and maintenance of Perinatal Repository provides the Afshar’s Lab with the 
possibility to pool perinatal clinical data and biospecimens into a single database that could 
be accessed by clinical investigators inside and outside the UCLA research team. 
The secure and shared research data storage and high-quality resource of clinical data 
and biological specimens (Repository Materials), across pregnancy pathology related to 
research protocols at the Dr. Afshar’s Lab will be created. Core variables of interest include 
clinical characteristics and relevant biological samples. Collection and retaining of the 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 10 of 40 
 
biospecimen will be performed by study team across perinatal pathology protocols at the 
Afshar’s Lab. 
The core data variables are selected to match those agreed upon by the Afshar’s Lab 
team members. Intention to collect perinatal data is aiding the efficiency and effectiveness of 
de-identified biorepository for pregnancy at risk outcome research. 
 
1.2 
Compliance Statement 
This study will be conducted in full accordance with Good Clinical Practice (GCP) 
and as required by the following regulations:  
• 
University of California, Los Angeles (UCLA), Office of Research 
Administration Research Policies and Procedures;  
• 
UCLA Human Research Protection Program;  
• 
UCLA IRB Guidance and Procedures; 
• 
United States Code of Federal Regulations (CFR): 21 CFR Parts 11 (Electronic 
Records and Electronic Signatures), 50 (Protection of Human Subjects), 54 (Financial 
Disclosure by Clinical Investigators), 56 (Institutional Review Boards), and 45 CFR Part 46 
(Protection of Human Subjects); 
• 
Health Insurance Portability and Accountability Act (HIPAA): Privacy Rule 
and Security Rule; 
• 
U.S. Department of Health and Human Services, Food and Drug 
Administration (FDA) Guidance Documents, as applicable; 
• 
International Conference on Harmonization (ICH) guidelines, but not limited 
to Good Clinical Practice (ICH E6), Clinical Trials in the Pediatric Population (ICH E11), and 
Genomic Sampling (ICH E18); 
• 
the Belmont Report; the Declaration of Helsinki; 
• 
National Institutes of Health (NIH) Office of Extramural Research, Research 
Involving Human Subjects, as applicable;  
• 
International Society for Biological and Environmental Repositories (ISBER) 
best practices; 
• 
Applicable Federal, State, Local Regulations and Guidance. 
Non-compliance issue, if any episode arises, will be timely documented. The PI will 
conduct the study in in due course with this clinical protocol, will obtain consent and assent 
(unless a waiver is granted), and will report unexpected issues in conformity with the UCLA 
IRB policies and procedures and applicable federal, state, and local requirements. Obtaining, 
recording, reporting and transmission of research data will comply with the regulations 
mentioned above to protect the privacy, health, and welfare of the research participants during 
and after the study and to ensure the integrity of the data collected. 
 
 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 11 of 40 
 
2 STUDY OBJECTIVES 
 
The purpose of this investigator-initiated prospective observational cohort study is to 
establish the new UCLA Perinatal Biospecimen Repository for collection, storage and 
distribution the human data and biospecimens of the participants with perinatal pathology.  
As a result of the clinical protocol implementation, the secure and shared research data 
storage and high-quality resource of clinical data and biological specimens, across perinatal 
pathology related to research protocols at the Afshar’s Lab will be created. 
 
2.1 
Primary Aims 
The primary aims of the project are: 
1. To design the case report forms (CRFs) for the clinical and biospecimen data. 
2. To create and update the project-specific policies, agreements, and Standard 
Operating Procedures (SOPs). 
3. To develop the data management system to assure personal health information 
de-identification, data integrity, participants welfare, and protocol compliance. 
4. To develop and implement a quality management system for the Perinatal 
Repository. 
5. To collect and record in the Repository protocol-related clinical information. 
6. To organize consistent system to bank high-quality biospecimens while 
protecting participant-donor safety and privacy. 
7. To establish the policies and procedures for Repository Materials 
dissemination and research collaboration. 
8. To analyze the scientific results of the Repository creation. 
 
2.2 
Secondary Aim 
The secondary aim of the study is to provide a mechanism to store and share the de-
identified biospecimen and information about participants at risk for adverse pregnancy 
outcomes for the research purposes. 
 
2.3   Hypothesis 
There is no hypothesis for this patient repository study. 
 
 
 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 12 of 40 
 
3 
INVESTIGATIONAL PLAN 
3.1 
Study Design 
This is a Phase 0, investigator-initiated, prospective, observational study design: 
Patient Registry. 
Observational Model:   Cohort. 
Time Perspective: 
Prospective. 
Follow-Up Duration: From enrollment to postpartum visit.  
The study is designed to create Repository of biospecimen and clinical data that may 
allow earlier evaluation of the patient’s risk of developing adverse pregnancy outcomes. 
Further in this protocol, the term “Material/ Materials” is used to refer to human data and/ or 
biospecimens collected from the research participants. This study will be conducted in UCLA 
Health collecting data of the inpatients and outpatients with perinatal pathology and birthing 
persons (volunteers). All study participants will continue to be managed by their personal 
physicians / pediatrician. Participants will receive the treatment recommended by their 
doctors; the study will not alter the treatment pathway and pregnancy management of the 
patients. This study does not restrict or introduce any therapeutic or surgery interventions, 
including medications. 
Along with biological specimens, this Register aims to collect and record the current 
treatment and outcomes during and after the pregnancy of participants diagnosed with 
perinatal pathology. Participants’ information and biospecimen will be obtained as described 
below in Study Procedures. The Repository will contain the new research database of perinatal 
pathology.   
 
3.1.1   Description of the Collecting Site  
Location of the collecting site: Afshar’s Lab, Dep.: Obstetrics & Gynecology, UCLA; 
200 Medical Plaza Driveway, Suite 430, Los Angeles, CA 90095; phone: 310-794-7274; 
email: yafshar@mednet.ucla.edu. The study site belongs to the UCLA Health System sites. 
Collecting activities will start after the UCLA IRB approval of the Protocol. 
 
3.1.2   Institutional Review Board Information 
Protocol of the study will be sent to the local UCLA IRB that is registered by the 
OHRP/ FDA [https://ohrp.cit.nih.gov/search/IrbDtl.aspx]. 
Parent Institution/Organization: IORG0000105 - University of California Los 
Angeles. 
Located at: Los Angeles, California, US. 
Expires: 12/10/2021. 
IRB00000172 - University of California Los Angeles - MIRB1 General Biomedical 
IRB #1 - General Biomedical - MIRB1-Biomedical  
 
3.1.3 Overview of the Data Collection 
After enrollment of the participant in the study, PI/ designee study personnel 
(according to Study Delegation Log) will conduct chart review, i.e., manually review patient 
chart in CareConnect. To contribute to the Perinatal Registry database, clinical information of 
inpatient and outpatient population will be collected. Patient encounters are related to Ronald 
Reagan Hospital and Santa Monica Hospital. 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 13 of 40 
 
Biospecimens will be collected prospectively to the Perinatal Repository. Clinical data 
will be linked to the biospecimens. Dataset entry and specimens processing will be performed 
at the Afshar’s Lab.  
 
3.2 
  Study Duration, Enrollment and Number of Sites 
3.2.1   Duration of the Study 
Duration of the project – 5 years.  
Duration of participation in the study - from 1 day to 10 months.  
Duration of follow-up period – from enrollment to postpartum visit. 
 
3.2.2 Total Number of Study Sites/ Total Number of Participants Projected 
Total number of study sites:  
Approximate number of participants screened – 1050. 
Approximate number of participants enrolled – 1000. 
 
3.3 
Study Population 
Ages Eligible for Study:   
Child, Adult 
Sexes Eligible for Study:   
All 
Accepts Volunteers:  Yes 
Sampling Method:   Non-Probability Sample 
Study Population: Any UCLA Health patient that is at risk for perinatal pathology.  
Estimated Enrollment:   1000 participants. 
 
3.3.1   Inclusion criteria: 
- 
Pregnant and postpartum birthing persons aged 18 and over with perinatal 
pathology; 
- 
Pregnant and postpartum birthing persons; 
-          Non-pregnant birthing persons (volunteers). 
The study has no inclusion criteria based on gender, race, ethnicity, and language 
spoken. The protocol contains inclusion criteria for enrollment in the study associated with 
term "pregnancy/childbearing potential". 
The nature of and scientific rationale for the inclusions: 
This observational study will establish the new UCLA Perinatal Biospecimen 
Repository, to collect, storage and distribute the clinical data and biospecimens of the 
participants with perinatal pathology. Therefore, pregnant and postpartum birthing persons 
are target population for this clinical protocol. 
 
