NHG Health Research Policies and Guidelines

Policies & Guidelines that Researchers should know

Prior to starting your research, we urge all researchers to familiarize themselves with the following policies/guidelines:

NHG Health Responsible Conduct of Research (RCR) Manual

As part of the NHG Health Office of Human Research Protection Programme (OHRPP)’s effort to promote the Responsible Conduct of Research (RCR) awareness within our research community, we have put together this manual so that researchers will be better equipped with knowledge about RCR and be better prepared to deal with any integrity dilemma that they will invariably encounter in their daily research activities and research career. The RCR Manual will provide researchers with insights to the outlines of the overall governance of research, provides procedural guidelines for meeting ethical requirements in research, and offer guidance on key ethical issues.

• Download the NHG Health Responsible Conduct of Research (RCR) Manual here.

NHG Health Investigator’s Manual

To ensure that our growing pool of PIs understand research ethics meaningfully, the NHG Health Investigator’s Manual is a handy reference tool catering to both new and experienced investigators alike.

This publication amalgamated the regulatory requirements, NHG Health DSRB research policies and institutional policies governing research conduct, allowing PIs to adeptly navigate the formidable convolutions of the research maze. The Investigator’s Manual is both practical and useful and you will actively use it to improve the ethical standards of your research.

• Download the NHG Health Investigator's Manual here.

NHG Health Proper Conduct of Research (PCR) SOPs and Templates

The NHG Health PCR SOPs and Templates are developed by NHG Health Group Research & Innovation to provide detailed procedures on conducting research in accordance with applicable guidelines and regulations.

• Download the NHG Health Proper Conduct of Research SOPs & Templates here.

NHG Health Research Institution Policy

The NHG Health Research Institution (RI) Policy outlines the functions and duties of NHG Health RI and duties of the NHG Health Principal Person-In-Charge (PIC) to fulfill the requirements of the HBRA and describes the NHG Health research governance framework that enables the RI to meet the requirements of the HBRA and other relevant Acts and regulations applicable to research.

• Download the NHG Health Research Institution (RI) Policy here (Restricted: NHG Health Intranet access required).

NHG Health Research Data Policy

The NHG Health Research Data Policy provides the framework for governing research data to ensure compliance with the HBRA, Personal Data Protection Act (PDPA), Healthtech Instruction Manual (HIM), Synapxe policies and all other relevant regulations.

• Download the NHG Health Research Data Policy here (Restricted: NHG Health Intranet access required).

NHG Health Human Tissue Bank Policy

The purpose of the NHG Health Human Tissue Bank Policy is to outline the definitions, the establishment, ethical consideration, ownership, governance and management of the NHG Health tissue banks for research to ensure that tissue banking activities are in accordance with the requirements of the Human Biomedical Research Act (HBRA).

• Download the NHG Health Human Tissue Policy here (Restricted: NHG Health Intranet access required).

Suggested Readings & References

• The Belmont Report (US Dept of Health and Human Services)
  The Belmont Report identifies basic ethical principles and guidelines that address ethical issues arising from the conduct of research with human subjects.

• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines
  The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together regulatory authorities and the pharmaceutical industry, through scientific and technical discussions; to achieve greater harmonisation worldwide in ensuring that safe, effective, and high quality medicines are developed and registered efficiently.

• Declaration of Helsinki
  Developed by the World Medical Association (WMA), the Declaration of Helsinki is a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

• Guidance by the Bioethics Advisory Committee (BAC)
  The Bioethics Advisory Committee (BAC) was established by the Singapore Cabinet in December 2000. It has been tasked to address the ethical, legal and social issues arising from biomedical sciences research in Singapore. The BAC actively gathers information and views from the international and local community, and after careful deliberation, makes recommendations to the Singapore Government on the regulation of human biomedical research.

• Ministry of Health (MOH) - Human Biomedical Research Act (HBRA)
  The Singapore Human Biomedical Research Act (HBRA) provides clarity regarding the roles and responsibilities of individuals and body corporates involved in human biomedical research and the handling of human tissue for use in research. Through the legislation, the Ministry of Health (MOH) strives to ensure that human biomedical research and tissue banking activities carried out in Singapore follow the law and principles of good clinical practice relating to ethics and science to protect the safety and welfare of research subjects and tissue donors.

• Singapore Statutes Online: Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021, Health Products Act (Chapter 122D)

• Health Sciences Authority (HSA) - Regulatory overview of Clinical Trials
  Understand the regulatory framework of clinical trials, clinical research materials and active ingredients used in its manufacturing, under the Health Products Act and the Medicines Act.

• Health Sciences Authority (HSA) - Guidance Documents for Clinical Trials
  This is a list of regulatory guidance's to help you understand the regulatory requirements for conducting clinical trials.