Broadening the Reach, Impact, and Delivery of Genetic Services
Phase: NA
Conditions: Cancer, Risk Reduction Behavior
Sponsor: University of Utah

PROTOCOL TITLE: Broadening the Reach, Impact, and Delivery of Gene@c Services (BRIDGE) 
NCT NUMBER: NCT03985852 
PROTOCOL DATE:  06/05/2019 
The full trial protocol is available at: 
Kaphingst KA, Kohlmann W, Chambers RL, et al. Comparing models of delivery for cancer 
gene@c services among pa@ents receiving primary care who meet criteria for gene@c evalua@on 
in two healthcare systems: BRIDGE randomized controlled trial. BMC Health Sciences Research. 
2021;21:542. doi:10.1186/s12913-021-06489-y 

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IRB_00123563
1. Contacts and Title
Date: Tuesday, August 6, 2024 10:49:19 AM
IRB_00123563
Created: 6/5/2019 3:01 PM  
PI: Kimberly Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and Delivery of
Genetic Services
 
1. Study Introduction
1. Responsible Investigator:
Kimberly Kaphingst
Email
Training
CoI Date
kim.kaphingst@hci.utah.edu 4/25/2022 SMCG
3/19/2024
a. Position of the Investigator:
Faculty or Non-Academic Equivalent
Student
Staff
Resident/Fellow
Other
2. Contact Persons for the Responsible Investigator:
Name
Email
Training
Kadyn Kimball
kadyn.kimball@hsc.utah.edu
2/22/2023 MCG
Kelsey Knight
Kelsey.Knight@hsc.utah.edu
3/4/2024 SMCG
Wendy Kohlmann
wendy.kohlmann@hci.utah.edu
3/21/2022 SMCG
Lindsey Martineau
lindsey.martineau@utah.edu
1/9/2023 SMCG
3. Guests of the Responsible Investigator:
Last Name
First Name
E-Mail
Berry
Therese
therese.berry@hci.utah.edu
Intveld
Andrew
Andrew.Intveld@hci.utah.edu
Ma
Debra
deb.ma@hci.utah.edu
Mathis
Elizabeth
elizabeth.mathis@hsc.utah.edu
Sama
Neetha Reddy
Neetha.Sama@hci.utah.edu
4. What type of application is being submitted?
New Study Application (or Amendment/Continuing Review)
5. Title Of Study:
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Broadening the Reach, Impact, and Delivery of Genetic Services
6. Study Purposes and Objectives:
The proposed study will employ an implementation science framework to compare two models of genetic services delivery for 1,920
patients in a randomized controlled trial with clinic-level randomization. We hypothesize that uptake of genetic testing (Study Aim 2) and
adherence to management recommendations (Study Aim 3) will be equivalent between the genetic services delivery models. We propose
the following Specific Aims:
Aim 1) Identify primary care patients who qualify for genetic risk assessment in two healthcare systems using a CDS
infrastructure to automatically evaluate family history.
*This aim has already been studied in IRB #105797. We will be utilizing this tool that is now available. Aim 1 will not be analyzed in this
protocol but is part of our overall research model. 
 
Research Aims to be studied in this protocol:
Aim 2) Compare uptake of genetic testing for patient-directed standard of care vs. enhanced standard of care genetic
services delivery models for 1,920 unaffected primary care patients. We will utilize a randomized trial design with clinic-level
randomization to compare two standard of care models: a patient-directed standard of care model and an enhanced model. In the
patient-directed model those identified by the clinical decision support (CDS) infrastructure as meeting testing criteria will be informed of
their cancer risks, provided with educational resources, and offered the option to select genetic testing through a patient portal. This
online portal will be overseen by HCI genetic counselors. The enhanced standard of care model in which primary care providers and
patients are notified through CDS when criteria are met (the enhancement of standard of care) and of the availability of standard of care
genetic services. We will compare uptake of genetic testing by model and by race/ethnicity and rurality.
Aim 3) Compare adherence to recommendations and other patient responses for the genetic services delivery models. We
will compare the effects of the genetic services delivery models on adherence to management recommendations at 12 months after
return of results, or last genetic services contact. We will assess cognitive (i.e., recall, comprehension, uncertainty, risk perceptions) and
affective (i.e., test-related distress, positive reactions, decision regret) responses at 4 weeks, and communication (i.e., family, provider)
interactions at 4 weeks and 12 months after last genetic services contact. We will also examine differences in effects by race/ethnicity
and rurality. 
7. Is this a multi-site study, where more than one site needs IRB approval?
    Yes No
8. Background and Introduction:
Identifying unaffected individuals with inherited cancer susceptibility is critical to risk reduction and clinical management. Hereditary
cancer syndromes affect risks of many common, adult-onset cancers.1-5 Pathogenic variants (i.e., variant that increases cancer risk;
PVs) in cancer predisposition genes can be identified in 7% of breast, 11%-15% of ovarian,2,6-8 10% of colorectal,3,9,10 4%-11% of
pancreas,11 and 12% of advanced prostate cancers.12,13 Prior evidence supports individualizing screening and prevention based on
cancer risk,14-19 such as more frequent or earlier screening or chemoprevention, and identification of a PV may allow for targeted
intervention and treatment if cancer occurs.20-23
Advances in technology are identifying more families with an inherited cancer susceptibility. Next generation sequencing-based testing of
panels of multiple genes for hereditary cancer (i.e., multigene panel) can more than double the rate of mutation detection compared to
testing single genes.24-27 A growing number of genes have been associated with increased risks for breast, ovarian, pancreas, and
prostate cancers,7,11,13,28-30 and multiple genes, in addition to Lynch syndrome, have been identified in association with colorectal
cancer risk.10,31,32 Newer sequencing technologies are also expanding the tumor spectrum associated with particular genes, leading to a
broader range of family histories being considered as an indication for genetic testing. For example, family history of prostate and
pancreas cancer are being incorporated into testing criteria for homologous DNA repair pathway genes (e.g., BRCA1/2), criteria that
were previously restricted to only breast and ovarian cancer.33 Healthcare systems are challenged by the clinical management of the
increasing number of patients who qualify for these services.19,34
There is a need to expand beyond cancer patient populations. Efforts to identify individuals with inherited cancer susceptibility are still
generally focused on cancer patients with testing of at-risk relatives recommended once a PV is found.35-37 However, this strategy
misses families in which there is no living, affected relative to test, and may be an important barrier to accessing genetic services. One
report found that 50% of unaffected patients presenting for clinical genetic counseling who received a recommendation for a relative to
be tested first were lost to follow-up.38 Studies have begun to explore the feasibility of screening primary care patients for inherited
cancer susceptibility.39-42 National guidelines recommend testing for unaffected individuals with a significant family history,43,44 and the
Affordable Care Act mandated coverage of genetic testing for hereditary breast/ovarian cancer for unaffected individuals with
appropriate family history.45 However, these initiatives have not yet been systematically implemented into primary care practice and it is
unclear to what extent the need for genetic testing for hereditary cancer in unaffected individuals is being met. The National Health
Interview Survey reported that only 9.5% of unaffected women with a family history of breast and ovarian cancer had discussed genetic
testing with their healthcare provider, and only 2.7% had genetic testing.46 Strategies to identify unaffected individuals across
healthcare systems are therefore needed.  
Family history can stratify patients’ cancer risk but is underutilized in primary care. While debate continues over population-wide cancer
genetic testing,47-50 this strategy has not yet been widely implemented outside of research contexts, and often only in specific
populations.51-54 Family history can be used effectively to identify those most likely to carry a PV and to tailor screening regardless of
whether a PV is identified.55-61 However, although some family history is generally collected in primary care, the information is
underutilized to stratify risk,62-64 leading to missed prevention opportunities. In recent research, 37% of newly diagnosed breast cancer
patients found to have PVs had a family history that warranted genetic testing even prior to their diagnosis.65 Commonly reported
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barriers to collection and use of family history information in clinical practice include limited visit time, competing demands,
reimbursement criteria, and providers’ training, knowledge and skills.63,66-70 To address these barriers, over 75 tools have been
developed71-76 for patients to collect their family history information prior to a clinic visit to improve discussions with primary care
providers (PCPs).63,64,66,67,77-80 However, many of these tools require significant time and resources, were developed independent of
workflow standards in clinics, and widespread implementation of these tools has not occurred.64 Therefore, it is critical to develop novel
strategies to capitalize on family history information already being collected in the EHR, regardless of the method, and pair it with
automated tools for evaluation and stratification of risk.
Clinical decision support (CDS) tools and electronic health record (EHR) technology can utilize available family history information.
System-level strategies have been suggested to assist PCPs in providing genetic services for patients.81 EHR technology, together with
CDS tools, are promising as systematic approaches to address many of the PCP time, knowledge, and skills barriers that limit the use of
available family history information. CDS entails providing providers and patients with pertinent knowledge and/or person-specific
information, intelligently filtered or presented at appropriate times, to enhance health and healthcare.82 While CDS interventions have
not always improved clinical care, we and others have identified best practices for optimizing effectiveness.83,84 In prior studies, CDS
tools have increased the efficiency of a hereditary cancer service,85 improved referral patterns for patients at high risk for familial
cancers,86 and enhanced identification of Lynch syndrome among newly diagnosed colon cancer patients.87
Prior research comparing approaches for delivering cancer genetic services is limited. Once at-risk individuals are identified, genetic
services (e.g., genetic counseling, genetic testing, risk-reduction recommendations) need to be delivered. The number of trained genetic
specialists is limited with more sustainable approaches needed to accommodate an increasing patient volume.88 Prior studies have
compared mode of delivery (i.e., in-person vs. telephone) based on a traditional service model, with patient contact by a genetic
counselor before and after genetic testing, examining outcomes such as uptake of genetic testing, adherence to follow-up, and patient
responses (e.g., anxiety).89-91 However, few studies have involved PCPs or explored supplementing genetic counselors with other
models (i.e., computer-based pre-test education92,93) within the healthcare system. Implementation research studies94 are urgently
needed to compare the outcomes in real-world settings of different models to genetic services delivery, particularly models that direct
genetic counseling resources to those patients with the greatest needs for genetic services.
Potential of patient-directed models of genetic services delivery has not been explored. Genetic testing is now available direct-to-
consumer (DTC), including testing with multi-gene cancer panels, with no or minimal involvement of a clinician or genetic counselor.95
Advocates believe DTC approaches increase access to genetic testing, particularly for patients in areas with few genetic services.
However, it is unknown whether DTC genetic testing will result in appropriate management.96 Clinicians need to be aware of the results
to incorporate them into care, but a study of early adopters found that only 27% of patients had shared DTC results with their PCPs.97 In
addition, PCPs may have limited knowledge about how to use the results to individualize care.98 Healthcare systems have a vested
interest in ensuring that information as significant as genetic testing be part of the EHR in a meaningful way.99 Therefore, there is
significant need to develop genetic services delivery strategies that incorporate features of the DTC approach (e.g., patient-directed,
increased access) but within the healthcare system and with support for providers interpreting these results.
Need to address disparities in access and use of genetic services across population subgroups. Prior research has often shown that
individuals from racial and ethnic minority groups have decreased access to and utilization of genetic services,100 even when cost
barriers are minimized.101 These disparities have been attributed to individual-level factors (e.g., awareness, knowledge, attitudes)102-
104 and system-level factors (e.g., insurance, access to specialists, lower trust).103,105 One study with women diagnosed with breast
cancer showed a strong desire for genetic testing among Latinas, but also that minority patients had more unmet needs for discussion of
testing with providers.106 Prior work has also indicated the importance of examining how race and ethnicity impact the delivery of
genetic services. A randomized trial comparing in-person vs. telephone-based genetic counseling found that the effect of mode of
delivery differed by race; minority women assigned to telephone counseling were the least likely to complete genetic testing.107
Even less research has examined access and use of genetic services by rurality (rural/frontier vs. urban). Rurality is a critical issue for
Utah; 96% of the landmass is defined as rural (<100 persons per square mile) and 70% as frontier (<7 persons per square mile).108
Individuals in rural areas in the U.S. have less access to care109 and worse health outcomes.110,111 Rural counties have higher incidence
of cancers potentially preventable through screening.112,113 Some disparities in cancer mortality are likely due to barriers to accessing
health services in rural areas.113 Clinical sites in rural areas may not have physicians knowledgeable about genetics.114 In addition, in
rural/frontier regions, clinics and hospitals can be hundreds of miles from patients’ homes, so rural/frontier residents have less access to
specialty genetics care.70,115
 
Citations can be found in the appropriate Documents & Attachments section. 
 
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IRB_00123563
2. Study Location and Sponsors
IRB_00123563
Created: 6/5/2019 3:01
PM
 
PI: Kimberly
Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and
Delivery of Genetic Services
 
2. Study Location and Sponsors
1. Add all locations applying for approval of research via the University of Utah IRB or Human Research
Protection Program (HRPP).
Click the appropriate button(s) below to add locations:
 
Site Name
Investigators Name
Covered Entity
Sub Sites
View NYU School of Medicine
Ophira Ginsburg
No
 
View University of Utah
Kimberly Kaphingst
Yes
 
a. Select the lead site. Select N/A if there is no lead site.
University of Utah
 N/A
2. Will a Central IRB (CIRB) or Single IRB (SIRB) model be used for review of this study for the sites listed in
this application?
  Yes No
a. Provide the name of the organization providing CIRB/SIRB review:
University of Utah
 
3. Indicate the source(s) of funding obtained or applied for to support this study.
 
Sponsor
Sponsor Type
Sponsor Contact Information
Prime
Sponsor
Prime
Sponsor Type OrgID
View NIH NATIONAL
CANCER INSTITUTE
Federal
Government
NCI Grants Management
Specialist: Kimery Griffin
Email: griffink3@mail.nih.gov
Phone: 240-276-6315
 
 
11259
4. Does this study have functions assigned to a Contract Research Organization (CRO)?
  Yes No
5. Does this study involve use of the Utah Resource for Genetic and Epidemiologic Research (RGE)?
Examples: Utah Population Database (UPDB), Utah Cancer Registry (UCR), All Payers Claims Database (APCD),
etc.
  Yes No
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IRB_00123563View/Edit
IRB_00123563
Created: 6/5/2019 3:01 PM  
PI: Kimberly Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and Delivery of Genetic
Services
 
Addition of a Site
1. Site Name:
NYU School of Medicine
2. Site Principal Investigator
Mark if Same as Responsible Investigator (syncs with investigator on
the first page) 
If the Site Principal Investigator does not have an ERICA account, fill out
their name:
Ophira Ginsburg
Email:
a. Position of the Site Principal Investigator
Faculty or Non-Academic Equivalent
3. Site Contact Persons, if different from the Site PI:
Mark if Same as Contacts for Responsible Investigator (syncs with
contacts on the first page)
Name
Email
Training
There are no items to display
4. Site Guests:
Name
Email
Training
There are no items to display
5. Select HIPAA coverage for this study:
Study procedures will be conducted outside a HIPAA Covered Entity at this
site (HIPAA Privacy Rule does not apply)
6. Select the study procedures that will be conducted at this site:
Recruitment
Consent/Enrollment
Research observation/intervention with participants
Data collection
Data analysis
Do you have an enrollment goal or anticipated enrollment number
for this site?
 
Yes
No
7. Add any additional sites that are part of this performance group
There are no items to display
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IRB_00123563View/Edit
IRB_00123563
Created: 6/5/2019 3:01 PM  
PI: Kimberly Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and Delivery of Genetic
Services
 
Addition of a Site
1. Site Name:
University of Utah
2. Site Principal Investigator
Mark if Same as Responsible Investigator (syncs with investigator on
the first page) 
Kimberly Kaphingst
Email
Training
CoI Date
kim.kaphingst@hci.utah.edu 4/25/2022
SMCG
3/19/2024
a. Position of the Site Principal Investigator
Faculty or Non-Academic Equivalent
b. Will the Site PI consent participants?    Yes No
3. Site Contact Persons, if different from the Site PI:
Mark if Same as Contacts for Responsible Investigator (syncs with
contacts on the first page)
Name
Email
Training
Kadyn Kimball
kadyn.kimball@hsc.utah.edu
2/22/2023 MCG
Kelsey Knight
Kelsey.Knight@hsc.utah.edu
3/4/2024 SMCG
Wendy Kohlmann
wendy.kohlmann@hci.utah.edu
3/21/2022 SMCG
Lindsey Martineau
lindsey.martineau@utah.edu
1/9/2023 SMCG
4. Site Staff and Sub-Investigators
Name
Email
Training
Obtaining
Consent CoI Date
Jo Anson jo.anson@hci.utah.edu
3/7/2022
MCG

6/13/2024
Kenneth
Boucher
ken.boucher@hci.utah.edu
11/2/2022
MCG

7/11/2024
Saundra
Buys
saundra.buys@hci.utah.edu
6/26/2024
MCG

5/23/2024
Sarah
Colonna
Sarah.Colonna@hsc.utah.edu
10/4/2021
MCG

5/17/2024
Whitney
Espinel
Whitney.Espinel@hci.utah.edu
11/14/2022
MCG

4/12/2024
Amanda
Gammon amanda.gammon@hci.utah.edu
8/19/2021
MCG

11/7/2023
Kinley
Garfield
kinley.garfield@hci.utah.edu
C

5/2/2023
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Name
Email
Training
Obtaining
Consent CoI Date
Samantha
Greenbergsamantha.greenberg@hci.utah.edu12/6/2023
MCG

12/15/2023
Kelsi
Hagerty
kelsi.hagerty@hci.utah.edu
C

6/12/2019
Priyanka
Kanth
Priyanka.kanth@hsc.utah.edu
8/16/2022
MC

5/3/2023
Kensaku
Kawamoto kensaku.kawamoto@utah.edu
1/19/2024
MCG

6/28/2024
Kadyn
Kimball
kadyn.kimball@hsc.utah.edu
2/22/2023
MCG

5/2/2023
Wendy
Kohlmann wendy.kohlmann@hci.utah.edu
3/21/2022
SMCG

7/17/2024
Cathryn
Koptiuch
cathryn.koptiuch@hci.utah.edu
C

1/26/2022
Ryan
Mooney
u0576405@utah.edu
3/20/2023
MC

5/26/2023
Anne
Naumer
anne.naumer@hci.utah.edu
9/26/2023
MCG

2/7/2024
Joshua
Schiffman Joshua.Schiffman@hci.utah.edu
5/18/2024
MCG

7/25/2024
Katie
Tobik
katie.tobik@hci.utah.edu
C

3/6/2019
Jennie
Vagher
Jennie.Vagher@hci.utah.edu
1/3/2022
MCG

6/12/2024
David
Wetter
david.wetter@hci.utah.edu
1/11/2023
MCG

4/27/2024
5. Site Guests:
Name
Email
Training
There are no items to display
6. Select HIPAA coverage for this study:
Study procedures will be conducted within a HIPAA Covered Entity at this site
(HIPAA Privacy Rule applies)
7. Select the study procedures that will be conducted at this site:
Recruitment
Consent/Enrollment
Research observation/intervention with participants
Data collection
Data analysis
Do you have an enrollment goal or anticipated enrollment number for
this site?
 
