Intestinal Microbiota Changes After Ultra Violet Radiation B Exposure
Phase: NA
Conditions: Healthy
Sponsor: University of British Columbia

 
 
 
The University of British Columbia
Office of Research Ethics
Clinical Research Ethics Board – Room 210, 828 West 
10th Avenue, Vancouver, BC V5Z 1L8
  
ACKNOWLEDGEMENT LETTER 
 
PRINCIPAL INVESTIGATOR:
INSTITUTION / DEPARTMENT:
UBC CREB NUMBER:
Bruce A. Vallance 
UBC/Medicine, Faculty 
of/Paediatrics 
H17-00303
SPONSORING AGENCIES:
- BC Children's Hospital Research Institute - "UVB influences the human microbiota, a pilot study"
- Natural Sciences and Engineering Research Council of Canada (NSERC) - "Vitamin D - A regulator of 
host-microbe interactions in the mammalian GI tract?" 
PROJECT TITLE:
Intestinal Microbiota Changes after Ultraviolet Radiation B Exposure
  
This letter will acknowledge receipt of the study closure.
 
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please consult:  http://it.ubc.ca/services/security/ubc-information-security-office & 
http://universitycounsel.ubc.ca/access-and-privacy/
a. Make appropriate plans for archiving your project data to meet UBC policy requirements for study data to be 
retained for at least 5 years after presentation or publication within a UBC facility.
b. Ensure plans for final data destruction comply with the minimum standards set out in Clearing and Declassifying 
Electronic Data Storage Devices (ITSG-06).
c. Track and log disposal of all University-owned devices and electronic information.
d. Be prepared to provide a data destruction certificate upon request to a data steward.
Research Data Management
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the creation, management and dissemination of their data. The Dataverse platform allows management of datasets, 
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DATE OF 
ACKNOWLEDGEMENT:
February 12, 2019
Acknowledged on behalf of the Clinical Research Ethics Board by:
 
Pia Ganz, Manager, Clinical 
Ethics
 

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Date: 5/22/2019, 3:08:53 PM
Print
Close
 
 
 
The University of British Columbia 
Office of Research Services 
Clinical Research Ethics Board 
Room 210, 828 West 10th Avenue 
Vancouver, BC V5Z 1L8
 
H17-00303   UVB: skin to gut study   (Version 3.0)
Principal Investigator: Bruce A. Vallance
1. Principal Investigator & Study Team - Human Ethics [View Form]
1.1. Principal Investigator    
Please select the Principal
Investigator (PI) for the study.
Once you hit Select, you can
enter the PI's name, or enter the
first few letters of his or her
name and hit Go. You can sort
the returned list alphabetically by
First name, Last name, or
Organization by clicking the
appropriate heading.
Last
Name
First
Name
Employer.Name Email
Vallance
Bruce A.
Paediatrics
bvallance@cw.bc.ca
 
Enter Principal Investigator
Primary Department and also the
primary location of the PI's
Institution:
Pediatics, BCCHR  
1.2. Primary Contact   Provide
the name of ONE primary
contact person in addition to the
PI who will receive ALL
correspondence, certificates of
approval and notifications from
the REB for this study. This
primary contact will have online
access to read, amend, and
track the application.
Last Name
First Name
Rank
Bosman
Else Susan
Graduate Student
 
1.3. Co-Investigators   List all the
Co-Investigators of the study.
These members WILL have
online access which will allow
them to read, amend and track
the application. These members
will be listed on the certificate of
approval (except BC Cancer
Agency Research Ethics Board
certificates).  If this research
application is for a graduate
degree, enter the graduate
student's name in this section.
Last
Name
First
Name Institution/Department
Rank
Lui
HarveyUBC/Medicine, Faculty
of/Dermatology & Skin Science Professor
BosmanElse
Susan
UBC/Medicine, Faculty
of/Paediatrics
Graduate
Student
Dutz
Jan P. UBC/Medicine, Faculty
of/Dermatology & Skin Science Professor
 
Role in Study: Describe each co-  

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I's role in study, e.g. statistician,
supervisor, adviser, student etc.
1.4. Additional Study Team
Members - Online Access   List
the additional study team
members who WILL have online
access to read, amend, and
track the application but WILL
NOT be listed on the certificate
of approval.
Last Name First Name Institution/Department
Rank
 
Role in Study:
 
1.5. Additional Study Team
Members - No Online Access   
Click Add to list study team
members who WILL NOT have
online access to the application
and will NOT be listed on the
certificate of approval.
Last
Name
First
Name
Institution /
Department
Rank /
Job
Title
Email Address
Stintzi Alain
Faculty of
Medicine,
University of
Ottawa
Vice-
Dean
astintzi@uottawa.ca
 
Role in Study:
 
Tri Council Policy Statement2
(TCPS2) Tutorial All study team
members (including but not
limited to faculty, undergraduate
and graduate students, medical
residents and research staff) are
required to complete the TCPS2
Tutorial (CORE) before
submission. Indicate completion
of the TCPS2 (CORE) tutorial
below:  1.6.A. All Faculty,
including hospital appointment
equivalents deemed a PI by an
affiliated institution or by a Dean:
Yes 
1.6.B. All Other Study Team
members:
Yes 
Comments:
 