3.3.2   Exclusion criteria: 
- 
Pregnant and postpartum birthing person unwilling to give written informed 
consent to participate in the study. 
The study has no exclusion criteria based on gender, race, ethnicity, and language 
spoken. The protocol contains inclusion criteria for enrollment in the study associated with 
term "pregnancy/childbearing potential". 
The nature of and scientific rationale for the exclusions: 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 14 of 40 
 
According to the low, only a person who has given informed consent can be enrolled 
in the study. If the birthing person has not given written informed consent, this person cannot 
be the study participant. 
 
4   STUDY PROCEDURES 
 
4.1   Data Collection Procedures 
 
4.1.1 Data Collection 
The original Material collection date: The day after the approval of the Protocol by the 
UCLA IRB. Inclusion and exclusion criteria are listed above. Duration of the study: 5 years. 
Duration of maintenance and using of the Repository: 15 years.  
Approximate number of data records to be collected in the Perinatal Repository: data 
of 1000-1050 participants. 
After enrollment of the participant in the study, PI/ designee study personnel 
(according to Study Delegation Log) will conduct chart review, i.e., manually review patient 
chart in CareConnect. To contribute to the Perinatal Registry database, clinical information of 
inpatient and outpatient population will be collected. Patient encounters are related to Ronald 
Reagan Hospital and Santa Monica Hospital. 
Biospecimens will be collected prospectively to the Perinatal Repository. Clinical data 
will be linked to the biospecimens. 
 
4.1.2.   Schedule of Events 
 
Recruitment of pregnant birthing persons and volunteers will happen consecutively at 
the UCLA Health facilities. Table 1 outlines the events and biospecimen collection schedule 
for the study.  
 
 
Table 1.   Schedule of Events 
Procedures/ 
Assessments  
Enrolment/ 
Baseline 
Visit 
The Stages of Pregnancy 
Postpartum  
Visitd 
1st 
Trimester 
(from 
conception 
to 12 
weeks) 
2nd 
Trimester 
(from 
week 13 
to week 
27) 
3rd 
Trimester: 
(from 
week 28 
until birth) 
Delivery/  
End of  
Pregnancy 
Eligibility 
Criteria 
X 
 
 
 
 
 
Informed 
Xa 
 
 
 
 
 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 15 of 40 
 
Consent  
Medical 
History c 
X 
Xb 
Xb 
Xb 
Xb 
Xb 
Pregnancy 
Status 
X 
Xb 
Xb 
Xb 
Xb 
Xb 
Pregnancy 
Outcomes 
 
 
 
 
Xb 
Xb 
AE  
X 
Xb 
Xb 
Xb 
Xb 
Xb 
Neonatal/ 
Fetal Status  
X 
Xb 
Xb 
Xb 
Xb 
Xb 
Neonatal/ 
Fetal 
Outcomes  
 
 
 
 
Xb 
Xb 
Biospecimens 
Banking e: 
 
 
 
 
 
 
Blood f 
X 
Xb 
Xb 
Xb 
Xb 
Xb 
UC Blood 
 
 
 
 
Xb 
 
Urine 
Xb 
Xb 
Xb 
X 
Xb 
Xb 
Tissue: 
Placenta 
 
 
 
 
Xb 
 
Tissue: UC 
 
 
 
 
Xb 
 
Other Tissue: 
POC g 
 
 
 
 
Xb 
 
Amniotic fluid 
 
 
 
 
Xb 
 
Breastmilk 
 
 
 
 
 
Xb 
 
Footnotes for Schedule of Events: 
 
X:  Required activities. 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 16 of 40 
 
a : Informed Consent process should take place prior to undergoing any Protocol-specific 
procedures. 
b : Optional, based on the PI decision. 
c : Medical History includes, but not limited to: demographics, physical examination, 
concomitant medications, ECG, laboratory assessment. Laboratory assessment includes, but is not 
limited to hematology, blood chemistry, coagulation, endocrine function, urinalysis, serum/ urine 
pregnancy test, TORCH infections: toxoplasmosis, rubella virus, cytomegalovirus, and HIV. 
Procedures and assessments will be performed according to the routine standard at the UCLA Health, 
and are documented as available (with the exception of Informed Consent). 
d : Postpartum Visit should take place within 6 months of delivery/ end of pregnancy.  
e : For biospecimens banking, trained research team personnel will collect the biospecimens 
per standard operating procedures. 
f: The study protocol provides for the collection of blood samples as a procedure combined 
with routine blood sampling for clinical laboratory testing. For research purposes, it is intended to 
collect additional amount of the venous blood – up to 20 mL per procedure. The blood will not be 
drawn for research more often than twice in a single week.  Blood drawing will be performed as follow: 
Red Top Tube (Serology tube) – 10 mL and Lavender Top Tube (EDTA tube) – 10 mL. Blood samples 
will be collected for whole blood, plasma, and serum banking.  
g : Other tissue: In case of a miscarriage, abortion, or stillbirth, the participant will be asked to 
donate POC tissue for Repository collection.  
 
Participation in the Repository Protocol can be offered by the PI/ designee for the 
outpatients and inpatients. Eligibility criteria will be checked during baseline visit. Informed 
consent form should be signed at enrolment, following which baseline medical history will be 
collected. Medical history includes, but not limited to demographics, physical examination, 
concomitant medications, ECG, laboratory assessment. Information about pregnancy and fetal 
status will be recorded. Laboratory assessment includes, but is not limited to hematology, 
blood chemistry, coagulation, endocrine function, urinalysis, serum/ urine pregnancy test, 
TORCH infections: toxoplasmosis, rubella virus, cytomegalovirus, and HIV. Procedures and 
assessments will be performed according to the routine standard at the UCLA Health, and are 
documented as available (with the exception of Informed Consent).  
 
Enrolment/ Baseline Visit: After consenting, the birthing person will be asked to 
donate blood (maternal blood) or/ and urine specimen to the Repository. Trained research 
team personnel will collect the biospecimens per standard operating procedures. The study 
protocol provides for the collection of blood samples as a procedure combined with routine 
blood sampling for clinical laboratory testing.  
For research purposes, it is intended to collect  additional amount of the venous 
maternal blood – up to 20 mL per procedure. The blood will not be drawn for research more 
often than twice in a single week.  Blood drawing will be performed as follow: Red Top Tube 
(Serology tube) – 10 mL and Lavender Top Tube (EDTA tube) – 10 mL. Blood samples will 
be collected for whole blood, plasma, and serum banking.  
Collection of the cord blood after delivery will be performed once as the same order. 
The research Protocol does not involve collecting any specimens of the vital neonates, such 
as venous blood or urine.  

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 17 of 40 
 
All biological sampling for the Repository (blood, urine, breastmilk, placenta, 
umbilical cord, i.e.) will follow the Afshar’s Lab standard operating procedures, UCLA, local 
and federal guidance documents on the proper handling and processing of potentially 
infectious biospecimens.  
After participant enrollment, the PI will monitor and record, if any, the AEs, and 
informs the UCLA IRB according to the established policy and regulations. 
 
Follow-up Visits: For pregnant birthing persons, biospecimens donation during 
follow-up visits is optional, based on the PI decision. Repository Material will be collected by 
research team during follow-up research visits (each once per pregnancy trimester): 
- 
1st Trimester Visit (from conception to 12 weeks): medical history, pregnancy 
and fetus status, AE, biobank specimens: blood and urine. 
- 
2nd Trimester Visit (from week 13 to week 27): medical history, pregnancy and 
fetus status, AE, biobank specimens: blood and urine.  
- 
3rd Trimester Visit: (from week 28 until birth): medical history, pregnancy and 
fetus status, biobank specimens: blood and urine.  
 
Delivery/ End of Pregnancy Visit: Medical history, pregnancy status, pregnancy 
outcome, neonatal/ fetus status, neonatal/ fetus outcome, AE, biobank specimens: maternal 
blood, cord blood (UC blood), maternal urine, placenta, umbilical cord, amniotic fluid.  
Umbilical cord and placenta are temporary fetus organs. For the Repository collection, 
placenta, umbilical cord, and therefore, cord blood, will be obtained for the Repository 
purposes after childbirth. 
In case of a miscarriage, abortion, or stillbirth, the participant will be asked to donate 
POC tissue to the Repository.  
 
Postpartum Visit: Medical history, pregnancy outcome, neonatal status, neonatal 
outcome, AE, biobank specimens: maternal blood, maternal urine, breastmilk. 
All biological sampling for the Repository (blood, urine, breastmilk, placenta, 
umbilical cord, i.e.) will follow Afshar’s Lab standard operating procedures, UCLA, local 
and federal guidance documents on the proper handling and processing of potentially 
infectious biospecimens. 
For non-pregnant volunteers, participation in the project is limited to the one-time 
biospecimens donation and granting access to their medical records. 
 
