Singapore legislation

Schedule 1

of Human Biomedical Research Regulations 2017

Schedule 1

Declaration of compliance

FIRST SCHEDULERegulation 7(1)Declaration of compliance I declare, on behalf of _____________________ (name of research institution), 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 23(3) of the Human Biomedical Research Act 2015 or regulation 8 of the Human Biomedical Research Regulations 2017, all human biomedical research conducted under the supervision and control of the research institution between __________ and _________ (insert dates) comply with the Act.3.The composition and appointment of all the institutional review boards of the research institution comply with the Act.4.The research institution —

(a)

has formulated and implemented appropriate standards, policies and procedures to supervise, review and monitor the conduct of the human biomedical research conducted under its supervision and control;

(b)

supervises, reviews and proactively monitors the conduct of the human biomedical research conducted under its supervision and control;

(c)

has formulated and implemented a policy on whether or not the research subject should be re-identified and informed in the case of an incidental finding and has informed all institutional review boards and researchers under its purview of this policy;

(d)

ensures that the human biomedical research conducted under its supervision and control complies with the Act, and is conducted in accordance with the standards, policies and procedures mentioned to in sub‑paragraph (a);

(e)

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

(f)

in respect of human biomedical research conducted jointly or in collaboration with more than one research institution, has agreed among the research institutions for one research institution to be appointed as the lead research institution for the purpose of coordinating the research;

(g)

has performed all other functions and duties as may be prescribed by the Minister; and

(h)

regularly reviews —

(i)

the standards, policies and procedures formulated and implemented by the Research Institution to supervise, review and monitor the conduct of the human biomedical research conducted under its supervision and control;

(ii)

all serious adverse events, including unexpected serious adverse events;

(iii)

all safety lapses;

(iv)

all reports of any data and safety monitoring board established by the research institution; and

(v)

the performance of all institutional review boards appointed by the research institution. Signature, name anddesignation of principal person in charge Date

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