1.7. Project Title   Enter the title
of this research study as it will
appear on the certificate. If
applicable, include the protocol
number in brackets at the end of
the title. If this is a class-based
project, see guidance on the
right. Title given must match the
title on all study documents.
Intestinal Microbiota Changes after Ultraviolet Radiation B
Exposure 
1.8. Project Nickname   Enter a
nickname for this study. What
would you like this study to be
UVB: skin to gut study 

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known as to the Principal
Investigator and study team?
2. Study Dates and Funding - Human Ethics [View Form]
You plan to start collecting data
immediately after obtaining
ethics and any other required
approvals (the start date on the
ethics certificate will reflect the
approval date),
yes 
You plan to start data collection
at a later date i.e., 2 months or
more after approvals are
obtained. Click the calendar icon
below to select the dates
(Internet Explorer) or enter the
dates manually using the format
yyyy-mm-dd.  Estimated start
date:
 
2.1. B.  Estimated end date:
8/31/2018 
2.2.A. Types of Funds   Please
select the applicable box(es)
below to indicate the type(s) of
funding you are receiving to
conduct this research. You must
then complete section 2.3 and/or
section 2.4 for the name of the
source of the funds to be listed
on the certificate of approval.
Grant 
2.2.B. For Industry Sponsored
studies, please provide a
sponsor contact.
 
2.2.C. Please enter any
applicable information about
your funding which is not already
shown in Box 2.3 or 2.4
(including funding applied for but
not yet received).
 
2.3. Research Funding
Application/Award Associated
with the Study that was
Submitted to the UBC Office of
Research Services   Please click
Add to identify the research
funding application/award
associated with this study.
Selecting Add will list the
sources of all research funding
applications that have been
submitted by the PI (and the
person completing this
application if different from the
UBC
Number Title
Sponsor
F12-
04845
Vitamin D - A regulator of
host-microbe interactions
in the mammalian GI
tract?
Natural Sciences and
Engineering Research
Council of Canada
(NSERC)
F17-
05461
UVB influences the
human microbiota, a pilot
study
BC Children's Hospital
Research Institute
 

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PI). If the research funding
application/award associated
with this study is not listed below,
please enter those details in
question 2.4.
2.4. Research Funding
Application/Award Associated
with the Study not listed in
question 2.3.   Please click Add
to enter the details for the
research funding
application/award associated
with this study that is not listed in
question 2.3. When you press
Add you can do a search for
your funding award by doing a
search in the Sponsor box - over
7000 options are listed
UBC Number
Title
Sponsor
 
2.5.A. Is this a DHHS grant? (To
view a list of DHHS funding
agencies click on add in 2.5.B
below)
no 
2.5.B. If yes, please select the
appropriate DHHS funding
agency from the selection box,
and attach the grant to box 9.8.
of the application.
DHHS Sponsor List:
Order:
Active:
 
Attach DHHS Grant Application
for each sponsor listed above
 
2.6. Conflict of Interest   Conflicts
of Interest (COIs) can arise
naturally from an Investigator’s
engagement inside and outside
the University, and the mere
existence of a COI or the
perception of a COI does not
necessarily imply wrongdoing on
anyone’s part. Nonetheless, real
and perceived COI must be
recognized, disclosed, and
assessed. This question asks
Investigators to disclose COIs
that may relate to the research
study that is the subject of the
REB application.  Do the
Principal Investigator, Co-
Investigators and/or their related
parties (defined at s.8.12 UBC
Policy 97) have any personal
interest(s) that could
compromise or reasonably be
perceived to compromise the
no 

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objective conduct of the research
or the integrity of the data
generated by the study?
Personal interests may include
business, commercial or
financial interests, as well as
personal matters and career
interests.
4. Study Type - Human Ethics Application [View Form]
4.1. UBC Research Ethics Board 
  Indicate which UBC Research
Ethics Board you are applying to
and the type of study you are
applying for:
UBC Clinical Research Ethics Board 
N/A
no 
4.2.A. Institutions and Sites for
Study
Institution
Site
Vancouver Coastal Health
(VCHRI/VCHA)
Vancouver General
Hospital
Children's and Women's Health
Centre of BC (incl. Sunny Hill)
BC Children's Hospital
(includes Research
Institute)
 
4.2.B.  Please enter any other
locations where the research will
be conducted under this
Research Ethics Approval (e.g.,
Name of privately owned clinic,
community centre, school,
classroom, participant's home, in
the field - provide details).
The data will be collected in The Skin Care Center, located
at Vancouver General Hospital and data analysis will be
done by Life Labs and by the University of Ottawa in
collaboration with professor Stintzi. Data storage will be
done in the BCCHR institute.  
 
4* Clinical Study Review Type [View Form]
4.3. Relationship with other
proposals  4.3.A.  If this proposal
is closely linked to any other
proposal
previously/simultaneously
submitted, enter the Research
Ethics Board number of that
proposal.
No  
4.3.B.  If applicable, please
describe the relationship
between this proposal and the
previously/simultaneously
submitted proposal listed above.
 
