Document

Report
IRB, Human Subjects and Data
Security
Vipin Awatramani
Staff Training, Mahabalipuram 2012
Presentation format
Presentation/
Lecture
(40 minutes)
Q&A
Quiz
(10 minutes)
(15 minutes)
Group
Exercise
(30 minutes)
Agenda
Presentation
Ethics, IRB, PII, IRB applications
Data security
Data handling at various stages
Quiz
Three questions (Poll)
Group
Exercise
Scenario
Q&A
Connecting to experts
Have you worked on ANY IRB documentation for your study?
(created a new protocol, renewed or amended it?)
A. Yes
B. No
54%
No
Ye
s
46%
Have you completed a Human Subjects training certificate (via
CITI or NIH)?
81%
No
19%
Ye
s
A. Yes
B. No
Have YOU, a new project staff interacting and handling data of
human subjects, been added to your IRB protocols as a
project member?
A. Yes, I did it myself
B. Yes, someone else
did it
C. No, not yet
D. I don’t know
35%
31%
20%
,s
om
Ye
s
Ye
s
,I
no
w
Id
on
’t
k
et
ot
y
di
d
it
No
,n
di
eo
ne
d
it
el
se
m
ys
el
f
15%
Ethics in Research
• Studies involve human subjects
• Under U.S. Federal Policy for
the Protection of Human
Subjects, all studies involving
human subjects must meet
institutional guidelines of
ethical research
• Approved by an accredited IRB
(Institutional Review Board)
Image Source: http://www.becoming-galactic.org/ethicslogic.html
What is IRB and what studies require
these approvals?
• Institutional review board
A group designated by an institution (such as a university or
non-profit) to approve, monitor, and review research involving
human subjects to assure appropriate steps are taken to
protect the rights and welfare of those subjects.
• Studies that require IRB approval include:
• Studies interacting with human subjects
• Studies collecting data on individuals including personally
identifying information
Why do you need IRB approval?
Protection of human subjects
—Ensure ethical research design
—Field projects often collect personally
identifiable information (PII) from
respondents
Non-compliance can jeopardize
—Funding
—Research progress
—Organization’s reputation
What is PII?
• Personally identifiable information:
Information that can be used to identify an
individual or households with a reasonable
level of confidence.
• Names, telephone numbers, email addresses,
account numbers, photographs, Government
identification numbers, GPS coordinates
• Smaller geographical subdivisions/units,
elements of date related to an individual
Four Questions that you need to
address
1. When do you need IRB
approval? Renewal/updates?
2. How do you prepare IRB
applications?
3. What about my field staff?
4. What about data security
(storing, transmission)?
When do you think you need to update you IRB committee?
A. Significant
additions to
survey, design
Should get
approval
B. New
PI/RA/expansion
C. Grants awarded
D. All
74%
25%
Al
d
aw
nt
s
Gr
a
A/
ex
PI
/R
w
Ne
ar
de
n
sio
pa
n
s..
.
to
ns
tio
ad
di
nt
fic
a
gn
i
Si
l
2%
0%
When do you need IRB approval?
Renewal/updates?
• Before starting any field activity
• IRB Protocol Updates:
– Renew every year
– Submit modifications for:
•
•
•
•
Significant additions to survey, design or field activities?
Changes in security management
Grants awarded
New PI/RA/expansion
• All IRB applications should be submitted 1-2
months in advance.
How do you prepare for IRB
application?
• Explain that risks to participants, if any, will be minimal
• Emphasize that no one in the study will be worse off
• Explain why the project is withholding the program
from the control group
• Explain how participation in the study may leave to
improvement in the subjects’ lives and any other
benefits
• How security of the data will be maintained
• Names of all Key Study Personnel with access to data
How do you prepare for IRB
application?
• Human Subjects training
certifications of all Key Study
Personnel (Citi/NIH)
• Questionnaires and Consent form
– English and translated into language of use
– Certification of translation
– Consent form as a separate document
• MOU or letter of support from
partner organizations
• Additional requirements (No PII on
Dropbox (even if it’s encrypted)
Know your IRB coordinators
•
•
•
•
JPAL Global: Heather McCurdy
— [email protected]
IPA Global: Zahra Niazi
— [email protected]
JPAL SA: Vipin Awatramani
CMF: Shahid Vaziralli([email protected]),
Anup Roy ([email protected])
Check with your field office for any local IRB requirements, you can get in touch with
responsible person at the field office to get support for these applications
Where to go for more information?
