NOTES TO USE“THE ADDENDUM TO PARTICIPANT INFORMATION SHEET”

  1. The enclosed Addendum is to supplement participant information sheetfor the purposes of complying with the Personal Data Protection Act 2012 (No. 26 of 2012).
  1. 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
  1. Please note that you do not need to submit this Addendum to CIRB for approval.
  1. 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:

Addendumto 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 abovecaptioned 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

______

Signature/Thumbprint (Right / Left) of participant Date of signing

Addendum to PIS+ICD (PDPA) Template v1 27Aug2014