4.3.C.  Have you received any
information or are you aware of
any rejection of this study by any
Research Ethics Board? If yes,
please provide known details
no 

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and attach any available relevant
documentation in question 9.7.
4.3.D.  Will biological materials
be collected or analyzed by UBC
researchers or a UBC research
lab? If yes, please provide the
UBC Biosafety Permit Number:
No  
4.3.E.  Will radioisotopes be
used in this project? If yes,
provide the UBC Radiation
Permit Number:
N/A 
4.4. Level of Risk   After
reviewing the minimal risk
guidance notes and the criteria
for minimal risk, does this study
qualify for minimal risk review?
Note that all studies which do not
fall into the minimal risk category
will undergo full board review.
no 
Peer Review  If this research
proposal has received any
independent
scientific/methodological peer
review, please include the
names of committees or
individuals involved in the
review. State whether the peer
review process is ongoing or
completed. All above minimal
risk studies generally require a
peer review.  4.5.A.   External
peer review details:
NO 
4.5.B.  Internal (UBC or hospital)
peer review details:
Yes: dr. Vincent Ho, MD, FRCPC, FRCP. completed  
4.5.C.  If this research proposal
has NOT received any
independent
scientific/methodological peer
review, explain why no review
has taken place.
N/A 
4.6. Multi-jurisdictional studies  
Please read and review the
guidance note on the right prior
to completing this question.  Is
this study a multi-jurisdictional
study that will also require review
by one or more REB with which
the University of British
Columbia has a collaborative
review agreement? (See the
guidance to the right for details
about the harmonized process.)  
no 

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Simon Fraser University  
University of Alberta  University
of Northern British Columbia  
Northern Health Authority  
University of Saskatchewan  
University of Victoria  Island
Health Authority  Fraser Health
Authority  Interior Health
Authority  Note: If submitting an
amendment for an already
approved study, you must
respond “No” to this question)
4* Clinical Study Review Type (Q 4.7, 4.8)  [View Form]
4.7.A Creation of a Registry
(Data or Tissue Bank)   Does
this study involve the creation of
a registry (data or tissue bank)
for future use in other research?
[if no, skip to 4.8]
no 
4.7.B  Is the purpose of this
application exclusively to obtain
approval for the creation of a
research database, registry or
tissue bank? [Note if the creation
of the database or registry or
tissue repository is part of a
bigger project also included in
this application, you must
answer no below.]
no 
Clinical Chart Review  4.8.A.  Is
this an application for research
requiring access to clinical charts
OR data from registries or
databases such as PopData BC
or Pharmanet?
no 
4.8.B.  Insert the date range of
the charts/data to be included in
this research. (e.g. 7 September
2005 – 6 September 2011)
 
4.8.C.  Is this study exclusively a
retrospective chart review where
the only source of data will be
medical charts/records that are
currently in existence? (i.e., will
pre-date the date of your initial
ethics approval?)
 
4.8.D.  Are you collecting and
retaining personally identifiable
information to be a part of the
data set?
 
4.8.E.  Is this a retrospective
 

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chart review study for which
participant consent will be
obtained?
5. Summary of Study and Recruitment - Clinical Study [View Form]
5.1. Study Summary  5.1.A  
Provide a short summary of the
project written in lay language
suitable for non-scientific REB
members. DO NOT exceed 100
words and do not cut and paste
directly from the study protocol.
This research will explore the potential effects of Narrow-
Band Ultra Violet B (NB-UVB) radiation on the intestinal
microbiota composition and confirm a regulatory skin-to-gut
axis during baseline conditions. Changes in the intestinal
microbiota composition caused by NB-UVB phototherapy
could be beneficial for patients with chronic/auto-
inflammatory diseases like IBD by removing dangerous
bacteria, increasing beneficial bacteria, and ultimately
modulating immune responses.  
5.1.B  Summarize the research
proposal: Purpose, Hypothesis ,
Justification, Objectives,
Research Design and Statistical
Analysis
Purpose:  
To explore the potential effects of Narrow-Band Ultra Violet
B (NB-UVB) radiation on the intestinal microbiota
composition in humans and confirm a regulatory skin-to-gut
axis during baseline conditions.  
 
Hypothesis:  
Humans exposed to UVB-NB light will show changes in the
intestinal microbiota composition with selection of certain
phyla of bacteria.  
 
Justification:  
To date, there is no data that describes a biological
response to UVB light in the body that affects the intestinal
microbiota. Changes in the intestinal microbiota
composition caused by NB-UVB phototherapy could be
beneficial for patients with chronic/auto-inflammatory
diseases like IBD by removing dangerous bacteria,
increasing beneficial bacteria, and ultimately modulating
immune responses. 
 
Objectives:  
1. Establish if there is an skin regulatory response towards
NB-UVB light in humans.  
2. Examine what changes in the microbiota composition
can be observed on bacterial phyla and class level.  
3. Determine if this research is worth pursuing in a larger
cohort. 
 
Research design:  
During the first visit, the skin type will be assessed by using
the Fitzpatrick skin type questionnaire. 
Subsequently, subjects will be exposed three times within
one week to full body NB-UVB light in The Skin Care
Centre to a sub erythemic dose (cause slight redness of the
skin but not burning). The exposures will happen during the
winter months to prevent UVB exposure from the sun
during daily activities to interfere with our observations.
Stool samples will be collected before the first exposure
(2x) and after the last exposure (2x) to analyse the

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microbiota composition. Also serum vitamin D (25-hydroxy
vitamin D) will be measured before and after the UVB
exposure as a marker of previous UVB exposure before the
experiment.  
 
