Download Addendum to Participant Information Sheet

NOTES TO USE “THE ADDENDUM TO PARTICIPANT INFORMATION SHEET”
1. The enclosed Addendum is to supplement participant information sheet for the purposes of
complying with the Personal Data Protection Act 2012 (No. 26 of 2012).
2. The Addendum should only be used if the approved participant information sheet and
informed consent document based on the SingHealth template do not contain the following
Paragraphs in the “Confidentiality of study and medical records” section :
By signing the Informed Consent Form attached, you or your legal representative are
authorizing (i) collection, access to, use and storage of your “Personal Data, and (ii)
disclosure to authorised service providers and relevant third parties.
“Personal Data” means data about you which makes you identifiable (i) from such data or
(ii) from that data and other information which an organisation has or likely to have access.
This includes medical conditions, medications, investigations and treatment history.
Research arising in the future, based on this Personal Data, will be subject to review by
the relevant institutional review board.
By participating in this research study, you are confirming that you have read, understood
and consent to the SingHealth Data Protection Policy- the full version is available at
www.singhealth.com.sg/pdpa.
3. Please note that you do not need to submit this Addendum to CIRB for approval.
4. Should you wish to use the updated participant information sheet and informed consent
document template with the above mentioned Paragraphs included, you may download the
updated version from CIRB website:
http://research.singhealth.com.sg/pages/centralisedinstitutionalreviewboard.aspx
Addendum to PIS+ICD (PDPA) Template v1 27Aug2014
Addendum to Participant Information Sheet
STUDY INFORMATION
Protocol Title:
(Use the full protocol title as used in the CIRB Application)
Principal Investigator:
(Please include full name, department, address, phone number*)
(*For all studies, please include your Institution’s mainline. For more than minimal risks
studies, please include the mobile number of PI or Study Coordinator, in addition to your
Institution’s mainline.)
Sponsor:
(Delete this section if this is an investigator-initiated study without specific funding.)
This is an Addendum to supplement the Patient Information Sheet for the above captioned
Study for the purposes of complying with the Personal Data Protection Act 2012 (No. 26 of
2012).
By signing the Informed Consent Form attached, you or your legal representative are
authorizing (i) collection, access to, use and storage of your “Personal Data, and (ii) disclosure
to authorised service providers and relevant third parties.
“Personal Data” means data about you which makes you identifiable (i) from such data or (ii)
from that data and other information which an organisation has or likely to have access. This
includes medical conditions, medications, investigations and treatment history.
Research arising in the future, based on this Personal Data, will be subject to review by the
relevant institutional review board.
By participating in this research study, you are confirming that you have read, understood and
consent to the SingHealth Data Protection Policy- the full version is available at
www.singhealth.com.sg/pdpa.
____________________________________
Signature/Thumbprint (Right / Left) of participant
Addendum to PIS+ICD (PDPA) Template v1 27Aug2014
______________________
Date of signing