Yes
No
8. Select the University of Utah department responsible for this research:
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HUNTSMAN CANCER INSTITUTE
9. Add any additional sites that are part of this performance group
There are no items to display
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IRB_00123563
IRB Smart Form
IRB_00123563
Created: 6/5/2019 3:01 PM  
PI: Kimberly Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and Delivery of Genetic
Services
 
Sponsor Information
Please review these previously entered fields as you fill out the new form:
Sponsor: NIH NATIONAL CANCER INSTITUTE
Contact: NCI Grants Management Specialist: Kimery Griffin Email: griffink3@mail.nih.gov Phone:
240-276-6315
Grant Number: 1U01CA232826
Awardee: University of Utah (lead) and NYU Principal Investigators: Saundra Buys and Kimberly
Kaphingst (Utah); Ophira Ginsburg (NYU)
Effective Date Start: 9/1/2018
Effective Date End: 8/31/2023
a. Are you receiving award or contract management for the
sponsored funds through the University of Utah Office of
Sponsored Projects?
  Yes No
If yes, select the associated OSP Proposal ID/DSS through eAward to link it to the
ERICA system.
You must have a fully approved Proposal ID/DSS number through eProposal which will show up
in eAward after OSP has integrated the ID. To access the eAward application, use the
instructions on the OSP website.
Link to a Proposal ID/DSS through eAward
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IRB_00123563
3. Participants
Adapted Criteria for Genetic Testing for Inherited Cancer
Susceptibilities
First Degree Relative or Second Degree Relative diagnosed with the
following regardless of age: Ovarian Cancer, Pancreas Cancer
First Degree Relative or Second Degree Relative diagnosed with the
following <50 years of age: Breast Cancer, Colorectal Cancer,
Endometrial Cancer
Three or more relatives on the same side of the family diagnosed with
the following clusters of cancer regardless of age:
Breast Cancer, Ovarian Cancer, Pancreas Cancer, Prostate Cancer
Colorectal Cancer, Endometrial Cancer, Ovarian Cancer, Pancreas
Cancer, urinary tract, brain, small intestine
Melanoma, Pancreas Cancer
Ashkenazi Jewish ancestry and family history of Breast Cancer,
Ovarian Cancer, Pancreas Cancer, Prostate Cancer
IRB_00123563
Created: 6/5/2019 3:01 PM  
PI: Kimberly Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and Delivery of Genetic
Services
 
3. Participants
1. Ages of Participants:
18 and older
(Consent form needed)
2. Specific age range of participants (e.g., 7-12 years old, 60+, etc.):
25-60 years old
3. Indicate any vulnerable participant groups (other than children) included:
None
 
 If "Other", please specify: 
 
 If "None" and no children are involved, answer the following question.
Has the participant selection process overprotected potential subjects who are considered
vulnerable so that they are denied opportunities to participate in research?
  Yes No
4. Number of participants to be included and/or enrolled in this entire study, across all study locations: 1,920
consent cover letters sent; up to 20,000 EHR records
 
At Utah prior to October 2019: 960 consent cover letters sent; up to 20,000 EHR records
5. Characteristics of Participants/Inclusion Criteria:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion Criteria:
Criteria will be simplified to focus on first- and second-degree relatives, specific cancer type, number of family members, and age at diagnosis
(See Table)
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The algorithms to stratify patients’ risk for this study will be based on National Comprehensive Cancer Network (NCCN) criteria for testing for
genes in the homologous DNA repair pathway associated with breast, ovarian, prostate, and pancreas cancer and Lynch syndrome, and
international consensus recommendations for genetic testing for hereditary melanoma.
Participants will be eligible to participate if they speak English. 
Future possible amendment will to be include Spanish speaking patients. 
 
 
6. Participant Exclusion Criteria:
Exclusion Criteria:
We will exclude patients who have a prior cancer diagnosis, other than non-melanoma skin cancer, and/or prior genetic counseling or testing
related to hereditary cancer.
We will also exclude patients who do not have access to internet and therefore unable to access the patient portal.
 
 
7. Is a substantial percentage of the participant population anticipated to be non-English
speaking?
  Yes No
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4. Study Information
IRB_00123563
Created: 6/5/2019 3:01 PM  
PI: Kimberly Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and Delivery of
Genetic Services
 
4. Study Information
1. Design of Study (select all that apply):
Non-Experimental and/or Descriptive Research Design:
There are no items to display
Experimental and/or Interventional Research Design:
Survey/Questionnaire Research
Randomized Trial
Development of a research resource (repositories, databases, etc.)
There are no items to display
 Other
2. Does your study involve the use of any placebo?
  Yes No
3. Length of entire study, from initiation through closeout:
5 Years
4. How will participants be recruited or identified for inclusion in the study?
a. Select all methods that will be used:
In-person contact (e.g., patients, students, etc.)
Written or electronic record review
b. Describe the recruitment/participant identification process in detail (e.g. who will review charts or
records, who can refer participants to the study, where will flyers be posted, how often will recruitment
letters be sent, when will follow-up phone calls be made, etc.):
Using the EHR algorithms, individuals will be identified as meeting any genetic testing criterion. The patients will be flagged and
forwarded through the electronic health record (EHR) as a work list to a genetic counseling assistant (GCA). The flag will include
what criteria were reported. Eligible patients will receive an initial contact attempt in an email through the patient portal. If there
is no response within a week, the patient will be resent the email through patient portal, followed by a letter to their home
address, and 3 follow-up phone calls. Patients who complete genetic counseling will be sent the consent cover letter and the
follow-up questionnaires.
 
5. How will consent be obtained?
Informed Consent Process (with or without a document)
Waiver or Alteration of Informed Consent
6. Describe all the procedures chronologically, from screening/enrollment through study closeout, which will be
completed in the research project.
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Clinical Standard of Care Procedures
Patient Screening
Patients meeting National Comprehensive Cancer Network guidelines for referral for genetic services will be
identified using the screening tool developed and implemented in the EPIC EHR (Study Aim 1). The primary
care providers (PCPs) of eligible patients will be notified of their patient’s eligibility one week prior to patients
being notified of the recommendation for genetic services. Patients will then be referred to participate in
standard of care genetic services, with the clinical procedures depending on the study arm to which the clinic
was randomized: enhanced standard of care or patient-directed standard of care.
Patients meeting criteria will be notified of the recommendation through the patient portal (i.e. MyChart). Those
who do not have MyChart will be notified by mail. Those notifications will be followed by standard scheduling
procedures. Patients who do not have MyChart will be asked to sign up for MyChart when they are contacted.
Those who were not actively using MyChart will be provided with a refresher on the use of MyChart since this
project focuses on using this tool to deliver genetic services more effectively.
Patients who do not have access to the internet or are unwilling or able to use MyChart will be directed to in
person genetic counseling services. A waiver of consent will be requested to track the individuals who are not
able to participate through MyChart, but they will not be asked to complete study questionnaires.
 
Study Arms – Clinic Randomized
Enhanced Standard of Care
This arm is referred to as enhanced since clinical decision support (CDS) tools are used to identify
patients meeting guidelines rather than relying solely on provider identification of patients. Patients in this
arm will have an in-person or telephone pre-test genetic counseling visit. Pre-test counseling includes
review of the family history, risk assessment, discussion of the purpose of genetic testing and possible
outcomes, implications for insurance coverage, costs, and assessment of psychosocial needs. 
Patients can opt to proceed with genetic testing during this session. Consent for testing will be
documented and a sample can be collected at that time or scheduled at another time that is convenient for
the patient. All test results are returned by a genetic counselor by phone or in person based on patient
preference per clinic protocol. A copy of the results and letter with tailored screening recommendations are
returned to the PCP and patient via the patient portal (i.e. MyChart) or via a letter in the mail.
Patient-Directed Standard of Care
Patients in this arm will be offered genetic services through the patient portal (i.e. MyChart). These
educational resources will present standard pre-test genetic counseling information as described in the
Enhanced Standard of Care Arm. Patients who decide to proceed with genetic testing will be asked to
document consent for testing.
Patients who decide to have genetic testing will have a saliva collection kit, instructions, and shipping
materials sent to their homes to collect and return a sample to the testing laboratory; this is a service
offered by commercial laboratories. Patients will have an opportunity to contact the genetics clinic with any
questions or to request an appointment with a genetic counselor at any time.
All results will be reviewed by a genetic counselor. Negative results will be returned along with a letter
including screening recommendations tailored based on family history to the patient and PCP via the
patient portal. Genetic counselors will return results for pathogenic variants and variants of uncertain
significance via phone. A copy of the results and letter with tailored screening recommendations will be
provided to the patient and PCP via the patient portal.
All patients will be offered the option to schedule follow-up appointments in the genetics clinics; these
contacts and appointments will be tracked.
Standard of Care Genetic Testing
Genetic testing will be performed at Clinical Laboratory Improvement Act (CLIA)-certified, commercial
laboratories. Based on standard clinical practice, the choice of laboratory will be based on services provided
and patient’s insurance and/or financial status. Testing will be billed to insurance. Patients who are uninsured
or lack coverage for genetic testing will be assisted in applying for aid through programs offered by the
laboratories.
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Genetic testing will not be required to participate in the research questionnaires.
 
Research Procedures
1.  A research coordinator or genetic counseling assistant will determine who is eligible to participate in the
research procedures based on participation in genetic services and access to MyChart, the patient portal. A
wavier of recruitment is being requested for this authorization. Up to 20,000 unique electronic health records
may be accessed to determine inclusion in this study, and basic health outcomes tracked for comparison.  
2.  Consent cover letter will be sent via patient portal to offer participation in this research study, with a link to an
online questionnaire. The consent cover letter will be sent to patients approximately 4 weeks after genetic test
results are returned for those who decide to test and about 8 weeks after participation in pre-test genetic
counseling services for those who decide not to test.
If no response is received to the first message, after 1 week another message in the patient portal will be sent.
If still no response up to 3 phone calls will be made. 
3.  Online questionnaires will utilize REDCap, which has a HIPAA-compliant interface. Estimated 960 patients will
be offered participation through University of Utah Health; 1,960 patients over both participating sites.
i. Questionnaire #1: At about 4 weeks after return of results for those who decide to test (8 weeks
after pre-test genetic counseling), we will assess cognitive (i.e., recall, comprehension, uncertainty, risk
perceptions), affective (i.e., test-related distress, positive reactions, decision regret), communication (i.e.,
family, provider) responses, experience with genetic counseling, and sociodemographic characteristics
including numeracy for those who decide to test. For those who do not decide to test, we will assess
experience with genetic counseling, reason for not testing, decision regret, risk perceptions, and
sociodemographic characteristics including numeracy.
ii. Questionnaire #2: At about 12 months, we will ask about discussion of their test results with their PCP,
family members, or others, and self-reported use of cancer screenings for those who decide to test. We
will also utilize EHR data to examine adherence to recommendations. For those who decide not to receive
genetic testing, we will assess the self-reported use of cancer screenings, whether genetic testing was
pursued at another time or through another source, communication with family members and whether
other relatives had testing.
iii. After each returned questionnaire, participants will be compensated via the patient portal with a thank
you message and a $10 e-gift card. This totals $20 dispersed if both questionnaires are returned.
iv. For any participants who would like to complete questionnaires by telephone, a genetic counseling
assistant or research coordinator will administer the questionnaire. Calls will be digitally recorded to allow
for analysis of comprehension. Each questionnaire will take about 15 minutes to complete. Participants
may also complete the questionnaires by mail if they choose.
4.  Study staff will track the EHR of participants who were identified by the CDS algorithms. Any screenings, care
or health procedures related to genetic services will be recorded in the research record to determine if an
impact is made because of participation in genetic services. This is estimated to be up to 20,000 individual
records in the EHR.  
5.  Data analysis for outcome data will occur after patient enrollment is complete. Patients who return
questionnaires will be compared to similar cohorts that were not directly involved with research questionnaires.
More specific details of data analysis are outlined in the statistical methods section.
 
7. Are all procedures for research purposes only (non-standard or non-standard of care procedures)?
  Yes No
If no, list the procedures that are performed for research purposes only (non-standard or non-standard
of care procedures):
Questionnaire #1: estimated 4-8 weeks from last genetic services contact (4 weeks for those who decide to test and 8 weeks for
those who decide not to test)
Questionnaire #2:  estimated 12-months from last genetic services contact 
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Data Analysis of genetic services impact and outcomes
8. Is there a safety monitoring plan for this study?
  Yes No
9. Provide a summary of the statistical methods, data analysis, or data interpretation planned for this study.
Factors for determining the proposed sample size (e.g., power) should be stated.
Research Aims Analysis for this specific IRB:
Aim 2 Analysis.
Aim 2 analyses will address the dimensions of Reach, Effectiveness, Adoption, and Implementation from our conceptual
framework. For Effectiveness, we will be testing for equivalence between study arms in uptake of genetic testing. We will check
randomization by comparing demographic characteristics between patients in the two arms. Any characteristic(s) that are
significantly different will be controlled for in the multivariable analysis. We will examine descriptive statistics, and will use Fisher’s
Exact test with a two-sided 0.05 significance level for univariate comparison of proportions to examine the association between
study arm and uptake of genetic testing. We will next build multilevel multivariable logistic regression models to examine the
effect of study arm on the outcome controlling for clinic-level (clinic type, patient volume, patient composition, number of
providers), provider-level (specialty, years in practice, gender), and patient-level (e.g., sociodemographic, clinical) variables. We
will examine the intra-class correlation (ICC) by clinic and provider. If a significant ICC is observed, the regression models will be
extended to include random effects for clinic or provider, and fit using software for generalized mixed models. Covariates will be
included in models if significant in unadjusted analyses. For Reach, using the multivariable regression models with interaction
terms, we will examine whether the effects of study arm on uptake of genetic testing is modified by race/ethnicity or rurality. For
Adoption, we will examine the proportions of providers and patients who access educational resources and with referrals, and
whether this differs by population subgroup. For Implementation, we will assess responses to patient portal messages and
completion of study workflows. Statistical significance will be assessed as p<0.05; SAS 9.4 and/or Stata 15.1 will be used for
analysis. 
Aim 2 Sample Size 
Sample size for Aim 2 was calculated using PASS 15 based on an equivalence test for the difference of two proportions in a
cluster-randomized design. Sample sizes of 480 in the patient-directed arm and 480 in enhanced standard of care arm, which
were obtained by sampling 32 clusters (clinics) with 15 participants each and 16 clusters (clinics) with 30 participants each,
respectively, achieve 80% power to detect equivalence. The margin of equivalence, given in terms of the difference between
proportions, extends from -0.10 to 0.10. The calculations assume Likelihood Score Tests (Farrington & Manning) were used with
an ICC of 0.05, and a significance level of 0.05. We believe that this is likely an overestimate of ICC based on our prior work. This
sample size is sufficient for a multilevel multivariable regression analysis and achieves >95% power to detect a small effect size
(0.02) attributable to 1 independent variable using an F-Test with an alpha of 0.05, adjusted for an additional 20 independent
variables. To examine effect modification, sample size is calculated based on logistic regression of a binary response variable (Y)
on a binary independent variable (X) and a binary confounder variable (Z). A sample size of 1,710 observations achieves 80%
power at a 0.05 significance level to detect the X-Z interaction odds ratio of 1.5, using a two-sided Wald test. We will therefore
enroll 1,920 patients in the Aim 2 trial to allow for about 10% attrition.
Aim 3 Analysis 
Aim 3 analysis will follow analytic procedures to address the dimension of Effectiveness from our conceptual framework. For
comprehension, concordance between patient responses and information from genetic counselors’ notes will be scored. We will
test bivariate relationships between the outcome variables and study arm using Student’s t-test or the nonparametric Wilcoxon
rank-sum test between continuous variables, and chi-square test (or Fisher’s exact test if small cell counts) for categorical data.
We will examine distributions for continuous outcomes and transform the data if skewed. Procedures for building multilevel
multivariable linear (continuous outcomes) or logistic (binary outcomes) regression models are described above. Regression
models extended to include random effects for clinic or provider will be fit using software for linear mixed models for continuous
outcomes and generalized linear mixed models for categorical outcomes. As with Aim 2, we will examine effect modification by
testing for significant interactions between variables in regression models.
Aim 3 Sample Size 
We estimate a sample size of 1,100 for a multilevel multivariable regression analysis with >90% power to detect a small effect
size (0.02) attributable to 2 independent variables using an F-Test with an alpha of 0.05 using PASS 15 Software. The variables
tested are adjusted for an additional 20 independent variables. To examine effect modification sample size is calculated based on
logistic regression of a binary response variable (Y) on a binary independent variable (X) and a binary confounder variable (Z)
with a sample size of 1,710 observations achieves 80% power at a 0.05 significance level to detect the X-Z interaction odds ratio
of 1.5. Calculations assume that a two-sided Wald test is used.
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IRB_00123563
- Request for Waiver of Consent
IRB_00123563
Created: 6/5/2019 3:01
PM
 
PI: Kimberly
Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and
Delivery of Genetic Services
 
Request for Waiver or Alteration of Consent
* Requested Waivers
 
Date Created
Type of Request
Purpose of Waiver Request
View 3/18/2019
Waiver of Informed Consent
Wavier of consent for chart review without patient contact
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IRB_00123563
IRB Smart Form
IRB_00123563
Created: 6/5/2019 3:01 PM  
PI: Kimberly Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and Delivery of Genetic
Services
 
Request for Waiver or Alteration of Consent
1. Purpose of the Waiver Request:
Wavier of consent for chart review without patient contact
2. Type of Request:
Waiver of Informed Consent
3. List the identifying information you plan to collect or keep a link to (e.g.
names, dates, or identification numbers such as social security
numbers or medical record numbers, etc.).
Name and contact information
Demographics
Race/ethnicity
Prior referral to genetic counseling
Family history
Genetic counseling and testing
Primary care provider
Date of last appointment
History of reading and responding to messages via the patient portal
Other health conditions
Identifiers will be deleted from the research record, but we will keep the other
information used in planning patient recruitment in order to compare
differences between those who did and did not participate in the research
questionnaires.
4. Explain why the research could not be practicably conducted without
using identifiable information. Examples of such explanation could
include the following:
Identifiable information is needed to determine health outcomes in regards to
genetic delivery services, in alignment with the research aims.
5. Explain why the research could not practicably be conducted without
the waiver or alteration.  For example, complete the following sentence
"If I had to obtain consent, the research could not be conducted
because...":
The investigators would be unable to answer the research question if consent
were necessary for chart review without any patient contact. In addition the
time for staff to obtain consent to review the EHR would be inefficient for
practicable analysis of how genetic delivery impacts primary care.
6. Explain why the research and privacy risk of the research are no more
than minimal:
Because the review of the patient's electronic heath records is specific in data
abstraction and will be hosted on secure university servers. Breach of
confidentially is a risk, but minimal and unlikely.
7. Describe the measures you will take to ensure the waiver or alteration
will not adversely affect the rights and welfare of the subjects:
The information to be collected is standard of care and research use of such
information will not alter care received.
8. Explain how you will, if applicable and appropriate, provide the subjects
with additional pertinent information after they have participated in the
study, or indicate "Not applicable":
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Not applicable
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IRB_00123563
- Consent Process
IRB_00123563
Created: 6/5/2019 3:01 PM  
PI: Kimberly Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and Delivery of
Genetic Services
 
Consent Process
1. The following investigators and internal staff will obtain consent (as indicated on the Study Location and
Sponsors Page):
Jo Anson
University of Utah
Whitney Espinel
University of Utah
Amanda Gammon
University of Utah
Kinley Garfield
University of Utah
Samantha Greenberg
University of Utah
Kelsi Hagerty
University of Utah
Kadyn Kimball
University of Utah
Wendy Kohlmann
University of Utah
Cathryn Koptiuch
University of Utah
Ryan Mooney
University of Utah
Katie Tobik
University of Utah
Jennie Vagher
University of Utah
List by name, role, and affiliation any others who will obtain consent (e.g. Dr. John Smith, Co-Investigator, etc.).
Jo Anson, Kadyn Kimball-study coordinator
Kelsi Hagerty, Ryan Mooney, Katie Tobik-genetic counseling assistant(s)
Wendy Kohlmann, Co-I, senior genetic counselor
HCI Genetic Counseling Shared Resource (GCSR) Team:
Whitney Espinel
Amanda Gammon
Kinley Garfield
Samantha Greenberg
Cathryn Koptiuch
All are certified, licensed genetic counselors who will conduct all genetic counseling following the standard FCAC
clinical practices.
2. Describe the location(s) where consent will be obtained.
Consent will be obtained electronically via the web-based patient portal
3. Describe the consent process(es), including the timing of consent. Describe whether there is a waiting period
between the consent process and obtaining consent from the participant (i.e., any time between informing
participants and actually obtaining consent).
Patients who receive genetic services, whether or not they decide to test, will be sent the consent cover letter via patient
portal inviting them to participate in the research procedures, with a link to an online questionnaire. The consent cover
letter will be sent 4 weeks after genetic test results are returned for those who decide to test and about 8 weeks after
participation in pre-test genetic counseling services for those who decide not to test. If no response is received to the
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first message, after 1 week another message in the patient portal will be sent. If still no response up to 3 phone calls will
be made.
4. Describe what measures will be taken to minimize the possibility of coercion or undue influence.
The consent cover letter will explain to the patient that not participating in this study will have no effect on the clinical
care they receive.
5. Describe the provisions that are made to allow adequate time to exchange information and questions between
the investigator and participant.
Participants are encouraged to ask questions and are given the contact information for Dr. Kaphingst (one of the
Principal Investigators) if any questions or concerns come up after the introduction of the study.
6. Will a legally authorized representative (LAR) be used?
  Yes No
7. Will a language other than English be used to obtain consent?
  Yes No
8. Are you requesting that documentation of informed consent be waived by the IRB (a consent process in place,
but no documentation of consent, e.g. questionnaire cover letter, web-based consent, consent without
signature, etc.)?
  Yes No
If yes, complete the following:
a. Explain why the waiver of consent documentation is being requested.
The research procedures in the study are two follow-up questionnaires. These procedures present no more than
minimal risk of harm to subjects and involve no procedures for which consent is normally required outside of the
research context.
 
b. Justification for the waiver is one of the following:
The research presents no more than minimal risk of harm to subjects and involves no procedures for which written
consent is normally required outside of the research context.
 