Subjects will be healthy Caucasian females between 19-40
years of age with a Fitzpatrick skin type I, II or III to
minimise the variability in skin responses towards the UVB-
NB light since fair skin colour is less adapted to absorb the
UVB radiation than dark coloured skin. 
The microbiota composition will be analysed with 16S rRNA
Illumina sequencing and calculated for differential
abundance on phylum level. 
 
Statistical analysis: 
The statistical analysis will focus the personal microbiota
composition variation after NB-UVB light exposure in
comparison to before the UVB light exposure. Because we
collect two samples before and two samples after the UVB
exposures, each individual can serve as her own internal
control. 
 
5.2. Inclusion Criteria   Inclusion
Criteria. Describe the
participants being selected for
this study, and list the criteria for
their inclusion. For research
involving human pluripotent stem
cells, provide a detailed
description of the stem cells
being used in the research.
Healthy Caucasian females between 19-40 years of age.  
Fitzpatrick skin type I, II or III (see box 9.8A for Fitzpatrick
skin type assessment).  
 
 
5.3. Exclusion Criteria   
Exclusion Criteria. Describe
which potential participants will
be excluded from participation,
and list the criteria for their
exclusion.
The participants will be excluded if they have skin photo
sensitivity or taking medication that promotes photo
sensitivity of their skin. Also participants that have been on
vacation to a sunny destination since October 2017 or visit
tanning beds on a regular basis will be excluded because
they have been exposed to UVB radiation.  
5.4. Recruitment   Provide a
detailed description of the
method of recruitment. Include
where applicable A) Who will
contact prospective participants
B) by what means this will be
done. C) How prospective
participants will be identified D)
Ensure that any letters of initial
contact or other recruitment
materials are attached to this
submission on Page 9.
The recruitment will be done via social media with
Facebook (UVBstudy page). The recruitment advertisement
is included in the submission. The researcher will contact
prospective participants after they voluntarily contacted the
study email address: UVBstudy@alumni.ubc.ca 
Initial contact will be through email conversation until the
potential participant expresses interest participating by
email. Once the participant has signed the consent form, a
study identifier will be assigned to the participant to protect
the individuals identity.  
5.5. Recruitment of
Normal/Control Participants   
Describe how prospective
normal/control participants will
Each participant will serve as her own control. All
participants will be recruited the same way.  
 

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be identified, contacted, and
recruited, if the method differs
from the above.
5.6. Use of Records   If existing
records (e.g. health records,
clinical lists or other
records/databases) will be used
to IDENTIFY potential
participants or COLLECT DATA,
please describe how permission
to access this information, and to
collect and use this information
will be obtained.
No existing records will be used for this study.  
5.7. Summary of Study
Procedures
Participants will contact the study coordinator and will be
invited to participate by and email that will be sent along
with the consent form. A first meeting will be set up
between the research coordinator and the participant at the
Skin Care Center to explain the protocol and to sign
consent forms. Also four stool collection kits will be handed
to the participant. After signing the consent form, the
Fitzpatrick skin type will be assessed with the hand of a
questionnaire about the sun exposure habits.  
 
The participant is responsible to collect two stool samples
during the week prior to the first light exposure and store it
in her freezer at home.  
 
On the Monday of the first NB-UVB exposure, the research
coordinator will confirm that a stool sample is collected by
the participant. The participant will be referred to the lab at
Life Labs to collect one blood sample (one tube of 15 ml,
approximately one table spoon full) and will later go to The
Skin Care Centre at VGH where the participants will be
assessed under supervision of dr. Harvey Lui MD, for their
first full body NB-UVB exposure. The participants will wear
specialised goggles to protect the eyes from the UVB rays,
and wear broad spectrum sunscreen on face and hands to
protect these areas from the light. The NB-UVB light
exposure will happen in a full body cabin, like an upright
tanning bed, and will take no longer than 5 minutes. A time
will be scheduled for the next two sessions with the
participants. On Wednesday and Friday, the participant will
receive a NB-UVB dose that is 10% higher than the fisrt
visit, if tolerated well. 
 
Description of blood collection procedure at Life Labs: A
blood sample will be taken by first applying a tourniquet to
the upper arm. The skin on the inner side of the elbow will
be sterilised and a small, sterile needle will be inserted into
the vein. Two blood collection tubes will then be attached to
the needle which will fill with blood. When the tube is full,
the needle will be removed. A plaster or small 
bandage will be applied to cover the site where the needle

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was removed. 
 
Blood samples will be marked with their study identifiers
and analysed in Life labs for of serum 25-hydroxy vitamin
D3 according to Standards Council of Canada’s Good
Laboratory Practice (GLP) principles and Good Clinical
Practice (GCP).  
 
The participant is responsible to collect tw stool samples
the week after the three NB-UVB light exposures and store
it in the freezer. The research coordinator will contact the
participant when and where to pick up the stool samples, or
participant can drop them off at their own convenience at
the Skin Care Centre during on Monday, Wednesday and
Friday nights.  
 
The stool samples that are collected from the participant
will be stored in the BCCHR in a -80C freezer, in a locked
lab until all samples from all participants are collected.
Once all stool samples are collected, they will be send off
to the Stintzi Lab at the University of Ottawa for 16S rRNA
sequencing. The results will be analysed and stored on the
BCCHR password-secured computer.  
 
