HSPP

DSRB - Introduction

The Domain Specific Review Board (DSRB)

The NHG Domain Specific Review Board (DSRB) is an independent committee constituted of medical, scientific and nonscientific members, whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a research study by, among other things, reviewing, approving, and providing continuing review of research studies, of protocols and amendments, and of the methods and materials to be used in obtaining and documenting informed consent of the research subjects.

The DSRB is empowered under the auspices of the NHG Chairmen Medical Boards Committee, whose authority applies to all research involving patients, staff, premises, or facilities of NHG institutions and all other institutions under its oversight. Other officials of institutions which conduct research under the oversight of NHG DSRB, may not override the decision of DSRB (or REC, where applicable).

The Six Domains
There are currently five Biomedical Domains (A-E) that are based on broad but related disease groupings and a Population Health Domain (F). Each Board is made up of 11-15 members and constituted in compliance with the Singapore Guideline for Good Clinical Practice.

The characteristic of such an arrangement is to ensure that more appropriate expertise can be concentrated within each Domain to assess the scientific and ethical merits of the protocols submitted for ethics review.

The specialties under DSRB are as follows (as of 02 November 2012):

NOTE: For Allied Health, Nursing & Para-clinical research protocols, please select the most appropriate Domain according to the main disease type/condition being studied. Do note that the DSRB may re-assign your application to another Domain upon preliminary review of your application.

Domain B – Two Independent Boards (as of 01 February 2011)

Over the years, the volume of research studies submitted to the DSRB has increased significantly. This trend is especially evident for oncology-related clinical research and clinical trials submitted to Domain B.

In order to maintain the high quality of review and ethics oversight, as well as to expand the capabilities of the DSRB to manage the increase effectively, it is necessary for the formation of two independent Boards to oversee the research studies submitted to Domain B. Each Board comprises its own Chairperson and Committee Members and will hold separate meetings every month. The decisions made by each Board will be recognized by the other DSRBs, therefore Investigators will not be allowed to submit the same ethics application more than once.

With effect from 01 February 2011, all new and existing studies under the oversight of Domain B will be triaged to either Domain B Board 1 or Board 2. This will be done by the Domain B Secretariat and Investigators will be notified accordingly. There will be no change to the submission process as Investigators need only indicate that his/her ethics application is submitted to Domain B.

Please contact the Domain B Secretariat if you have further queries.

DSRB Meeting Dates for 2013

Please note that the above timetable is correct as of 22 Feb 2013 and may be subject to change without prior notice.

The above timetable is only for information. Investigators must follow the following deadlines for the submissions to be reviewed accordingly.

Full Board Study Application

• The submission deadline for new studies requiring full board review is the 1st working day of each calendar month.

• Studies received by this deadline will be reviewed within the same calendar month*. For example, applications to be reviewed at the meeting in July 2013 must reach DSRB by 1 July 2013.

• The PI should submit with sufficient lead time for the Department Representative and Institutional Representative to endorse prior to the 1st working day of the month.
• Submissions received after the 1st working day would be tabled for the subsequent full board meeting.

Full Board Study Amendments

• Similarly, the deadline for any study amendments (page 44) that require full board review by the DSRB is the 1st working day of each calendar month.*

Exempt and Expedited studies

• There is no specific deadline for new studies that qualify for exempt (page 63) or expedited (page 66) review. Studies that do not qualify for exempt or expedited review will require full board review by the DSRB.

All new completed applications accepted by the DSRB will be reviewed within thirty calendar days**. However, the time frame from submission to approval will vary depending on factors such as the completeness of the application, complexity of the study, and the response of the Investigator to DSRB's queries.

The DSRB Full Board meeting dates can be downloaded here.

For any further queries, please feel free to contact the DSRB listed below.

* Except in December
** Subject to availability of a meeting quorum

NHG Domain Specific Review Board (DSRB) Contact List

Download DSRB Contact List

Correct as of 2 May 2013

Domain Specific Review Board (DSRB)

Research & Development Office (RDO)
No. 6, Commonwealth Lane,
GMTI Building, Level 4, Unit 01/02
Singapore 149547

T : (65) 6471 3266
F : (65) 6496 6257
E : rdo-dsrb@nhg.com.sg