Royal Center for Disease Control
Bhutan
National sentinel surveillance for Influenza-likeillness (ILI)
ILI/SARI sentinel surveillance (CDC
and various supports)
 Since 2008
 Few sites- Paro, Punakha,
JDWNRH
 Number of sites expanded in
following years
 11 sites by 2010
 Current Sites:
 Paro Hospital
 Punakha Hospital
 Trongsa Hospital
 Phuntsholing Hospital
 Trashigang Hospital
 Samdrupjongkhar Hospital
 Samtse Hospital
Human Influenza study (AFRIMS)
 Since 2010
 5 year study
 Expired in 2015 and renewed
 Sites:
 ERRH, Mongar*
 JDWNRH, Thimphu*
 CRRH, Gelephu*
 Paro Hospital
 Punakha Hospital
 Trongsa Hospital
 Phuntsholing Hospital
 Trashigang Hospital
National sentinel surveillance for Influenza-likeillness (ILI)
Human Influenza study
(AFRIMS)
 Need to send samples
weekly (Bhutan Post)
 Forms:
 Demographic form
 Informed consents for
various age groups
 Temperature maintenance
 Subjet enrollment
ILI sentinel surveillance
(CDC and various
supports)
 Need to send samples
weekly (Bhutan Post)
 Need to report weekly
cases (online), except *
 Forms:
 Sample requisition (1)
 Temperature maintenance
(2)
 Rapid test result (3)
Human Influenza study (AFRIMS)
 Amendments
 Collaborators
 Study objectives
 Subject enrollment
 Obtaining Informed Consent(updated version)
 Demographic/Clinical form (updated version)
 Enrollment log
 Cold-chain Maintenance Table Form
Amendments to the study
 Protocol version has been updated to V. 6 from previous V.
5
 Amendments:
 Extension of the study duration for an additional 5 years.
 Removed Mr. TandinDorji from Co-Principal Investigator.
 Changed Mr. SonamWangchuk from investigator to Co-
Principal Investigator to replace Mr. TandinDorji.
 Removed Dr. In Kyu Yoon, Dr.PirayaBhoomiboonchoo and
Dr. Stefan Fernandez from investigators list.
 Added Dr. Damon W. Ellison and Mr. BinayThapa as
investigator.
 Changed the duration of reported fever onset from 3 days to 5
days in the inclusion criteria.
Collaborators
 Public Health Laboratory, Department of Public Health in
Bhutan (PHL)
 Armed Forced Research Institute of Medical Sciences
(AFRIMS)
 Centers for Disease Control and Prevention (CDC)
 Walter Reed Army Institute of Research (WRAIR)
 U.S. Air Force School of Aerospace Medicine (USAFSAM)
Study Objectives
Primary objectives:
• To collect and characterize influenza viruses circulating within the human
population in Bhutan.
• To provide influenza surveillance data to the US CDC and WHO
surveillance network towards the annual re-formulation of the influenza
vaccine.
• To report the circulating influenza strains and other respiratory pathogens
to Ministry of Health, Bhutan.
Secondary objectives:
• To evaluate new technologies for specimen collection and preservation as
well as different molecular platforms to identify respiratory pathogens.
• To maintain an influenza sample repository for evaluation of newer
diagnostics as they are developed.
• To provide early warning of H5N1 and other novel influenza strains
circulating in human population.
Subject Enrollment
Inclusion Criteria:
Subjects meeting all of the following criteria will be considered
eligible for enrollment in the study:
 Male or female patients ≥ 6 months of age
 Fever : Oral temperature ≥ 100.5˚F or 38˚C;
Axillary temperature ≥ 99.5˚F or 37.4˚C;
Rectal temperature ≥ 101˚F or 38.6˚C
“AND cough or sore throat”
 Presentation to health care within 5 days of reported fever
onset
 Signed informed consent by patient and parent or legal guardian.
For minor ages between 7-17 years, a signed assent is required.