4.1.3 Data Elements 
In the Perinatal Repository, the following clinical data from the UCLA Health records 
will be linked to the collected biospecimens: 
- Patient Demographics. 
- Patient Identifiers. 
- Encounters (including hospitalizations, outpatient visits, and other encounter types). 
- Provider. 
- Hospital Unit Transfers. 
- Diagnoses. 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 18 of 40 
 
- Procedures completed. 
- Problem List. 
- Appointments. 
- Vital Signs and Other Flow sheet Data. 
- Laboratory Test Results. 
- Medication Orders (Prescriptions) or Med Administration. 
- Social History. 
- Family History. 
- Allergies. 
- Provider Notes (Clinical Documents). 
- Pathology and Cytology. 
- Imaging Orders and Results. 
- Cultures / Isolates (Microbiology). 
- Cultures / Isolates Susceptibility and Sensitivity (Microbiology). 
After collecting the necessary clinical information, all personal identifiable 
information of the participant will be encoded. The PI will retain access to the codes.  
In case of an MTA arrangement and providing access to the Repository to the third 
party, only de-identified participants’ information and de-identified biospecimens can be 
shared.  
 
4.1.4   PHI Elements Collected 
In the course of the study, the PI/ designee will approach and collect personally 
identifiable health information (PHI) of research participants in accordance with Table 2.  
 
Table 2 – List of the PHI collected by the PI 
N 
PHI Elements 
Intention to collect 
1 
First Name, Last Name, Middle Name 
Yes 
 
2 
All geographical subdivisions smaller than a state, including 
street address, city, county, precinct, zip code 
Yes 
 
3 
All elements of dates for dates directly related to the 
participant, including birth date, admission date, discharge 
date, date of death (if applicable) 
Yes 
 
4 
Phone numbers 
Yes 
 
5 
Fax numbers 
 
No 
6 
E-mail  
Yes 
 
7 
Social Security number 
 
No 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 19 of 40 
 
8 
Medical record number 
Yes 
 
9 
Health plan beneficiary numbers 
 
No 
10 
Account numbers 
 
No 
11 
Certificate/license numbers 
 
No 
12 
Vehicle identifiers and serial numbers, including license 
plate numbers 
 
No 
13 
Device identifiers and serial numbers 
 
No 
14 
Web Universal Resource Locators (URLs) 
 
No 
15 
Internet Protocol (IP) address numbers 
 
No 
16 
Biometric identifiers, including finger and voice prints 
 
No 
17 
Full face photographic images and any comparable images 
 
No 
18 
Other unique identifying numbers, characteristic, or code  
 
No 
 
The five PHI core elements listed in Table 1 are subject to HIPAA regulations: 
- 
Name; 
- 
Address; 
- 
Dates directly related to the participant; 
- 
Phone number; 
- 
Medical record number. 
This study will use PHI that enters the participants’ medical records and / or is used 
for standard healthcare services. As known, HIPAA regulations grant the PI and authorized 
team members the right to approach and use PHI necessary to conduct clinical research.  
It is necessary to be emphasize that during the conduct of the study PI endeavor to 
collect and record the minimum of PHI.  
In the UCLA Health clinical departments, the medical personnel participating in the 
study will perform the sampling procedures.  An example of these procedures is taking blood 
into a test tube, placing the umbilical cord or pieces of the placenta in containers with a 
solution.  A label should be attached to each container or tube containing information about 
the patient's name, date of birth, age, date of sample collection, date of hospitalization (if 
applicable), name of the physician who organized the collection of the sample, and medical 
record number. 
After the samples are transported to the Afshar’s Lab, the registration and processing 
of the biospecimens is carried out. All labels are removed from the test tubes / containers and 
pasted onto a A4 paper sheet/sheets. Next to the label, the following information should be 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 20 of 40 
 
recorded: the participant’s ID in the Repository, the date of the sample processing, the initials 
of the personnel performing processing, the final number of the biospecimens collected and 
stored. 
The paper sheet with these labels and notes is considered to be the primary source 
document containing PHI. 
To preserve the confidentiality of the participants, the primary source documents are 
kept by the PI in the separate closed cabinet in the Afshar’s Lab, to which only authorized 
UCLA personnel has access. 
The PHI of the participants will be collected in the Repository according to Table 3. 
 
Table 3 – List of the PHI collected in the Repository 
N 
PHI Elements 
Intention to collect 
1 
First Name, Last Name, Middle Name 
 
No 
2 
All geographical subdivisions smaller than a state, including 
street address, city, county, precinct, zip code 
 
No 
3 
Dates directly related to the participant:  birth date, 
admission date, discharge date, date of death (if applicable) 
Yes 
 
4 
Phone numbers 
 
No 
5 
Fax numbers 
 
No 
6 
E-mail  
 
No 
7 
Social Security number 
 
No 
8 
Medical record number 
Yes 
 
9 
Health plan beneficiary numbers 
 
No 
10 
Account numbers 
 
No 
11 
Certificate/license numbers 
 
No 
12 
Vehicle identifiers and serial numbers, including license 
plate numbers 
 
No 
13 
Device identifiers and serial numbers 
 
No 
14 
Web Universal Resource Locators (URLs) 
 
No 
15 
Internet Protocol (IP) address numbers 
 
No 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 21 of 40 
 
16 
Biometric identifiers, including finger and voice prints 
 
No 
17 
Full face photographic images and any comparable images 
 
No 
18 
Other unique identifying numbers, characteristic, or code  
Yes 
No 
At the site, 3 PHI elements will be maintained by the collector by collecting data: 
dates, MRN, and other unique identifying numbers, characteristic, or code. In adult 
participants, instead of the first and last name, the initials will be entered in the Repository. 
Dates directly related to the participant:  birth date, admission date, discharge date, date of 
death (if applicable). 
The participant’s ID (e.g., the unique code assigned by the PI/ designee to code the 
data) and biospecimen processing dates are examples of the Research Health Information 
(RHI). RHI is outside the HIPAA jurisdiction, but is subject to the UCLA IRB and Office of 
Research Administration regulations. In the event, that another research Institution will be 
granted access to the Repository, information about participant’s MRNs should be eliminated 
or encoded.  
After the study is completed, personal identifiers and/ or codes linking the data and/ 
or specimens to the personal identifiers will be maintained for future research. Only the PI 
will have access to these identifiers and/ or codes after study completion. 
Specific measures to assure de-identification/ coding of Material for future research 
collaboration include: 
- 
Confidentiality agreement with each investigator, granted this investigator access to 
the research Material. 
- 
Use of firewalls. 
- 
Utilization of honest broker model – coding identifiable Material by independent third-
party entity/ vendor. 
Therefore, the Repository creation will be accompanied by the collection of the 
minimum amount of the PHI, using study identifiers, that contribute to the maximum 
protection of the privacy and confidentiality of the study participants. 
 
4.1.5   Screening 
The UCLA IRB approved ICF for this study should be signed and dated by each 
participant before any protocol-related procedures are performed. For the potential 
participants of this study, the outpatients/ inpatients clinical routine procedures may be 
administered before signing the ICF.  
A copy of the signed ICF should be handed to the participant by the person who 
provided the consent process. 
The patient's attending physician makes an appropriate entry in the medical records 
confirming the implementation of the informed consent process. The name and surname of 
the person who carried out the consent process, position, date of signing the form is recorded 
in the medical records. In addition, the date of signing the form is entered directly into the 
study register. 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 22 of 40 
 
PI / co-PIs must assess each participant for risk that affects the collection of 
biospecimens. Any AEs considered by the PI to be related to the biospecimens collection 
procedures, should be documented in the patient’s medical record and administered according 
to the GCP and this protocol. Information about AE should also be captured in the study 
register.  
Additional research data of the results from the genomic analysis will be documented 
and utilized in the register as part of this protocol. 
 
4.1.6   Screen Failures 
Participants who sign and dated the ICF will be considered screen failures for this 
study under the following conditions: 
- 
Participant fails to undergo blood /or placenta/ or umbilical cord/ or breast milk 
collection procedure. 
- 
Participant is otherwise found by PI / designee to be ineligible to the study 
engagement. 
 
4.1.7 Study Termination and Participants Withdrawal 
This clinical study can be terminated at any time for any reason by the PI. The PI will 
be responsible for informing the UCLA IRB and the participants (if applicable) of the 
termination of the study. 
Participant may voluntarily withdraw from this clinical protocol. Any future planned 
biospecimens collection after consent withdrawal will be discontinued, as will clinical 
assessment of the participant. The participant is not obliged to provide an explanation of the 
reasons for termination of participation in a clinical study. However, the PI should make 
appropriate efforts to clarify the primary reason for the participant's withdrawal from the 
study.  
The PI / designee can use phone calls, messages, e-mail, the Internet, and other 
communication channels to make contact to the participant. The results of this communication 
should be documented in the study register. If the participant withdraws from the study, the 
PI will still collect the output of the data collected from these studies up to moment of the 
participant’s withdrawal. 
For participants, whose status is undetermined because they fail the study visits 
without expressing an intention to discontinue or withdraw the study participation, the PI and 
study personnel must show "due diligence".  Reasonable steps taken to contact the participant 
should be documented in the research records like dates of phone calls, messages, e-mails, 
etc. A participants cannot be considered as lost to follow-up until the time point of participants 
planned end of study visit has passed. 
Participant may be dropped from participating in the Repository at the discretion of 
the PI at any time. The PI / designee will document the reason for the discontinuation in the 
research documents. Date and reason for discontinuation should also be recorded on the 
Repository. If the participant withdraws the ICF, the Dr. Afshar’s Lab will continue to 
maintain and use all research data that have already been collected per protocol. All 
biospecimens not yet analyzed at the time of withdrawal may still be used for further 
testing/analysis in accordance with the terms of this clinical study. If the participant withdraws 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 23 of 40 
 
from the study, the PI will still collect the output of the data collected from these studies up 
to moment of the participant’s withdrawal. 
 
