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X : INCLUDEPICTURE "https://mir-s3-cdn-cf.behance.net/project_modules/disp/fa290e38282275.575bf7cae3cfc.png" \* MERGEFORMATINET
UTB Research Committee (URC)
This form must be typed on the computer. Ideally, digital signatures can be utilized, and the word document form will be emailed by the PI/Supervisor (if applicable) to the Ethics Coordinator.\
I. BASIC INFORMATIONApplication InfoResearch Title: FORMTEXT
S u b m i t t e d t o E t h i c s C o m m i t t e e i n F O R M T E X T S c h o o l / F a c u l t y / C e n t r e
A p p l i c a n t I n f o T i t l e
N a m e
R o l e
S t u d y ( i f s t u d e n t )
A f f i l i a t i o n ( i f a p p l i c a b l e )
F O R M T E X T
F O R M T E X T
F O R M C H E C K B O X PI/Supervisor
FORMCHECKBOX Researcher
FORMCHECKBOX Student
FORMCHECKBOX Undergraduate
FORMCHECKBOX Postgraduate
Programme:
FORMTEXT
School/Faculty/Centre:
FORMTEXT
Area and Position:
FORMTEXT
(please complete Section III for all co-investigators, if any)
Supervisor (if applicable) Project/Research Duration Title
Name
Affiliation
FORMTEXT
F O R M T E X T
S c h o o l / F a c u l t y / C e n t r e :
F O R M T E X T
A r e a a n d P o s i t i o n :
F O R M T E X T
P r o p o s e d S t a r t D a t e : F O R M T E X T
E x p e c t e d E n d D a t e : F O R M T E X T
R e f e r r al to Policy and ProceduresI confirm that I have read Universitys document UTB Research Ethics Policy and Procedures, version No. ____ , prior to filling this form, and that I understand, to the best of my ability, all mentioned issues related to the nature of my research and ethics clearance (tick to confirm FORMCHECKBOX ) Has this research been previously reviewed by an ethics committee or URC? FORMCHECKBOX No FORMCHECKBOX Yes (give details and attach copy of previous applicat i o n a n d f e e d b a c k )
D e t a i l s : F O R M T E X T I n v o l v e m e n t f r o m o u t s i d e U T B W i l l a n y o f t h e c o n c e r n e d r e s e a r c h a c t i v i t i e s t a k e p l a c e o u t s i d e B r u n e i D a r u s s a l a m , o r o u t s i d e t h e p r e m i s e s o f U T B ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o
W i l l r e s e a r c h e r s f r o m o u t s i d e U T B t a k e p a r t i n t h i s r e s e a r c h ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o
I f y o u a n s w e r y e s t o a n y o f a b o v e q u e s t i o n s , p r o v i d e t h e f o l l o w i n g :
D e t a i l s a n d j u s t i f i c a t i o n : F O R M T E X T
I s t h e r e a n y e t h i c a l a p p r o v a l p r o c e s s ( o t h e r t h a n U T B s ) r e q u i r e d b y t h e o t h e r i n s t i t u t i o n s / c o u n t r i e s ? H o w i s t h a t d e t e r m i n e d , a n d w h e t h e r s u c h p r o c e s s h a s b e e n i n i t i a t e d o r a p p r o v a l o b t a i n e d ?
F O R M T E X T
R e s e a r c h R e l a t e d t o H e a l t h c a r e / C l i n i c a l T r i a l s W i l l t h e r e s e a r c h c o n d u c t c l i n i c a l t r i a l s , o r b e r e l a t e d t o h e a l t h c a r e e x p e r i m e n t a t i o n o f m e d i c a t i o n s , e q u i p m e n t , o r b i o c h e m i c a l r e a c t i o n s ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o .
I f y e s , a n s w e r t h e f o l l o w i n g :
D e t a i l s a n d j u s t i f i c a t i o n : F O R M T E X T
H a v e t h e c o n c e r ned authorities in Brunei Darussalam, such as the Medical Health Research and Ethics Committee (MHREC), the National Adverse Drug Reaction Monitoring Centre (NADRMC), or the Ministry of Health, been contacted to clear the research activities? Give details about the clearance process and its outcome.
