Training Requirements | SingHealth Duke-NUS

All SingHealth PI/Site-PI, Co-I, and study team members are required to complete the minimum research ethics and compliance trainings to help them understand and apply the principles underlying the day-to-day practice of research. This helps to ensure safety, integrity, and quality of research, in compliance with local laws, regulations and international standards. The training requirements are as follows:

Minimum Training Requirements [Mandatory for IRB submission]

From 1 April 2024, all researchers (i.e., PI/Site-PI, Co-I, and study team members) who are directly involved in the conduct of research must meet the following training requirements:

Types of Research	Training Requirements
Human Biomedical Research and all other human subject's research	CITI Program - Biomedical Research Investigators and Key Personnel Module and SingHealth eHBRA training or equivalent (please see self-enrolment instructions below)
Clinical Trials regulated under Health Products Act or Medicines Act	CITI Program - Biomedical Research Investigators and Key Personnel Module and ICH-GCP course

All researchers are encouraged to complete the above courses, if not already done so. This is because researchers are required to submit their training certificates in the ECOS [Ethics and Compliance Online System] Minimum Training Module, prior to being able to submit new IRB applications via ECOS. Details on submission of the certificates will be shared later.

Collaborative Institutional Training Initiative (CITI) Program – Click here to access.
- Biomedical Research Investigators and Key Personnel module
  This web-based training program is designed to educate researchers about ethical research and protection of participants in research. Upon completion of the program, a certificate will be issued. All researchers should maintain a valid (non-expired) CITI certificate.
- The CITI Biomedical Research with 10 core modules are:

1. History and Ethics of Human Research

2. Informed Consent

3. Social and Behavioral Research (SBR) for Biomedical Researchers

4. Records-Based Research

5. Genetic Research in Human Populations

6. Populations in Research Requiring Additional Considerations and/or Protections

7. Research Involving Prisoners

8. Research Involving Children

9. Research Involving Pregnant Women, Fetuses, and Neonates

10. Conflict of Interest in Human Subjects Research

International Committee on Harmonization of Good Clinical Practice (ICH-GCP)
The ICH-GCP course aims to equip participants with fundamental knowledge of clinical trial quality standards for designing, conducting, recording, and reporting trials that involve research participants. Certificate of completion from any ICH-GCP course providers (including online providers) will be acceptable.

Please take note:
From 1 April 2024 – All researchers performing significant study tasks (please refer to the examples of significant study tasks in the HSA website) must complete the ICH-GCP course as a training requirement in addition to the CITI Program.
Human Biomedical Research Act (HBRA)
The Human Biomedical Research Act (HBRA) regulates Human Biomedical Research (HBR) and tissue banking activities conducted in Singapore to protect the safety and welfare of research participants and tissue donors.

From 1 April 2024, all researchers involved in the conduct of HBR and tissue banking activities are required to complete the e-learning course "Human Biomedical Research Act (HBRA) Essentials". A certificate will be issued upon completion of the online training. Please see instructions below on how to access the e-learning courses.

Proper Conduct of Research (Accessible via SingHealth's e-learning platform)

Research Start-up

Course Name

Course Description

Human Subject Research Start-up Course*

• Learn to plan and start up a human subject research by considering ethical and regulatory requirements and preparing documents that are required to be in place.

IRB 201 – Waiver of Consent*

• Learn the criteria for waiver of consent required under HBRA and HBR not regulated under the scope of HBRA.

• Understand the information to be included in the IRB application when requesting for waiver of consent.

*Recommended courses

Proper Conduct of Research

Course Name	Course Description
Research Conduct 101 – Study Recruitment *	• Learn to conduct subject recruitment and be aware of the common errors • Learn the relevant documentation required
Research Conduct 102 – Informed Consent Process and Conduct *	• Understand the considerations when designing and obtaining informed consent• Learn the proper informed consent documentation required
Research Conduct 103 - Research Data Management *	• Understand the overview of Research Data Management • Learn about data management plan, data collection and documentation, data storage, data retention, data sharing, and data protection
Research Conduct 201 – Remote Consent	• Understand what remote consent is and when it is used for research • Learn the remote consent process and documentation requirement

*Recommended courses

Step-by-Step Instructions to Access SingHealth e-learning courses

After logging in to Blackboard Learn (singhealthacademy.edu.sg):

1. Click on 'Courses' located at the orange column on the left.

2. Navigate to 'Course Catalog' located at the top right-hand corner.

3. Enter the keyword(s) relating to the course that you would like to be enrolled in in the search bar (e.g. “Human Subject Research Start-Up Course”).

4. Click on 'Go'.

5. The courses will appear at the bottom of the search bar. Hover your cursor to the 'Course ID' for your desired course. An arrow will appear beside the 'Course ID'. Click on the arrow and a dropdown list with 'Enrol' will appear. Click on 'Enrol'.

6. A pop-up window will appear, click ‘Submit’ to proceed with enrolment to the course.