Conducting Research

HBR Essential Research Conduct (ERC) Course

New NHG HBR Minimum Training Requirement for NHG PI and Study Team

[Announcement: Please access our course via this new eLEARN link https://elearn.sg/nhg.]

HBR Essential Research Conduct (ERC) Course

The Human Biomedical Research (HBR) Essential Research Conduct (ERC) Course aims to equip all NHG PIs and study team members conducting HBR studies with knowledge on the regulations and institutional policies to ensure the proper conduct of research.

Participants will gain knowledge on the Human Biomedical Research Act (HBRA) regulatory framework and its requirements, the NHG Research Data Policy, NHG Policy for Tissue Bank Management and Release of Human Tissue Specimen.

In addition, participants will be exposed to the key principles of subject recruitment, subject follow-up, the informed consent process, as well as the necessary safeguards for taking consent in the vulnerable and special populations.

NHG HBR Minimum Training Requirement for NHG PI and Study Team

Who must complete this
The HBR ERC online course is to be completed as part of the NHG HBR Minimum Training Requirement for NHG PI and Study Team:

From 1 November 2019, all NHG Institution staff (PIs, Site-PIs, Co-Investigators and study team members) involved in the design, conduct or reporting of new HBR studies / sites* approved by a NHG appointed IRB (i.e. DSRB, SingHealth CIRB, NUS IRB, NTU IRB), will be required to complete the NHG HBR Essential Conduct of Research (ERC) Course as part of the minimum training requirements prior to the commencement of their study involvement. *sites: refers to any new sites added to any ongoing HBR research protocol.

The NHG HBR ERC Course is also applicable to all:

NHG-based MOHH residents/doctors who are participating in HBR studies (approved by NHG appointed IRB from 1 November 2019) in the capacity of NHG PI / Co-I or Study Team, from 1 October 2020.
NHG-based SAF staff/doctors* who are participating in HBR studies (approved by NHG appointed IRB from 1 December 2021) in the capacity of NHG PI/Co-I or study team member, from 1 December 2021.

*Staff with formal appointment with NHG Institutions (including affiliate or joint appointments.

HBR ERC Online Course

Announcement:

HBR ERC Online (V.2) has been launched on eLEARN

Effective 24 April 2023, all new HBR PI & Study team members will only need to complete the updated HBR ERC Online V.2.

Existing HBR PI & Study Team members who completed past version of the online course do not need to repeat V.2 online course to meet the minimum training requirements, but may do so for refresher or enhanced learning purposes.

Please access our course via this eLEARN link https://elearn.sg/nhg.

Information for NHG-based MOHH Residents & NHG-based SAF Staff/Doctors:

Available Guides

Announcement for HBR ERC Classroom Workshop & HBR ERC Alternative Online Assessment:

Both the HBR ERC Classroom Workshop and HBR ERC Alternative Online Assessment will cease after the launch of the new (upgraded) HBR ERC Online (V.2) interactive online module.

All NHG CRCs, Research Assistant (RAs) and other supporting Study Team members involved in the subject recruitment & informed consent process for HBR studies will no longer be required to complete the HBR ERC Workshop / Alternative Online Assessment to meet the minimum NHG HBRA minimum training requirements.

EXEMPTION Criteria for completing the HBR ERC Course
(Exemptions may be self-determined. Please ensure supporting documents are available.)

WAIVER Criteria for Completing HBR ERC Course

NHG PI / Investigators who have assumed the roles and responsibilities of a PI / Co-I for multiple HBR studies may apply for a waiver for the ERC Online requirement provided ALL the following conditions are met:

Conducted a minimum of 5 ongoing HBR studies with at least 2 completed HBR studies in the last 2 years, either as a PI, site PI or Co-I within NHG or its partner institutions under the oversight of DSRB
Must have enrolled at least 1 subject for these HBR studies
There were no major research ethics violations, non-compliances, unjustified DSRB SOP deviations, research misconduct and / or complaints for these HBR studies (completed and ongoing)

*Additional Requirement: Applicant to also submit a summary of the NCRs that had occurred in the recent HBR studies to demonstrate knowledge of lapses and requirements.

Submission of Waiver for ERC Course Form:

Please download a copy of the Waiver for HBR ERC Online Course Form and send it to NHGRISecretariat@nhg.com.sg for the waiver request.

Click here to download the Waiver for HBR ERC Online Course Form

Note: Approval for the waiver for HBR ERC Course (online) DOES NOT exempt NHG Investigators (PI, Site PI, Co-I)/ Study Team members from fulfilling the NHG Financial Conflict of Interest (FCOI) training requirements.

Supplementary Readings:

For HBR studies with Waiver of Consent granted by the DSRB, all NHG Investigators (PI/ Co-I) or NHG Study Team members are encouraged to read through the supplementary readings below:

1. Information on Human Biomedical Research Act (HBRA) – Regulatory Framework & Requirements.

Section I: HBR Background & Framework

Section II: Studies excluded from HBRA

Section III: Restricted & Prohibitive Research

Section IV: HBRA and its implications on studies

For more information on the above, click on Information Pack for Researchers on the HBR Framework.

2. NHG Research Data Policy (Click here to access the policy. NHG Intranet access required )

3. HBRA Case Studies

4. NHG RQM Common Study Review Findings

5. HBRA – Human Tissue Framework

6. NHG Policy for Tissue Bank Management and Release of Human Tissue Specimen [click here]

Contact Details

For more information or queries on the HBR ERC Course, please contact your respective Institution’s Clinical Research Office/ Units or the Research Education Course Administrator at research_courseadmin@nhg.com.sg.

Updated: 24 April 2023