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IRB_00123563
5. Data Monitoring
IRB_00123563
Created: 6/5/2019 3:01 PM  
PI: Kimberly Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and Delivery of
Genetic Services
 
5. Data Monitoring Plan
1. Privacy Protections: Privacy refers to persons and to their interest in controlling access of others to themselves. Privacy
can be defined in terms of having control over the extent, timing and circumstances of sharing oneself (physically,
behaviorally, or intellectually) with others. What precautions will be used to ensure subject privacy is protected?
 
Select all that apply:
The research intervention is conducted in a private place
The collection of information about participants is limited to the amount necessary to achieve the aims of the research, so
that no unneeded information is being collected
De-identification of photos, audio tapes, or video tapes of the participant that will be made during the study
 
 Other or additional details (specify):
All EHR and questionnaire data collected as part of the study will be computerized, maintained, and secured in a local
database at either UU or NYU with password protection (at both the system and file levels). Any hardcopy data
gathered will be stored in secure rooms or locked filing cabinets.
Under the direction of Dr. Kaphingst at UU and Dr. Ginsburg at NYU, all data will be safeguarded and identifiable data
will be accessible only by individuals involved in the research project on a need-to-know basis. Personally identifying
contact information (e.g., name, email addresses, mailing addresses) will be kept in a separate, password-protected
file. No names will be used on any data representations; identifying data are only available to and used by the
individuals involved in contacting and/ or counseling the study subjects. Data sent from NYU to UU for analysis will be
de-identified. Any identifying material that is no longer needed will be shredded.
Consistent with the NCI Cancer Moonshot Public Access and Data Sharing Policy, we will share de-identified, non-
genomic individual-level data with a data repository such as the Cancer Epidemiology Data Repository (CEDR).
Underlying primary data will be de-identified according to the standards set forth in the HHS Regulations for the
Protection of Human Subjects to ensure that the identities of research subjects cannot be readily ascertained with the
data and will be stripped of identifiers according to the HIPAA Privacy Rule. The consent document will describe sharing
of de-identified individual-level human subjects data with the data repository and researchers at other institutions.
Participants will be told that they do not have to answer any questionnaire items that make them uncomfortable.
2. Confidentiality Precautions: Confidentiality is an extension of the concept of privacy; it refers to the subject's
understanding of, and agreement to, the ways identifiable information will be stored and shared. Identifiable information
can be printed information, electronic information or visual information such as photographs. What precautions will be
used to maintain the confidentiality of identifiable information?
 
Select all that apply:
Storing research data on password protected computers or in locked cabinets or offices
Participant identifiers will be stored separately from the coded, participant data
 
 Other or additional details (specify):
All EHR and questionnaire data collected as part of the study will be computerized, maintained, and secured in a local
database at either UU or NYU with password protection (at both the system and file levels). Any hardcopy data
gathered will be stored in secure rooms or locked filing cabinets.
Under the direction of Dr. Kaphingst at UU and Dr. Ginsburg at NYU, all data will be safeguarded and identifiable data
will be accessible only by individuals involved in the research project on a need-to-know basis. Personally identifying
contact information (e.g., name, email addresses, mailing addresses) will be kept in a separate, password-protected
file. No names will be used on any data representations; identifying data are only available to and used by the
individuals involved in contacting and/ or counseling the study subjects. Data sent from NYU to UU for analysis will be
de-identified. Any identifying material that is no longer needed will be shredded.
Consistent with the NCI Cancer Moonshot Public Access and Data Sharing Policy, we will share de-identified, non-
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genomic individual-level data with a data repository such as the Cancer Epidemiology Data Repository (CEDR).
Underlying primary data will be de-identified according to the standards set forth in the HHS Regulations for the
Protection of Human Subjects to ensure that the identities of research subjects cannot be readily ascertained with the
data and will be stripped of identifiers according to the HIPAA Privacy Rule. The consent document will describe sharing
of de-identified individual-level human subjects data with the data repository and researchers at other institutions.
Participants will be told that they do not have to answer any questionnaire items that make them uncomfortable.
3. Will photos, audio recordings, or video recordings, or medical images of participants be made
during the study?
  Yes No
 
 If yes, describe the recording/images and what will become of them after creation (e.g.,
shown at scientific meetings, stored in the medical/research record, transcribed, erased,
etc.):
For any patients who would like to complete questionnaires by telephone, a genetic counseling assistant or research
coordinator will administer the questionnaire. Calls will be digitally recorded to allow for analysis of comprehension.
These digital recordings will be stored in the research record and erased at the end of the study.
4. How will study data and documentation be monitored throughout the study?
 
Select all that apply:
Periodic review and confirmation of participant eligibility
Periodic review of the transfer/transcription of data from the original source to the research record
 
 Other additional details (specify):
5. Who will be the primary monitor of the study data and documentation?
 
Select all that apply:
Principal Investigator
Study Coordinator or Research Nurse
Other or additional details (specify):
 
 Other or additional details (specify):
HCI Population Sciences Regulatory Team, working with Dr. Kaphingst and the Study Coordinator at Utah
6. How often is study data and documentation monitoring planned (e.g., monthly, twice a year,
annually, after N participants are enrolled, etc.)?
annually
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IRB_00123563
6. Risks and Benefits
IRB_00123563
Created: 6/5/2019 3:01 PM  
PI: Kimberly Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and Delivery of
Genetic Services
 
6. Risks and Beneﬁts
1. Describe the reasonable foreseeable risks or discomforts to the participants:
The risks of this study are minimal. The participant may feel upset thinking about or talking about personal information
related to genetic testing. These risks are similar to the experience when discussing personal information with others. 
Some questions could make participants feel distressed or uncomfortable.
2. Describe the potential benefits to society AND to participants (do not include compensation):
Participants may receive some benefit from this research. They may learn more about any inherited cancer risks. The
potential benefit to society is to allow us to understand whether a CDS infrastructure can improve identification of primary
care patients who may qualify for genetic risk assessment, and whether a patient-directed standard of care model to
cancer genetic services delivery has equivalent outcomes to an enhanced standard of care model.
3. Are there any costs to the participants from participation in research?
  Yes No
 
 
If yes, specify:
4. Is there any compensation to the participants?
  Yes No
 
a.
If yes, answer the following:
Specify overall amount:
Participants who return the questionnaires at week 4 and at month 12 will be compensated for each individual
questionnaire.
 
b. Specify when participants will be paid (e.g. at each visit, at end of study, etc.):
A $10 gift card will be sent to participants once a questionnaire has been received back.
 
c. If applicable, please specify payment by visit or other time interval (e.g. $10 per visit, etc.):
$10 per questionnaire, for a maximum compensation of $20.
 
d. If applicable, explain plan for prorating payments if participant does not complete the study:
Will not prorate compensation.
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IRB_00123563
7. HIPAA & the Covered Entity
IRB_00123563
Created: 6/5/2019 3:01
PM
 
PI: Kimberly
Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and Delivery
of Genetic Services
 
7. HIPAA and the Covered Entity
1. Does this study involve Protected Health Information (PHI) or de-identified health
information?
  Yes No
a. Select the method(s) of authorization that will be used:
Waiver or Alteration of Authorization
Limited data set
De-identified
Select the method of de-identification:  Safe Harbor De-Identification
b. Will PHI be disclosed outside the Covered Entity?
  Yes No
To whom?
NIH/NCI
And for what purposes?
To follow the Cancer Moonshot Public Access and Data Sharing Policy and other regulatory needs.
Does this study involve any of the following:
2. The investigational use of a drug?
  Yes No
Mark yes, for an expanded access application.
 
3. The investigational use of a medical device or humanitarian use device?
  Yes No
Mark yes, for an expanded access application. 
4. The investigational use of a dietary supplement, food, or cosmetic?
  Yes No  
5. Is this an investigator-initiated drug or device trial lead by the Principal Investigator'
  Yes No 
All investigator-initiated drug or device trials are required to have a full research protocol attached to the Documents
and Attachments page.
 
6. Will this study involve the use of an imaging modality from the department of Radiology?
  Yes No 
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7. Exposure to radioisotopes or ionizing radiation?
  Yes No
8. Genetic testing and/or analysis of genetic data?
  Yes No
9. Creating or sending data and/or samples to a repository to be saved for future research
uses?
  Yes No
10. Are you:
Collecting samples of blood, organs or tissues from participants for research purposes;  
Introducing Recombinant or Synthetic Nucleic Acids (e.g. viral vectors, oligonucleotides) or cells
containing recombinant nucleic acids (e.g. CAR-T) into participants; OR  
Introducing other biological materials (e.g. bacteria, viruses) into participants.  
  Yes No
11. Does this study involve any of the following?
Cancer Patients
Cancer Hypothesis
Cancer risk reduction
Cancer prevention
  Yes No
12. Any component of the Clinical and Translational Science Institute (CTSI)?
  Yes No
The Clinical Research Center (CRC)?
  Yes No
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IRB_00123563
- Request for Waiver of Authorization
IRB_00123563
Created: 6/5/2019
3:01 PM
 
PI: Kimberly
Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and
Delivery of Genetic Services
 
Request for Waiver or Alteration of Authorization
 
Request for Waiver of Authorization for Recruitment Only
This option must only be used if you are reviewing PHI in order to identify eligible participants BEFORE approaching them to obtain consent and
authorization.  All other waiver requests must be entered below.
Waiver of Authorization for Recruitment Requested
Other Requests for Waivers of Authorization:
 
Click "Add" below to add a new waiver request to this application.
Click the waiver name link to edit a waiver that has already been created.
To delete a waiver request, contact the IRB.
 
Date
Created
Type of
Request
Purpose of Waiver Request
View 2/21/2019 Waiver of
Authorization
Waver of Authorization for access to EHR for chart review of patients that are identified by
CDS tool for inclusion/exclusion criteria. This would be to track patients utilizing genetic
services up to 24 months to assess the impact of genetic services on their health and/or
health decisions.
View 3/18/2019 Waiver of
Authorization
Wavier of authorization to not include authorization language in the consent cover letter.
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IRB_00123563
Waiver of Authorization for Recruitment Only
IRB_00123563
Created: 6/5/2019
3:01 PM
 
PI: Kimberly
Kaphingst ScD
Submitted:
3/5/2019
 
Title: Broadening the Reach, Impact,
and Delivery of Genetic Services
 
Request for Waiver or Alteration of Authorization
Request for Waiver of Authorization for Recruitment Only
 
The PI must agree to the terms of this waiver request as described on this page. 
When the PI uses the “Submit” activity to submit the application for IRB review, a
checkbox to accept the terms will be available in the “Submit” activity window.
This waiver request includes justification for waivers of consent for recruitment
only, according to 45 CFR 46.116(d).
 
Terms for the Waiver of Authorization:
 
·       The purpose of this waiver of authorization is to allow for the use of PHI in
order to identify and recruit individuals who may be eligible to participate in
the specific research described in this IRB application.  The waiver of
authorization is necessary to accommodate this minimal-risk research
activity prior to seeking a full authorization from research participants.
·       Methods for identifying individuals may include the following:
o   Reviewing medical charts
o   Reviewing databases that include PHI
o   Reviewing other medical- or health-based documents that include PHI
·       Identifiable information used under this waiver may include the following, as
this is the minimum necessary for identifying eligible individuals:
o   Name
o   Contact information, such as phone number, address, or email address
o   An ID number, such as MRN or SSN
o   Date of birth
o   Medical and health information that may determine study eligibility
·       Any PHI recorded by the study team will only be used for recruitment and
determining study eligibility.  After this has been completed, the PHI must be
removed from the research record or destroyed, unless the participants have
given authorization for continued use of the PHI.
·       PHI will only be viewed by approved members of the study team and will not
be disclosed for research purposes to any individual or institution without the
participants’ authorization for such use and disclosure of the PHI.
·       PHI will be stored in a secure manner according to HIPAA privacy and
security provisions.
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IRB_00123563
IRB Smart Form
IRB_00123563
Created: 6/5/2019 3:01 PM  
PI: Kimberly Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and Delivery of Genetic
Services
 
Request for Waiver or Alteration of Authorization
1. Purpose of the Waiver Request:
Waver of Authorization for access to EHR for chart review of patients that are
identified by CDS tool for inclusion/exclusion criteria. This would be to track
patients utilizing genetic services up to 24 months to assess the impact of genetic
services on their health and/or health decisions.
2. Type of Request:
Waiver of Authorization
3. List the identifying information you plan to collect or keep a link
to (e.g. names, dates, or identification numbers such as social
security numbers or medical record numbers, etc).
We would like to collect the following information on patients identified to meet
criteria in order to determine eligibility, invite them to participate, and to be able to
compare those who participate and those who decline:
Name and contact information
Demographics
Race/ethnicity
Prior referral to genetic counseling
Family history
Genetic counseling and testing
Primary care provider
Date of last appointment
History of reading and responding to messages via the patient portal
Other health conditions
Identifiers will be deleted from the research record, but we will keep the other
information used in planning patient recruitment in order to compare differences
between those who did and did not participate in the research questionnaires.
4. Explain why the PHI to be used or disclosed is the minimum
necessary to accomplish the research objectives:
The PHI data will be used only better define which populations are utilizing genetic
services, and if different delivery models impact a patient's health or their primary
care decisions.
5. Explain why the research could not practicably be conducted
without the waiver of authorization. For example, complete the
following sentence: "If I had to obtain authorization, the research
could not be conducted because..."
The research could not be conducted because there is no other non-intrusive or
unbiased way to determine patient adherence to recommendations from the
genetic services.
Study team requests authorization to access patient EHR who participate in
genetic services. If not, no insights can be gained to determine the efficacy of
genetic services in different patient populations, as well as the impact of genetic
counseling, testing and education in collaboration with primary care.
6. Describe your plan to protect the identifiers from improper use
and disclosure, and indicate where the PHI will be stored and
who will have access:
Study team will work closely with HCI FCAC genetic counselors and genetic
counseling assistants to minimize PHI used in the research record. Unique
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participant identifiers will be used as name-holders.
Only authorized personnel listed on this IRB application, with updated trainings,
will have access to study data and tracking methods.
7. The identifiers must be destroyed at the earliest opportunity
consistent with conduct of the research, unless there is a health
or research justification for retaining the identifiers or such
retention is otherwise required by law. Describe how and when
you will destroy the identifiers, or justify their retention:
PHI identifiers will be destroyed at the end of this study, when the IRB is fully
closed to research activity.
8. Describe the measures you will take to ensure the PHI will not
be reused or disclosed to any other person or entity, except as
required by law, for authorized oversight of the research study,
or for other research approved by the IRB:
Only individuals listed on the IRB will access patient EHR, and associated study
records kept for research aims.
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IRB_00123563
IRB Smart Form
IRB_00123563
Created: 6/5/2019 3:01 PM  
PI: Kimberly Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and Delivery of Genetic
Services
 
Request for Waiver or Alteration of Authorization
1. Purpose of the Waiver Request:
Wavier of authorization to not include authorization language in the consent cover
letter.
2. Type of Request:
Waiver of Authorization
3. List the identifying information you plan to collect or keep a link
to (e.g. names, dates, or identification numbers such as social
security numbers or medical record numbers, etc).
Name and contact information
Demographics
Race/ethnicity
Prior referral to genetic counseling
Family history
Genetic counseling and testing
Primary care provider
Date of last appointment
History of reading and responding to messages via the patient portal
Other health conditions
4. Explain why the PHI to be used or disclosed is the minimum
necessary to accomplish the research objectives:
The PHI data will be used only better define which populations are utilizing genetic
services, and if different delivery models impact a patient's health or their primary
care decisions.
5. Explain why the research could not practicably be conducted
without the waiver of authorization. For example, complete the
following sentence: "If I had to obtain authorization, the research
could not be conducted because..."
The research could not be conducted because there is no other non-intrusive or
unbiased way to determine patient adherence to recommendations from the
genetic services.
Study team requests authorization to access patient EHR who participate in
genetic services. If not, no insights can be gained to determine the efficacy of
genetic services in different patient populations, as well as the impact of genetic
counseling, testing and education in collaboration with primary care.
6. Describe your plan to protect the identifiers from improper use
and disclosure, and indicate where the PHI will be stored and
who will have access:
Study team will work closely with HCI FCAC genetic counselors and genetic
counseling assistants to minimize PHI used in the research record. Unique
participant identifiers will be used as name-holders.
Only authorized personnel listed on this IRB application, with updated trainings,
will have access to study data and tracking methods.
7. The identifiers must be destroyed at the earliest opportunity
consistent with conduct of the research, unless there is a health
or research justification for retaining the identifiers or such
retention is otherwise required by law. Describe how and when
you will destroy the identifiers, or justify their retention:
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PHI identifiers will be destroyed at the end of this study, when the IRB is fully
closed to research activity.
8. Describe the measures you will take to ensure the PHI will not
be reused or disclosed to any other person or entity, except as
required by law, for authorized oversight of the research study,
or for other research approved by the IRB:
Only individuals listed on the IRB will access patient EHR, and associated study
records kept for research aims.
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IRB_00123563
- - Information for Accounting of Disclosures
IRB_00123563
Created: 6/5/2019
3:01 PM
 
PI: Kimberly
Kaphingst ScD
Submitted:
3/5/2019
 
Title: Broadening the Reach, Impact, and
Delivery of Genetic Services
 
Information for Accounting of Disclosures
 
1. Earliest planned date of disclosure:  7/1/2019
2. Latest planned date of disclosure:  3/1/2025
3. Name and address of the entity or person outside of the Covered Entity who will receive the
Protected Health Information:
National Cancer Institute
4. A brief description of the PHI disclosed:
Whatever information is requested under the Moonshot Underlying Primary Data Policy. The NCI defines underlying
primary data as: "recorded factual material commonly accepted in the scientific community as necessary to document and
support research findings in Publications."
5. A brief statement of the purpose of the disclosure that reasonably informs the individual whose
information is disclosed of the basis for the disclosure:
To follow the Cancer Moonshot Public Access and Data Sharing Policy and other regulatory needs.
https://www.cancer.gov/research/key-initiatives/moonshot-cancer-initiative/funding/public-access-policy?redirect=true
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IRB_00123563
- Limited Data Set Agreement
IRB_00123563
Created: 6/5/2019 3:01
PM
 
PI: Kimberly
Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and Delivery
of Genetic Services
 
Limited Data Set Statement and Assurance
This assurance applies to the following part(s) of this study (select all that apply):

All of the information used or
disclosed in this study
 

The information received or
collected from these sources:
New York University

The information shared with or
disclosed to these groups:
New York University
Data Use Assurance:
1. As an employee of the University of Utah and the Principal Investigator for the attached study, I understand that I must
comply with the requirements below regarding the permitted uses and disclosure of the limited data set I am receiving
from the University.
2. I have described the limited data set with specificity in the Protocol submitted with this form.
3. I have described who will be permitted to use or receive the limited data set in the same Protocol.
4. If I am disclosing the limited data set outside the Covered Entity, I am submitting, in addition to this form, a Limited Data
Set Statement and Assurance (if the recipient is within the University of Utah) or a Data Use Agreement (if the recipient
is outside the University of Utah) signed by an individual able to bind the entity receiving the limited data set.
5. I understand that the use of the limited data set is governed by federal law (45 CFR Parts 160 and 164, particularly
164.514(e)).
6. I agree to the following:
a. I will only use or disclose the information as described or permitted in the Protocol, or as permitted in writing by
the Institutional Review Board; 
b. I will use appropriate safeguards, which I have described in the Protocol, to prevent use or disclosure of the
information in any ways outside the Protocol or as permitted in writing by the Institutional Review Board; 
c. I will promptly report to the IRB any use or disclosure of the information not provided for in the Protocol; 
d. I will take all reasonable measures to ensure that any agents, including any subcontractors, to whom I provide the
limited data set will follow the same restrictions and conditions regarding that information that I have set forth in
the Protocol, and will report any violations to the Institutional Review Board (801 581-3655); and 
e. I will not attempt to identify the information and will not contact the individuals. 
Limited Data Set Statement.
I declare that none of the following types of information, regarding subjects or relatives, employers, or household members of
subjects, are used in this study:
1. Names;
2. Postal address information (but town or city, State, and zip code may be kept);
3. Telephone numbers;
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4. Fax numbers;
5. Electronic mail addresses;
6. Social security numbers;
7. Medical record numbers;
8. Health plan beneficiary numbers;
9. Account numbers;
10. Certificate/license numbers;
11. Vehicle identifiers and serial numbers, including license plate numbers;
12. Device identifiers and serial numbers;
13. Web Universal Resource Locators (URLs);
14. Internet Protocol (IP) address numbers;
15. Biometric identifiers, including finger and voice prints; and
16. Full face photographic images and any comparable images.
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IRB_00123563
- Safe Harbor De-Identification Agreement
IRB_00123563
Created: 6/5/2019
3:01 PM
 
PI: Kimberly
Kaphingst ScD
Submitted:
3/5/2019
 
Title: Broadening the Reach, Impact, and
Delivery of Genetic Services
 
Safe Harbor De-Identiﬁcation
1. This declaration applies to the following part(s) of this study:
A. All of the information used
or disclosed in this study.
 
