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Latest News. The Third Edition of the NHG Investigator's Manual (for DSRB Biomedical Domains) has been launched! Incorporating regulatory and DSRB policy changes following the implementation of revised regulatory framework for Clinical Trials. Read the latest regulatory requirements for clinical trials, ethical
Investigator's Manual Addendum Version 1.5 Jan 2016. Page 4. Page 7 – This section has been revised as follows. In its entirety, the OHRPP comprises 4 divisions: a. DSRB Operations & Management – All research involving NHG patients, NHG staff, NHG premises, or NHG facilities are to be reviewed and approved by the.
In 2007, the NHG Domain Specific Review Board (DSRB) received only 104 study applications submissions for ethics review. In 2017. (as of November), this figure stands at 1008 study submissions. The statistics for the number of active NHG Principal Investigators. (PIs) are equally encouraging – in 2009, 338 PIs
To ensure that our growing pool of PIs understand research ethics meaningfully, the Investigator's Manual is a handy reference tool catering to both new and experienced investigators alike. This publication amalgamated the regulatory requirements, NHG DSRB research policies and institutional policies governing
Dec 9, 2016 For Investigators, Researchers & Study Administrators. DSRB: Guide to Submitting Studies to Domain F. DSRB: Domain F Sample Application Form. DSRB: NHG Good Practice Guidelines for Standing Databases & Tissue Banks. ROAM: Researchers' Guidebook, Version 1. ROAM: Online DSRB
All approved research projects must comply with DSRB requirements as outlined in the NHG DSRB Investigator Manual. The DSRB requirements are based on Declaration of Helsinki and the ethical principles in the Belmont Report. The DSRB requirements are also compliant with the guidelines stipulated by the Bioethics
You may refer to our Qualite publication for a summary of the key differences between the current requirements and new HBRA requirements. Most changes pertain to informed consent practices in minors and cognitively impaired adults. The DSRB Informed Consent Form Template will be updated subsequently to include
Oct 5, 2017 Research Governance. Introduction to NHG OHRPP Role of Institutions (Department & Institution Representatives, Investigators and Study Team) Role of DSRB and the Different DSRB Domains
Nov 29, 2017 This latest Third Edition of the Investigator's Manual amalgamates the regulatory requirements (especially the revised regulatory framework for clinical trials), ethical provisions and institutional policies governing research conduct. Download the e-Copy of the Investigator Manual below: DSRB: NHG
Nov 22, 2017 205-026. Notice of Intent to Rely on NHG-DSRB Application Form. Ver 1.0, dated 30 Mar 12. 205-029 Principal Investigator's Declaration. Ver 1.0, dated 19 Jan 07. E03. Study Team These templates contain the critical elements which are required by the DSRB. While it is not compulsory to use these

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March 2018