DSRB Minimum Training Policy for Researchers
Introduction
With Singapore's push to become a regional hub for biomedical research and the increasing number of clinical trials studies, there is a growing need to ensure that all key investigators, such as the Principal Investigators, Site Principal Investigators, and Co-Investigators, and other staff who are involved in research activities have basic research ethics training.
PART A – Minimum Training Requirements for Staff from NHG and Partner Institutions
There are 3 main types of training courses available:
- Collaborative Institutional Training Initiative’s (CITI Program) “Biomedical Research Investigators and Key Personnel” Course
- Financial Conflicts of Interest (FCOI) Course (sub-component of the CITI Program)
- Singapore Guideline for Good Clinical Practice (SGGCP) Course
The minimum training requirements for staff from NHG and partner institutions differs according to their study roles.
Table A below summarises the DSRB Minimum Training requirements.
[1]: NHG CITI: Please refer to Section 1 for more information.
[2]: NHG CITI FCOI: Please refer to Section 2 for more information.
[3]: SGGCP: Please refer to Section 3 for more information.
You can find more information about the different requirements and how to complete the relevant courses by reading the sections below.
SECTION 1 - Minimum Training Requirements of Principal Investigators and Co-Investigators for DSRB Applications (header 4)
All Principal Investigators, Site Principal Investigators and Co-Investigators of research conducted within NHG and partner institutions are required to complete the CITI Program’s “Biomedical Research Investigators and Key Personnel” course or the Singapore Guideline for Good Clinical Practice (SGGCP) course.
The DSRB will continue to accept and review applications from Investigators who have yet to complete the CITI Program or SGGCP course. However, the DSRB will NOT grant ethics approval for the applications until receipt of the Investigator's CITI or SGGCP Certificate.
Click here to download more information and answers to the following FAQs.
What is the CITI Program?
- I’m conducting Biomedical Research (Submission to DSRB Domains A-E), which CITI modules should I complete?
- I’m conducting Population Health Research (Submission to DSRB Domain F), which CITI modules should I complete?
- How do I register for the CITI Program?
- I’ve completed other research ethics training programmes, can I use it to waive the completion of the CITI Program?
- How do I apply for the waiver of CITI Program?
SECTION 2 – *NEW* Financial Conflicts of Interest Training Requirements for All Investigators and Study Team Members
With effect from 1st January 2015, all investigators and study team members who are involved in the design, conduct or reporting of the research in institutions under the oversight of NHG DSRB are required to complete the Financial Conflicts of Interest (FCOI) course. It aims to educate investigators and study team members on how conflicting interests may adversely affect the protection of participants or the credibility of the human research protection programme.
Click here to download more information and answers to the following FAQs.
- What is the NHG CITI FCOI course?
- I have not obtained my CITI certification, do I need to complete the FCOI course/modules in addition to the basic set of CITI modules?
- I have obtained my CITI certification, do I need to complete the FCOI course/modules?
SECTION 3 – Minimum Training Requirements of Principal Investigators Who Are Conducting Clinical Trials
With effect from 1st August 2014, Principal Investigators and Site Principal Investigators who will be conducting new Clinical Trial studies will have to complete Singapore Guideline for Good Clinical Practice (SGGCP) course regardless of whether they have completed the CITI Program. Clinical Trials are defined as studies that require a Clinical Trial Certificate (CTC) from the Health Sciences Authority (HSA) prior to initiation. This will apply to Clinical Trial studies that are received by DSRB from 1 August 2014 onwards (i.e. the application has been endorsed by the Institution Representative on/after 1 August 2014).
The purpose of this new training requirement is to ensure that the Principal Investigators and Site Principal Investigators will receive the minimum training for good clinical practices prior to the initiation of a clinical trial as they are responsible for ensuring proper conduct of clinical trial and safety of the subjects by adhering to the relevant local regulations and guidelines.
Principal Investigators and Site Principal Investigators will need to produce proof of attendance or completion by submitting a copy of the certificate.
Click here to download more information and answers to the following FAQs.
- What is the SGGCP Course?
- What are the accepted SGGCP/GCP Courses?
- I’ve conducted multiple clinical trials, can I apply for a waiver of SGGCP Course?
SECTION 4 – List of Available Guides, Forms and Useful Links
Click on the following links to download more information
SECTION 5 – Updating your Minimum Training Status with the DSRB and the Research Online Administration & Management (ROAM) Portal
When you have completed the CITI Program’s “Biomedical Research Investigators and Key Personnel” course, you will need to upload a copy of the completion certificate onto your ROAM profile under ‘Personal Info’ -> ‘Upload Minimum Training Status Proof’.
Upon receipt and verification, the Administrator will update your Minimum Training status in the ROAM portal to “Completed”. Please allow some time for processing.
If you have multiple certificates for verification, please upload a zipped folder containing these documents.
Please note that whenever you re-upload a document onto your ROAM profile, the Minimum Training status will revert to “Not Completed” until the uploaded document is verified.
If you have completed the SGGCP course as an additional requirement for Principal Investigators who are conducting clinical trials, you will need to forward a copy of the completion certificate to min_ethics_training@nhg.com.sg.
PART B – Minimum Training Requirements for Staff from SingHealth and Partner Institutions
The SingHealth CIRB minimum training requirements are slightly different from DSRB. The CIRB requirements will apply to staff from SingHealth and partner institutions who are involved in cross-cluster studies that are submitted to DSRB for review.
You can refer to the CIRB website for more details.
Table B below summarises the CIRB minimum training requirements.
[4]: If a staff from SingHealth or its partner institutions is involved in the design, conduct or reporting of a research that is conducted in NHG or its partner institutions, the minimum training requirements for FCOI applies to him/her and he/she is required to complete the FCOI course (See Part A, Section 2 above).
Contact Details
For more information and queries, please contact the Administrator for Investigator’s Minimum Training:
Email: min_ethics_training@nhg.com.sg
DID: 6471 3266
Fax: (Attention: Mr James Lee / Ms Stella Chee)
Office of Human Research Protection Program (OHRPP)
NHG Research & Development Office