B. 
The information received or
collected from these
sources:
C. 
The information shared with
or disclosed to these
groups:
CEDR: Cancer Epidemiology Data Repository
2. As the principal investigator for this study, I declare the following:
1. To the best of my knowledge, the information could not be used (alone or with other information) to identify an
individual who is a subject of the information, and
2. None of the following types of information, regarding subjects or relatives, employers, or household members of
subjects, are used or disclosed in the part of this study indicated above:
a. Names;
b. All geographic identifiers except state or the first three digits of a zip code (however, all data from the following
17 3-digit zips are combined together under "000": 036, 059, 063, 102, 203, 556, 692, 790, 821, 823, 830, 831,
878, 879, 884, 890, and 893)
c. The month and day (the year can be kept) from all dates directly related to an individual, including birth date,
admission date, discharge date, date of death. Ages over 89 are combined in a single category of "Age 90 and
older."
d. Telephone numbers;
e. Fax numbers;
f. Electronic mail addresses;
g. Social security numbers;
h. Medical record numbers;
i. Health plan beneficiary numbers;
j. Account numbers;
k. Certificate/license numbers;
l. Vehicle identifiers and serial numbers, including license plate numbers;
m. Device identifiers and serial numbers;
n. Web Universal Resource Locators (URLs);
o. Internet Protocol (IP) address numbers;
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p. Biometric identifiers, including finger and voice prints;
q. Full face photographic images and any comparable images; and,
r. Any other unique identifying number, characteristic, or code, except as permitted for re-identification.
3. If I assign a code or other means of record identification to allow de-identified information to be re-identified,
1. The code or other means of record identification is not derived from or related to information about the individual
and is not otherwise capable of being translated so as to identify the individual, and
2. I will not use or disclose the code or other means of record identification for any purpose other than re-identification,
and I will not disclose the mechanism for re-identification.
4. Before I allow a code to be used to re-identify this information,
1. If the purpose of the re-identification is within the scope of the original protocol, I will obtain approval of an
amendment from the IRB and comply with the requirements of HIPAA; or
2. If the purpose of the re-identification is outside the scope of the original protocol, I will submit a full New Study
Application, obtain IRB approval, and comply with the requirements of HIPAA.
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IRB_00123563
8. Resources and Responsibilities
IRB_00123563
Created: 6/5/2019
3:01 PM
 
PI: Kimberly
Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and
Delivery of Genetic Services
 
8. Resources and Responsibilities
1. * State and justify the qualifications of the study staff:
Drs. Saundra Buys and Kimberly Kaphingst will serve as Principal Investigators, with Kenneth Boucher and Wendy Kohlmann as Co-
Investigators at Utah. 
The Genetic Counseling Shared Resource will provide the genetic counseling and related services at Utah for the study; the Director, Ms.
Kohlmann, of the GCSR is a PI. 
The Cancer Biostatistics Shared Resource will conduct the quantitative analyses at Utah.
Study and research coordinators with appropriate CITI training will be involved as well. 
2. * Describe the training that study staff and investigators will receive in order to be informed
about the protocol and understand their research-related duties and functions:
All investigators and study staff will complete required human subjects training.  They will meet regularly with Dr. Kaphingst (PI) to
discuss study progress. The Population Sciences Trials Office at HCI will train study staff on regulatory requirements and conduct of the
research study.
3. * Describe the facilities where the research activities will be performed (e.g. hospitals,
clinics, laboratories, classrooms/schools, offices, tissue banks, etc.).
Secure offices at Huntsman Cancer Institute, secure offices at New York University, locations where patients opt to access their patient
portal
4. * Describe the medical or psychological resources available at this site (and other
participating sites, if applicable) that participants might require as a consequence of the
research. If not applicable, please state.
Genetic counselors will be available to answer any participant questions.
5. * How will adverse events, unanticipated problems, interim results, and changes to the
research be communicated between the participating sites and the Principal Investigator?
Regular bi-weekly study meetings between main site (Utah) and the participating site (NYU).
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IRB_00123563
Documents and Attachments
IRB_00123563
Created: 6/5/2019 3:01
PM
 
PI: Kimberly
Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and Delivery
of Genetic Services
 
Documents and Attachments
If any of your documents (such as investigational brochures, sponsor protocols, advertisements, etc.) are not available in an electronic format, please scan
and save them as PDF files or contact our office for assistance.
Naming Documents: Please use the title field to clearly indicate the content of each form. The name you enter will be listed on your approval letter. Use
names that will differentiate from earlier versions.
Examples:
Consent Document Control Group 04/14/05
Consent Document Treatment Group 4/14/05
Sponsor Protocol 04/14/05 Version 2
Assent Document(Highlighted Changes)
Apple/Macintosh Users:MS Word documents must have a .doc file extension. See ERICA home page for instructions.
Print View: IRB Draft Protocol Summary
eProtocol Summary:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Consent Documents, Consent Cover Letters, Consent Information Sheets, Consent Scripts, etc.:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Parental Permission Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Assent Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
VA Consent Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Surveys, Questionnaires, Interview Scripts, etc.:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Full Protocol (company protocol, sponsor protocol, investigator-initiated protocol, etc.):
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Investigational Brochure (IB) for Investigational Drug or Drug/Device Package Insert:
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Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Grant Application:
The Federal Government is a direct or indirect sponsor of your research. You are required to provide a copy of the grant
proposal, grant award, or sub-award.
By submitting to the IRB, you are confirming the grant and the study protocol are consistent (Design, Study Population,
Study Objectives and Goals, Test Interventions and Procedures, etc.)
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Literature Cited/References:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Principal Investigator's Scholarly Record (CV/Resume):
Name
Version Date Created
Date Modified
Date Approved
Kaphingst CV(0.04)
0.04
4/2/2015 12:18 PM
8/27/2018 3:25 PM
 
Faculty Sponsor's Scholarly Record (CV/Resume):
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Other Stamped Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Recruitment Materials, Advertisements, etc.:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Other Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
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IRB_00123563
- HCI PRMC
Huntsman Cancer Institute
Protocol Review and Monitoring Committee (PRMC)
New Project Cover Sheet
HCI Clinical Trials Office
PRMC@hci.utah.edu
(801) 585-6746
IRB_00123563
Created: 6/5/2019 3:01 PM  
PI: Kimberly Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and Delivery of Genetic
Services
 
HCI PRMC
Date: 6/5/2019 3:01 PM
Principal Investigator: Kimberly Kaphingst
Department: COMMUNICATION
Site Staff and Enrollment:
Site Name
Investigator
Staff
Enrollment Number
NYU School of Medicine
 
 
Not Answered
University of Utah
Kimberly Kaphingst
Priyanka Kanth
Sarah Colonna
Ryan Mooney
Whitney Espinel
Saundra Buys
Jennie Vagher
Katie Tobik
Samantha Greenberg
Kenneth Boucher
Wendy Kohlmann
Kadyn Kimball
Amanda Gammon
David Wetter
Kinley Garfield
Kensaku Kawamoto
Cathryn Koptiuch
Anne Naumer
Jo Anson
Kelsi Hagerty
Joshua Schiffman
Not Answered
Total number of subjects enrolled at the University of Utah in all years prior to October 2019: 960
consent cover letters sent; up to 20,000 EHR records
Title:Broadening the Reach, Impact, and Delivery of Genetic Services
 
The PRMC is charged with the review of the scientific merit, priorities, and progress of cancer research at the University of Utah.
What type of Clinical Research is this?
Health services research: Protocol designed to evaluate the delivery, processes, management, organization, or financing of
health care.
Multicenter Study: 
Yes
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IRB_00123563
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Coordinating Center or Organization:
Huntsman Cancer Institute
Project Funding:
 
Sponsor
Sponsor Type
Sponsor Contact Information
Prime
Sponsor
Prime Sponsor
Type
OrgID
View NIH NATIONAL CANCER
INSTITUTE
Federal
Government
NCI Grants Management Specialist:
Kimery Griffin
Email: griffink3@mail.nih.gov
Phone: 240-276-6315
 
 
11259
Has the Funding Source granted approval to conduct this study:
Approved
1. Clinical Research Category (Select One):
Observational (OBS)
2. Primary Purpose of the Research (Select One):
Health Services Research (HSR)
3. Study Source (Select One):
Externally Peer-Reviewed: R01s, SPORES, U01s, U10s, P01s, CTEP, or any other clinical research study
mechanism supported by the NIH or affiliate organizations (click HELP button for a full list)
4. Study Model Code (Select One):
5. Time Perspective Code (Select One):
6. Have project statistics been reviewed by a statistician:
7. How will accrual and demographic information be tracked:
REDCap
8. Does this study target a Rare Disease (meaning it targets a cancer with an incident rate of =
< 3 per 100,000 per year):
  Yes No  
 
9. Number of subjects to be enrolled at the University of Utah in year 1:
380  
 
10. Estimated number of potentially eligible subjects seen at the University in the past year:
500  
 
11. Source of data (e.g. CTRG estimate, cancer registry, clinic stats, TriNetX etc.):
FCAC clinic stats  
 
12. Estimated time (in months) for full accrual at the University of Utah:
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2.5 years  
 
13. Is this study run through the HCI Clinical Trials Office:
No  
14. Department overseeing this research:
Comments:
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IRB_00123563
IRB Smart Form - Read Only
IRB_00123563
Created: 6/5/2019 3:01
PM
 
PI: Kimberly
Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and Delivery
of Genetic Services
 
Sponsor Information
 
a. Sponsor:
NIH NATIONAL CANCER INSTITUTE
b. Sponsor Contact Information:
Address, phone number, fax number used for event reporting and study
correspondence.
NCI Grants Management Specialist: Kimery Griffin
Email: griffink3@mail.nih.gov
Phone: 240-276-6315
c.
If the funding type is "Federal Agency, or federal flow through",
provide the following information:
 
 Grant Number:
1U01CA232826
 
 Grant Awardee (Institution and Investigator):
University of Utah (lead) and NYU
Principal Investigators: Saundra Buys and Kimberly Kaphingst (Utah);
Ophira Ginsburg (NYU)
 
 Effective Start Date:  9/1/2018
 
 Effective End Date:  8/31/2023
 
 If the grant has been awarded to the University of Utah, please attach a
copy of the grant application to the Documents and Attachments page.
d. Are you working on this study with the University of Utah
Office of Sponsored Projects to obtain this funding?
Yes
 
 If no, please explain:
 
 A contract with the Office of Sponsored Projects may be required even if
you are not receiving direct funds. Any relationship with an outside entity
should be discussed with OSP:
Main Campus OSP: 801.581.6903
UUHSC OSP: 801.581.8949
VAMC OSP: 801.582.1565 x4866
8/6/24, 10:49 AM
IRB_00123563
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IRB_00123563 Finish
IRB_00123563
Created: 6/5/2019 3:01 PM  
PI: Kimberly Kaphingst ScD
Submitted: 3/5/2019  
Title: Broadening the Reach, Impact, and Delivery of Genetic
Services
 
Finish Instructions
 
Finish Instructions
1. To view errors, select the "Validate" option at the top-left of the page. If you have errors on your application,
you won't be able to submit it to the IRB.
2. Selecting the Finish button will NOT submit the application to the IRB.
You MUST select the "Submit" option on the workspace once you've selected the "Finish" button.
3. If your study has a faculty sponsor: Once the PI submits the application, it will be sent to the faculty sponsor
for final approval. The IRB cannot review the study until the faculty sponsor submits the application to the IRB.
 
8/6/24, 10:49 AM
IRB_00123563
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Date: Monday, May 4, 2020 9:30:11 PM
Print
Close
IRB_00115509 - CR_3/9/2020 2:18 PM
Created: 3/9/2020 2:18 PM  
PI: Kimberly Kaphingst
Submitted: 3/23/2020  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
1. Status
Overall, what is the enrollment status for this study?
Open to enrollment of new participants
IRB_00115509 - CR_3/9/2020 2:18 PM
Created: 3/9/2020 2:18 PM  
PI: Kimberly Kaphingst
Submitted: 3/23/2020  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
2. Progress of Study and Enrollment Information
Overall Study Enrollment Progress
Number of currently approved
enrollments for this study as a whole:
1,920 consent cover letters sent; up
to 20,000 EHR records
 
Number enrolled across all sites as of today೦s date:0
 
Describe the progress of the study, observations of the participants studied, and reason(s) for
continuing the study:
Progress for this study remains ongoing although delayed by the technical implementation timeline.
Enrollment at the Utah site is expected to commence in April with NYU enrollment projected to
begin in June.
The study team has completed building questionnaires in RedCap and is prepared to begin enrollment
once patients have completed the necessary clinical procedures.
 
What results (preliminary or final) have been obtained from the study? If the study is part of a
multi-center trial, this should be stated and any available results provided. If there are no
results that are appropriate to report to the IRB at this time, this should be stated and
explained:
Because this study has not enrolled any participants, there are no results to disclose at this point.  
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Please attach any abstracts or publications:
NameVersionDate CreatedDate ModifiedDate Approved
There are no items to display
Describe participant enrollment and its effect on the study design and scientific merit. If under-
accrued, describe any plans for increasing enrollment during the next approval period. If a
multicenter trial, also discuss enrollment at other sites.
This study has no participants enrolled. Enrollment is expected to begin at Utah in April and at NYU
in June.
 
 
IRB_00115509 - CR_3/9/2020 2:18 PM
Created: 3/9/2020 2:18 PM  
PI: Kimberly Kaphingst
Submitted: 3/23/2020  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
Progress of Sites and Enrollment
Select each site to update the enrollment information.
List of Study Controlled Locations
 
Site Name
Investigator's
Name
Enrollments since
Last CR
Enrollments as of
Today
Non English
Speakers
Withdrawn
View NYU School of
Medicine
Ophira Ginsburg  
0
0
0
View University of
Utah
Kimberly
Kaphingst
 
0
0
0
 
IRB_00115509 - CR_3/9/2020 2:18 PM
Created: 3/9/2020 2:18 PM  
PI: Kimberly Kaphingst
Submitted: 3/23/2020  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
3. Problems & Events
1.
Provide narrative summary of any available information regarding adverse events which
have occurred since the last IRB review.
There have been no adverse events.
2.
Have any additional risks to participation in this study been identified (from any site or
other relevant source) since last approval? If reports or amendments identifying additional
risks have been submitted since last approval, please mark ೦yes೦.
  
Yes 
No
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IRB_00115509 - CR_3/9/2020 2:18 PM
Created: 3/9/2020 2:18 PM  
PI: Kimberly Kaphingst
Submitted: 3/23/2020  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
5. Amendments
A list of amendments associated with this study since the last approval date.
Name
Date Submitted
IRB #
AM_Questionnaires
and Pilot
10/7/2019
AM_00035690
AM_Option to
email participants
and correct
questionnaire typo
1/22/2020
AM_00036697
1. Are there any changes to be made now?  (Including scientific design, procedures, participant
population, or any minor changes.)
  
Yes 
No
IRB_00115509 - CR_3/9/2020 2:18 PM
Created: 3/9/2020 2:18 PM  
PI: Kimberly Kaphingst
Submitted: 3/23/2020  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
6. Report Forms
Name
Date Submitted
IRB #
IRB_00115509 - CR_3/9/2020 2:18 PM
Created: 3/9/2020 2:18 PM  
PI: Kimberly Kaphingst
Submitted: 3/23/2020  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
7. Documents and Attachments
Approved eProtocol Summary:
Name
Version
Date Created
Date Modified
Date Approved
ID00000007(0.01)
0.01
5/4/2020 11:28 AM
5/4/2020 11:28 AM
ID00000007
 Print View: IRB Draft Protocol Summary
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Updated eProtocol Summary:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Consent Forms:
Name
VersionDate Created
Date Modified
Date Approved
03_2020 BRIDGE consent cover letter
V1.2(0.01)
0.01
3/12/2020 3:24
PM
3/12/2020 3:24
PM
5/4/2020 11:28
AM
 Updated Consent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Parental Permission Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Parental Permission Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Assent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Assent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved VA Consent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated VA Consent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Surveys, etc.:
Name
VersionDate Created
Date Modified
Date Approved
Questionnaire #1 - Genetic Testing 10042019
Clean.docx(0.01)
0.01
10/4/2019 3:36
PM
10/4/2019 3:36
PM
11/4/2019 4:30
PM
Questionnaire #1 - No Genetic Testing
100319.docx(0.01)
0.01
10/4/2019 3:36
PM
10/4/2019 3:36
PM
11/4/2019 4:30
PM
8/7/24, 12:06 PM
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Name
VersionDate Created
Date Modified
Date Approved
Questionnaire #2 - No Genetic Testing
10042019 Clean.docx(0.01)
0.01
10/4/2019 3:37
PM
10/4/2019 3:37
PM
11/4/2019 4:30
PM
Questionnaire #2 - Genetic Testing Clean
011320(0.01)
0.01
1/13/2020
10:47 AM
1/13/2020
10:47 AM
1/22/2020 9:28
AM
 Updated Surveys, etc.:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Company Protocol:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Company Protocol:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Investigational Brochure:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Investigational Brochure:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Grant Application:
Name
Version Date Created
Date Modified
Date Approved
Grant application(0.01)
0.01
1/20/2019 3:03 PM
1/20/2019 3:03 PM
6/5/2019 2:56 PM
 Updated Grant Application:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Literature/Cited References:
Name
VersionDate Created
Date Modified
Date Approved
Background and Introduction
References(0.01)
0.01
2/22/2019 8:32
AM
2/22/2019 8:32
AM
6/5/2019 2:56
PM
 Updated Literature/Cited References:
NameVersionDate CreatedDate ModifiedDate Approved
There are no items to display
Current PI Scholarly Record (CV/Resume):
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Name
Version
Date Created
Date Modified
Date Approved
Kaphingst CV(0.04)
0.04
4/2/2015 12:18 PM
8/27/2018 3:25 PM
 
Updated PI Scholarly Record (CV/Resume):
Name
Version Date Created
Date Modified
Date Approved
Kaphingst CV(0.04)
0.04
4/2/2015 12:18 PM
8/27/2018 3:25 PM
 
Current Faculty Sponsor Scholarly Record (CV/Resume):
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Faculty Sponsor Scholarly Record (CV/Resume):
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Other Stamped Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Other Stamped Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Recruitment Materials, Advertisements, etc.:
Name
VersionDate Created
Date Modified
Date Approved
Q1 invitation
message.docx(0.01)
0.01
10/21/2019 12:20
PM
10/21/2019 12:20
PM
11/4/2019 4:30
PM
Q2 reminder
message.docx(0.01)
0.01
10/21/2019 12:20
PM
10/21/2019 12:20
PM
11/4/2019 4:30
PM
 Updated Recruitment Materials, Advertisements, etc.:
NameVersionDate CreatedDate ModifiedDate Approved
There are no items to display
Approved Other Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Other Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
IRB_00115509 - CR_3/9/2020 2:18 PM
Created: 3/9/2020 2:18 PM  
8/7/24, 12:06 PM
CR_00035018 - CR_3/9/2020 2:18 PM
https://erica.research.utah.edu/erica/sd/Doc/0/MVUQKRKEG08UK6C1PDADR41500/fromString.html
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PI: Kimberly Kaphingst
Submitted: 3/23/2020  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
8. Instructions and Finish
1. To view errors in this application, select the "Hide/Show Errors" option at the top or bottom of the
page. If you have errors on your application, you won't be able to submit it to the IRB.
Changes to the Update Study Application
2. Be sure to make all proposed changes to the Update Study portion of the application by selecting
the "Update Study" button located on the left side of the amendment or continuing review
workspace, which will be available once you select the "Finish" button at the top or bottom of this
page.
3. To attach updated or new documents with this application, you may access the Documents and
Attachments page in the Update Study application.
4. If you are proposing changes to any ancillary applications (i.e. RDRC-HUS or RGE), you must
access these applications through the Update Study application on the Ancillary Applications page. 
All changes to ancillary applications must be approved by the corresponding committee prior to
IRB approval of the amendment.
Submitting the Completed Continuing Review Application
5. Selecting the ೦Finish೦ button alone will NOT submit the application to the IRB. You MUST also
select the "Submit" option on the workspace after you've selected the "Finish" button. Only the PI
can submit the application to the IRB.
6. If your study has a faculty sponsor: Once the PI submits the application, it will be sent to the faculty
sponsor for final approval. The IRB cannot review the study until the faculty sponsor submits the
application to the IRB.
IRB_00115509 - CR_3/9/2020 2:18 PM
Created: 3/9/2020 2:18 PM  
PI: Kimberly Kaphingst
Submitted: 3/23/2020  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
Study Location Questions
NYU School of Medicine
Site Status
What is the enrollment status for this site?
Open to enrollment of new participants
       
1,920 consent cover letters sent; up to 20,000
EHR records
Number of currently approved enrollments for this
study as a whole
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Enrollment since the beginning of the study at this site:
0Total number enrolled as of today೦s date at this site
Enrollment since the initial approval at this site:
How many non-English speakers have been enrolled?
0
How many participants signed consent forms but did not end up participating in the study?
0
Problems and Events
Have any unanticipated problems or adverse events involving risks to participants occured since the
last IRB approval?
  