 
 
 
 
6. Participant Information and Consent Process - Clinical Study [View Form]
6.1. Time to Participate How
much time will a participant be
asked to dedicate to the project
beyond that needed for normal
care? 
The first visit to sign the consent form and do the Skin type
assessment will take approximately 20 minutes. The visit
for the first UVB exposure will take approx 20 minutes to
review the exposure methods.  
The next two visits will take approximately 10-12 minutes
each.  
The visits for the blood draws will take about 30 minutes,
depending on the amount of waiting time of the Life Labs
location.  
The total time the participant will spend to this study will be
2 hours minutes.  
6.2. Time to Participate –
Normal/Control Participants If
applicable, how much time will a
normal/control volunteer be
asked to dedicate to the project?
Each participant will be treated similarly.  
6.3. Risks/Harms Describe what
is known about the risks
(harms) of the proposed
research.
The exposure to NB-UVB light will turn the skin slightly pink
for 1-2 days. NB-UVB is ultraviolet radiation and could
cause long term effects after excessive exposure, like skin
ageing and skin cancer. The exposure from this study is
equivalent to 5 min sun exposure during a summer’s day,
per visit and is unlikely to have any long-term effects. Short-
term side effects may include skin redness, skin dryness,
triggering of a cold sore. All of these effects are minor and

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will resolve, usually within a week. In rare cases the skin
might turn red and gives a sun burn-like sensation. In this
case, the sensation will fade away over the next days. The
participant should contact the researcher in this case.  
 
Although minimal, there is a 0.5% risk of bleeding from the
needle site. If this occurs the subject can be given a
pressure bandage. The risks of blood draw also includes
pain and/or discomfort, bruising, fainting and/or light
headed sensation, and the rare possibility of infection.  
6.4. Benefits Describe any
potential benefits to the
participant that could arise from
his or her participation in the
proposed research.
Exposure to NB-UVB will produce vitamin D in your skin
that helps against seasonal affective disorder (SAD) and is
important for your general health.  
 
6.5. Reimbursement Describe
any reimbursement for expenses
(e.g. meals, parking,
medications) or
payments/incentives/gifts-in-kind
(e.g. honoraria, gifts, prizes,
credits) to be offered to the
participants. Provide full details
of the amounts, payment
schedules, and value of gifts-in-
kind.
There is a $750 budget for this study for the 30 test
participants. Each participant will be given a $25 gift-
certificate when the stool samples are collected and the
participant is done with the study requirements.  
6.6. Obtaining Consent Specify
A) who will explain the consent
form B) who will consent
participants C) Include details of
where the consent will be
obtained and under what
circumstances and D) the
relationship of the person
obtaining consent and
participant.
Once the potential participants agree to participate to the
study by email, the consent form will be explained in person
by the research coordinator. The research coordinator will
be able to answer all questions about possible concerns
and about the procedure. The consent form will be
discussed in person with the participant in an office setting
in the Skin Care Center. Once the participants sign the
consent form, they agree to be a part of the study. The
participants will get the stool collection kits at that time and
will come back for the further procedures one week later.
The participant is free to withdraw from the study at any
given time for the duration of the study. 
The physicians at the Skin Care Centre will go through the
procedures with the participant and is able to answer any
questions regarding the UVB exposure.  
 
 
6.7.A. Waiver/Alteration of
Consent If you are asking for a
waiver or an alteration of the
requirement for participant
informed consent, please justify
the waiver or alteration and
explain how the study meets all
the criteria on the right.  Please
click Guidance Notes on right
and ensure that you address
There will be no waiver  

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each criteria individually. Include
the corresponding letter (A, B, C,
D, E) before each answer.
6.7.B. Waiver of Consent in
Individual Medical Emergencies
If you are asking for a waiver or
an alteration of the requirement
for participant informed consent
in individual medical
emergencies, please justify the
waiver or alteration and explain
how the study meets all the
criteria on the right.  Please click
Guidance Notes on right and
ensure that you address each
criteria individually. Include the
corresponding letter (A, B, C, D,
E) before each answer.
N/A 
6.8. Time to Consent How long
after being provided with detailed
information/consent form about
the study will the participant
have to decide whether or not to
participate?  Provide your
rationale for the amount of time
given.
Once the participant contacts the study by email the
consent form will be sent to them by email to read through
before the first meeting. The research coordinator will
discuss the contents of the consent form with the
participant one week prior to the UVB light exposure
protocol. Thus, participants will have 1-2 weeks to review
the consent form before making a decision about
participation.  
6.9. Capacity to Consent Will
every participant have the
capacity to give fully informed
consent on his/her own behalf?
Please click Select to complete
the question and view further
details.
Will the
participant
have the
capacity
to give
fully
informed
consent?
Details of
the nature
of the
incapacity
If not,
who
will
consent
on
his/her
behalf?
If not, will
he/she be
able to give
assent to
participate?
If Yes,
explain
how
assent
will be
sought.
Yes
[Details]
 
6.10. Renewal of Consent
Describe any situation in which
the renewal of consent for this
research might be appropriate,
and how this would take place.
There are no plans for renewal of consent. No further
contact is required after obtaining the samples. All samples
and data will be de-identified on collection and cannot be
tracked back to the subjects. 
6.11. Provisions for Consent
What provisions are planned for
participants, or those consenting
on a participant's behalf, to have
special assistance, if needed,
during the consent process (e.g.
consent forms in Braille, or in
languages other than English).
Participants have to be able bodied to be able to participate
in order to receive the UVB exposure. Subjects with no
understanding of the English language will not be
approached for involvement in the study unless a translator
is present who can converse in the first language of the
subject. 
 