4.2   Biospecimens 
Repository biospecimens collection (blood drawing, fetus tissue obtaining, etc.) will 
be performed by appropriately licensed / credentialed study personnel working within the 
scope of their licenses and credentials. 
 
4.2.1 Procedures 
Repository biospecimens collection (blood drawing, fetus tissue obtaining, etc.) will 
be performed by appropriately licensed/ credentialed study personnel working within the 
scope of their licenses and credentials. Biological specimens may include, but are not limited 
to, human tissue (e.g., placenta, umbilical cord, POC), blood, urine, breast milk, and cell 
samples.  
Donors of the Repository biospecimens are the birthing people with perinatal 
pathology, their fetuses, and adult volunteers. Adult persons will donate blood, urine, breast 
milk. After the pregnancy is over, the following fetal biospecimens will be collected and 
processed: cord blood, placenta, umbilical cord, POC. 
The Repository personnel will obtain and store according to the SOPs the following 
specimens: 
- 
Blood: whole blood, plasma, serum; 
- 
Placenta samples: RNAlater, snap freeze, 70% Alcohol, FFPE; 
- 
Umbilical cord: snap freeze, FFPE; 
- 
POC: 70% Alcohol and FFPE; 
- 
Cell Lines: HUVEC, trophoblastic, and other; 
- 
Protein, RNA, DNA; 
- 
Breastmilk; 
- 
Urine; 
- 
Other biospecimens. 
In the dataset, the following clinical data will be linked to the biospecimens: 
- 
Clinical data – human with PHI; 
- 
Clinical data – human with Limited Data Set; 
- 
Clinical data – human, de-identified. 
 
 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 24 of 40 
 
5   BANK ADMINISTRATION 
 
5.1   Study Organization 
The Perinatal Repository will be created and maintained by investigator, initiated this 
project – Dr. Yalda Afshar, and designee - the Dr. Afshar’s Lab. personnel. Dr. Yalda Afshar, 
PI, as a chief of the UCLA Perinatal Biospecimen Repository Advisory Committee is 
ultimately responsible for the Repository. According to the Committee Policy, the PI has right 
to delegate some of the PI’s authority to manage and ensure the proper operation of the 
Repository to other Committee / Dr. Afshar’s Lab members. 
 
5.1.1   Request of the Repository Biospecimens and/ or Data by the Investigators 
or other Entities 
Dr. Yalda Afshar is investigator, initiated this clinical research project. 
The original task of the Perinatal Repository creation is to provide Afshar’s Lab 
resources for ongoing and future clinical and non-clinical research.  
Access to the Repository Material may be granted to: 
- the PIs from the UCLA; 
- the PIs from other universities; 
- the institutions/ entities engaged in research in the field of the health science and 
biotechnology.  
The PI, external to the Afshar’s Lab, may contact chief of the Repository for 
preliminary information. If the Perinatal Repository stores samples and data necessary for the 
research, the PI fills out and sends a written request to the Afshar’s Lab according to the 
attached Request Form for the UCLA Perinatal Biospecimen Repository Advisory 
Committee. 
The adequacy of requests to obtain data and/or biospecimens is reviewed by the 
Committee on the terms and conditions established by the UCLA Perinatal Biospecimen 
Repository Advisory Committee Policy. 
In case of a positive decision of the Committee, the applicant-investigator receives a 
written response from the Afshar’s Lab explaining the next steps. Research projects planning 
to use the Repository Material must be approved by the UCLA IRB.  
Then the applicant-PI fills out and submit Request for the Receipt of Materials for 
Research Purposes. Negotiation and arrangement of the Material Transfer Agreement (MTA) 
or Data Use Agreement (DUA) is carried out by Dr. Afshar / designee and by direct support 
of the UCLA Technology Development group. 
After signing and registering the MTA/ DUA, the PI is granted access to the particular 
biospecimens and / or biospecimens and data in accordance with the agreed provisions. 
 
5.1.2   Distribution Rules 
Distribution rules and criteria used to determine the adequacy of investigators’ 
requests to acquire the Material from the Repository are set forth in the “UCLA Perinatal 
Biospecimen Repository Advisory Committee” Policy and “Request Form for the UCLA 
Perinatal Biospecimen Repository Advisory Committee”.  
 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 25 of 40 
 
 
5.1.3 The Structure of the Repository 
Figure 1 represents the structure of the Perinatal Repository. 
 
 
Biospecimens 
collection 
 
 
 
Distribution to the PI from  
Dr. Afshar’s Lab 
 
 
 
Perinatal 
Repository 
storage 
 
 
Clinical Data 
collection 
 
 
 
Distribution to the PI outside  
Dr. Afshar’s Lab 
 
 
Figure 1. The Structure of the Perinatal Repository 
 
5.1.4   The Person Responsible for Maintaining the Repository 
Perinatal Repository will be created and maintained by investigator, initiated this 
clinical project – Dr. Yalda Afshar, and designee - the Afshar’s Lab. personnel. Dr. Yalda 
Afshar, PI, as a chief of the UCLA Perinatal Biospecimen Repository Advisory Committee, 
is ultimately responsible for the Repository. According to the Committee Policy, the PI has 
right to delegate maintaining the Repository, stripping identifiers, coding and distribution 
biospecimens and dataset to the Repository Director and other Afshar’s Lab personnel. The 
specific tasks of each project member will be indicated in writing in the Study Delegation 
Log. The PI considers the qualification, training, experience and licensing/ credentials of each 
individual team member when determining personnel eligibility to carry out the assigned task 
within the framework of this project. 
 
5.1.5   Long-Term Storage of Biospecimens for Future Research 
Collected biospecimens may be kept and used by the PI for up to 15 years after the 
study is completed. See also Study Termination and Participants Withdrawal section, for 
sample handling if a participant withdraws consent. 
 
5.2 
Data Collection and Management 
To ensure human subject protection and reliability of the study results, the PI and the 
research team establish their approach to computer system validation on a risk assessment. 
The intended use of the research software and potential for the future use of the Repository 
Material are taken into consideration.  

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 26 of 40 
 
The Repository data collection and management will be conducted using Box (Box, 
Inc.), the cloud-based content management platform at UCLA. The Box platform and 
associated products are compliant with HIPAA, HITECH, and the final HIPAA Omnibus rule 
since November 2012. All PHI collected and stored in Box is secured in accordance with 
HIPAA, and Box signs Business Associate Agreements with all clients who plan to store PHI 
in the cloud. Box is a secure, metadata-driven electronic data processing system. This web-
based research validated tool designed for data collection, scientific collaboration, and data 
analysis.  Investigational team can develop new databases to collect clinical and biospecimen 
data. Box allows to audit data records and trace the users’ activity. Created raw data and syntax 
files may be exported to common statistical packages: R-system, SPSS, Stata R, SAS.  
 
5.2.1   Computer System 
The Perinatal Repository based on Box platform conforms to the UCLA IRB’s 
established requirements for computer data system validation: completeness, accuracy, 
reliability, and stable intended performance. The UCLA IRB and other regulatory authority 
may inspect computer software during a research site inspection.   
The project-related Data Management System will be created and maintained for using 
Box application. Creation of the DMS is one of the primaries aims of the study. 
 
