Firstly, check if your study is regulated under the HBRA scope. For HBR, all the elements listed in Section 12(1) (for HBR studies) and Section 12(2) (for removal, donation or use of human tissue) must be included in the consent form and communicated clearly to the subject/donor. If the element is stated as “where applicable”, e.g. Section 12(1)(e), Section 12(1)(j) and Section 12(2)(k), it should be included if it is relevant to the research.
PDPC clarified that consent is not required for re-contacting patients for the purpose of seeking their consent for research. This position is not based on the 'deemed consent' provision under the PDPA, but on the principle that the act of re-contacting the patients facilitates consent taking. For research using individually-identifiable health information, only members of the care team/related to the care team (e.g. employees of that organization who are working with the treating physician) should contact patients to obtain consent to participate in Human Biomedical Research. The institutions have the flexibility to determine by themselves who among their personnel would be considered as being part of a "care team".
The witness must be (a) 21 years of age or older; (b) have mental capacity; and (c) must not be the same individual taking the appropriate consent. The witness may be a member of the team carrying out the research of which the individual giving the consent is a research subject.
The witness must take reasonable steps to ascertain – (a)the identity of the individual giving the appropriate consent; and (b) that the consent was given voluntarily without any coercion or intimidation.
A member of the study team (eg. study coordinator) may be the witness, however this member must not be the same person taking the appropriate consent.
Although HBRA allows witness to be a study team member, ORIC will recommend that a higher standard be adopted when dealing with illiterate subjects and an impartial witness be present as witness when obtaining consent. The impartial witness in this case cannot be study team member.
The full NRIC number can be recorded in “subject identification code list /log” for means of identifying the patient accurately. The investigator shall keep this listing of the names and NRIC of all patients allocated to a subject number/subject initials confidential.For any other research logs/documents which are kept in the Investigator Site File (ISF), the subject study number and subject initials (eg. [study prefix]01/TAK ) that has been assigned should be recorded.
HBRA did not mention this but best practice for documentation should be followed. The process of informed consent should be documented in the subject’s medical records. This is required for ICH-GCP drug trials. Furthermore, this is also described in the intent of JCI requirement HRP.7.1 regarding informed consent where “When patients decide to participate in research and grant consent, the individual providing the information and obtaining the consent is noted in the medical record.” Take note that the other healthcare providers in the institution may also need to be aware of patient enrolled in a research study as it may have other implications (eg. Potential safety issues).
After you have obtained broad consent for the leftover tissues, you may carry on with your research and the leftover tissues will be transferred to the Tissue Bank after the study. There is also a possibility that there will be no leftovers to transfer, that is also fine. Please contact the Tissue Bank that you are using for the workflow and charging matters.
If you are supplying leftover samples to your own HBR Study B, you need not be subjected to HTF. If you are supplying to other studies, you are a tissue bank. A tissue bank will be required to be registered OR you can come under the oversight of an existing tissue bank to facilitate the downstream research. For release of tissues to Study B, the tissue bank will need to sight the IRB approval/exemption and have mechanisms of tracking for the release of tissues. The duties of tissue bank will need to be fulfilled.
Yes. HBRA compliant consent (ie. consent form containing all essential elements according to HBRA) needs to be obtained for use of these discarded tissues in research.
Yes, you will need to obtain HBRA compliant broad consent (containing all HBRA required consent elements) for use of these tissues/biological materials for future research, even though the materials are collected from HSA-regulated trial.
No, the HBRA First Schedule defines such materials as Human Biological Materials excluded from definition of Human Tissue. These will not be subject to the consent requirements for removal, donation or use of human tissue from a tissue donor under HBRA Section 12 (2), and also not fall under the scope of the duties of a tissue bank under HBRA Section 35. Even though consent meeting the elements of HBRA is not required, investigators should ensure that subjects have consented for use of their non-tissue samples for future research.
No. The record linkage key still resides in the same team. Research is still considered as working with individually identifiable information if the record linkage key is still accessible by the study team. For a research to be considered as working with de-identified information, the record linkage key must be held by a trusted third party.
Service Improvement and Quality Assurance projects do not need to be submitted to CIRB unless the projects subject the participants to additional risk or burden beyond the usual clinical practice. When publishing QA/QI study or clinical audit, the project should not be described as research and the publisher should be informed of the nature of the project accordingly.
No, NEHR is NOT to be used for research. Please be reminded that NEHR can only be used for clinical care. Any use of NEHR will need to be reported as a Protocol Non-Compliance to CIRB and Suspected Contravention to MOH.