6.12. Restrictions on Disclosure
Describe any restrictions
There are no restrictions on disclosure of information.  

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regarding the disclosure of
information to research
participants (during or at the end
of the study) that the sponsor
has placed on investigators,
including those related to the
publication of results. Also,
indicate any plans for
communicating study results to
participants.
7. Number of Participants and Study Drugs - Clinical Study [View Form]
7.1. Multi-Centre Studies  7.1.A.  
Is this a multi-centre study
(involves centres outside of
those applied for under this
Approval?)
no 
If known, please list the other
sites below:
 
7.1.B.  Is this study being
submitted for ethical approval to
any other Research Ethics
Board?
Description:
No
 
If yes, please provide the name
of the REB(s) and if available,
contact information:
 
7.2. Number of Participants  
7.2.A.  How many participants
(including controls) will be
enrolled in the entire study? (i.e.
the entire study, world-wide)
30 
7.2.B.  How many participants
(including controls) will be
enrolled at institutions covered
by this Research Ethics
Approval? (i.e. only at the
institutions covered by this
approval)
30 
7.2.C.   Of these, how many are
controls?
0 
7.2.D.  Please enter any
additional comments:
 
7.3. Drug approvals   Enter the
generic name of any
investigational drug(s) not yet
approved or any marketed
drug(s) used outside of its
approved indication.
N/A 
7.4. Marketed Drugs   Enter the
name of any marketed drug(s)
N/A 

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used within its approved
indication.
7.5. Natural Health Products   
Enter the name of any Natural
Health Products used:
N/A  
7.6. Experimental Devices   
Enter the name of any new
investigational devices, or
marketed devices used in
experimental mode, that will be
used outside of their approved
indication.
A whole body stand-up photo-unit with Phillips UVB-NB
fluorescent light bulbs as used in The Skin Care Center at
Vancouver General Hospital.  
 
 
7.7. PERs   Enter the name of
any positron-emitting
radiopharmaceuticals (PERs).
N/A 
7.8. Health Canada Regulatory
Approvals  7.8.A. Health Canada
Regulatory Approvals  Is this
study a clinical trial or
investigational test requiring
Health Canada regulatory
approval (If this study does not
require Health Canada approval,
skip to 7.10)
no 
7.8.B.  If Yes, check all that
apply from the list below.
Description Regulatory Approval:
 
7.8.C.   Name the
sponsor/institution/investigator
responsible for filing a Clinical
Trial Application (CTA) or
Investigational Testing
Authorization (ITA) with Health
Canada or Other.
 
7.9. Details of Health Canada
Regulatory Approvals    If
regulatory approval from a
Health Canada directorate is
required for this study, your
certificate of ethical approval will
not be released until the
regulatory approval certificate,
approval date and control
number are received by REB
administration.  Click Add to
enter the name of the regulatory
agency, the date of the
application (if pending) or the
date of the approval, and the
control number and the date of
approval, for either the initial
application or subsequent
Name of
Agency
Date of
Approval
Date of Pending
Application:
 

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amendments. A copy of the
approval (NOL, ITA, NOA) must
also be attached in question 9.1.
Health Canada NOL Control
Number
Health Canada NOL Control Number Date of Approval
 
7.10. Stem Cell Research   Does
this research fall within the
categories of pluripotent stem
cell research that need to be
submitted to the CIHR Stem Cell
Oversight Committee (SCOC)?
no 
7.11. Registration for Publication
of Clinical Trials  7.11.A.  Does
this clinical study fall within the
definition stated on the right (in
the guidelines)?
no 
7.11.B.  If Yes, click Add to enter
the following information.
(Please note that registration by
UBC ORS administration
requires the prior ethical
approval of the study. In that
case, registration information
should be added when it
becomes available.)
Has it been
registered?
Indicate the
Authorized Registry
used:
Enter your Clinical
Trial unique
identifier:
 
7.12. US Regulatory
Requirements  7.12.A.  Is there a
requirement for this research to
comply with United States
regulations for research ethics?
no 
7.12.B.  If yes, please indicate
whether or not FDA
(Investigational New Drug)
number (drug studies) or an FDA
Investigational Device Exception
(IDE) is required for the research
and provide documentation from
the Sponsor or the FDA verifying
the IND/IDE number, or
explaining the study exemption
status, in Question 9.1.C.
 
8. Data Monitoring and Storage - Clinical Study [View Form]
8.1. Unblinding in an Emergency 
 Describe the provisions made to
break the code of a double-blind
study in an emergency situation,
and indicate who has the code.
N/A 
8.2. Data Monitoring Procedures  
 Describe data monitoring
procedures while research is
N/A 

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ongoing. Include details of
planned interim analyses, Data
and Safety Monitoring Board, or
other monitoring systems.
8.3. Study Stoppage   Describe
the circumstances under which
the ENTIRE study could be
stopped early. Should this occur,
describe what provisions would
be put in place to ensure that the
participants are fully informed of
the reasons for stopping the
study.
Circumstances under which the entire study could be
stopped would be very unlikely because the study includes
healthy participants and the photo therapy irradiance
dosages have been established by dermatologists. In case
more than 50% of the included participants will have
adverse side effects (lasting burning sensation and redness
of the skin) from the UVB exposure(s), the study will be
stopped early. The participants will be contacted by email
about the situation and will be given the option to withdraw
the biological samples, in case they are already collected,
the samples will be discarded in the bio hazard waste
disposal.  
 