FORMTEXT
R e s e a r c h w i t h I n v o l v e m e n t o f H u m a n P a r t i c i p a n t s D o e s t h e r e s e a r c h i n v o l v e h u m a n p a r t i c i p a n t s ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o
I f y e s , a n s w e r t h e f o l l o w i n g a n d e l a b o r a t e m o r e i n S e c t i o n V :
P u r p o s e : F O R M T E X T
T a r g e t N u m b e r : F O R M T E X T
A r e t h e p a r t i c i p a n t s c o n s i d e r e d P o t e n t i a l l y V u l n e r a b l e a s d e f i n e d i n U n i v e r s i t y s e t h i c s p o l i c y ( e . g . c h i l d r e n , p a t i e n t s , p e o p l e w h o s e c o m p e t e n c e t o e x e r c i s e i n f o r m e d c o n s e n t i s i n d o u b t ; p e o p l e w h o m a y s o c i a l l y n o t b e i n a position to exercise unfettered informed consent; or people whose circumstances may unduly influence their decisions to consent)? FORMCHECKBOX Yes FORMCHECKBOX No
Is there any potential for physical and/or psychological harm/pain/distress to the participants? FORMCHECKBOX Yes FORMCHECKBOX No
Research Involving Sensitive TopicsDoes the research address topics that are considered sensitive? Such topics include: race or ethnicity; political opinion; religious, spiritual or other beliefs; physical or mental health conditions; sexuality or gender identity; abuse (child, adult); criminal or illegal activities; conflict situations; personal violence or terrorism; and personal finances. FORMCHECKBOX Yes FORMCHECKBOX No
If yes, name these topics below and elaborate further in Section V on justification, privacy concerns, potential implications, and any legality issues.
Topics: FORMTEXT
D a t a C o l l e c t i o n a n d S t o r a g e W i l l t h e r e s e a r c h i n v o l v e c o l l e c t i n g / g e n e r a t i n g a n d s t o r i n g d a t a ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o
I f y e s , p r o v i d e t h e f o l l o w i n g i n f o r m a t i o n o n m e a s u r e s y o u w i l l t a k e t o m a i n t a i n r e s e a r c h d a t a s e c u r i t y a n d c o n f i d e n t i a l i t y .
W h e r e w i l l t h e d a t a b e s t o r e d , a n d w h o w i l l a c t a s t h e c u s t o d i a n f o r t h e d a t a ?
F O R M T E X T
W h o w i l l h a v e a c c e s s t o t h e d a t a , a n d w h o w i l l p e r f o r m d a t a a n a l y s i s ?
F O R M T E X T
W h a t w i l l h a p p e n t o t h e d a t a a f t e r r e s e a r c h c o m p l e t i o n ?
F O R M T E X T
W i l l t h e d a t a b e s h a r e d w i t h a n y o t h e r c o l l a b o r a t o r s o r i n s t i t u t i o n s ?
F O R M T E X T
W i l l G e n e r a l C o n f i d e n t i a l i t y U n d e r t a k i n g a g r e e m e n t b e s i g n e d b y a l l p e o p l e w h o w i l l h a v e a c c e s s t o t h e d a t a ? W h e r e w i l l t h e s e a g r e e m e n t s b e k e p t ?
F O R M T E X T
W i l l t h e r e s e a r c h i n v o l v e c o l l e c t i n g p e r s o n a l d a t a , w h i c h c a n l e a d , e v e n i f i n d i r e c t l y , t o t h e i d e n t i f i c a t i o n o f p e r s o n s ( e . g . n a m e s , I D s o f a n y s o r t , a d d r e s s e s , c o n t a c t i n f o , p h o t o s , v i d e o s , g e n e t i c i n f o , e t c . ) ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o
I f y e s , p r o v i d e t h e f o l l o w i n g i n f o r m a t i o n o n m e a s u r e s y o u w i l l t a k e t o m a i n t a i n c o n f i d e n t i a l i t y o f p a r t i c i p a n t s d a t a .
W i l l t h e p a r t i c i p a n t s b e m a d e a w a r e o f t h e p e r s o n a l d e t a i l s t h a t w i l l b e s t o r e d ?
F O R M T E X T
H o w w i l l p a r t i c i p a n t s c o n s e n t t o t h e c o l l e c t i o n a n d s t o r a g e o f t h e i r p e r s o n a l d a t a ?
F O R M T E X T
W i l l t h e d a t a b e e n c r y p t e d o r a n o n y m i z e d , h o w w i l l t h i s b e d o n e , a n d a t w h a t s t a g e ?
F O R M T E X T
W i l l t h e p e r s o n a l d a t a b e d e l e t e d a f t e r t h e c o m p l e t i o n o f t h e p r o j e c t , o r u p o n r e q u e s t o f p a r t i c i p a n t s , a n d h o w w i l l t h a t h a p p e n ?