Yes 
No
Have there been any complaints about the research since the last IRB review?
  
Yes 
No
Local HRPP Reporting
Have any significant financial conflicts of interest for study personnel been identified since the last
approval that have not been reported to the IRB?
  
Yes 
No
Have there been any changes to human research protection reviews or approvals from your
institution since last approval that have not been reported to the IRB.
  
Yes 
No
 
 
IRB_00115509 - CR_3/9/2020 2:18 PM
Created: 3/9/2020 2:18 PM  
PI: Kimberly Kaphingst
Submitted: 3/23/2020  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
Study Location Questions
University of Utah
8/7/24, 12:06 PM
CR_00035018 - CR_3/9/2020 2:18 PM
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Site Status
What is the enrollment status for this site?
Open to enrollment of new participants
       
1,920 consent cover letters sent; up to 20,000
EHR records
Number of currently approved enrollments for this
study as a whole
Enrollment since the beginning of the study at this site:
0Total number enrolled as of today೦s date at this site
Enrollment since the initial approval at this site:
How many non-English speakers have been enrolled?
0
How many participants signed consent forms but did not end up participating in the study?
0
Problems and Events
Have any unanticipated problems or adverse events involving risks to participants occured since the
last IRB approval?
  
Yes 
No
Have there been any complaints about the research since the last IRB review?
  
Yes 
No
 
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Date: Monday, March 29, 2021 9:31:05 PM
Print
Close
IRB_00115509 - CR_2/22/2021 12:04 PM
Created: 2/22/2021 12:04 PM  
PI: Kimberly Kaphingst
Submitted: 3/16/2021  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
1. Status
Overall, what is the enrollment status for this study?
Open to enrollment of new participants
IRB_00115509 - CR_2/22/2021 12:04 PM
Created: 2/22/2021 12:04 PM  
PI: Kimberly Kaphingst
Submitted: 3/16/2021  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
2. Progress of Study and Enrollment Information
Overall Study Enrollment Progress
Number of currently approved
enrollments for this study as a whole:
1,920 consent cover letters sent; up
to 20,000 EHR records
 
Number enrolled across all sites at last Continuing Review:0
 
Number enrolled across all sites as of today೦s date:36
 
Number enrolled across all sites since last Continuing Review:36
 
Describe the progress of the study, observations of the participants studied, and reason(s) for
continuing the study:
Utah began enrollment for their pilot study in April 2020 and enrollment for their full study in
November 2020. To date, 81 participants have been invited to participate in Questionnaire #1 and 1
participant has been invited to participate in Questionnaire #2 at this site. Although delayed due to
COVID-19, recruitment remains ongoing and enrollment is expected to pick up during 2021 now that
the technical implementation has been completed.
NYU began enrollment for their pilot study in Dec 2020 and enrollment for the full study in February
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2020. To date, 23 participants have been invited to participate in Questionnaire #1. The technical
implementation was substantially delayed at this site was delayed due to COVID-19 but the study
team is confident that they can still meet enrollment goals in the outlined timeframe. 
What results (preliminary or final) have been obtained from the study? If the study is part of a
multi-center trial, this should be stated and any available results provided. If there are no
results that are appropriate to report to the IRB at this time, this should be stated and
explained:
There are no results to disclose at this point. 
    
Please attach any abstracts or publications:
NameVersionDate CreatedDate ModifiedDate Approved
There are no items to display
Describe participant enrollment and its effect on the study design and scientific merit. If under-
accrued, describe any plans for increasing enrollment during the next approval period. If a
multicenter trial, also discuss enrollment at other sites.
Although significantly delayed due to COVID-19 and technical implementation hurdles, enrollment
at both sites has officially begun. Now that the technical infrastructure has been completed, tested,
and implemented study teams at both sites anticipate the enrollment rate to increase substantially over
the next approval period. 
 
IRB_00115509 - CR_2/22/2021 12:04 PM
Created: 2/22/2021 12:04 PM  
PI: Kimberly Kaphingst
Submitted: 3/16/2021  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
Progress of Sites and Enrollment
Select each site to update the enrollment information.
List of Study Controlled Locations
 
Site Name
Investigator's
Name
Enrollments since
Last CR
Enrollments as of
Today
Non English
Speakers
Withdrawn
View NYU School of
Medicine
Ophira Ginsburg 2
2
0
0
View University of
Utah
Kimberly
Kaphingst
34
34
0
0
 
IRB_00115509 - CR_2/22/2021 12:04 PM
Created: 2/22/2021 12:04 PM  
PI: Kimberly Kaphingst
Submitted: 3/16/2021  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
8/7/24, 12:07 PM
CR_00037785 - CR_2/22/2021 12:04 PM
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3. Problems & Events
1.
Provide narrative summary of any available information regarding adverse events which
have occurred since the last IRB review.
There have been no adverse events.
2.
Have any additional risks to participation in this study been identified (from any site or
other relevant source) since last approval? If reports or amendments identifying additional
risks have been submitted since last approval, please mark ೦yes೦.
  
Yes 
No
 
IRB_00115509 - CR_2/22/2021 12:04 PM
Created: 2/22/2021 12:04 PM  
PI: Kimberly Kaphingst
Submitted: 3/16/2021  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
5. Amendments
A list of amendments associated with this study since the last approval date.
Name
Date Submitted
IRB #
AM_Adding
COVID items to
questionnaires
5/18/2020
AM_00038160
AM_Questionnaire
outreach and study
personnel changes
7/15/2020
AM_00038525
AM_Spanish
Translations
9/2/2020
AM_00039151
AM_Questionnaire
outreach
10/19/2020
AM_00039559
1. Are there any changes to be made now?  (Including scientific design, procedures, participant
population, or any minor changes.)
  
Yes 
No
IRB_00115509 - CR_2/22/2021 12:04 PM
Created: 2/22/2021 12:04 PM  
PI: Kimberly Kaphingst
Submitted: 3/16/2021  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
Amendment Description
1. Type of Amendment (check all that apply):
Administrative changes, for example:
Changes to study procedures, for example:
8/7/24, 12:07 PM
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3/14

Other changes
2. What changes are being made? List and number each change, grouping similar changes
together.
1. Administrative Changes
1. Remove Kelsey Kehoe and Andrew Intveld
2. Move personnel from guest to study staff
1. Joshua Schiffman
2. Sarah Colonna
3. Whitney Espinel
4. David Wetter
3. Add Rick Bradshaw as study staff
2. Changes to study procedures
a. Study staff will track COVID-related appointments and diagnoses for patients who were
identified by the algorithm.
3. Other changes
1. Update of study category in PRMC application.
3. Describe the reason for each of the changes described above. List and number the reasons
according to the list above.
1. Administrative Changes
1. Kelsey Kehoe is no longer at HCI
2. Guests have had an influence on study design and will be included as authors on
publications moving forward
3. Rick Bradshaw should be added to be up to date with study staff
2. Changes to study procedures
a. COVID-related experiences may impact the way patients use and intact with the health
system, including genetic services. We would like to report if patients' experience with
COVID may have impacted their decision to receive counseling or testing. 
3. Other changes
1. The study category in the PRMC application will be updated as requested by the
CCSG/HCI internal reporting team. We have not made any changes to the study design.
4. How does each change described above effect participants? List and number the effects
according to the list above.
1. Administrative changes will have no effect on participants
2. Changes to study procedures
a. Tracking COVID-related appointments and diagnoses would not directly affect
participants.
3. Other changes
1. Changing study category will not affect participants. 
5. Will the modification(s), in the opinion of the local PI, increase or decrease the risk to
participants?
Neither
 
 
If the risk changes, provide justification:
6. How will enrolled participants (current and past) be notified of this change?
Participants will not be notified
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If Other, please explain:
7. Which approved documents are affected by these changes?
There are no items to display
 
 
If Other, please list
8. Which sections of the Update Study Application are affected by these changes?
1. Contacts and title; #2
2. Study Location and Sponsors; #1 - University of Utah
4. Study information; #6
Request for waiver of consent; Waiver of Informed consent for chart review without patient contact
Request for waiver of authorization; Waiver of authorization for access to EHR for chart review
PRMC application; #5
Request for waiver of authorization; Waiver of authorization to not include authorization language
9. Select all study locations that are affected by these changes.
Prior Approved Study Controlled Locations
Site Name
Investigator Name
Covered Entity
 NYU School of Medicine
Ophira Ginsburg
Study procedures will be conducted
outside a HIPAA Covered Entity at
this site (HIPAA Privacy Rule does not
apply)
 University of Utah
Kaphingst
Study procedures will be conducted
within a HIPAA Covered Entity at this
site (HIPAA Privacy Rule applies)
New Sites
IRB_00115509 - CR_2/22/2021 12:04 PM
Created: 2/22/2021 12:04 PM  
PI: Kimberly Kaphingst
Submitted: 3/16/2021  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
Amendment Approvals
1. Is this amendment related to information that meets the IRB reporting policy for unanticipated
problems and non-compliance?
  
Yes 
No
 
If yes, a Report Form must also be submitted and then linked to this amendment. Link the
related report form to the amendment application by selecting the report form from the list
below.
ID
Name
Date Submitted
Status
8/7/24, 12:07 PM
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5/14

2. Investigational Drug Data Form (IDDF) Changes:   
Yes 
No
 
3. Are you adding the VA as a site?   
Yes 
No
 
IRB_00115509 - CR_2/22/2021 12:04 PM
Created: 2/22/2021 12:04 PM  
PI: Kimberly Kaphingst
Submitted: 3/16/2021  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
6. Report Forms
Name
Date Submitted
IRB #
IRB_00115509 - CR_2/22/2021 12:04 PM
Created: 2/22/2021 12:04 PM  
PI: Kimberly Kaphingst
Submitted: 3/16/2021  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
7. Documents and Attachments
Approved eProtocol Summary:
Name
Version
Date Created
Date Modified
Date Approved
ID00000007(0.01)
0.01
3/29/2021 11:11 AM
3/29/2021 11:11 AM
ID00000007
 Print View: IRB Draft Protocol Summary
Updated eProtocol Summary:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Consent Forms:
Name
VersionDate Created
Date Modified Date Approved
Consent Cover Letter
V1.2_CR2021.docx(0.01)
0.01
3/10/2021
12:55 PM
3/10/2021
12:55 PM
3/29/2021
11:11 AM
Consent Cover Letter
V1.2_CR2021_Spanish.docx(0.01)
0.01
3/10/2021
12:55 PM
3/10/2021
12:55 PM
3/29/2021
11:11 AM
 Updated Consent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
8/7/24, 12:07 PM
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Approved Parental Permission Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Parental Permission Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Assent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Assent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved VA Consent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated VA Consent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Surveys, etc.:
Name
VersionDate Created Date
Modified
Date
Approved
Questionnaire #1 - No Genetic Testing
07102020.docx(0.01)
0.01
7/13/2020
2:51 PM
7/13/2020
2:51 PM
8/11/2020
3:10 PM
Questionnaire #1 - Genetic Testing
07102020.docx(0.01)
0.01
7/13/2020
2:51 PM
7/13/2020
2:51 PM
8/11/2020
3:10 PM
Questionnaire #2 - No Genetic Testing
07102020.docx(0.01)
0.01
7/13/2020
2:51 PM
7/13/2020
2:51 PM
8/11/2020
3:10 PM
Questionnaire #2 - Genetic Testing
07102020.docx(0.01)
0.01
7/13/2020
2:51 PM
7/13/2020
2:51 PM
8/11/2020
3:10 PM
Questionnaire -1 - Genetic Testing
05182020_Clean_Spa_Final-Amend.docx(0.01)
0.01
9/1/2020
3:24 PM
9/1/2020
3:24 PM
9/15/2020
10:58 AM
Questionnaire - 2 - No Genetic Testing
05182020_Clean_Spa_Final-Amend.docx(0.01)
0.01
9/1/2020
3:24 PM
9/1/2020
3:24 PM
9/15/2020
10:58 AM
Questionnaire - 1 - No Genetic Testing
05182020_Clean_Spa_Final-Amend.docx(0.01)
0.01
9/1/2020
3:24 PM
9/1/2020
3:24 PM
9/15/2020
10:58 AM
Questionnaire - 2 - Genetic testing
05182020_Clean_Spa_Final-Amend.docx(0.01)
0.01
9/1/2020
3:24 PM
9/1/2020
3:24 PM
9/15/2020
10:58 AM
 Updated Surveys, etc.:
8/7/24, 12:07 PM
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7/14

Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Company Protocol:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Company Protocol:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Investigational Brochure:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Investigational Brochure:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Grant Application:
Name
Version Date Created
Date Modified
Date Approved
Grant application(0.01)
0.01
1/20/2019 3:03 PM
1/20/2019 3:03 PM
6/5/2019 2:56 PM
 Updated Grant Application:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Literature/Cited References:
Name
VersionDate Created
Date Modified
Date Approved
Background and Introduction
References(0.01)
0.01
2/22/2019 8:32
AM
2/22/2019 8:32
AM
6/5/2019 2:56
PM
 Updated Literature/Cited References:
NameVersionDate CreatedDate ModifiedDate Approved
There are no items to display
Current PI Scholarly Record (CV/Resume):
Name
Version
Date Created
Date Modified
Date Approved
Kaphingst CV(0.04)
0.04
4/2/2015 12:18 PM
8/27/2018 3:25 PM
 
Updated PI Scholarly Record (CV/Resume):
Name
Version Date Created
Date Modified
Date Approved
Kaphingst CV(0.04)
0.04
4/2/2015 12:18 PM
8/27/2018 3:25 PM
 
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Current Faculty Sponsor Scholarly Record (CV/Resume):
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Faculty Sponsor Scholarly Record (CV/Resume):
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Other Stamped Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Other Stamped Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Recruitment Materials, Advertisements, etc.:
Name
VersionDate Created Date
Modified
Date
Approved
Q1 invitation-No testing.docx(0.01)
0.01
7/14/2020
3:54 PM
7/14/2020
3:54 PM
8/11/2020
3:10 PM
Q1 invitation-Testing.docx(0.01)
0.01
7/14/2020
3:54 PM
7/14/2020
3:54 PM
8/11/2020
3:10 PM
Q2 Inivitation-No testing.docx(0.01)
0.01
7/14/2020
3:54 PM
7/14/2020
3:54 PM
8/11/2020
3:10 PM
Q2 Invitation-Testing.docx(0.01)
0.01
7/14/2020
3:54 PM
7/14/2020
3:54 PM
8/11/2020
3:10 PM
Q1 Mail Coverletter_Testing_NYU.docx(0.01)
0.01
7/15/2020
2:44 PM
7/15/2020
2:44 PM
8/11/2020
3:10 PM
Q1 Mail Coverletter_No testing_NYU.docx(0.01)
0.01
7/15/2020
2:44 PM
7/15/2020
2:44 PM
8/11/2020
3:10 PM
Q2 Mail Coverletter_Testing_NYU.docx(0.01)
0.01
7/15/2020
2:45 PM
7/15/2020
2:45 PM
8/11/2020
3:10 PM
Q2 Mail Coverletter_No testing_NYU.docx(0.01)
0.01
7/15/2020
2:45 PM
7/15/2020
2:45 PM
8/11/2020
3:10 PM
Q1 mail coverletter-No testing_Utah.docx(0.01)
0.01
7/15/2020
2:45 PM
7/15/2020
2:45 PM
8/11/2020
3:10 PM
Q1 mail coverletter-Testing_Utah.docx(0.01)
0.01
7/15/2020
2:45 PM
7/15/2020
2:45 PM
8/11/2020
3:10 PM
Q2 mail coverletter-Testing_Utah.docx(0.01)
0.01
7/15/2020
2:45 PM
7/15/2020
2:45 PM
8/11/2020
3:10 PM
Q2 mail coverletter-No Testing_Utah.docx(0.01)
0.01
7/15/2020
2:58 PM
7/15/2020
2:58 PM
8/11/2020
3:10 PM
Q1 mail coverletter-No
testing_Utah_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
8/7/24, 12:07 PM
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Name
VersionDate Created Date
Modified
Date
Approved
Q2 Mail Coverletter_No
testing_NYU_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q2 Invitation-Testing_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q1 invitation-Testing_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q1 Mail Coverletter_No
testing_NYU_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q2 mail coverletter-
Testing_Utah_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q1 invitation-No testing_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q1 Mail
Coverletter_Testing_NYU_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q2 mail coverletter-No
Testing_Utah_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q1 mail coverletter-
Testing_Utah_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q2 Inivitation-No testing_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q2 Mail
Coverletter_Testing_NYU_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
 Updated Recruitment Materials, Advertisements, etc.:
NameVersionDate CreatedDate ModifiedDate Approved
There are no items to display
Approved Other Documents:
Name
VersionDate Created Date
Modified
Date Approved
Translation certificate for Consent
Coverletter(0.01)
0.01
9/1/2020 3:27
PM
9/1/2020 3:27
PM
9/15/2020 10:58
AM
Translation Certificate for Questionnaires and
Recruitment Letters(0.01)
0.01
9/1/2020 3:28
PM
9/1/2020 3:28
PM
9/15/2020 10:58
AM
 Updated Other Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
IRB_00115509 - CR_2/22/2021 12:04 PM
Created: 2/22/2021 12:04 PM  
PI: Kimberly Kaphingst
Submitted: 3/16/2021  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
8/7/24, 12:07 PM
CR_00037785 - CR_2/22/2021 12:04 PM
https://erica.research.utah.edu/erica/sd/Doc/0/BSBI62CH108UMAC1PDADR41500/fromString.html
10/14

 
8. Instructions and Finish
1. To view errors in this application, select the "Hide/Show Errors" option at the top or bottom of the
page. If you have errors on your application, you won't be able to submit it to the IRB.
Changes to the Update Study Application
2. Be sure to make all proposed changes to the Update Study portion of the application by selecting
the "Update Study" button located on the left side of the amendment or continuing review
workspace, which will be available once you select the "Finish" button at the top or bottom of this
page.
3. To attach updated or new documents with this application, you may access the Documents and
Attachments page in the Update Study application.
4. If you are proposing changes to any ancillary applications (i.e. RDRC-HUS or RGE), you must
access these applications through the Update Study application on the Ancillary Applications page. 
All changes to ancillary applications must be approved by the corresponding committee prior to
IRB approval of the amendment.
Submitting the Completed Continuing Review Application
5. Selecting the ೦Finish೦ button alone will NOT submit the application to the IRB. You MUST also
select the "Submit" option on the workspace after you've selected the "Finish" button. Only the PI
can submit the application to the IRB.
6. If your study has a faculty sponsor: Once the PI submits the application, it will be sent to the faculty
sponsor for final approval. The IRB cannot review the study until the faculty sponsor submits the
application to the IRB.
IRB_00115509 - CR_2/22/2021 12:04 PM
Created: 2/22/2021 12:04 PM  
PI: Kimberly Kaphingst
Submitted: 3/16/2021  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
Study Location Questions
NYU School of Medicine
Site Status
What is the enrollment status for this site?
Open to enrollment of new participants
       
1,920 consent cover letters sent; up to 20,000
EHR records
Number of currently approved enrollments for this
study as a whole
Enrollment since the beginning of the study at this site:
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2Total number enrolled as of today೦s date at this site
Enrollment since the last continuing review approval at this site:
0Reported enrollment during the last continuing review
 
2Number enrolled since the last continuing review
 
How many non-English speakers have been enrolled?
0
How many participants signed consent forms but did not end up participating in the study?
0
Problems and Events
Have any unanticipated problems or adverse events involving risks to participants occured since the
last IRB approval?
  
