Singapore legislation

Schedule 1

of Human Biomedical Research (Tissue Banking) Regulations 2019

Schedule 1

Declaration of compliance

FIRST SCHEDULERegulation 8(1)Declaration of compliance I declare, on behalf of _____________________ (name of tissue bank), all of the following:1.I have read and understood the Human Biomedical Research Act 2015, and all regulations and codes of practice or ethics issued under that Act (collectively called the Act).2.Except for the offences and contraventions that have been notified to the Director‑General of Health in accordance with section 35(3) of the Human Biomedical Research Act 2015 or regulation 9 of the Human Biomedical Research (Tissue Banking) Regulations 2019, all tissue banking activities conducted under the supervision and control of the tissue bank between __________ and __________ (insert dates) comply with the Act.3.The tissue bank —

(a)

has formulated and implemented appropriate standards, policies and procedures to supervise, review and monitor the conduct of the tissue banking activity conducted under its supervision and control;

(b)

supervises, reviews and proactively monitors the conduct of the tissue banking activity conducted under its supervision and control;

(c)

ensures that the tissue banking activity conducted under its supervision and control, including those that are conducted by a third party under a contractual agreement, complies with the Act, and is conducted in accordance with the standards, policies and procedures mentioned in sub‑paragraph (a);

(d)

has formulated and implemented a policy on whether or not the donor should be re‑identified and informed in the case of an incidental finding and has informed all donors and recipients of the details of the policy and if the policy provides for the donor to be re‑identified and informed, whether the donor has expressed a wish to be re‑identified and informed;

(e)

investigates any areas of concern and takes the appropriate remedial measures;

(f)

performs all other functions and duties as may be prescribed in legislation; and

(g)

regularly reviews —

(i)

the standards, policies and procedures formulated and implemented by the tissue bank to supervise, review and monitor the conduct of the tissue banking activity conducted under its supervision and control;

(ii)

all serious adverse events and untoward occurrences; and

(iii)

all safety lapses. Signature, name and designation of principal person in charge Date

Read in full context — Human Biomedical Research (Tissue Banking) Regulations 2019 →