8.4. Personal Identifiers  8.4.A.  
Describe how the identity of the
participants will be protected
both during and after the
research study, including how
the participants will be identified
on data collection forms.
The blood and stool samples will be marked with a study
identifier (A,B,C,...) in executive letters to keep track what
samples belong to which participant. This identifier will also
be written on a master list that will be kept separately from
the other participant information. The master list will be
stored on a password protected computer in the BCCHR.
There wont be any other personal details written on the
samples to protect the identity of the participant.  
8.4.B.  Will any personal health
information or personal
identifiers be collected?
no 
If yes, please describe what
personal identifying information
will be collected, and justify the
need for it to be collected.
N/A 
8.5. Data Access and Storage  
8.5.A.  A) Explain who will have
access to the data at each stage
of processing and analysis, B)
indicate whether a current list of
the names of study personnel
(including co-investigators and
research staff) and their
delegated tasks will be
maintained in the study file. C) If
a list will not be maintained,
please explain.
A list of enrolled participants and their consent forms will be
available to the research coordinator. These files will be
stored in a locked cabinet at the BC Children's Hospital
Research Institute (Room 201, 950 West 28th Ave
Vancouver, BC Canada V5Z 4H4).  
 
All data is de-identified by study identifier at the point of
sample collection. The PI and students as listed on this
application will have access to the data during process and
analysis which will be stored on an analysis node which is
hosted by the BC Children's Hospital research institutes
network. The code number ensures the data cannot be
traced back to a subject's ID number, by the PI, co-PIs, and
students during processing and analysis. 
 
A list of names of study personnel and their delegated
tasks will be maintained in the study file. 
 
8.5.B.  Describe how the data
will be stored (e.g., computerized
The hard copy files from this study will be kept in a locked
file cabinet in a locked office in the BC Children's Hospital

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files, hard copy, video-recording,
audio recording, personal
electronic device, other).
Research Institute (Room 201, 950 West 28th Ave
Vancouver, BC Canada V5Z 4H4). The de-identified data is
gathered on paper clinical records forms and will be
transferred to an electronic spreadsheet. 
 
The data that will be collected from the microbiota analysis
will be stored and analysed on an analysis node which is
hosted by the BC Children's Hospital Research institute's
network. The data can be accessed on a password
protected computer.  
8.5.C.  Describe the safeguards
in place to protect the
confidentiality and security of the
data.
The hard copy files will be kept in a facility that has
restrictive access, ID badge only for employees. The files
are kept in a locked file cabinet in an locked office. The
electronic data will be saved on a password accessible
computer in the same room and is connected to a BCCHR
hosted network that can not be accessed from outside the
BCCHR.  
8.5.D.  If any data or images are
to be kept on the Web, what
precautions have you taken to
prevent it from being copied?
No data or images will be kept on the web.  
8.6. Disposition of Study Data
and Biospecmens  8.6.A.  
Describe A) what will happen to
the data at the end of the study
including B) how long the study
data will be retained, C) when
and how the data will be
destroyed, and D) what plans
there are for future use of the
data, including E) who will have
access to the data in the future
and for what purpose. If this
study involves the creation of a
research database or registry for
the purpose of future research,
please refer to the Guidance
note linked on the right and
provide the requisite information.
The raw and analysed data will be stored for 5 years on the
BCCHR computing hard drive. This data is only accessible
to people with a password to the computing node. The data
will be removed from the computing node after passing 5
years after publication of the study results. Once the study
is completed, the data will not be used for future research.  
Hard copies of the consent forms will be kept in the
BCCHR and is only accessible to the principle researchers.
The hard copies will be destroyed by a shredder once the 5
year term has ended.  
 
8.6.B.  If applicable, A) describe
what will happen to the study
samples/ biospecimens at the
end of the study, including B)
how long the study samples will
be retained and C) where, when
and how the samples will be
destroyed, and D) what plans
there are for future use of the
samples, including who will have
access to the sample in the
future and for what purpose.
The serum samples will be analysed by Life Labs in
Vancouver and will be discarded in the biological hazard
waste upon analysis. The DNA from the stool samples will
be collected with a commercial kit and shipped to the
University of Ottawa for analysis. The remainder of the
DNA will be stored in a -80C freezer in the BCCHR until
quality of the sequencing analysis is confirmed. DNA
samples will be discarded in the biological hazard waste
afterwards quality control of the sequencing run. Neither of
the labs get any personal information about the
participants.  
 8.7. Data Transfer to Other
yes 

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Institutions  8.7.A  Will data be
sent outside of the Institution
where it is being collected?:
8.7.B.  If yes, please describe A)
the type of data to be
transferred, B) who the data will
be transferred to, C) where the
data will be transferred, and D)
how the data will be sent.
The stool samples will be send to the University of Ottawa
for sequencing for bacterial composition analysis. The
samples will be send, labelled with a study identifier to our
collaborator in the Stintzi lab. The data for further analysis
will be send back electronically and encrypted to the
BCCHR researchers to store on password-protected
computers.  
8.8. Data Transfer to Institution  
8.8.A  Will the researchers be
receiving data from other sites?:
no 
8.8.B  If yes, please describe A)
the type of data to be received,
B) who the data will be received
from, C) where it will be received
from, and D) how the data will be
received.
 