1.
Sharepoint! -> Resources --> Human Subjects
What about my field staff
• Train field staff on fair treatment of human subjects,
importance of confidentiality and data security
• Ensure that sessions on these issues are well
delivered (Experienced staff/trainers)
• Ensure that the training covers all aspects of data
protection and ethical concerns
• Get Data Confidentiality Agreement signed by field
staff. (Add it as an annexure in their contract)
What about data security?
• Data security is a key component of protecting personal
data and related IRB approval
• Secure procedures ensures that private information of
human subjects is being protected
• Required reading
• Data Security Protocol
• Approved IRB protocol (additional requirements) for the
project, levels of data security
Level 1
Level 2
Level 3
Level 4
Not
confidential
PII: No material harm,
embarrassment(confidentiality)
PII:
Embarrassment,
harm reputation
HRCI (High risk
confidential data)
What about data security?
HRCI
Social security, credit/debit card, individual financial account,
driver’s license, ID (passport/state ID)
Medical information including biometric information
Risk of civil/social liability, moderate psychological harm
Level 1
Level 2
Level 3
Level 4
Not
confidential
PII: No material harm,
embarrassment(confidentiality)
PII:
Embarrassment,
harm reputation
HRCI (High risk
confidential data)
Five Principles of data security
Obtain Confidentiality agreement
Ensure physical security
Store, transmit and use PII separately
Encrypt all PII
Secure Devices handling decrypted PII (password)
Research Associates on IRB
• Ensure all individuals handling PII have
certifications
• Draft IRB application or renewals or IRB
updates
• Ensure accurate implementation of IRB
guidelines at field level
• Report any IRB breaches to your human
subjects coordinator immediately
Data handling at various stages
After survey
Before data
collection
(survey)
During data
collection
(survey)
Environment
for analysis
Wrapping up
field work
Making data
public
Before data collection (survey)
Train field staff
Confidentiality
Agreements
Detailed plan on
securely handling
data
Storing/handling
data securely (metal
cabinets)
Procedure if data
security breach
occurs
Separable PII – non
PII
Designing survey instrument
and data entry software
Ensure Certifications
Validate physical attributes
Educate yourself and others
IRB/data security
protocol
During data collection (survey)
PII
Other
Sensitive
information
Risk
• Ensure that you have a field for the Unique ID Code on every
page of the survey packet.
• Paper surveys received from surveyors should be physically
separated
• These two sections should be stored and transported
separately
After survey: Paper surveys and
data entry
•Designate a safe and secure place for survey storage
•Surveys should not be left out in the open for extended periods
•Ensure that data entry operators have signed a Confidentiality
Agreement
•Set up secure data entry system
•Internet-disabled computers with back-up
• Remove non-essential programs/software from computer
• Install an antivirus and analyze each computer
• Set up user accounts and intranet
•Continually back up data
•Data transfers: USB or SFTP (no email)
After survey: Transmission and
sharing
• Transfer data to password protected computer as an
encrypted file
• Confirm that data entry operators have removed the data
from their computers (if applicable)
Environment for analysis
• Maintain two
separate datasets: first which contains PII and the
unique id code and a second which contains the unique id code
and the rest of the data (make sure both contain the respondent
id code)
• Keep the dataset containing personally identifiable
information encrypted
Wrapping up field work
•Once data analysis is finished, hardcopies of surveys need to
be destroyed in a secure manner (e.g., shredded) within 3-5
years of completion of the study
•Once all data is received for cleaning and analysis and secure
back-up of the files has been confirmed, completely delete the
file from any field computers (make sure all data has been
transmitted from the field before deleting files)
Making data public
•Multiple team members need to review the dataset before it is
released publicly, preferably ones who are familiar with the survey
instruments and data collection
•The potential negative repercussions of making on mistake and
releasing PII on a public database can be huge (imagine leaving a
social security number in a public medical procedures database)
•Always get PI approval before making data public
Data security checklist
All project staff have take IRB course and sent certifications*
Survey structured with PII-Consent detachable from Main Questionnaire
Field staff sign a confidentiality agreement before working with
data/surveys*
Using IRB approved consent form*
Unique ID code written on every page*
PII-Consent separated from Main Questionnaire prior to data entry
Hard copies stored in a secure location*
Use encryption for storage, transmission and access of PII data*
Make 2 backup copies (encrypted) of the original data*
Store backup copies on a secured server
Confirm data entry operators have removed data from their computers*
Separate PII from non-PII whenever possible
* Required
Quiz
The PI asks a research assistant to download data from a govt
website to evaluate potential variables of interest
A. Must get approval
or can’t proceed
B. Should get approval
C. Proceed but submit
change with
modification/
renewal
D. IRB approval or
update not needed
75%
n.