F O R M T E X T
W i l l t h e r e s e a r c h i n v o l v e a c c e s s i n g n o n - p u b l i c d a t a , s u c h a s m a k i n g u s e o f a r c h i v e d d a t a o r e x i s t i n g d a t a b a s e s ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o
I f y e s , p r o v i d e t h e n e c e s s a r y d e t a i l s a b o u t t h e d a t a s o u r c e s , o w n e r s , a c c e s s p e r m i s s i o n s a n d s t e p s r e q u i r e d t o o b t a i n t h e s e p e r m i s s i o n s , a n d p l a n s i n c a s e p e r m i s s i o n s a r e n o t g i v e n .
F O R M T E X T
R e s e a r c h I n v o l v i n g A n i m a l S u b j e c t s D o e s t h e r e s e a r c h i n v o l v e a n i m a l s u b j e c t s ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o
I f y e s , p r o v i d e t h e f o l l o w i n g d e t a i l s :
A n i m a l ( s ) : F O R M T E X T ( T a r g e t N u m b e r : F O R M T E X T ) ( a d d m o r e a s n e c e s s a r y )
F O R M C H E C K B O X B l o o d F O R M C H E C K B O X T i s s u e s F O R M C H E C K B O X O t h e r s , p l e a s e s p e c i f y F O R M T E X T
I s t h e r e a n y s e p a r a t e e t h i c a l a p p r o v a l p r o c e s s r e q u i r e d ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o
( I f y e s , g i v e details about that process and whether it has been initiated/obtained)Safety IssuesDoes the research raise any issues of personal safety for you or other researchers involved in the project? (especially if taking place outside working hours or off University premises, working with potentially threatening people or conducting activities in a potentially dangerous environment) FORMCHECKBOX Yes FORMCHECKBOX No
If yes, have you obtained HSE Risk Assessment from the University to control p o t e n t i a l r i s k s ? ( F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o ) . I n e i t h e r c a s e , g i v e d e t a i l s b e l o w t o e x p l a i n a b o u t t h e s a f e t y i s s u e s r a i s e d a n d h o w t h e s e i s s u e s w i l l b e m a n a g e d .
F O R M T E X T
D o t h e r e s e a r c h a c t i v i t i e s r e q u i r e t h e d i s p o s a l o f e x p e riments equipment, materials, or waste, which are hazardous or have environmental, health, safety, or statutory bodies concerns? FORMCHECKBOX Yes FORMCHECKBOX No
If yes, explain the respective disposal regulations and how this will be managed.
FORMTEXT
D o e s a n y o f t h e r e s e a r c h e r s r e q u i r e p r i o r t r a i n i n g ( s ) t h a t c a n m i n i m i z e p o t e n t i a l r i s k ( s ) r e s u l t i n g f r o m r e s e a r c h a c t i v i t i e s ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o
I f y e s , e x p l a i n a b o u t t h e p l a n t o m e e t a n y t r a i n i n g r e q u i r e m e n t s .
F O R M T E X T
O t h e r C o n s i d e r a t i o n s W i l l t h e r e s e a r c h r e q u i r e s h a r i n g o f p r i v a t e i n f o r m a t i o n o r d e t a i l s a b o u t i n t e l l e c t u a l p r o p e r t y w i t h o t h e r p a r t i e s ( i n - h o u s e r e s e a r c h e r s o r e x t e r n a l e n t i t i e s ) ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o
I f y e s , e x p l a i n a b o u t t h e n a t u r e o f s u c h d i s c l o s u r e a n d p l a n s t o a d d r e s s t h i s i s s u e , i n c l u d i n g s i g n i n g N D A a g r e e m e n t s e t c .
F O R M T E X T
A r e y o u a w a r e o f a n y r e a l o r p o t e n t i a l c o n f l i c t o f i n t e r e s t t h a t m a y a r i s e f r o m u n d e r t a k i n g y o u r r e s e a r c h a c t i v i t i e s ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o
I f y e s , d e c l a r e t h e s e c o n f l i c t s a n d e l a b o r a t e o n t h e s t e p s t o b e t a k e n t o m a n a g e t h e m i n o r d e r n o t t o c o m p r o m i s e t h e i n t e g r i t y o f t h e r e s e a r c h .
F O R M T E X T
D o y o u b e l i e v e t h a t t h e r e a r e o t h e r e t h i c a l i s s u e s t h a t c o u l d b e c o n s i d e r e d f o r c l e a r a n c e , w h i c h w e r e n o t c o v e r e d i n a n y o f t h e q u e s t i o n s a b o v e ? F O R M C H E C K B O X Y e s F O R M C H E C K B O X N o
I f y e s , p l e a s e e l a b o r a t e : F O R M T E X T
I I . D E C L A R A T I O N O F T H E A P P L I C A N T
T h e i n f o r m a t i o n p r ovided in this form is correct.