Yes 
No
Have there been any complaints about the research since the last IRB review?
  
Yes 
No
Local HRPP Reporting
Have any significant financial conflicts of interest for study personnel been identified since the last
approval that have not been reported to the IRB?
  
Yes 
No
Have there been any changes to human research protection reviews or approvals from your
institution since last approval that have not been reported to the IRB.
  
Yes 
No
 
 
IRB_00115509 - CR_2/22/2021 12:04 PM
Created: 2/22/2021 12:04 PM  
PI: Kimberly Kaphingst
Submitted: 3/16/2021  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
8/7/24, 12:07 PM
CR_00037785 - CR_2/22/2021 12:04 PM
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Study Location Questions
University of Utah
Site Status
What is the enrollment status for this site?
Open to enrollment of new participants
       
1,920 consent cover letters sent; up to 20,000
EHR records
Number of currently approved enrollments for this
study as a whole
Enrollment since the beginning of the study at this site:
34Total number enrolled as of today೦s date at this site
Enrollment since the last continuing review approval at this site:
0Reported enrollment during the last continuing review
 
34Number enrolled since the last continuing review
 
How many non-English speakers have been enrolled?
0
How many participants signed consent forms but did not end up participating in the study?
0
Problems and Events
Have any unanticipated problems or adverse events involving risks to participants occured since the
last IRB approval?
  
Yes 
No
Have there been any complaints about the research since the last IRB review?
  
Yes 
No
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8/7/24, 12:07 PM
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Date: Monday, March 14, 2022 9:30:14 PM
Print
Close
IRB_00115509 - CR_12/8/2021 12:59 PM
Created: 12/8/2021 12:59 PM  
PI: Kimberly Kaphingst
Submitted: 1/11/2022  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
1. Status
Overall, what is the enrollment status for this study?
Open to enrollment of new participants
IRB_00115509 - CR_12/8/2021 12:59 PM
Created: 12/8/2021 12:59 PM  
PI: Kimberly Kaphingst
Submitted: 1/11/2022  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
2. Progress of Study and Enrollment Information
Overall Study Enrollment Progress
Number of currently approved
enrollments for this study as a whole:
1,920 consent cover letters sent; up
to 20,000 EHR records
 
Number enrolled across all sites at last Continuing Review:36
 
Number enrolled across all sites as of today೦s date:457
 
Number enrolled across all sites since last Continuing Review:421
 
Describe the progress of the study, observations of the participants studied, and reason(s) for
continuing the study:
Utah began enrollment for their pilot study in April 2020 and enrollment for their full study in
November 2020. To date, 225 participants have been invited to participate in Questionnaire #1 and 10
participants have been invited to participate in Questionnaire #2 at this site. Although delayed due to
COVID-19, recruitment remains ongoing and enrollment has picked up during 2021.
NYU began enrollment for their pilot study in Dec 2020 and enrollment for the full study in February
2021. To date, 130 participants have been invited to participate in Questionnaire #1. The technical
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implementation was substantially delayed at this site due to COVID-19 but recruitment and
enrollment have been successful during 2021 and remains ongoing. 
What results (preliminary or final) have been obtained from the study? If the study is part of a
multi-center trial, this should be stated and any available results provided. If there are no
results that are appropriate to report to the IRB at this time, this should be stated and
explained:
We will be conducting analysis after accrual is complete.  
    
Please attach any abstracts or publications:
NameVersionDate CreatedDate ModifiedDate Approved
There are no items to display
Describe participant enrollment and its effect on the study design and scientific merit. If under-
accrued, describe any plans for increasing enrollment during the next approval period. If a
multicenter trial, also discuss enrollment at other sites.
Although significantly delayed due to COVID-19 and technical implementation hurdles, enrollment
at both sites during 2021 has been successful and on track with the projected study timeline. 
 
IRB_00115509 - CR_12/8/2021 12:59 PM
Created: 12/8/2021 12:59 PM  
PI: Kimberly Kaphingst
Submitted: 1/11/2022  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
Progress of Sites and Enrollment
Select each site to update the enrollment information.
List of Study Controlled Locations
 
Site Name
Investigator's
Name
Enrollments since
Last CR
Enrollments as of
Today
Non English
Speakers
Withdrawn
View NYU School of
Medicine
Meena Sigireddi 177
179
0
0
View University of
Utah
Kimberly
Kaphingst
244
278
7
0
 
 
IRB_00115509 - CR_12/8/2021 12:59 PM
Created: 12/8/2021 12:59 PM  
PI: Kimberly Kaphingst
Submitted: 1/11/2022  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
8/7/24, 12:07 PM
CR_00040728 - CR_12/8/2021 12:59 PM
https://erica.research.utah.edu/erica/sd/Doc/0/7699I8L4208UOSDSOLT94LIG00/fromString.html
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3. Problems & Events
1.
Provide narrative summary of any available information regarding adverse events which
have occurred since the last IRB review.
There have been no adverse events
2.
Have any additional risks to participation in this study been identified (from any site or
other relevant source) since last approval? If reports or amendments identifying additional
risks have been submitted since last approval, please mark ೦yes೦.
  
Yes 
No
 
IRB_00115509 - CR_12/8/2021 12:59 PM
Created: 12/8/2021 12:59 PM  
PI: Kimberly Kaphingst
Submitted: 1/11/2022  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
5. Amendments
A list of amendments associated with this study since the last approval date.
Name
Date Submitted
IRB #
AM_Spanish
enrollment
6/16/2021
AM_00041845
AM_NYU PI
Change
8/24/2021
AM_00042488
1. Are there any changes to be made now?  (Including scientific design, procedures, participant
population, or any minor changes.)
  
Yes 
No
IRB_00115509 - CR_12/8/2021 12:59 PM
Created: 12/8/2021 12:59 PM  
PI: Kimberly Kaphingst
Submitted: 1/11/2022  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
Amendment Description
1. Type of Amendment (check all that apply):
Administrative changes:
Changes to study procedures:
2. What changes are being made? List and number each change, grouping similar changes
together.
1. Administrative changes:
8/7/24, 12:07 PM
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3/14

Remove Kadyn Kimball, Priyanka Kanth, and Kenneth Boucher
2. Changes to study procedures:
Change language to replace the Cancer Biostatistics Shared Resource with NYU for where data
analyses will be conducted.
3. Describe the reason for each of the changes described above. List and number the reasons
according to the list above.
1. Administrative changes:
Kadyn Kimball and Priyanka Kanth are no longer at HCI.
Kenneth Boucher is being removed because data analysis is being done at NYU.
2. Changes to study procedures:
Data analysis will be conducted at NYU, not Utah.
4. How does each change described above effect participants? List and number the effects
according to the list above.
1. Administrative changes will have no effect on participants
2. Changes to study procedures will have no effect on participants
5. Will the modification(s), in the opinion of the local PI, increase or decrease the risk to
participants?
Neither
     If the risk changes, provide justification:
    
6. How will enrolled participants (current and past) be notified of this change?
Participants will not be notified
     If Other, please explain:
    
7. Which approved documents are affected by these changes?
There are no items to display
     If Other, please list
    
8. Which sections of the Update Study Application are affected by these changes?
1. Contacts and title; #2 and #3
2. Study Location and Sponsors; #1 - University of Utah
4. Study Information; Consent Process #1
8. R&R #1 and 3
HCI PRMC; Site staff
9. Select all study locations that are affected by these changes.
Prior Approved Study Controlled Locations
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Site Name
Investigator Name
Covered Entity
 NYU School of Medicine
Meena Sigireddi
Study procedures will be conducted
outside a HIPAA Covered Entity at
this site (HIPAA Privacy Rule does
not apply)
 University of Utah
Kaphingst
Study procedures will be conducted
within a HIPAA Covered Entity at this
site (HIPAA Privacy Rule applies)
New Sites
IRB_00115509 - CR_12/8/2021 12:59 PM
Created: 12/8/2021 12:59 PM  
PI: Kimberly Kaphingst
Submitted: 1/11/2022  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
Amendment Approvals
1. Is this amendment related to information that meets the IRB reporting policy for unanticipated
problems and non-compliance?
  
Yes 
No
 
If yes, a Report Form must also be submitted and then linked to this amendment. Link the
related report form to the amendment application by selecting the report form from the list
below.
ID
Name
Date Submitted
Status
2. Investigational Drug Data Form (IDDF) Changes:   
Yes 
No
 
3. Are you adding the VA as a site?   
Yes 
No
 
IRB_00115509 - CR_12/8/2021 12:59 PM
Created: 12/8/2021 12:59 PM  
PI: Kimberly Kaphingst
Submitted: 1/11/2022  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
6. Report Forms
Name
Date Submitted
IRB #
IRB_00115509 - CR_12/8/2021 12:59 PM
Created: 12/8/2021 12:59 PM  
PI: Kimberly Kaphingst
Submitted: 1/11/2022  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
8/7/24, 12:07 PM
CR_00040728 - CR_12/8/2021 12:59 PM
https://erica.research.utah.edu/erica/sd/Doc/0/7699I8L4208UOSDSOLT94LIG00/fromString.html
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7. Documents and Attachments
Approved eProtocol Summary:
Name
Version
Date Created
Date Modified
Date Approved
ID00000007(0.01)
0.01
3/14/2022 8:57 AM
3/14/2022 8:57 AM
ID00000007
 Print View: IRB Draft Protocol Summary
Updated eProtocol Summary:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Consent Forms:
Name
VersionDate Created
Date Modified
Date Approved
Consent Cover Letter V2.0(0.01)
0.01
1/6/2022 11:48
AM
1/6/2022 11:48
AM
3/14/2022 8:57
AM
Consent Cover Letter
V2.0_Spanish(0.01)
0.01
1/6/2022 11:48
AM
1/6/2022 11:48
AM
3/14/2022 8:57
AM
 Updated Consent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Parental Permission Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Parental Permission Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Assent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Assent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved VA Consent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated VA Consent Forms:
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Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Surveys, etc.:
Name
VersionDate Created Date
Modified
Date
Approved
Questionnaire #1 - No Genetic Testing
07102020.docx(0.01)
0.01
7/13/2020
2:51 PM
7/13/2020
2:51 PM
8/11/2020
3:10 PM
Questionnaire #1 - Genetic Testing
07102020.docx(0.01)
0.01
7/13/2020
2:51 PM
7/13/2020
2:51 PM
8/11/2020
3:10 PM
Questionnaire #2 - No Genetic Testing
07102020.docx(0.01)
0.01
7/13/2020
2:51 PM
7/13/2020
2:51 PM
8/11/2020
3:10 PM
Questionnaire #2 - Genetic Testing
07102020.docx(0.01)
0.01
7/13/2020
2:51 PM
7/13/2020
2:51 PM
8/11/2020
3:10 PM
Questionnaire -1 - Genetic Testing
05182020_Clean_Spa_Final-Amend.docx(0.01)
0.01
9/1/2020
3:24 PM
9/1/2020
3:24 PM
9/15/2020
10:58 AM
Questionnaire - 2 - No Genetic Testing
05182020_Clean_Spa_Final-Amend.docx(0.01)
0.01
9/1/2020
3:24 PM
9/1/2020
3:24 PM
9/15/2020
10:58 AM
Questionnaire - 1 - No Genetic Testing
05182020_Clean_Spa_Final-Amend.docx(0.01)
0.01
9/1/2020
3:24 PM
9/1/2020
3:24 PM
9/15/2020
10:58 AM
Questionnaire - 2 - Genetic testing
05182020_Clean_Spa_Final-Amend.docx(0.01)
0.01
9/1/2020
3:24 PM
9/1/2020
3:24 PM
9/15/2020
10:58 AM
 Updated Surveys, etc.:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Company Protocol:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Company Protocol:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Investigational Brochure:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Investigational Brochure:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
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Approved Grant Application:
Name
Version Date Created
Date Modified
Date Approved
Grant application(0.01)
0.01
1/20/2019 3:03 PM
1/20/2019 3:03 PM
6/5/2019 2:56 PM
 Updated Grant Application:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Literature/Cited References:
Name
VersionDate Created
Date Modified
Date Approved
Background and Introduction
References(0.01)
0.01
2/22/2019 8:32
AM
2/22/2019 8:32
AM
6/5/2019 2:56
PM
 Updated Literature/Cited References:
NameVersionDate CreatedDate ModifiedDate Approved
There are no items to display
Current PI Scholarly Record (CV/Resume):
Name
Version
Date Created
Date Modified
Date Approved
Kaphingst CV(0.04)
0.04
4/2/2015 12:18 PM
8/27/2018 3:25 PM
 
Updated PI Scholarly Record (CV/Resume):
Name
Version Date Created
Date Modified
Date Approved
Kaphingst CV(0.04)
0.04
4/2/2015 12:18 PM
8/27/2018 3:25 PM
 
Current Faculty Sponsor Scholarly Record (CV/Resume):
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Faculty Sponsor Scholarly Record (CV/Resume):
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Other Stamped Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Other Stamped Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Recruitment Materials, Advertisements, etc.:
8/7/24, 12:07 PM
CR_00040728 - CR_12/8/2021 12:59 PM
https://erica.research.utah.edu/erica/sd/Doc/0/7699I8L4208UOSDSOLT94LIG00/fromString.html
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Name
VersionDate
Created
Date
Modified
Date
Approved
Q1 invitation-No testing.docx(0.01)
0.01
7/14/2020
3:54 PM
7/14/2020
3:54 PM
8/11/2020
3:10 PM
Q1 invitation-Testing.docx(0.01)
0.01
7/14/2020
3:54 PM
7/14/2020
3:54 PM
8/11/2020
3:10 PM
Q2 Inivitation-No testing.docx(0.01)
0.01
7/14/2020
3:54 PM
7/14/2020
3:54 PM
8/11/2020
3:10 PM
Q2 Invitation-Testing.docx(0.01)
0.01
7/14/2020
3:54 PM
7/14/2020
3:54 PM
8/11/2020
3:10 PM
Q1 mail coverletter-No testing_Utah.docx(0.01)
0.01
7/15/2020
2:45 PM
7/15/2020
2:45 PM
8/11/2020
3:10 PM
Q1 mail coverletter-Testing_Utah.docx(0.01)
0.01
7/15/2020
2:45 PM
7/15/2020
2:45 PM
8/11/2020
3:10 PM
Q2 mail coverletter-Testing_Utah.docx(0.01)
0.01
7/15/2020
2:45 PM
7/15/2020
2:45 PM
8/11/2020
3:10 PM
Q2 mail coverletter-No Testing_Utah.docx(0.01)
0.01
7/15/2020
2:58 PM
7/15/2020
2:58 PM
8/11/2020
3:10 PM
Q1 mail coverletter-No
testing_Utah_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q2 Invitation-Testing_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q1 invitation-Testing_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q2 mail coverletter-Testing_Utah_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q1 invitation-No testing_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q2 mail coverletter-No
Testing_Utah_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q1 mail coverletter-Testing_Utah_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q2 Inivitation-No testing_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
20210812_MS_CLEAN_Q1 Mail
Coverletter_Testing_NYU.docx(0.01)
0.01
8/16/2021
8:15 AM
8/16/2021
8:15 AM
8/25/2021
10:25 AM
20210812_MS_CLEAN_Q2 Mail
Coverletter_Testing_NYU.docx(0.01)
0.01
8/16/2021
8:15 AM
8/16/2021
8:15 AM
8/25/2021
10:25 AM
20210812_MS_CLEAN_Q1 Mail
Coverletter_Testing_NYU_Spa_Final.docx(0.01)
0.01
8/16/2021
8:15 AM
8/16/2021
8:15 AM
8/25/2021
10:25 AM
20210812_MS_CLEAN_Q2 Mail
Coverletter_Testing_NYU_Spa_Final.docx(0.01)
0.01
8/16/2021
8:15 AM
8/16/2021
8:15 AM
8/25/2021
10:25 AM
20210812_MS_CLEAN_Q1 Mail Coverletter_No
testing_NYU.docx(0.01)
0.01
8/16/2021
8:16 AM
8/16/2021
8:16 AM
8/25/2021
10:25 AM
20210812_CLEAN_Q2 Mail Coverletter_No
testing_NYU.docx(0.01)
0.01
8/16/2021
8:16 AM
8/16/2021
8:16 AM
8/25/2021
10:25 AM
20210812_MS_CLEAN_Q1 Mail Coverletter_No
testing_NYU_Spa_Final.docx(0.01)
0.01
8/16/2021
8:16 AM
8/16/2021
8:16 AM
8/25/2021
10:25 AM
8/7/24, 12:07 PM
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Name
VersionDate
Created
Date
Modified
Date
Approved
20210812_MS_CLEAN_Q2 Mail Coverletter_No
testing_NYU_Spa_Final.docx(0.01)
0.01
8/16/2021
8:16 AM
8/16/2021
8:16 AM
8/25/2021
10:25 AM
 Updated Recruitment Materials, Advertisements, etc.:
NameVersionDate CreatedDate ModifiedDate Approved
There are no items to display
Approved Other Documents:
Name
VersionDate Created
Date Modified Date Approved
Translation certificate for Consent
Coverletter(0.01)
0.01
9/1/2020 3:27
PM
9/1/2020 3:27
PM
9/15/2020
10:58 AM
Translation Certificate for Questionnaires and
Recruitment Letters(0.01)
0.01
9/1/2020 3:28
PM
9/1/2020 3:28
PM
9/15/2020
10:58 AM
Sigireddi CITI Biomed Research(0.01)
0.01
8/23/2021
10:01 AM
8/23/2021
10:01 AM
8/25/2021
10:25 AM
Sigireddi CITI Clinical Practice(0.01)
0.01
8/23/2021
10:02 AM
8/23/2021
10:02 AM
8/25/2021
10:25 AM
Sigireddi Coi(0.01)
0.01
8/23/2021
10:02 AM
8/23/2021
10:02 AM
8/25/2021
10:25 AM
Sigireddi CV(0.01)
0.01
8/23/2021
10:03 AM
8/23/2021
10:03 AM
8/25/2021
10:25 AM
 Updated Other Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
IRB_00115509 - CR_12/8/2021 12:59 PM
Created: 12/8/2021 12:59 PM  
PI: Kimberly Kaphingst
Submitted: 1/11/2022  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
8. Instructions and Finish
1. To view errors in this application, select the "Validate" option at the top-left of the page. If you have
errors on your application, you won't be able to submit it to the IRB.
Changes to the Update Study Application
2. Be sure to make all proposed changes to the Update Study portion of the application by selecting
the "Update Study" button located on the left side of the amendment or continuing review
workspace, which will be available once you select the "Finish" button at the top or bottom of this
page.
3. To attach updated or new documents with this application, you may access the Documents and
Attachments page in the Update Study application.
4. If you are proposing changes to any ancillary applications (i.e. RDRC-HUS or RGE), you must
access these applications through the Update Study application on the Ancillary Applications page. 
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All changes to ancillary applications must be approved by the corresponding committee prior to
IRB approval of the amendment.
Submitting the Completed Continuing Review Application
5. Selecting the ೦Finish೦ button alone will NOT submit the application to the IRB. You MUST also
select the "Submit" option on the workspace after you've selected the "Finish" button. Only the PI
can submit the application to the IRB.
6. If your study has a faculty sponsor: Once the PI submits the application, it will be sent to the faculty
sponsor for final approval. The IRB cannot review the study until the faculty sponsor submits the
application to the IRB.
IRB_00115509 - CR_12/8/2021 12:59 PM
Created: 12/8/2021 12:59 PM  
PI: Kimberly Kaphingst
Submitted: 1/11/2022  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
Study Location Questions
NYU School of Medicine
Site Status
What is the enrollment status for this site?
Open to enrollment of new participants
       
1,920 consent cover letters sent; up to 20,000
EHR records
Number of currently approved enrollments for this
study as a whole
Enrollment since the beginning of the study at this site:
179Total number enrolled as of today೦s date at this site
Enrollment since the last continuing review approval at this site:
2Reported enrollment during the last continuing review
 
177Number enrolled since the last continuing review
 
How many non-English speakers have been enrolled?
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0
How many participants signed consent forms but did not end up participating in the study?
0
Problems and Events
Have any unanticipated problems or adverse events involving risks to participants occured since the
last IRB approval?
  