5.2.2   Participants’ Privacy 
The PI will maintain participants’ privacy providing all protocol-related activities and 
procedures in strong adherence to the requirements of the UCLA OHRPP Quick Guide 
“Protecting Privacy and Maintaining Confidentiality”. The Afshar’s Lab researchers, assigned 
by the protocol implementation, have / will have completed the CITI Program and UCLA IRB 
HIPAA trainings on the participants privacy topic.  
To protect the Repository participant’s privacy, the protocol plans to use the 
Acceptable Recruitment Methods. The potential study participants will be identified and 
contacted using: 
- 
Dissemination of appropriate information about the study through 
advertisement, flyers, notices, Internet, and media.  
- 
Disclosing the certain privacy protection provisions in the Informed Consent 
Form. 
- 
Sending introduction letters to the PI’s colleagues to notify the physicians and 
eligible patients interested in research participation. 
- 
Contacting those patients that qualify to determine interest by primary care 
staff. 
- 
Providing necessary information about the project to patients under direct 
medical care of the PI and co-investigators who are licensed clinical specialists, qualified by 
education, training and experience. 
Participant’s privacy is also protected by Appropriate Method of Material collection: 
- 
Respecting sensitivity of the information being gathered. 
- 
Interviewing each participant individually, in a room or area where 
conversations cannot be overheard by others in the research setting. 
- 
Conducting study procedures in the manner, that give the participants 
possibility to feel comfortable. 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 27 of 40 
 
 
5.2.3   Participants’ Confidentiality 
The PI will maintain data confidentiality conducting all study-related activities and 
procedures in strictly adherence to the requirements of the UCLA OHRPP Quick Guide 
“Protecting Privacy and Maintaining Confidentiality”. 
The Afshar’s Lab personnel have / will have completed the CITI Program and UCLA 
IRB HIPAA trainings on the data confidentiality topic.  
To protect the data confidentiality, the protocol contains special provisions, including, 
but not limited to: 
- 
Maintaining of identifiable research Material. 
- 
Addressing an extension of participants privacy issues. 
- 
Statement of the PI agreement about confidentiality maintenance. 
- 
Accessibility of the participants identifiable information by the study team. 
Conducting the study per this protocol, the PI protects the participants’ confidentiality 
from inappropriate disclosure of PHI. 
With reference to the HIPAA the following measures will be implemented: 
- 
Study design: Clinical Protocol is designed according to “minimum necessary” 
standard of the participants PHI. 
- 
Collecting and maintaining of the identifiable Material: Clinical Protocol 
safeguards PHI and data security regarding the risk from disclosure.  
- 
Provisions to maintain confidentiality of the Material: in Clinical Protocol and 
ICF, confidentiality of the PHI is offered; study will be performed in strict adherence to the 
applicable international, federal (including the HIPAA), state, and UCLA requirements; the 
risk of unauthorized disclosure of the PHI during the study is minimized. 
- 
Limit access to the Repository: Repository Materials provided to authorized, 
non-UCLA institutions will not contain identifiable information about the research 
participants. 
- 
ICF indicates study personnel who has access to the participants’ personal 
health information and biospecimens. 
In the Repository records, the research participants data will be coded. 
Participants’ privacy data and records generated during the study will be kept 
confidential in accordance with applicable federal, state and local low, the UCLA Office of 
Research Administration Research Policies and Procedures, the UCLA Human Research 
Protection Program, and the UCLA IRB Guidance and Procedures. The PI and study team 
will use the Protected Health Information, the Privately Identifiable Information, and the 
Research Health Information solely for the purpose of conducting approved clinical research. 
The use of participants’ privacy data for purposes other than those listed above is prohibited.  
To limit access to the identifiable Material, the study personnel are granted different 
level of data access. All team members have received CITI Program and UCLA IRB HIPAA 
training and certification. Only PI and designee (in writing, according to the Study Delegation 
Log) will have access to the participants identifiable information. 
 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 28 of 40 
 
5.3 
Material Collection and Management 
Repository biospecimens collection (blood drawing, placenta obtaining, etc.) will be 
performed by appropriately licensed / credentialed study personnel working within the scope 
of their licenses and credentials. 
Biological specimens may include, but are not limited to, human tissue (e.g., placenta, 
umbilical cord, POC), blood, urine, breast milk, and cell samples.  
Donors of the Repository biospecimens are the birthing people with perinatal 
pathology, their fetuses, and adult volunteers. 
Adult persons will donate blood, urine, breast milk. 
After the pregnancy is over, the following fetal biospecimens will be collected and 
processed: cord blood, placenta, umbilical cord, amniotic fluid, and/ or POC. 
The Repository personnel will obtain and store according to the SOPs the following 
specimens: 
- 
Blood: whole blood, plasma, serum; 
- 
Placenta samples: RNAlater, snap freeze, 70% Alcohol, FFPE; 
- 
Umbilical cord: snap freeze, FFPE; 
- 
POC: 70% Alcohol and FFPE; 
- 
Cell Lines: HUVEC, trophoblastic, and other; 
- 
Protein, RNA, DNA; 
- 
Breastmilk; 
- 
Urine; 
- 
Other biospecimens. 
In the dataset, the following clinical data will be linked to the biospecimens: 
- 
Clinical data – human with PHI; 
Clinical data – human with Limited Data Set; 
Clinical data – human, de-identified. 
 
5.3.1   Research Data Ownership and Transfer 
The UCLA Health holds in demesne the primary research results generated from all 
research, development, and related activities conducted under this protocol.  The UCLA 
Health owns clinical data recorded in both paper and electronic medical records.   
Consistent with the academic tradition and its Intellectual Property regulations, the 
UCLA Health does not claim ownership of the Afshar’s Lab copyrightable research works 
that will appear due to this clinical protocol implementation.  
In the event the PI leaves the UCLA and wishes to take Repository to her/ his new 
institution, ownership of the Repository Research Data may be transferred to the new 
institution with the documented approval of the UCLA IRB and the UCLA Office of Research 
Administration and, if applicable, with the permission of the study sponsor.  Like this would 
happen, the UCLA will execute a written MTA with the new PI’s institution. The situation 
wherein the Repository data will eventually be used by both institutions. 
According to the MTA, the new PI’s institution should admit all legal and financial 
obligations for the Repository maintenance. The MTA should ensure the UCLA’s access to 
the original Repository data if that should become essential.  If the conclusion and observance 
of the MTA will be impossible due to any circumstances, the PI may take with her/ him a 
copy of the primary source documents, assuming no third-party limitations. 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 29 of 40 
 
If co-investigator, another then the PI, leaves the UCLA, hi/ she may apply to the PI 
regarding primary source documents transcribing. If the PI considers it reasonable to give 
written permission to duplicate data, the co-investigator may to copy the primary Research 
Data obtained due to his/ her immediate professional actions in the Afshar’s Lab within the 
framework of this protocol. 
5.3.2   Missing Variables and Outliers 
The study team will make all attempts to collect the necessary data per protocol. As 
missing information is expected to be minimal, no imputation will be performed for missing 
variables.  
Any qualitative and quantitative values that appear to be erroneous or inexplicit based 
on the PI clinical judgment will be investigated as the potential outliers.  
If variable is identified as outlier, statistic sensitivity analyses will be undertaken to 
examine the impact of including or excluding this data point to the data set. Any significant 
differences found from the sensitivity analyses will be reported in the final study report and 
publications. 
 
5.3.3   Statistical Analysis Plan 
Developing this research project, we have followed the UCLA OHRPP 
recommendations for research involving use and storage of data and/ or human biological 
specimens, and data and specimen repositories [https://ohrpp.research.ucla.edu/policies-and-
guidance/]. 
UCLA OHRP Guidance “Data and Specimen Repositories (April 13, 2009)” does not 
provide instruction about developing the Statistical Analysis Plan (SAP) for repositories. 
There is also no statistics section in the template repository protocol (IMAGING / DATA 
BANK TEMPLATE) recommended by OHRPP. 
Taking into account all aspects of the clinical protocol design and reporting specific 
for non-interventional methods of Material collection, we do not create the SAP for this study.  
 
5.3.4   Providing Results to Participants 
Research (non-validated) test results that are of uncertain clinical significance will not 
be reported back to the participants and their families. The PI also does not intend to routinely 
share the results of the research tests with the participant's primary care physician / 
pediatrician unless the latter is a delegated study team member. 
If there is written consent / statement from the particular participant, the results of 
research tests may be included in the medical records if the PI deems it appropriate and 
reasonable to do so.  
 
 
5.4   Regulatory and Ethical Considerations 
 
5.4.1   Risks and Benefits 
 
5.4.1.1   Potential Benefits of Participation 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 30 of 40 
 
Potential direct benefits (physical, psychological, social, or other) to study 
participants: 
There are no direct benefits to the study participants. But the person’s decision to 
donate biospecimens to Repository will significantly contribute to solving problem of 
perinatal disorders. Also, the study participant can help another patient with pregnancy 
complications. The study results will benefit other birthing persons and their babies/ fetuses 
in the future by providing important information about the risk factors of perinatal disorders. 
Implementation the results of research study into clinical care may decrease the risk of 
pregnancy complications and therefore prevent non-favorable pregnancy outcomes.  
Some study participants receive the indirect psychological and social benefits from 
being involved in research as documented in the literature. 
Potential benefits to society: 
Community gets new generalizable knowledge about regarding social significant 
diseases as perinatal pathology. The research society, the Dr. Afshar’s Lab and collaborators, 
get access to the high quality biospecimens and reliable clinical data to facilitate clinical 
research in the field of the maternal and child health. 
 