I will not initiate this research until I receive written notification of approval by the reviewing committee.
I will not initiate any change in methodology of research protocol without prior written approval from the reviewing committee, except when it is necessary to reduce or eliminate immediate risk to participants.
I will promptly report any unexpected or serious adverse events, unanticipated problems or incidents that may occur in the course of this research.
I will maintain all relevant documents and recognize that UTBs ethics committee or regulatory authorities may inspect these records.
I understand that failure to comply with all applicable regulations and University policy requirements may result in the suspension or termination of this research.
I am aware of the fact that UTB holds the authority to penalize the researchers associated with this project in the case of intentional misrepresentation of information or intentional violation of ethical guidelines and principals.
Remarks (if any):
__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
________________________________ FORMTEXT _ _ _ _ _ _ _ _ _ _ A p p l i c a n t s n a m e a n d s i g n a t u r e D a t e P h o n e : F O R M T E X T F a x : F O R M T E X T
M a i l i n g A d d r e s s : F O R M T E X T
E m a i l : F O R M T E X T
III. CO-INVESTIGATORSAll co-investigators who will be conducting research activities that may have ethical implications (e.g. obtaining participation consent, data collection, handling dangerous experiments or machines) should be listed below (expand the list as necessary). All coinvestigators need to sign the form below.
Name: FORMTEXT E m a i l : F O R M T E X T
P o s i t i o n : F O R M T E X T P h o n e : F O R M T E X T
D e p a r t m e n t : F O R M T E X T F a x : F O R M T E X T
I n s t i t u t i o n : F O R M T E X T
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
S i g n a t u r e o f C o - i n v e s t i g a t o r D a t e
N a m e : F O R M T E X T E m a i l : F O R M T E X T
P o s i t i o n : F O R M T E X T P h o n e : F O R M T E X T
D e p a r t m e n t : F O R M T E X T F a x : F O R M T E X T
I n s t i t u t i o n : F O R M T E X T
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
S i g n a t u r e o f C o - i n v e s t i g a t o r D a t e
N a m e : F O R M T E X T E m a i l : F O R M T E X T
P o s i t i o n : F O R M T E X T P h o n e : F O R M T E X T
D e p a r t m e n t : F O R M T E X T F a x : F O R M T E X T
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S i g n a t u r e o f C o - i n v e s t i g a t o r D a t e
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S i g n a t u r e o f C o - i n v e s t i g a t o r D a t e
I V . C O M M E N T S O F P I / S u p e r v i s o r ( i f a p p l i c a b l e ) ( c i r c l e o n e ) 1 . A p p r o a c h a n d M e t h o d o l o g y I s t h e a p p r o a c h o r c o n c e p t u a l f r a m e w o r k f o l l o w e d i n t h i s r e s e a r c h a d e q u a t e l y d e v e l o p e d ? A r e t h e m e t h o d s , t o o l s , a n d a c t i v i t i e s a p p r o p r i a t e a n d a d e q u a t e l y c h o s e n ?
Y E S N O 2 . C o l l a b o r a t o r s / R e s e a r c h e r s A r e t h e r e s e a r c h e r s a n d c o l l a b o r a t o r s i n v o l v e d i n t h i s r e s e a r c h a p p r o p r i a t e l y t r a i n e d t o c o n d u c t t h e e t h i c a l l y c o n c e r n e d a c t i v i t i e s ?
Y E S N O 3 . I n f o r m a t i o n A c c u r a c y A r e t h e a n s w e r s a n d i n f o r m a t i o n p r o v i d e d b y t h e a p p l i c a n t a c c u r a t e a n d b e s t d e s c r i b e t h e r e s e a r c h a c t i v i t i e s ?
Y E S N O 4 . L o w / H i g h P o t e n t i a l E t h i c a l R i s k A c c o r d i n g t o U n i v e r s i t y s R e s e a r c h E t h i c s P o l i c y , t h e p o t e n t i a l e t h i c a l r i s k o f a c t i v i t i e s i n v o l v e d i n t h e r e s e a r c h c a n b e c a t e g o r i z e d a s :
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I a c k n o w l e d g e t h a t t h i s a p p l i c a t i o n i s p r e p a r e d i n l i g h t o f U T B s R e s e a r c h E t h i c s P o l i c y a n d P r o c e d u r e s .