Yes 
No
Have there been any complaints about the research since the last IRB review?
  
Yes 
No
Local HRPP Reporting
Have any significant financial conflicts of interest for study personnel been identified since the last
approval that have not been reported to the IRB?
  
Yes 
No
Have there been any changes to human research protection reviews or approvals from your
institution since last approval that have not been reported to the IRB.
  
Yes 
No
 
 
IRB_00115509 - CR_12/8/2021 12:59 PM
Created: 12/8/2021 12:59 PM  
PI: Kimberly Kaphingst
Submitted: 1/11/2022  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
Study Location Questions
University of Utah
Site Status
What is the enrollment status for this site?
Open to enrollment of new participants
       
1,920 consent cover letters sent; up to 20,000
EHR records
Number of currently approved enrollments for this
study as a whole
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Enrollment since the beginning of the study at this site:
278Total number enrolled as of today೦s date at this site
Enrollment since the last continuing review approval at this site:
34Reported enrollment during the last continuing review
 
244Number enrolled since the last continuing review
 
How many non-English speakers have been enrolled?
7
Which non-English languages were used in the enrollment process since the last review?
Yes
Spanish
 
How many Spanish fully translated long forms were
used?
7 How many Spanish short forms were
used?
0
Mandarin
 
Nepali
 
Vietnamese
 
Russian
 
Other
 
How many participants signed consent forms but did not end up participating in the study?
0
Problems and Events
Have any unanticipated problems or adverse events involving risks to participants occured since the
last IRB approval?
8/7/24, 12:07 PM
CR_00040728 - CR_12/8/2021 12:59 PM
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Yes 
No
Have there been any complaints about the research since the last IRB review?
  
Yes 
No
 
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Date: Monday, February 13, 2023 9:30:25 PM
Print
Close
IRB_00115509 - CR_12/15/2022 9:44 AM
Created: 12/15/2022 9:44 AM  
PI: Kimberly Kaphingst
Submitted: 1/19/2023  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
1. Status
Overall, what is the enrollment status for this study?
Open to enrollment of new participants
IRB_00115509 - CR_12/15/2022 9:44 AM
Created: 12/15/2022 9:44 AM  
PI: Kimberly Kaphingst
Submitted: 1/19/2023  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
2. Progress of Study and Enrollment Information
Overall Study Enrollment Progress
Number of currently approved
enrollments for this study as a whole:
1,920 consent cover letters sent; up
to 20,000 EHR records
 
Number enrolled across all sites at last Continuing Review:457
 
Number enrolled across all sites as of today೦s date:794
 
Number enrolled across all sites since last Continuing Review:337
 
Describe the progress of the study, observations of the participants studied, and reason(s) for
continuing the study:
Utah began enrollment for their pilot study in April 2020 and enrollment for their full study in
November 2020. To date, appox. 450 participants have been invited to participate in Questionnaire #1
and 100 participants have been invited to participate in Questionnaire #2 at this site. Although
delayed due to COVID-19, recruitment remains ongoing and enrollment has picked up during 2022.
NYU began enrollment for their pilot study in Dec 2020 and enrollment for the full study in February
2021. To date, 480 participants have been invited to participate in Questionnaire #1. The technical
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implementation was substantially delayed at this site due to COVID-19 but recruitment and
enrollment have been successful during 2022 and remains ongoing.  
What results (preliminary or final) have been obtained from the study? If the study is part of a
multi-center trial, this should be stated and any available results provided. If there are no
results that are appropriate to report to the IRB at this time, this should be stated and
explained:
We will be conducting analysis after accrual is complete.  
    
Please attach any abstracts or publications:
NameVersionDate CreatedDate ModifiedDate Approved
There are no items to display
Describe participant enrollment and its effect on the study design and scientific merit. If under-
accrued, describe any plans for increasing enrollment during the next approval period. If a
multicenter trial, also discuss enrollment at other sites.
Although significantly delayed due to COVID-19 and technical implementation hurdles, enrollment
at both sites during 2021 & 2022 has been successful and on track with the projected study timeline.
Enrollment for this continuing review was defined as those who had completed only research
procedures (i.e., research questionnaires) at both sites. We realized that in the prior continuing review,
the number reported as enrolled was the number who completed both clinical and research
procedures rather than research procedures only. This is why ERICA seems to have a negative
number within the progress of the sites within this application. At the last CR the number enrolled
should have been the 157 individuals completing research procedures. Between sites, we have
enrolled 150 participants since the last CR, for a total enrolled of 307 between sites. 
 
IRB_00115509 - CR_12/15/2022 9:44 AM
Created: 12/15/2022 9:44 AM  
PI: Kimberly Kaphingst
Submitted: 1/19/2023  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
Progress of Sites and Enrollment
Select each site to update the enrollment information.
List of Study Controlled Locations
 
Site Name
Investigator's
Name
Enrollments since
Last CR
Enrollments as of
Today
Non English
Speakers
Withdrawn
View NYU School of
Medicine
Meena Sigireddi -108
71
0
0
View University of
Utah
Kimberly
Kaphingst
-42
236
2
0
 
 
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IRB_00115509 - CR_12/15/2022 9:44 AM
Created: 12/15/2022 9:44 AM  
PI: Kimberly Kaphingst
Submitted: 1/19/2023  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
3. Problems & Events
1.
Provide narrative summary of any available information regarding adverse events which
have occurred since the last IRB review.
N/A there have been no adverse events
2.
Have any additional risks to participation in this study been identified (from any site or
other relevant source) since last approval? If reports or amendments identifying additional
risks have been submitted since last approval, please mark ೦yes೦.
  
Yes 
No
 
IRB_00115509 - CR_12/15/2022 9:44 AM
Created: 12/15/2022 9:44 AM  
PI: Kimberly Kaphingst
Submitted: 1/19/2023  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
5. Amendments
A list of amendments associated with this study since the last approval date.
Name
Date Submitted
IRB #
1. Are there any changes to be made now?  (Including scientific design, procedures, participant
population, or any minor changes.)
  
Yes 
No
IRB_00115509 - CR_12/15/2022 9:44 AM
Created: 12/15/2022 9:44 AM  
PI: Kimberly Kaphingst
Submitted: 1/19/2023  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
6. Report Forms
Name
Date Submitted
IRB #
IRB_00115509 - CR_12/15/2022 9:44 AM
Created: 12/15/2022 9:44 AM  
PI: Kimberly Kaphingst
Submitted: 1/19/2023  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
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7. Documents and Attachments
Approved eProtocol Summary:
Name
Version
Date Created
Date Modified
Date Approved
ID00000007(0.01)
0.01
2/13/2023 7:43 AM
2/13/2023 7:43 AM
ID00000007
 Print View: IRB Draft Protocol Summary
Updated eProtocol Summary:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Consent Forms:
Name
VersionDate Created
Date Modified
Date
Approved
Consent Cover Letter
V2.0_CR2023.docx(0.01)
0.01
12/15/2022
10:22 AM
12/15/2022
10:22 AM
2/13/2023
7:43 AM
Consent Cover Letter
V2.0_CR2023_Spanish.docx(0.01)
0.01
12/15/2022
10:22 AM
12/15/2022
10:22 AM
2/13/2023
7:43 AM
 Updated Consent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Parental Permission Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Parental Permission Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Assent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Assent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved VA Consent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
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 Updated VA Consent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Surveys, etc.:
Name
VersionDate Created Date
Modified
Date
Approved
Questionnaire #1 - No Genetic Testing
07102020.docx(0.01)
0.01
7/13/2020
2:51 PM
7/13/2020
2:51 PM
8/11/2020
3:10 PM
Questionnaire #1 - Genetic Testing
07102020.docx(0.01)
0.01
7/13/2020
2:51 PM
7/13/2020
2:51 PM
8/11/2020
3:10 PM
Questionnaire #2 - No Genetic Testing
07102020.docx(0.01)
0.01
7/13/2020
2:51 PM
7/13/2020
2:51 PM
8/11/2020
3:10 PM
Questionnaire #2 - Genetic Testing
07102020.docx(0.01)
0.01
7/13/2020
2:51 PM
7/13/2020
2:51 PM
8/11/2020
3:10 PM
Questionnaire -1 - Genetic Testing
05182020_Clean_Spa_Final-Amend.docx(0.01)
0.01
9/1/2020
3:24 PM
9/1/2020
3:24 PM
9/15/2020
10:58 AM
Questionnaire - 2 - No Genetic Testing
05182020_Clean_Spa_Final-Amend.docx(0.01)
0.01
9/1/2020
3:24 PM
9/1/2020
3:24 PM
9/15/2020
10:58 AM
Questionnaire - 1 - No Genetic Testing
05182020_Clean_Spa_Final-Amend.docx(0.01)
0.01
9/1/2020
3:24 PM
9/1/2020
3:24 PM
9/15/2020
10:58 AM
Questionnaire - 2 - Genetic testing
05182020_Clean_Spa_Final-Amend.docx(0.01)
0.01
9/1/2020
3:24 PM
9/1/2020
3:24 PM
9/15/2020
10:58 AM
 Updated Surveys, etc.:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Company Protocol:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Company Protocol:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Investigational Brochure:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Investigational Brochure:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
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Approved Grant Application:
Name
Version Date Created
Date Modified
Date Approved
Grant application(0.01)
0.01
1/20/2019 3:03 PM
1/20/2019 3:03 PM
6/5/2019 2:56 PM
 Updated Grant Application:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Literature/Cited References:
Name
VersionDate Created
Date Modified
Date Approved
Background and Introduction
References(0.01)
0.01
2/22/2019 8:32
AM
2/22/2019 8:32
AM
6/5/2019 2:56
PM
 Updated Literature/Cited References:
NameVersionDate CreatedDate ModifiedDate Approved
There are no items to display
Current PI Scholarly Record (CV/Resume):
Name
Version
Date Created
Date Modified
Date Approved
Kaphingst CV(0.04)
0.04
4/2/2015 12:18 PM
8/27/2018 3:25 PM
 
Updated PI Scholarly Record (CV/Resume):
Name
Version Date Created
Date Modified
Date Approved
Kaphingst CV(0.04)
0.04
4/2/2015 12:18 PM
8/27/2018 3:25 PM
 
Current Faculty Sponsor Scholarly Record (CV/Resume):
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Faculty Sponsor Scholarly Record (CV/Resume):
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Other Stamped Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Other Stamped Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
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Approved Recruitment Materials, Advertisements, etc.:
Name
VersionDate
Created
Date
Modified
Date
Approved
Q1 invitation-No testing.docx(0.01)
0.01
7/14/2020
3:54 PM
7/14/2020
3:54 PM
8/11/2020
3:10 PM
Q1 invitation-Testing.docx(0.01)
0.01
7/14/2020
3:54 PM
7/14/2020
3:54 PM
8/11/2020
3:10 PM
Q2 Inivitation-No testing.docx(0.01)
0.01
7/14/2020
3:54 PM
7/14/2020
3:54 PM
8/11/2020
3:10 PM
Q2 Invitation-Testing.docx(0.01)
0.01
7/14/2020
3:54 PM
7/14/2020
3:54 PM
8/11/2020
3:10 PM
Q1 mail coverletter-No testing_Utah.docx(0.01)
0.01
7/15/2020
2:45 PM
7/15/2020
2:45 PM
8/11/2020
3:10 PM
Q1 mail coverletter-Testing_Utah.docx(0.01)
0.01
7/15/2020
2:45 PM
7/15/2020
2:45 PM
8/11/2020
3:10 PM
Q2 mail coverletter-Testing_Utah.docx(0.01)
0.01
7/15/2020
2:45 PM
7/15/2020
2:45 PM
8/11/2020
3:10 PM
Q2 mail coverletter-No Testing_Utah.docx(0.01)
0.01
7/15/2020
2:58 PM
7/15/2020
2:58 PM
8/11/2020
3:10 PM
Q1 mail coverletter-No
testing_Utah_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q2 Invitation-Testing_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q1 invitation-Testing_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q2 mail coverletter-Testing_Utah_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q1 invitation-No testing_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q2 mail coverletter-No
Testing_Utah_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q1 mail coverletter-Testing_Utah_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q2 Inivitation-No testing_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
20210812_MS_CLEAN_Q1 Mail
Coverletter_Testing_NYU.docx(0.01)
0.01
8/16/2021
8:15 AM
8/16/2021
8:15 AM
8/25/2021
10:25 AM
20210812_MS_CLEAN_Q2 Mail
Coverletter_Testing_NYU.docx(0.01)
0.01
8/16/2021
8:15 AM
8/16/2021
8:15 AM
8/25/2021
10:25 AM
20210812_MS_CLEAN_Q1 Mail
Coverletter_Testing_NYU_Spa_Final.docx(0.01)
0.01
8/16/2021
8:15 AM
8/16/2021
8:15 AM
8/25/2021
10:25 AM
20210812_MS_CLEAN_Q2 Mail
Coverletter_Testing_NYU_Spa_Final.docx(0.01)
0.01
8/16/2021
8:15 AM
8/16/2021
8:15 AM
8/25/2021
10:25 AM
20210812_MS_CLEAN_Q1 Mail Coverletter_No
testing_NYU.docx(0.01)
0.01
8/16/2021
8:16 AM
8/16/2021
8:16 AM
8/25/2021
10:25 AM
20210812_CLEAN_Q2 Mail Coverletter_No
testing_NYU.docx(0.01)
0.01
8/16/2021
8:16 AM
8/16/2021
8:16 AM
8/25/2021
10:25 AM
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Name
VersionDate
Created
Date
Modified
Date
Approved
20210812_MS_CLEAN_Q1 Mail Coverletter_No
testing_NYU_Spa_Final.docx(0.01)
0.01
8/16/2021
8:16 AM
8/16/2021
8:16 AM
8/25/2021
10:25 AM
20210812_MS_CLEAN_Q2 Mail Coverletter_No
testing_NYU_Spa_Final.docx(0.01)
0.01
8/16/2021
8:16 AM
8/16/2021
8:16 AM
8/25/2021
10:25 AM
 Updated Recruitment Materials, Advertisements, etc.:
NameVersionDate CreatedDate ModifiedDate Approved
There are no items to display
Approved Other Documents:
Name
VersionDate Created
Date Modified Date Approved
Translation certificate for Consent
Coverletter(0.01)
0.01
9/1/2020 3:27
PM
9/1/2020 3:27
PM
9/15/2020
10:58 AM
Translation Certificate for Questionnaires and
Recruitment Letters(0.01)
0.01
9/1/2020 3:28
PM
9/1/2020 3:28
PM
9/15/2020
10:58 AM
Sigireddi CITI Biomed Research(0.01)
0.01
8/23/2021
10:01 AM
8/23/2021
10:01 AM
8/25/2021
10:25 AM
Sigireddi CITI Clinical Practice(0.01)
0.01
8/23/2021
10:02 AM
8/23/2021
10:02 AM
8/25/2021
10:25 AM
Sigireddi Coi(0.01)
0.01
8/23/2021
10:02 AM
8/23/2021
10:02 AM
8/25/2021
10:25 AM
Sigireddi CV(0.01)
0.01
8/23/2021
10:03 AM
8/23/2021
10:03 AM
8/25/2021
10:25 AM
 Updated Other Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
IRB_00115509 - CR_12/15/2022 9:44 AM
Created: 12/15/2022 9:44 AM  
PI: Kimberly Kaphingst
Submitted: 1/19/2023  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
8. Instructions and Finish
1. To view errors in this application, select the "Validate" option at the top-left of the page. If you have
errors on your application, you won't be able to submit it to the IRB.
Changes to the Update Study Application
2. Be sure to make all proposed changes to the Update Study portion of the application by selecting
the "Update Study" button located on the left side of the amendment or continuing review
workspace, which will be available once you select the "Finish" button at the top or bottom of this
page.
3. To attach updated or new documents with this application, you may access the Documents and
Attachments page in the Update Study application.
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4. If you are proposing changes to any ancillary applications (i.e. RDRC-HUS or RGE), you must
access these applications through the Update Study application on the Ancillary Applications page. 
All changes to ancillary applications must be approved by the corresponding committee prior to
IRB approval of the amendment.
Submitting the Completed Continuing Review Application
5. Selecting the ೦Finish೦ button alone will NOT submit the application to the IRB. You MUST also
select the "Submit" option on the workspace after you've selected the "Finish" button. Only the PI
can submit the application to the IRB.
6. If your study has a faculty sponsor: Once the PI submits the application, it will be sent to the faculty
sponsor for final approval. The IRB cannot review the study until the faculty sponsor submits the
application to the IRB.
IRB_00115509 - CR_12/15/2022 9:44 AM
Created: 12/15/2022 9:44 AM  
PI: Kimberly Kaphingst
Submitted: 1/19/2023  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
Study Location Questions
NYU School of Medicine
Site Status
What is the enrollment status for this site?
Open to enrollment of new participants
       
1,920 consent cover letters sent; up to 20,000
EHR records
Number of currently approved enrollments for this
study as a whole
960Number of currently approved enrollments for this study location
Enrollment since the beginning of the study at this site:
71Total number enrolled as of today೦s date at this site
From the beginning of the study, how many non-English speakers have been enrolled?
0
From the beginning of the study, how many participants signed consent forms but did not end up
participating in the study?
0
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Enrollment since the last continuing review approval at this site:
179Reported enrollment during the last continuing review
 
-108Number enrolled since the last continuing review
 
Problems and Events
Have any unanticipated problems or adverse events involving risks to participants occured since the
last IRB approval?
  
Yes 
No
Have there been any complaints about the research since the last IRB review?
  
Yes 
No
Local HRPP Reporting
Have any significant financial conflicts of interest for study personnel been identified since the last
approval that have not been reported to the IRB?
  
Yes 
No
Have there been any changes to human research protection reviews or approvals from your
institution since last approval that have not been reported to the IRB.
  
Yes 
No
 
 
IRB_00115509 - CR_12/15/2022 9:44 AM
Created: 12/15/2022 9:44 AM  
PI: Kimberly Kaphingst
Submitted: 1/19/2023  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
Study Location Questions
University of Utah
Site Status
What is the enrollment status for this site?
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Open to enrollment of new participants
       
1,920 consent cover letters sent; up to 20,000
EHR records
Number of currently approved enrollments for this
study as a whole
960Number of currently approved enrollments for this study location
Enrollment since the beginning of the study at this site:
236Total number enrolled as of today೦s date at this site
From the beginning of the study, how many non-English speakers have been enrolled?
2
Which non-English languages were used in the enrollment process since the last review?
Yes
Spanish
 
How many Spanish fully translated long forms were
used?
2 How many Spanish short forms were
used?
0
Mandarin
 
Nepali
 
Vietnamese
 
Russian
 
Other
 
From the beginning of the study, how many participants signed consent forms but did not end up
participating in the study?
0
Enrollment since the last continuing review approval at this site:
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278Reported enrollment during the last continuing review
 
-42Number enrolled since the last continuing review
 
Problems and Events
Have any unanticipated problems or adverse events involving risks to participants occured since the
last IRB approval?
  
Yes 
No
Have there been any complaints about the research since the last IRB review?
  