5.4.1.2   Potential Risks 
Risk for birthing person: 
There is minimal risk study for both pregnant and postpartum birthing person with 
perinatal pathology, and for health birthing person. Sociological, economic, and legal risk for 
participation in the Registry is no higher, than in general population. 
There is minimal physical and psychological risk associated with venous blood 
drawing. Blood sampling by performing standard medical procedures may cause fainting or 
lightheadedness or some discomfort. Other risks include bleeding or bruising where the needle 
enters the body. A small blood clot may form where the needle enters the body or swelling of 
the surrounding skin may occur. There is also a small risk of a minor infection at the blood 
draw site. During pregnancy, the birthing person will be asked to donate blood samples from 
one to 4 times. After labor, it is planned to collect the specimens one or two times.  
Birthing persons may be asked also to donate urine samples and, after labor, small 
amount (2-3 teaspoons) of breastmilk. Physical and psychological risk associated with these 
procedures is no higher, than in general population. 
Risks associated with loss of privacy and confidentiality: 
Participation in the study may involve a loss of privacy and confidentiality for the 
birthing person and the neonate/ fetus. 
Risks Associated with Loss of Privacy in Genomic Research: 
- 
Since some genetic variations can help to predict the future health problems of 
your child, this information might be of interest to health providers, life insurance companies, 
and others. Patterns of genetic variation also can be used by law enforcement agencies to 
identify a person or his/ her blood relatives. Therefore, your fetus/newborns genetic 
information could potentially be used in ways that could cause you or your family distress. 
There also may be other privacy risks that we have not foreseen. 
- 
Genetic information that results from this study does not have medical or 
treatment importance at this time. However, there is a risk that information about taking part 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 31 of 40 
 
in a genetic study may influence insurance companies and/ or employers regarding health-
related decisions. To further safeguard participant’s privacy, genetic information obtained in 
the research will not be placed in the participant’s medical record. 
- 
In the event of an unexpected breach of confidentiality, a federal law called the 
Genetic Information Non-Discrimination Act (GINA) will help protect the participant from 
health insurance or employment discrimination based on genetic information obtained about 
neonate/ fetus. In general, this law makes it illegal for health insurance companies, group 
health plans, and most employers to discriminate against the person based on the child's 
genetic information. However, it does not protect the neonate against discrimination by 
companies that sell life insurance, disability insurance, or long-term care insurance. 
Therefore, special precocious designed to respect and protect participants’ privacy and 
data confidentiality. 
Risk for neonates/ fetus: 
There is minimal physical and psychological risk associated with cord blood drawing. 
Blood sampling is often performed after birth as the standard medical procedure for fetal blood 
gas, pH, and hematocrit evaluation. Percutaneous fetal blood sampling is not planned in this 
study and will not be performed for the project purposes. The collection of a small amount of 
cord blood after birth poses no real risk to the neonate participating in the study. Cord blood 
collection from the clamped umbilical cord is safe for the infant and its mother, with no 
complications reported in the research publications. 
The collection of fetus tissue (e.g., placenta, umbilical cord) poses after birth no risk 
to the neonate.  
The potential risk of privacy and confidentiality breaches due to the inclusion of the 
neonates/fetuses in the study is outlined above. 
Therefore, the Perinatal Repository represents the minimal risk study for neonates/ 
fetuses. Physical, psychological, sociological, economic, and legal risk for participation in the 
Registry is no higher, than in general population. 
 
5.4.1.3   Risk/ Benefit Analysis 
Study medical procedures (blood drawing, assessment, physical examinations, 
medical record, etc.) will be performed by appropriately licensed / credentialed study site 
personnel working within the scope of their licenses and credentials. 
To alleviate the participant’s physical and psychological discomfort, the study 
protocol provides for the collection of blood samples as a procedure combined with routine 
blood sampling for clinical laboratory testing. For research purposes, it is intended to collect 
additional amount of the venous blood – up to 20 mL per procedure. 
If qualified study staff will have difficulty in obtaining the blood sample, the staff will 
attempt the blood draw no more than two times per one day, with the consent and approval of 
the patient. 
Special precocious will be taken by the study personnel to prevent breach of the 
participants’ privacy and confidentiality. 
There is minimal risk study for the birthing persons and their neonates/ fetuses. 
Possible risks, associated with the study participation, are no higher, than in general 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 32 of 40 
 
population. The risks to the participants are reasonable in relation to the importance of the 
knowledge that may be expected upon the study completion.  
 
5.4.2   Standard of Care 
Screening and enrollment of study participants will be organized on the labor and 
delivery units at both Ronald Reagan Medical Center and Santa Monica Hospital. High-
professional physicians, nurses, midwives, and staff of the Department of Obstetrics and 
Gynecology represent the nationally and internationally recognized leaders in the delivery of 
women's medical care. The provision of patient care is carried out in accordance with the strict 
standards of medical care implementation at the David Geffen School of Medicine at UCLA. 
Whatever the birthing person does consent / or does not consent the participation in 
the study, it will not change the person’s labor management. 
 
5.5   Recruitment Strategy 
Recruitment will be maintained according to the UCLA policies, state’s and Federal 
regulations. Participants’ rights participate/ do not participate/ withdraw at any time will be 
explained by the PI or designee (physician) during informed consent process.  
Participants’ privacy will be maintained according to the UCLA policies, state’s and 
Federal regulations. PI or designee (physician) will contact potential study participants during 
visits. 
 
5.6   Informed Consent 
Informed consent process should be performed by the PI/ designee in accordance with 
the UCLA OHRP Guidance “Obtaining and Documenting Informed Consent (March 2, 
2021)”. Consenting will be arranged in the private room in non-emergency or emergency 
setting of the UCLA Health. Signed and dated ICF will be obtained from the research 
participant. Prospective study participants will be provided with sufficient opportunity to 
consider whether or not to participate in the study: 
- 
The PI/ designee meets the prospective participants/ families to review the ICF 
and provide an oral explanation of the study. Individuals will be given a chance to ask 
questions before making a considered decision about taking a part in the study. 
- 
Prospective study participants/ families will have the opportunity to take the 
ICF home and discuss the documents with others prior to making decision. 
- 
The persons will be given unlimited time until childbirth to decide whether 
they wish to participate in the study. 
Investigator or study team member will evaluate person’s comprehension of the 
information conveyed during the consent process. The PI/ designee provides initial assessment 
of patient’s capacity to consent trough routine interactions with the potential study participant.  
The PI should ensure that the patient understands the following information: 
- 
Writing the ICF means enrollment the persons as the research participant to the 
study “The UCLA Perinatal Biospecimen Repository”. 
- 
Participation in research is completely voluntarily. The birthing person may 
agree to participate in the study or disagree to participate without any negative consequences. 
The research participant has the right at any time to refuse to participate in the project without 
explanation and withdraw the consent. 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 33 of 40 
 
- Participation in the Protocol means donation of patient’s biospecimens and clinical 
data to the study team. 
- Protocol-specific procedures will take place according to the Schedule of events. 
The Perinatal Repository in non-interventional minimal risk study without direct 
benefits to the birthing persons and their neonates/ fetuses. 
- 
Research participants receive copy of the signed ICF with contacts of the  
Afshar’s Lab and UCLA OHRP. If the participants have questions about the study or 
experiences problems or changes their opinion regarding participation, they can reach out to 
the investigator or UCLA Research Administration using that information. 
By signing and dating the ICF, the PI/ designee confirms that the birthing person has 
the decision-making capacity and expresses the choice to participate in this study. 
In case of doubts about the correctness of the information received by the individual 
about participation in the project, the use of the Decision-Making Capacity Assessment Tool 
(UCLA OHRP Form: Decision-Making Capacity Assessment Tool (August 22, 2012)) is 
provided. Signed and dated permission, as part of the ICF, will be obtained from the birthing 
person to enroll the neonate/ fetus in the study under the informed consent procedure. 
 
5.6.1   Vulnerable Population 
The study will include vulnerable populations as research participants. Adult research 
participants (birthing persons) may be the persons with Limited English Proficiency (LEP), 
illiterate persons, unable to read and write, or visually impaired, or deaf persons.   
Enrollment of the research participants will be provided at the Los Angeles County 
Area - one of the most culturally and ethnically diverse cities in the US. The likelihood of 
encountering eligible participants with limited English proficiency is high. With respect to  
the cultural and ethnic diversity of Los Angeles population, recruitment of the LEP  and / or 
illiterate birthing persons will be arranged according to the UCLA OHRP Guidance “Research 
Involving Non-English Speaking Research Participants (May 9, 2019)”. 
In case of LEP, the informed consent process will be conducted using the services of 
the qualified interpreters using one of the two available consent methods: Preferred Method 
or Short-Form Method. 
 