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V . R E S E A R C H S U M M A R Y ( m a x i m u m o f 5 p a g e s ) Y o u r a p p l i c a t i o n i s m o r e l i k e l y t o b e r e v i e w e d q u i c k l y i f y o u p r o v i d e t h e r e v i e w e r s w i t h e n o u g h i n f o r m a t i o n s o t h a t t h e y c a n m a k e a n i n f o r m e d j u d g e m e n t a b o u t t h e r e s e a r c h w i t h o u t h a v i n g t o a s k f o r f u r t h e r d e t a i l s . P l e a s e u s e l a y t e r m s ; i f t h i s i s n o t p o s s i b l e , a n y t e c h n i c a l o r m e d i c a l t e r m s s h o u l d b e e x p l a i n e d i n s i m p l e l a n g u a g e . 1 . A b s t r a c t I n n o m o r e t h a n 5 0 0 w o r d s , d e s c r i b e c o n c i s e l y t h e s p e c i f i c a i m s , o b j e c t i v e s , a n d a p p r o a c h o f t h e r e s e a r c h , i n d i c a t i n g t h e s c i e n t i f i c , s o c i a l , o r e c o n o m i c i m p o r t a n c e o f r e s e a r c h o u t c o m e .
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2 . M e t h o d o l o g y P r o v i d e a s u m m a r y o f t h e m e t h o d s a n d p r o c e d u r e s t o b e u s e d t o a c c o m p l i s h t h e a i m s o f t h e r e s e a r c h .
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D e s c r i b e t h e e x p e r i m e n t a l i n s t r u m e n t s a n d m a t e r i a l s ( i f a n y ) t h a t w i l l b e u s e d .
F O R M T E X T 3 . P o t e n t i a l R i s k s W h a t a r e t h e p o t e n t i a l p h y s i c a l a n d / o r p s y c h o l o g i c a l h a r m / p a i n / d i s t r e s s , t o r e s e a r c h e r s o r p a r t i c i p a n t s , w h i c h m a y r e s u l t f r o m c o n d u c t i n g t h e r e s e a r c h a c t i v i t i e s ? H o w w i l l t h e s e b e m i n i m i z e d a n d m a n a g e d t o e n s u r e a p p r o p r i a t e p r o t e c t i o n a n d w e l l - b e i n g o f r e s e a r c h e r s a n d p a r t i c i p a n t s ?
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I f t h e r e s e a r c h a d d r e s s e s a t o p i c t h a t i s c o n s i d e r e d s e n s i t i v e , e x p l a i n h e r e a b o u t t h e j u s t i f i c a t i o n f o r a d d r e s s i n g t h e s e t o p i c s , p o t e n t i a l i m p l i c a t i o n s o n p a r t i c i p a n t s a n d t h e p u b l i c , p r i v a c y c o n c e r n s , a n d a n y l e g a l i t y i s s u e s t h a t m a y e n t a i l f r o m c o n d u c t i n g t h e r e s e a r c h a c t i v i t i e s ?
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4 . I n v o l v e m e n t o f H u m a n P a r t i c i p a n t s E x p l a i n a b o u t t h e p o t e n t i a l h u m a n p a r t i c i p a n t s a n d i n c l u d e i n f o r m a t i o n o n h o w y o u w i l l i d e n t i f y t h e p o t e n t i a l p a r t i c i p a n t s .
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I f p o t e n t i a l l y v u l n e r a b l e p a r t i c i p a n t s w i l l b e i n v o l v e d , y o u s h o u l d j u s t i f y w h y t h e r e s e a r c h n e e d s t o b e d o n e u s i n g t h i s p a r t i c i p a n t g r o u p , a n d a n y p o s s i b l e r i s k s o r i m p l i c a t i o n s f r o m i n v o l v i n g t h e s e p a r t i c i p a n t s .
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H o w w i l l t h e p a r t i c i p a n t s ( w h e t h e r p o t e n t i a l l y v u l n e r a b l e o r n o t ) b e a p p r o a c h e d a n d r e c r u i t e d ? E x p l a i n t h e r e c r u i t m e n t p r o c e s s i n d e t a i l a n d a t t a c h r e l a t e d d o c u m e n t s ( e . g . a d v e r t i s e m e n t s / p o s t e r s ) t h a t w i l l b e u s e d .
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W i l l i n f o r m e d c o n s e n t b e o b t a i n e d f r o m t h e p a r t i c i p a n t s ? I f y e s , h o w w i l l y o u g i v e p a r t i c i p a n t s e n o u g h i n f o r m a t i o n s o t h a t t h e y c a n m a k e a n i n f o r m e d d e c i s i o n a b o u t w h e t h e r t o t a k e p a r t i n t h e r e s e a r c h ? A t t a c h r e l a t e d d o c u m e n t s i n S e c t i o n V I .
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