Yes 
No
 
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Date: Friday, February 2, 2024 9:30:05 PM
Print
Close
IRB_00115509 - CR_12/15/2023 4:09 PM
Created: 12/15/2023 4:09 PM  
PI: Kimberly Kaphingst
Submitted: 1/4/2024  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
1. Status
Overall, what is the enrollment status for this study?
Open to enrollment of new participants
IRB_00115509 - CR_12/15/2023 4:09 PM
Created: 12/15/2023 4:09 PM  
PI: Kimberly Kaphingst
Submitted: 1/4/2024  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
2. Progress of Study and Enrollment Information
Overall Study Enrollment Progress
Number of currently approved
enrollments for this study as a whole:
1,920 consent cover letters sent; up
to 20,000 EHR records
 
Number enrolled across all sites at last Continuing Review:794
 
Number enrolled across all University affiliated sites as of today೦s date:335
 
Number enrolled across all sites since last Continuing Review:-459
 
Describe the progress of the study, observations of the participants studied, and reason(s) for
continuing the study:
Utah has completed accrual. We would like to keep the protocol open for enrollment until NYU
completes questionnaire 2, which is anticipated in April 2024.
 
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What results (preliminary or final) have been obtained from the study? If the study is part of a
multi-center trial, this should be stated and any available results provided. If there are no
results that are appropriate to report to the IRB at this time, this should be stated and
explained:
We are working on analysis of primary trial outcomes and anticipate having those ready in 2024. 
    
Please attach any abstracts or publications:
NameVersionDate CreatedDate ModifiedDate Approved
There are no items to display
Describe participant enrollment and its effect on the study design and scientific merit. If under-
accrued, describe any plans for increasing enrollment during the next approval period. If a
multicenter trial, also discuss enrollment at other sites.
As in the approved protocol and consistent with the last continuing review, we are counting
enrollment as those who completed questionnaire 1 or questionnaire 2 as those are the research
procedures for this study. There are some participants at the NYU site who may still complete
questionnaire 2, which is why the study is left open for enrollment at this time.
The negative number above in the enrolled at all sites comes from the discrepancy in the correction in
last year's reporting of enrolled numbers and the continuation of counting only participants who
complete research activities. Our accrual numbers to date are 237 at Utah and 98 at NYU, leading to
the 335 reported above. In the last approved CR, we reported accrual of 307 but we are not able to
indicate that in the fields above.
 
 
IRB_00115509 - CR_12/15/2023 4:09 PM
Created: 12/15/2023 4:09 PM  
PI: Kimberly Kaphingst
Submitted: 1/4/2024  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
Progress of Sites and Enrollment
Select each site to update the enrollment information.
List of Study Controlled Locations
 
Site Name
Investigator's
Name
Enrollments since
Last CR
Enrollments as of
Today
Non English
Speakers
Withdrawn
View NYU School of
Medicine
Meena Sigireddi 27
98
0
0
View University of
Utah
Kimberly
Kaphingst
1
237
2
0
 
 
8/7/24, 12:08 PM
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IRB_00115509 - CR_12/15/2023 4:09 PM
Created: 12/15/2023 4:09 PM  
PI: Kimberly Kaphingst
Submitted: 1/4/2024  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
3. Problems & Events
1.
Provide narrative summary of any available information regarding adverse events which
have occurred since the last IRB review.
no events to report
2.
Have any additional risks to participation in this study been identified (from any site or
other relevant source) since last approval? If reports or amendments identifying additional
risks have been submitted since last approval, please mark ೦yes೦.
  
Yes 
No
 
IRB_00115509 - CR_12/15/2023 4:09 PM
Created: 12/15/2023 4:09 PM  
PI: Kimberly Kaphingst
Submitted: 1/4/2024  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
5. Amendments
A list of amendments associated with this study since the last approval date.
Name
Date Submitted
IRB #
1. Are there any changes to be made now?  (Including scientific design, procedures, participant
population, or any minor changes.)
  
Yes 
No
IRB_00115509 - CR_12/15/2023 4:09 PM
Created: 12/15/2023 4:09 PM  
PI: Kimberly Kaphingst
Submitted: 1/4/2024  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
Amendment Description
1. Type of Amendment (check all that apply):
Administrative changes:
2. What changes are being made? List and number each change, grouping similar changes
together.
1. Administrative changes to research staff
8/7/24, 12:08 PM
CR_00050987 - CR_12/15/2023 4:09 PM
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3. Describe the reason for each of the changes described above. List and number the reasons
according to the list above.
1. Administrative changes to reflect those who are no longer part of the study team and add a new
team member. 
4. How does each change described above effect participants? List and number the effects
according to the list above.
1. Administrative changes will have no effect on the participants. 
5. Will the modification(s), in the opinion of the local PI, increase or decrease the risk to
participants?
Neither
     If the risk changes, provide justification:
    
6. How will enrolled participants (current and past) be notified of this change?
Participants will not be notified
     If Other, please explain:
    
7. Which approved documents are affected by these changes?
There are no items to display
     If Other, please list
    
8. Which sections of the Update Study Application are affected by these changes?
1.3 and 2.1
9. Select all study locations that are affected by these changes.
Prior Approved Study Controlled Locations
Site Name
Investigator Name
Covered Entity
 NYU School of Medicine
Meena Sigireddi
Study procedures will be conducted
outside a HIPAA Covered Entity at
this site (HIPAA Privacy Rule does
not apply)
 University of Utah
Kaphingst
Study procedures will be conducted
within a HIPAA Covered Entity at this
site (HIPAA Privacy Rule applies)
New Sites
IRB_00115509 - CR_12/15/2023 4:09 PM
Created: 12/15/2023 4:09 PM  
PI: Kimberly Kaphingst
Submitted: 1/4/2024  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
Amendment Approvals
1. Is this amendment related to information that meets the IRB reporting policy for unanticipated
problems and non-compliance?
8/7/24, 12:08 PM
CR_00050987 - CR_12/15/2023 4:09 PM
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Yes 
No
 
If yes, a Report Form must also be submitted and then linked to this amendment. Link the
related report form to the amendment application by selecting the report form from the list
below.
ID
Name
Date Submitted
Status
2. Investigational Drug Data Form (IDDF) Changes:   
Yes 
No
 
3. Are you adding the VA as a site?   
Yes 
No
 
IRB_00115509 - CR_12/15/2023 4:09 PM
Created: 12/15/2023 4:09 PM  
PI: Kimberly Kaphingst
Submitted: 1/4/2024  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
6. Report Forms
Name
Date Submitted
IRB #
RP_Findings from
routine audit
7/25/2023
RP_00018128
IRB_00115509 - CR_12/15/2023 4:09 PM
Created: 12/15/2023 4:09 PM  
PI: Kimberly Kaphingst
Submitted: 1/4/2024  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
7. Documents and Attachments
Approved eProtocol Summary:
Name
Version
Date Created
Date Modified
Date Approved
ID00000007(0.01)
0.01
2/13/2023 7:43 AM
2/13/2023 7:43 AM
ID00000007
ID00000007(0.01)
0.01
2/2/2024 1:13 PM
2/2/2024 1:13 PM
ID00000007
 Print View: IRB Draft Protocol Summary
Updated eProtocol Summary:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Consent Forms:
8/7/24, 12:08 PM
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Name
VersionDate Created
Date Modified
Date Approved
Consent Cover letter
Spanish_WM.docx(0.01)
0.01
2/2/2024 1:13
PM
2/2/2024 1:13
PM
2/2/2024 1:13
PM
Consent Cover Letter _NYU
(1).docx(0.01)
0.01
2/2/2024 1:13
PM
2/2/2024 1:13
PM
2/2/2024 1:13
PM
 Updated Consent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Parental Permission Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Parental Permission Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Assent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Assent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved VA Consent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated VA Consent Forms:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Surveys, etc.:
Name
VersionDate Created Date
Modified
Date
Approved
Questionnaire #1 - No Genetic Testing
07102020.docx(0.01)
0.01
7/13/2020
2:51 PM
7/13/2020
2:51 PM
8/11/2020
3:10 PM
Questionnaire #1 - Genetic Testing
07102020.docx(0.01)
0.01
7/13/2020
2:51 PM
7/13/2020
2:51 PM
8/11/2020
3:10 PM
Questionnaire #2 - No Genetic Testing
07102020.docx(0.01)
0.01
7/13/2020
2:51 PM
7/13/2020
2:51 PM
8/11/2020
3:10 PM
8/7/24, 12:08 PM
CR_00050987 - CR_12/15/2023 4:09 PM
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Name
VersionDate Created Date
Modified
Date
Approved
Questionnaire #2 - Genetic Testing
07102020.docx(0.01)
0.01
7/13/2020
2:51 PM
7/13/2020
2:51 PM
8/11/2020
3:10 PM
Questionnaire -1 - Genetic Testing
05182020_Clean_Spa_Final-Amend.docx(0.01)
0.01
9/1/2020
3:24 PM
9/1/2020
3:24 PM
9/15/2020
10:58 AM
Questionnaire - 2 - No Genetic Testing
05182020_Clean_Spa_Final-Amend.docx(0.01)
0.01
9/1/2020
3:24 PM
9/1/2020
3:24 PM
9/15/2020
10:58 AM
Questionnaire - 1 - No Genetic Testing
05182020_Clean_Spa_Final-Amend.docx(0.01)
0.01
9/1/2020
3:24 PM
9/1/2020
3:24 PM
9/15/2020
10:58 AM
Questionnaire - 2 - Genetic testing
05182020_Clean_Spa_Final-Amend.docx(0.01)
0.01
9/1/2020
3:24 PM
9/1/2020
3:24 PM
9/15/2020
10:58 AM
 Updated Surveys, etc.:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Company Protocol:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Company Protocol:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Investigational Brochure:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Investigational Brochure:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Grant Application:
Name
Version Date Created
Date Modified
Date Approved
Grant application(0.01)
0.01
1/20/2019 3:03 PM
1/20/2019 3:03 PM
6/5/2019 2:56 PM
 Updated Grant Application:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Literature/Cited References:
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Name
VersionDate Created
Date Modified
Date Approved
Background and Introduction
References(0.01)
0.01
2/22/2019 8:32
AM
2/22/2019 8:32
AM
6/5/2019 2:56
PM
 Updated Literature/Cited References:
NameVersionDate CreatedDate ModifiedDate Approved
There are no items to display
Current PI Scholarly Record (CV/Resume):
Name
Version
Date Created
Date Modified
Date Approved
Kaphingst CV(0.04)
0.04
4/2/2015 12:18 PM
8/27/2018 3:25 PM
 
Updated PI Scholarly Record (CV/Resume):
Name
Version Date Created
Date Modified
Date Approved
Kaphingst CV(0.04)
0.04
4/2/2015 12:18 PM
8/27/2018 3:25 PM
 
Current Faculty Sponsor Scholarly Record (CV/Resume):
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Faculty Sponsor Scholarly Record (CV/Resume):
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Other Stamped Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
 Updated Other Stamped Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Approved Recruitment Materials, Advertisements, etc.:
Name
VersionDate
Created
Date
Modified
Date
Approved
Q1 invitation-No testing.docx(0.01)
0.01
7/14/2020
3:54 PM
7/14/2020
3:54 PM
8/11/2020
3:10 PM
Q1 invitation-Testing.docx(0.01)
0.01
7/14/2020
3:54 PM
7/14/2020
3:54 PM
8/11/2020
3:10 PM
Q2 Inivitation-No testing.docx(0.01)
0.01
7/14/2020
3:54 PM
7/14/2020
3:54 PM
8/11/2020
3:10 PM
Q2 Invitation-Testing.docx(0.01)
0.01
7/14/2020
3:54 PM
7/14/2020
3:54 PM
8/11/2020
3:10 PM
Q1 mail coverletter-No testing_Utah.docx(0.01)
0.01
7/15/2020
2:45 PM
7/15/2020
2:45 PM
8/11/2020
3:10 PM
8/7/24, 12:08 PM
CR_00050987 - CR_12/15/2023 4:09 PM
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Name
VersionDate
Created
Date
Modified
Date
Approved
Q1 mail coverletter-Testing_Utah.docx(0.01)
0.01
7/15/2020
2:45 PM
7/15/2020
2:45 PM
8/11/2020
3:10 PM
Q2 mail coverletter-Testing_Utah.docx(0.01)
0.01
7/15/2020
2:45 PM
7/15/2020
2:45 PM
8/11/2020
3:10 PM
Q2 mail coverletter-No Testing_Utah.docx(0.01)
0.01
7/15/2020
2:58 PM
7/15/2020
2:58 PM
8/11/2020
3:10 PM
Q1 mail coverletter-No
testing_Utah_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q2 Invitation-Testing_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q1 invitation-Testing_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q2 mail coverletter-Testing_Utah_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q1 invitation-No testing_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q2 mail coverletter-No
Testing_Utah_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q1 mail coverletter-Testing_Utah_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
Q2 Inivitation-No testing_Spa_Final.docx(0.01)
0.01
9/1/2020
3:25 PM
9/1/2020
3:25 PM
9/15/2020
10:58 AM
20210812_MS_CLEAN_Q1 Mail
Coverletter_Testing_NYU.docx(0.01)
0.01
8/16/2021
8:15 AM
8/16/2021
8:15 AM
8/25/2021
10:25 AM
20210812_MS_CLEAN_Q2 Mail
Coverletter_Testing_NYU.docx(0.01)
0.01
8/16/2021
8:15 AM
8/16/2021
8:15 AM
8/25/2021
10:25 AM
20210812_MS_CLEAN_Q1 Mail
Coverletter_Testing_NYU_Spa_Final.docx(0.01)
0.01
8/16/2021
8:15 AM
8/16/2021
8:15 AM
8/25/2021
10:25 AM
20210812_MS_CLEAN_Q2 Mail
Coverletter_Testing_NYU_Spa_Final.docx(0.01)
0.01
8/16/2021
8:15 AM
8/16/2021
8:15 AM
8/25/2021
10:25 AM
20210812_MS_CLEAN_Q1 Mail Coverletter_No
testing_NYU.docx(0.01)
0.01
8/16/2021
8:16 AM
8/16/2021
8:16 AM
8/25/2021
10:25 AM
20210812_CLEAN_Q2 Mail Coverletter_No
testing_NYU.docx(0.01)
0.01
8/16/2021
8:16 AM
8/16/2021
8:16 AM
8/25/2021
10:25 AM
20210812_MS_CLEAN_Q1 Mail Coverletter_No
testing_NYU_Spa_Final.docx(0.01)
0.01
8/16/2021
8:16 AM
8/16/2021
8:16 AM
8/25/2021
10:25 AM
20210812_MS_CLEAN_Q2 Mail Coverletter_No
testing_NYU_Spa_Final.docx(0.01)
0.01
8/16/2021
8:16 AM
8/16/2021
8:16 AM
8/25/2021
10:25 AM
 Updated Recruitment Materials, Advertisements, etc.:
NameVersionDate CreatedDate ModifiedDate Approved
There are no items to display
Approved Other Documents:
8/7/24, 12:08 PM
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Name
VersionDate Created
Date Modified Date Approved
Translation certificate for Consent
Coverletter(0.01)
0.01
9/1/2020 3:27
PM
9/1/2020 3:27
PM
9/15/2020
10:58 AM
Translation Certificate for Questionnaires and
Recruitment Letters(0.01)
0.01
9/1/2020 3:28
PM
9/1/2020 3:28
PM
9/15/2020
10:58 AM
Sigireddi CITI Biomed Research(0.01)
0.01
8/23/2021
10:01 AM
8/23/2021
10:01 AM
8/25/2021
10:25 AM
Sigireddi CITI Clinical Practice(0.01)
0.01
8/23/2021
10:02 AM
8/23/2021
10:02 AM
8/25/2021
10:25 AM
Sigireddi Coi(0.01)
0.01
8/23/2021
10:02 AM
8/23/2021
10:02 AM
8/25/2021
10:25 AM
Sigireddi CV(0.01)
0.01
8/23/2021
10:03 AM
8/23/2021
10:03 AM
8/25/2021
10:25 AM
 Updated Other Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
IRB_00115509 - CR_12/15/2023 4:09 PM
Created: 12/15/2023 4:09 PM  
PI: Kimberly Kaphingst
Submitted: 1/4/2024  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
 
8/7/24, 12:08 PM
CR_00050987 - CR_12/15/2023 4:09 PM
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8. Instructions and Finish
1. To view errors in this application, select the "Validate" option at the top-left of the page. If you have
errors on your application, you won't be able to submit it to the IRB.
Changes to the Update Study Application
2. Be sure to make all proposed changes to the Update Study portion of the application by selecting
the "Update Study" button located on the left side of the amendment or continuing review
workspace, which will be available once you select the "Finish" button at the top or bottom of this
page.
3. To attach updated or new documents with this application, you may access the Documents and
Attachments page in the Update Study application.
4. If you are proposing changes to any ancillary applications (i.e. RDRC-HUS or RGE), you must
access these applications through the Update Study application on the Ancillary Applications page. 
All changes to ancillary applications must be approved by the corresponding committee prior to
IRB approval of the amendment.
Submitting the Completed Continuing Review Application
5. Selecting the ೦Finish೦ button alone will NOT submit the application to the IRB. You MUST also
select the "Submit" option on the workspace after you've selected the "Finish" button. Only the PI
can submit the application to the IRB.
6. If your study has a faculty sponsor: Once the PI submits the application, it will be sent to the faculty
sponsor for final approval. The IRB cannot review the study until the faculty sponsor submits the
application to the IRB.
IRB_00115509 - CR_12/15/2023 4:09 PM
Created: 12/15/2023 4:09 PM  
PI: Kimberly Kaphingst
Submitted: 1/4/2024  
Title: Broadening the Reach, Impact, and Delivery of Genetic Services
Study Location Questions
NYU School of Medicine
Site Status
What is the enrollment status for this site?
Open to enrollment of new participants
       
1,920 consent cover letters sent; up to 20,000
EHR records
Number of currently approved enrollments for this
study as a whole
960Number of currently approved enrollments for this study location
Enrollment since the beginning of the study at this site:
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98Total number enrolled as of today೦s date at this site
From the beginning of the study, how many non-English speakers have been enrolled?
0
From the beginning of the study, how many participants signed consent forms but did not end up
participating in the study?
0
Enrollment since the last continuing review approval at this site:
71Reported enrollment during the last continuing review
 
27Number enrolled since the last continuing review
 
Problems and Events
Have any unanticipated problems or adverse events involving risks to participants occured since the
last IRB approval?
  
Yes 
No
Have there been any complaints about the research since the last IRB review?
  
Yes 
No
Local HRPP Reporting
Have any significant financial conflicts of interest for study personnel been identified since the last
approval that have not been reported to the IRB?
  
Yes 
No
Have there been any changes to human research protection reviews or approvals from your
institution since last approval that have not been reported to the IRB.
  
Yes 
No
 
 
IRB_00115509 - CR_12/15/2023 4:09 PM
Created: 12/15/2023 4:09 PM  
PI: Kimberly Kaphingst
Submitted: 1/4/2024  
8/7/24, 12:08 PM
CR_00050987 - CR_12/15/2023 4:09 PM
https://erica.research.utah.edu/erica/sd/Doc/0/T5CMF3E29G8UT05SOLT94LIG00/fromString.html
12/14

Title: Broadening the Reach, Impact, and Delivery of Genetic Services
Study Location Questions
University of Utah
Site Status
What is the enrollment status for this site?
Permanently closed to enrollment of new participants
     
Will consent forms be used to re-consent participants after this application is approved?
  
Yes 
No
 
Select all of the remaining research activities that will be performed at this site after approval of
this continuing review:
Data and/or biospecimen analysis
 
Indicate the type(s) of data/biospecimens are being analyzed:
Identifiable private data/biospecimens
A HIPAA Limited Data set
1,920 consent cover letters sent; up to 20,000
EHR records
Number of currently approved enrollments for this
study as a whole
960Number of currently approved enrollments for this study location
Enrollment since the beginning of the study at this site:
237Total number enrolled as of today೦s date at this site
From the beginning of the study, how many non-English speakers have been enrolled?
2
Which non-English languages were used in the enrollment process since the last review?
Yes
Spanish
 
How many Spanish fully translated long forms were
used?
2 How many Spanish short forms were
used?
0
Mandarin
 
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Nepali
 
Vietnamese
 
Russian
 
Other
 
From the beginning of the study, how many participants signed consent forms but did not end up
participating in the study?
0
Enrollment since the last continuing review approval at this site:
236Reported enrollment during the last continuing review
 
1Number enrolled since the last continuing review
 
Problems and Events
Have any unanticipated problems or adverse events involving risks to participants occured since the
last IRB approval?
  
Yes 
No
Have there been any complaints about the research since the last IRB review?
  
Yes 
No
 
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