For Spanish research subjects, the Preferred Method of enrollment of the non-
English speaking research participants will be used. After IRB approval of the ICF English 
version, this form will be translated by qualified translator into the Spanish language, send to 
the IRB as an amendment for reviewing and subsequent approval. The IRB approval of the 
Spanish ICF version should be obtained by the research team before enrollment of the Spanish 
birthing persons with LEP. Potential study participants will be given the opportunity to review 
the ICFs in Spanish. Additionally, the PI, or the member of the research team, or qualified 
interpreter, who speaks Spanish and English, will be available during the study to answer 
questions and conduct the project. If Spanish speaking patient decides to participate in the 
research, the patient prints, signs, and dates the ICF. Then person conducting consent process, 
also prints, signs, dates ICF, and provides the copy of the ICF to the birthing person.  
 
For the occasional and unexpected enrollment of the non-Spanish research subjects 
with LEP, the Short Form Method may be implemented during enrollment. The UCLA 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 34 of 40 
 
OHRP documents: “Checklist for Using the “Short Form” Method of Consent for Non-
English Speaking Research Participants (February 20, 2020)” and “Research Participant Bill 
of Rights/ Experimental Subjects Bill of Rights (July 12, 2021)” (Bill of Rights) will be used 
to assure all UCLA IRB requirements are met.  
The Short Form Method is appropriate for enrollment the participants under certain 
circumstances: 
- 
The patient wants to be study participant and is otherwise eligible, but did not 
speak English or Spanish; 
- 
the PI has not sufficient time to translate the ICF and obtain the IRB approval 
before planned date of the participant’s enrollment; 
- 
the research project is the minimal risk study; 
- 
the study has a short window to enroll the birthing person. 
 
The Short Form informed consent procedure will be as follows: 
- 
The study personnel upload from the UCLA OHRP website the Bill of Rights 
on the birthing person’s native language, or language, that the patient is fluent in.  
- 
If the UCLA OHRP website does not contain the Bill of Rights on the 
necessary language, and the PI would like to enroll the patient, the study personnel arrange 
the professional/ certified translation of the Bill of Rights into the patient’s language. 
- 
The statement “The elements of consent from the consent form were presented 
orally” is added to the translated Bill of Rights. 
- 
Lines for the participant’s printed first and last names, signature, and date are 
added to the Bill of Rights. 
- 
Lines for the PI/ designee’s printed first and last names, title, signature, and 
date are added to the Bill of Rights. 
- 
Lines for the Interpreter/ Witness’s printed first, and last names, signature, and 
date are added to the Bill of Rights. 
- 
The PI secures the qualified interpreter who speaks both English and the 
birthing’s person language to obtain, document and sign the consent documents. 
- 
The PI/ designee explains the research to the birthing person, using Patient-
Centered approach, answers questions, and assess participant’s comprehension of the study.  
- 
Study participant prints first name and last name on the translated Bill of 
Rights, signs, and dates the document. 
- 
Study participant prints first name and last name on the English version of the 
ICF, signs, and dates the document. 
- 
After consenting, the PI gives the copy of the signed Bill of Rights and English 
version of the ICF to the birthing person.  
- 
The researcher documents all details of the informed consent process in the 
research document.  
- 
Within 30 days after consenting, the study personnel arrange translation of the 
ICF from the English to the participants own language, that is the language used during Short 
Form Method. 
- 
The PI/ designee submits the Post Approval Incident Report to the UCLA IRB, 
notifying them of about implementation of the Short Form Method for enrollment the birthing 
person into the Perinatal Repository Protocol. The amendment should be submitted to the IRB 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 35 of 40 
 
along with the translated ICF and copy of the Bill of Rights. The PI provides the IRB with the 
description of the plan, including timing, to provide the full translated ICF to the study 
participant.  
- 
After obtaining the IRB approval of the translated ICF, the PI provide the 
birthing person with the translated ICF in person during visit or by mail/ email. All details are 
recorded by study personnel in the research records. 
- 
At the time of the Continuing Review, the PI summarizes any and all uses of 
the Short Form Method. 
- 
During the participant’s visits, the PI, or the member of the research team, or 
qualified interpreter, who speaks the target subject population will be available to answer 
questions and conduct the project. 
 
A special approach will also be applied to visually impaired persons and illiterate 
persons who understand English. The ICF will be read aloud, explained, and checked by the 
PI / designee for comprehension.  
For consenting deaf participant, the PI will use deaf service available through the 
UCLA Health System Interpreter/ Translation and Deaf Services program. 
By answering and asking questions, the PI/ designee determines whether the potential 
participant comprehends the consent information to ensure the informed consent is valid. An 
impartial third-party witness will confirm the informed consent process has taken place. Both 
the PI and the witness will sign and date the ICF. The copy of the ICF will be provided to the 
research participant. 
 
5.6.2   Additional Protection for Pregnant Birthing Person and Neonate/ Fetus 
According to 45 CFR 46: Protection of Human Subjects under United States Law 
(1974), the additional protections for pregnant birthing persons, neonates, and fetuses are 
provided in the Protocol. Additional protection of Repository participants will be arranged 
according to the UCLA OHRP Guidance: “Special Populations – Pregnant Women, Fetuses, 
Neonates or In Vitro Fertilization” and “Chart for Regulatory Requirements for Pregnant 
Women, Fetuses and Neonates”. 
The Repository does not imply direct benefits to the birthing person, both the birthing 
person and the fetus/ neonate. Risk for the study participant is minimal.  
The research participants will be recruited during perinatal visits. The birthing persons 
may also be recruited and consented while they are in early labor (infrequent contractions 
(less than 3 per minute) and cervix < 4 cm. 
The study will not recruit and seek to consent research participant under the following 
conditions: 
- 
birthing person is in active labor: contractions every 3-4 minutes, cervix > 4 
cm; 
- 
birthing person is distracted, exhausted, and in a degree of pain or discomfort 
that could preclude valid consent; 
- 
patient is sedated. 
Results of the Protocol implementation make the substantial scientific contribution to 
the prevention of the non-favorable clinical outcome for high-risk pregnancy. Creation of the 
Perinatal Repository address an important clinical issue. It is necessary postulate that the 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 36 of 40 
 
birthing person will not be provided inducements like money to terminate the pregnancy. The 
PI and co-PIs do not have part in determining the viability of the fetus. Postpartum, no research 
tests of infants for research purposes will be performed. Repository Material records clinical 
data on the newborns condition. The research will not terminate the functioning of the heart 
and respiration of the nonviable neonate. After delivery, the viable neonates ate protected by 
the protections allotted to normal study participants and the additional protections of children.  
Therefore, there is no added risk to the fetus/ neonate and the birthing person. . 
Intention to collect perinatal data is aiding the efficiency and effectiveness of de-identified 
biorepository for pregnancy at risk outcome research. The results of the study are important 
and cannot be obtained through other means. 
 
5.7   Payment to Participant/ Families 
There is no financial incentive foreseen in this study. No payment will be provided to 
the participants/ families. 
 
5.8   Confidentiality 
All study Materials, data and records generated per this protocol will be kept 
confidential in accordance with UCLA Health policies and guidance. Special HIPAA 
compliance activities for this study are outlined above. The PI and the study personnel will 
not use biospecimens and linked clinical data for any purpose other than conducting the study 
per protocol.  
The safeguards to maintain participant’s privacy and confidentiality are described 
above. To ensure compliance with the HIPAA requirements, separate measures have been 
developed in case the PI moves to another university, as well as in case of the future 
dissemination of the scientific institutions and organizations. The additional safeguard 
measures are set forth under Data Collection and Management section. 
 
5.9   Ethical Considerations 
Under implementation of this Protocol, the researchers plan to conduct study 
specifically involving following populations/ specimens: 
1. Pregnant birthing persons/ fetuses. 
2. Adults who are competent to give written informed consent. 
3. Participants unable to read, speak, and/ or understand English. 
4. Fetal tissue. 
5. Neonates (clinical data only). 
 
Inclusion of the vulnerable patient populations is necessary to achieve the purpose the 
study and implement the objectives of the research project. Additional safeguards are 
developed to protect this population from coercion, undue influence, and exploitation. The PI/ 
designee will provide assessment of capacity to consent for the birthing person as the primary 
additional safeguard measure. If upon assessment the potential participant will be found as 
person unable to give informed consent, or person with diminished capacity to consent, the 
PI/ designee will not seek surrogate consent for their participation in the Perinatal Repository 
Protocol. 
 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 37 of 40 
 
 
6   SAFETY MANAGEMENT 
 
The Perinatal Repository is a minimal risk study.  
 
6.1 
  Clinical Adverse Events 
 
Unanticipated problems involving risks to subjects and others will be monitored 
throughout the study according to the UCLA OHRP Guidance “Decision Tree: Adverse 
Events (February 20, 2021)”. 
 
