Translating Research into Highest Quality Patient Care

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.]

 

From 1 November 2019, for all new HBR studies / sites* approved by a NHG appointed IRB (i.e. NHG DSRB, SingHealth CIRB, NUS IRB, NTU IRB), all NHG Institution staff (Principal Investigators, Site-PIs, Co-Investigators and other study team members) involved in the design, conduct or reporting of the Human Biomedical Research Act (HBRA) regulated studies will be required to complete the NHG HBR Essential Research Conduct (ERC) Course prior to the commencement of their study involvement.

 

*sites: refers to any new sites added to any ongoing HBR research protocol.

 

 From 1 December 2021, all *NHG-based SAF staff/doctors who are participating in Human Biomedical Research (HBR) studies (approved from 1 December 2021) in the capacity of NHG PI/Co-I or study team member are required to complete the NHG HBR Minimum Training Requirement i.e. the HBR Essential Research Conduct (ERC) Online Course prior to the commencement of involvement in the study.

*NHG-based SAF staff/doctor with formal appointment with NHG Institutions (including affiliate or joint appointments).

From 1 October 2020, all NHG-based MOHH residents/ doctors who are participating in Human Biomedical Research (HBR) studies (approved from 1 November 2019) in the capacity of NHG PI/Co-I or Study Team are required to complete the NHG HBR Minimum Training Requirement i.e. the HBR Essential Research Conduct (ERC) Online Course prior to the commencement of involvement in the study.

Note: This also applies when such MOHH residents/doctors based in NHG institutions are involved in HBR reviewed by other appointed IRBs as a NHG Co-I or Collaborator.

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.

For more info: HBR ERC Course General Publicity Poster

The HBR ERC Course consists of 2 components, the HBR ERC Online Course and the HBR ERC Classroom Workshop.

 

HBR ERC Online Course
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.
 

 Who should complete this: 
1. All NHG PIs, site PIs, Co-Investigators and Study Team members conducting HBR studies.
2. All NHG-based MOHH Residents who are participating in Human Biomedical Research (HBR) in the capacity of NHG PI/Co-I or Study Team.
3.  NHG-based SAF Staffs/Doctors who are participating in Human Biomedical Research (HBR) in the capacity of NHG PI/Co-I or Study Team.
 
Information for NHG-based MOHH Residents & NHG-based SAF Staff/Doctors:
1. Note for NHG-based MOHH Residents & NHG-based SAF Staff/Doctors 
2. (Template) Request to Access HBR ERC Online for NHG-based MOHH Residents & NHG-based SAF Staff/Doctors

 All NHG-based MOHH Residents/Doctors who are participating in Human Biomedical Research (HBR) in the capacity of NHG PI/Co-I or Study Team.

 

When to Complete: Prior to the commencement of their study involvement.

For more info: HBR ERC Online Course Info Brochure

 

 

HBR ERC Classroom Workshop

Additionally through the classroom workshop, opportunities will also be provided for learners to apply concepts of informed consent to different subject population, and identify common errors in the consent process.

Who should complete this: All NHG CRCs, Research Assistant (RAs) and other supporting Study Team members involved in the subject recruitment & informed consent process for HBR studies.

When to Complete: Prior to the recruitment & consenting of subjects.

NOTE:
(i)     HBR ERC Online course should be completed before attending the classroom workshop.
(ii)     A *HBR ERC Alternative Online Assessment (alternative to the Classroom Workshop) will be made available from 30 Sept 2019.

*HBR ERC Alternative Online Assessment  - meets the same Classroom workshop objectives of facilitating application of knowledge learnt from online training into actual research conduct through case scenarios.

For experienced NHG Research Fellows/RA/CRCs or those who are unable to attend the Workshop, a waiver will be allowed if they are able to pass the Alternative Online Assessment. The purpose of this online assessment is to ascertain whether the individual is able to apply the knowledge gathered from the online module.

For more info: HBR ERC Classroom Info Brochure

 

 

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

 

 

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 Contraventions 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]

 

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:

  1. 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
  2. Must have enrolled at least 1 subject for these HBR studies
  3. 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 (either online or classroom) DOES NOT exempt NHG Investigators (PI, Site PI, Co-I)/ Study Team members from fulfilling the NHG Financial Conflict of Interest (FCOI) training requirements

 

Available Guides
1. HBR ERC FAQ
2. eLEARN LMS Navigation Guide for HBR Online Course   
3. eLEARN LMS FAQ

 

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

 

 

Updated: 29 Nov 2021