.
ru
lo
ov
a
ap
pr
IR
B
bu
t
ee
d
te
ch
a
su
bm
it
ta
ge
Pr
oc
Sh
ou
ld
n.
.
va
l
pp
ro
an
..
rc
lo
ov
a
ap
pr
et
us
tg
M
5%
pd
a
7%
13%
A small-scale survey is launched to collect data from subjects,
including identifiers, to use for power calculations but not
for analysis that will be used for the final paper
A. Must get approval
or can’t proceed
B. Should see if
approval is needed
C. Proceed but submit
change with
modification/
renewal
D. IRB approval or
update not needed
53%
33%
8%
n.
.
pd
a
lo
ov
a
ap
pr
IR
B
bu
t
ee
d
Pr
oc
ru
su
bm
it
pr
o
ap
if
e
se
te
ch
a
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a
Sh
ou
ld
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et
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M
n.
.
i. .
.
an
..
5%
The consent form is changed from being written to being verbal,
since it has become obvious that many of the respondents
can’t read and the additional printed consent forms aren’t
being used.
A. Must get approval
or can’t proceed
B. Should see if
approval is needed
C. Proceed but submit
change with
modification/
renewal
D. IRB approval or
update not needed
47%
41%
9%
n.
.
pd
a
lo
ov
a
ap
pr
IR
B
bu
t
ee
d
Pr
oc
ru
su
bm
it
pr
o
ap
if
e
se
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ch
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ou
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.
i. .
.
an
..
3%
Group Exercise
Scenario 1: You are done with your field work
and need to shut down your temporary field
office. You are transporting all you surveys on a
Truck to a different city for storage. The truck
met with an accident and two boxes got
lost…What will you do?
Group Exercise
Scenario 2 : You just completed data entry and
have data ready for cleaning. The
drive/USB/Laptop is lost during your visit to
field.
What will you do?
You are done with your field work and need to shut down your
temporary field office. You are transporting all you surveys
on a ruck to a different city for storage. The truck met with
an accident and one box got lost…What will you do?
A. You have that data
in soft copy, so no
worries
B. Inform your PI and
IRB coordinator
C. You inform IRB
committee
95%
3%
ee
m
itt
m
co
IR
B
fo
rm
in
Yo
u
yo
u
In
fo
rm
Yo
u
ha
ve
th
a
rP
Ia
td
nd
at
a
IR
B
in
c. .
.
so
..
2%
You just completed data entry and have data ready for cleaning.
The drive/USB/Laptop is lost during your visit to field.
A. You have the data
on your email
chains so you can
retrieve, You just
need to inform your
HR/admin about
laptop
B. Inform PI’s and IRB
coordinator,
retrieve all the data,
store it ‘securely’
89%
an
d
PI
’s
In
fo
rm
Yo
u
ha
ve
th
e
da
t
IR
B
ao
n
co
or
y.
..
...
11%
What do you think?
FEEDBACK
Which of the following best represents how you
feel about the length of this presentation?
A.
B.
C.
D.
Much too long
Long, but bearable
Right length
Not quite long
enough
E. Much more, please!
Which of the following best represents how you
feel about the pace of this presentation?
A. Too fast! I couldn’t
keep up.
B. Somewhat rushed
C. Right pace
D. Somewhat slow
E. Very slow
How likely are you to use the content covered in
this lecture/exercise in your work?
A.
B.
C.
D.
E.
Very unlikely
Unlikely
Uncertain
Likely
Very likely

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