6.2 
  Adverse Event Reporting 
 
Since the study procedures are not greater than minimal risk, SAEs are not expected. 
If any unanticipated problems related to the research involving risks to subjects or others 
happen during the course of this study these will be reported to the IRB in accordance with 
UCLA IRB Guidance and Procedure: Post-Approval Reporting Requirements (PAR) for 
Investigators: Reporting of Unanticipated Problems, Including Adverse Events as well as 
Protocol Violations, Deviations and Incidents and the Reporting of Updated Study Safety 
Information.   
 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 38 of 40 
 
7   PUBLICATION   POLICY 
 
The PI reserves the right to make public presentation of the scientific data in any way 
related to this clinical study. Study participants’ identifiers will not be used in public 
presentation. 
Acquaintance of the scientific community with research data can be carried out in the 
form of research publications, articles, reviews, abstracts at research congresses, oral / video 
presentations, reports, press releases, publication of information about the research on the 
Internet and in other ways, opted by a discrete PI decision. 
Public presentation of the research material may be implemented during the 
preparation of this clinical study, throughout the conducting of the study, and upon completion 
of the study for an unlimited period of time.  
The PI should assure that the actual information relating to the study will be publicly 
available on the Internet at the website www.clinicaltrials.gov. 
The inclusion of illustrative cases in the presentation of study is not intended. If, in the 
future, during the implementation of the research project, special circumstances arise that may 
result in disclosure of identifiable information, or may create opportunities for such disclosure, 
the PI will promptly notify the IRB in writing. Study presentation approval should not be 
withheld unreasonably.  
In case of a difference of opinion regarding the data reported and publication, the PI 
will contact the UCLA Office of Research Administration for a prompt review and a decision 
that satisfies all concerned parties. 
Any scientific work designed and generated in connection with this protocol will be 
the intellectual property of the PI / Afshar’s Lab as author and owner of copyright for such 
document. 
 
 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 39 of 40 
 
8 REFERENCES 
 
 
1. Access to the Penn Medicine BioBank. P. 1-3. Accessed: June 9, 2021. 
https://www.itmat.upenn.edu/biobank/ 
2. Harati M.D., Williams R.R., Movassaghi M., Hojat A., Lucey G.M., Yong W.H. 
(2019) An Introduction to Starting a Biobank. In: Yong W. (eds) Biobanking. Methods in 
Molecular Biology, vol 1897. Humana Press, New York, NY. https://doi.org/10.1007/978-1-
4939-8935-5_2 
3. Individualized Medicine Mayo Clinic Biobank Access Committee. P. 1-2. Accessed: 
June 9, 2021. https://www.mayo.edu/research/documents/biobank-access-principles/DOC-
20086427  
4. Ridpath JR, Greene SM, Wiese CJ; PRISM Readability Toolkit. 3rd ed. Seattle: 
Group Health Research Institute (2010). P. 1-82. Accessed: July 12, 2021. 
https://www.nhlbi.nih.gov/files/docs/ghchs_readability_toolkit.pdf.  
5. UCLA OHRP Chart for Regulatory Requirements for Pregnant Women, Fetuses and 
Neonates. P. 1-3. Accessed: July 15, 2021. 
https://ora.research.ucla.edu/OHRPP/Documents/Policy/9/Subpart_B_Table.pdf. 
6. UCLA OHRP Form: Checklist for Using the “Short Form” Method of Consent for 
Non-English Speaking Research Participants (February 20, 2020). P. 1. Accessed: July 14, 
2021. https://ora.research.ucla.edu/OHRPP/Documents/Policy/9/ShortForm_Checklist.pdf. 
7. UCLA OHRP Form: Decision-Making Capacity Assessment Tool (August 22, 
2012). P. 1. Accessed: July 12, 2021. 
https://ora.research.ucla.edu/OHRPP/Documents/Consent/Decision_Assessment_Tool.pdf. 
8. UCLA OHRP Form: Investigator Certification of Surrogate Decision Maker for 
Potential Subject’s Participation in University of California Research (March 2, 2021). P. 1. 
Accessed: July 13, 2021. https://researchmemos.ucop.edu/php-
app/index.php/site/document?memo=UlBBQy0yMS0wMQ==&doc=3787. 
9. UCLA OHRP Guidance and Procedure: Collection, Use, Sharing and Secondary 
Analyses of Human Specimens and/or Data for Research Purposes (January 8, 2016). P. 1-6. 
Accessed: July 16, 2021. 
https://ora.research.ucla.edu/OHRPP/Documents/Policy/3/Data_Specimens.pdf. 
10. UCLA OHRP Guidance and Procedure: Data and Specimen Repositories (April 13, 
2009). P. 1-5. Accessed: July 16, 2021. 
https://ora.research.ucla.edu/OHRPP/Documents/Policy/7/Repositories.pdf. 
11. UCLA OHRP Guidance and Procedure: NIH Genomic Data Sharing (GDS) and 
Genome Wide Association Studies (GWAS) (October 20, 2020). P. 1-4. Accessed: July 16, 
2021. https://ora.research.ucla.edu/OHRPP/Documents/Policy/7/NIH_GDS_&_GWAS.pdf. 
12. UCLA OHRP Guidance and Procedure: Obtaining and Documenting Informed 
Consent (March 2, 2021). P. 1-9. Accessed: July 13, 2021. 
https://ora.research.ucla.edu/OHRPP/Documents/Policy/5/Obtain_Informed_Consent.pdf.  
13. UCLA OHRP Guidance and Procedure: Research Involving Non-English Speaking 
Research Participants (May 9, 2019). P. 1-9. Accessed: July 14, 2021. 
https://ora.research.ucla.edu/OHRPP/Documents/Policy/9/NonEnglish_Participants.pdf. 

Version date: 11/13/2025 
UCLA: Afshar’s Lab 
Protocol ID:IRB#21-001018 
Perinatal Repository                                                                                           Page 40 of 40 
 
14. UCLA OHRP Guidance and Procedure: Research Involving Persons with Cognitive 
Impairments (March 2, 2021). P. 1-30. Accessed: July 13, 2021. 
https://ora.research.ucla.edu/OHRPP/Documents/Policy/9/Cognitive_Impairments.pdf. 
15. UCLA OHRP Guidance and Procedure: Special Populations – Pregnant Women, 
Fetuses, Neonates or In Vitro Fertilization (October 24, 2011). P. 1-7. Accessed: July 15, 
2021. 
https://ora.research.ucla.edu/OHRPP/Documents/Policy/9/Pregnant_Fetuses_Neonates.pdf. 
16. UCLA OHRP Guidance: Planned Research in Emergency Settings with Waiver of 
Consent (June 9, 2016). P. 1-3. Accessed: July 12, 2021. 
https://ora.research.ucla.edu/OHRPP/Documents/Policy/8/Emergency_Setting.pdf. 
17. UCLA OHRP Guidance: Use of Legally Authorized Representative (Surrogate 
Consent) (March 2, 2021). P. 1-5. Accessed: July 12, 2021. 
https://ora.research.ucla.edu/OHRPP/Documents/Policy/5/Surrogate_Consent.pdf. 
18. UCLA OHRP Quick Guide: Protecting Privacy and Maintaining Confidentiality 
(October 21, 2020). P. 1-3. Accessed: July 16, 2021. 
https://ora.research.ucla.edu/OHRPP/Documents/Policy/6/Privacy_Confidentiality.pdf. 
19. UCLA OHRP: Research Participant Bill of Rights/ Experimental Subjects Bill of 
Rights (July 12, 2021). Accessed: July 14, 2021. https://ohrpp.research.ucla.edu/participant-
bill-of-rights/. 
20. UCLA OHRP: Self-Certification of Surrogate Decision Makers for Potential 
Subject’s Participation in University of California Research (March 2, 2021). P. 1. 
Accessed: July 14, 2021. 
https://ora.research.ucla.edu/OHRPP/Documents/Consent/Surrogate_Self_Cert.pdf. 
21. UCLA OHRPP Decision Tree: Adverse Events (February 20, 2021). P. 1. Accessed: 
July 15, 2021. 
https://ora.research.ucla.edu/OHRPP/Documents/Policy/11/AE_DecisionTree.pdf. 
22. UCLA OHRPP Guidance: Requirements for IRB Review and Approval (April 14, 
2021). P. 1-5. Accessed: May 24, 2021. 
https://ora.research.ucla.edu/OHRPP/Documents/Policy/12/IRB_Review_Requirements.pdf 
23. UCLA OHRPP Guidance: Scientific or Scholarly Review of Human Subjects 
Research Protocols (August 12, 2011). P. 1-2. Accessed: May 24, 2021. 
https://ora.research.ucla.edu/OHRPP/Documents/Policy/4/Scientific_Review.pdf 
24. University of CA Policy: Surrogate Consent for Research – Updated Guidance, N. 
21-01 (February 16, 2021). P. 1-5. Accessed: July 12, 2021. 
https://researchmemos.ucop.edu/php-
app/index.php/site/document?memo=UlBBQy0yMS0wMQ==&doc=3789.