8.9. Data Linkage  8.9.A.  Will
the data be linked to any other
data source (including a
biorepository)?
no 
8.9.B.  A) Identify the data set,
B) how the linkage will occur,
and C) explain how
confidentiality regarding the
shared information will be
preserved.
 
9. Documentation - Clinical Study [View Form]
9.1.A. Protocol   Examples of
types of protocols are listed on
the right. Click Add to enter the
required information and attach
the documents.
Document
Name
VersionDate
Password (if
applicable)
Ethics
proposal
5
January 23,
2018
[View]
 
9.1.B.  Health Canada regulatory
approval (receipt will be
acknowledged)
Document Name Version DatePassword (if applicable)
 
9.1.C.  FDA IND or IDE letters
(receipt will be acknowledged)
Document Name Version DatePassword (if applicable)
 
9.2. Consent Forms   Examples
of types of consent forms are
listed on the right. Click Add to
enter the required information
and attach the forms.
Document
Name
VersionDate
Password (if
applicable)
Consent Form
UVB study
5.2
February
13, 2018
[View]
 
9.3. Assent Forms   Examples of
types of assent forms are listed
Document Name Version DatePassword (if applicable)
 

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on the right. Click Add to enter
the required information and
attach the forms.
9.4. Investigator
Brochures/Product Monographs   
Please click Add to enter the
required information and attach
the documents.
Document Name Version DatePassword (if applicable)
 
9.5. Advertisement to Recruit
Participants   Examples are
listed on the right. Click Add to
enter the required information
and attach the documents.
Document Name VersionDate
Password (if
applicable)
Recruitment
Poster UVB study 5
January
23, 2018
[View]
facebook page
UVB study
1
May 15,
2017
[View]
 
9.6. Questionnaire,
Questionnaire Cover Letter,
Tests, Interview Scripts, etc.   
Please attach each separately.
Please click Add to enter the
required information and attach
the documents.
Document Name Version DatePassword (if applicable)
 
9.7. Letter of Initial Contact 
Please click Add to enter the
required information and attach
the forms.
Document Name
VersionDate
Password (if
applicable)
Letter of initial contact
research participant
3
May
4,
2017
[View]
 
9.8. Data collection forms and
Other Documents  9.8.A.   
Please attach Data collection
Forms, Chart extraction forms,
CRF or other documents.
Examples of other types of
documents are listed on the
right.
Document
Name
VersionDate
Password (if
applicable)
Response to
REB review
3
May 12,
2017
[View]
Fitzpartick scale 3
May 4,
2017
[View]
UVBstudy peer
review
1
February
1, 2017
[View]
 
9.8.B.   If a Web site is part of
this study, enter the URL below.
Since URL's may change over
time or become non-existent,
you must also attach a copy of
the documentation contained on
the web site to this section or
provide an explanation.
 
10. Fee for Service - Clinical Study [View Form]
Please indicate which of the
following methods of payment
N/A (Not funded by an Industry For-Profit Sponsors) 

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will be used for this application.
Enter information stating when
the fee will be sent:
 
11. UBC Children's and Women's Research Ethics Board [View Form]
11.1.   In order for a research
project to be undertaken at
C&W, either an employee or a
member of the medical staff (as
legally defined) needs to be
designated as the Principal
Investigator. This individual must
have actual responsibility with
respect to the project.  Select the
Principal Investigator for the
Children's and Women's Health
Centre.
Last Name
First Name
Rank
Vallance
Bruce A.
Associate Professor
 
11.2.   Does the Children's and
Women's Principal Investigator
in question 1.1 (and 11.1, if
different) have a UBC academic
or clinical appointment?
yes 
Select Browse to attach the
declaration form.
[View] 
11.3.   Select which hospital
form(s) are required for this
application.
Not Applicable 
If you selected Other
Resource/Service Utilization,
please specify below.
 
11. Hospital Information - Vancouver Coastal Health [View Form]
11.1   Have you already received
approval from VCHA to conduct
this study?
no 
If Yes, please provide the
VCHA/VCHRI approval number
(e.g. V06-0000)
 
11.2. A.   Does the Principal
Investigator in question 1.1 have
a medical appointment with
VCHRI/VCHA and a UBC faculty
appointment?
no 
11.2.B.  Does the Principal
Investigator in question 1.1 have
a medical appointment with
VCHRI/VCHA (but not a faculty
appointment at UBC), or is the
Principal Investigator an
employee of VCHA?
no 
Select the Browse button to
attach the declaration form.
[View] 

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11.2. C.  Does the Principal
Investigator in question 1.1 have
a UBC appointment?
yes 
Select the Site Investigator at
VCHA if different from the
Principal Investigator in question
1.1.
lastName
firstName
Dutz
Jan P.
 
11.3.   Select the VCHA Health
Service Delivery Area(s) that will
be involved in this study.
Vancouver Acute (Vancouver Acute encompasses the
following sites: Vancouver General Hospital, UBC Hospital,
GF Strong Rehabilitation Centre, Arthritis Research Centre
of Canada, Mary Pack Arthritis Centre, Djavad
Mowafaghian Centre for Brain Health) 
12. Save Application - Human Ethics [View Form]
Print
Close