NUS-logo-blue-1200 HBRA e-Training Materials

DURING THE STUDY

Appropriate Consent

Consent - A fundamental ethical principle and legal requirement for the conduct of HBRA studies

  • Unless the IRB has waived this requirement, consent must be taken from the individual research subjects and tissue donors for their participation or donation of tissue for the research.
  • The HBRA refers to this consent as “appropriate consent”.
  • It prescribes requirements on the consent-taking procedure and the type of information which must be communicated to the subject or donor.

TransparentItem6_HBRAppropriate Consent Requirements, Elements & Waiver

General Requirements

For more information, please click here 

Required information/elements to be included in appropriate consent form

For more information, please click here.

Special conditions for vulnerable groups like minors, mentally incapacitated persons etc

For more information, please click here.

Waiver of Consent

For more information, please click here.

For Imported or Locally Supplied Tissues

For the sample letter of declaration from tissue supplier for imported tissues, click here.
For the sample letter declaration for receipt of tissues from external party in Singapore, click here.

For Tissue Banks: Tracking of Consent

Every TB must establish a system to ensure that every donor's consent in relation to each tissue under the supervision and control of the TB is accurately tracked. Please refer to the sample Appropriate Consent Tracking Log.

For NUS Researchers, please see the current version of the NUS-IRB PIS&CF template which can be downloaded from NUS-IRB website. This template contains all the required elements of appropriate consent. The NUS Guide on Taking HBRA  Appropriate Consent is available here.

 

Consent must be given voluntarily

No coercion, intimidation, deception, misrepresentation or other means should be used to compel participation or tissue donation

Examples:  Denying or withholding treatment if the research subject does not participate or paying the research subject a commercial fee for participation, are not permitted.