Subject Enrollment (Cont)
Exclusion Criteria:
Subjects meeting any of the following criteria will be
excluded from the study:
 Immunocompromised host (Acquired Immune
Deficiency -Syndrome, Lymphoma or Leukemia)
 Suspected case of TB
Subject/Specimen Identification
and Confidentiality
The subject number will be created by using the letters
FLU and country code then collection site code and ended
up with the running number of subject (example FLU-BTA00000).
The subject number will identify the patient by using a
Subject Enrollment log sheet that will be maintained in a
locked office at enrollment site to track specimen
accountability and volunteer notification.
Unanticipated Problem Reporting
Any of unanticipated problems involving risk to
subjects or others related to participation in the
study will be promptly reported to the
investigator (Mr. Sonam Wangchuk )
Study Workflow
Informed Consent
 A process by which a subject voluntarily
confirms his/her willingness to
participate in a particular trial, after
having been informed of all aspects of
the trial that are relevant to the subject’s
decision to participate.
 Informed consent is documented by
means of a written, signed and dated
informed consent form.
 IRB/EC approved current version
(version 6.0 dated 16 July 2015)
Informed Consent Process

Potential subjects will have the study explained in detail
by an investigator or designee to the subject or child
 The subjects will be given time to review the study
explanation form and opportunity for any questions
before signing the consent/ assent form
 Sign and date by subject and investigator
 A copy of the signed consent/ assent form will be
provided to the subject for their record.
OR
 Sign 2 copies of consent/assent forms and provide one
copy to subject for their record
Informed Consent Process
• Explain study& procedures
• Adequate time to read & ask
questions
• No undue influence or coercion
• Participation is voluntary
Consent
Form
Subject/ Parents
or legal guardians
• Language
“understandable” to
the subject
(Bhutanese)
• Signed/Dated by subject and
person obtaining consent
• Completion of all signature blanks
Signed &
Dated
Original
Signed &
Dated
Copy
• Obtained prior to
participation in the Study
Subject
and/or Parent or
Legal Guardian
signing consent form
Informed Consent Form
subject age group
Subject age ≥ 18
Subject
one parent or legal
guardian
Subject age
≥ 7 and < 18
Subject age < 7
Study Explanation and
consent form for Adult
N/A
Subject
Study Explanation and
consent form (7-17 years
old)
one parent or legal
guardian
Study Explanation and
consent form for
Parental//Guardian
Subject
N/A
one parent or legal
guardian
Study Explanation and
consent form for
Parental//Guardian
Informed Consent Best Practice
•
Name of Participant__________________________
Subject Printed Name
•
•
Sign by subject
Signature of Participant_______________________
Date of consent: _ _/_ _ _/_ _ _ Date by subject
•
•
(dd/mmm/yyyy)
Complete by subject
Permanent Address: ____________________________________________________
•
•
Investigator or designee Printed Name
Name of Clinician/representative __________________________________________
•
•
Signature of Clinician/representative _______________________Date:
_ _/_ _ /_ _
Sign by Investigator
__
or designee
•
Date by
Investigator or
designee
(dd/mmm/yyyy)
•
•
Impartial Witness Printed Name
Name of Witness: ______________________________________________________
•
•
•
Signature of witness: ____________________________________Date:
_ _/_ _ _/_ _ _Date by Impartial
Sign by Impartial Witness
Witness
(dd/mmm/yyyy)
* Every signature blank on the IRB/EC approved version of the informed consent *
MUST be completed!!!
Informed Consent Form
 If a child capable of assenting refuses to
give his/her assent he/she will not be
enrolled in the study.
 Consent will be obtained from ONE parent
or LEGAL guardian
Consent forms for ILI study
Study Explanation and Consent Form for Adult
version 6.0 dated 16 July 2015 (English and Bhutanese
version)
2. Study Explanation and Consent Form for Parental
/Guardian version 6.0 dated 16 July 2015 (English and
Bhutanese version)
3. Study Explanation and Assent Form (7–17years old)
version 6.0 dated 16 July 2015 (English and Bhutanese
version)
Annex C
1.