Translating Research into Highest Quality Patient Care


General FAQs (Questions 1-10)
DSRB Application Form FAQs (Questions 11-20)

General FAQs

1. How do I know if my study is considered research and requires ethics approval?

Any study, which is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalisable knowledge is called "research" and needs ethics approval from the NHG DSRB if it involves patients, staff, premises, or facilities of NHG institutions and all other institutions under the oversight of NHG DSRB.

Do contact us for clarification if you are unsure.


2. I'm doing a simple survey! Do I need ethics approval?

Yes, all research projects involving human subjects will require ethics approval from the DSRB. Some research projects may qualify for a category of review that "exempts" it from a full review by the DSRB.

If your research is a survey or medical records review type of study in which the participants will be anonymous (no patient identifiers or links that connect to patient identifiers are maintained), the research proposal will be reviewed by the exempt procedure. This procedure involves review by the Chairperson and the process is likely to be considerably shorter.

Your study may qualify for "expedited review" if the Chairperson determines that it involves only minimal risk. Research proposals that involve simple non invasive procedures that are commonly done in clinical settings, such as collection of hair, saliva, excreta or small amounts of blood (excluding genetic studies) may qualify for review by expedited procedure.

A study that qualifies for expedited review is still held to the same standards used in full board review, but the approval process may take less time.

Do contact us if you have questions about the qualification of your project for review by the different categories.

3. How do I apply for ethics approval and is there a deadline?

You must submit each new DSRB application via the NHG Research website. For new studies that require full review by the DSRB, the deadline is the first working day of the month for review at the full board meeting held in that same month (e.g. deadline for applications to be reviewed at the meeting held in July 2009 will be by 1 July 2009). However, there is no deadline for studies that qualify for exempt or expedited review.

Similarly, the deadline for any amendments to the study that require full review by the DSRB is the first working day of the month for review at that month's full board meeting, but there is no deadline for amendments that qualify for exempt or expedited review.


4. Do I need to pay for ethics review of my application?

For studies which are initiated by staff from NHG or partner institutions, there is no direct charge for the ethics review of their initial application and any subsequent amendments.

For studies which are sponsored by industry / commercial entities, the following review fees will apply:-
•        Initial Application review - S$1070 (includes 7% GST)
•        Subsequent Study Protocol Amendments* review - S$214 (includes 7% GST)
*Only applicable when amendments are made to the Study Protocol.

Payment should be made via cheques payable to “National Healthcare Group Pte Ltd” and enclosed with an acknowledgement slip indicating the DSRB Reference Number. The cheque should be sent to the address below. Please ensure that the cheques are submitted early as DSRB will not be able to release the Approval Letters if payment has not been received.

If an invoice is required for the payment of the DSRB review fees, please contact the Assistant IRB Analyst of the Domain that the study is being submitted to. The selected Domain is indicated in Section B4 of the DSRB application form. The DSRB Contact List can be found here.

Cheques should be sent to:

NHG Domain Specific Review Board (DSRB)
3 Fusionopolis Link
#03-08 Nexus@one-north
Singapore 138543


5. What if I am part of a multi-center study in Singapore and the PI of this study is from SingHealth?

From 1st October 2014 onwards, multi-center study involving both SingHealth and NHG sites can be submitted to either SingHealth CIRB or NHG DSRB, depending on the Overall Principal Investigator’s (PI) cluster. 


  • If it is a grant-awarded study, the Overall PI, would be the person who is awarded the grant, and the application should be submitted to his/ her cluster’s IRB.
  • If it is an industry or commercially sponsored study, the Overall PI would have to be selected and application to be submitted to his/her cluster’s IRB.
  • If it is an investigator-initiated study (no grant/ funding required), the Overall PI would be the person who initiated the study, and the application should be submitted to his/ her cluster’s IRB.

6. What if the study PI or collaborators are from NUS?

NHG DSRB has a Cooperative Agreement with NUS IRB. If a research proposal involves NUS and NHG researchers, the study can be reviewed either by NUS IRB or NHG DSRB. In general, indirect biomedical research may be reviewed by NUS IRB, and direct biomedical research may be reviewed by NHG DSRB.

Do contact us or NUS IRB if you are unsure if your study may be covered by the cooperative agreement.

For more information on the definition of Direct Biomedical Research and Indirect Biomedical Research, please refer to the Bioethics Advisory Committee's (BAC) Ethics Guidelines for Human Biomedical Research.


7. How long is the ethics review process?

All new completed applications accepted by the DSRB will be reviewed within a thirty-day time period from the monthly deadline for submission. However, the time frame from submission to approval will vary depending on several factors such as the completeness of the application, complexity of the study, response time of the Investigator to DSRB's queries etc.

8. What sort of communications can I expect from the DSRB after the submission of my application?

Application Accepted by DSRB - The NHG Research Online Administration & Management (ROAM) portal will send out an email notification once the application has been accepted by the DSRB.

Preliminary Queries - You may receive an email request for more information / clarification after a preliminary assessment of the application by the DSRB staff or member. You will be given adequate time to address these questions.

Post Review Query - You may receive an email request for more information / clarification or suggestions / recommendations after the DSRB has completed review of the application.

Approval Letter - You will receive a formal letter from the DSRB with the outcome of the review. There are two possible outcomes - Approved and Not Approved. If a study is not approved, the DSRB will list reasons for the decision. The NHG ROAM portal will send out an email notification once the outcome has been determined and the letter will be available for download in the ROAM portal.

9. When can I start my study e.g. recruit subjects?

Only when you have received a written Approval letter from the relevant DSRB and fulfilled any prior requirements set forth by your institution, may you start your research. No subjects should be admitted to a research study before you receive a written approval letter from the DSRB.


10. I need more information. Who can I contact?

Contact details can be found here.

DSRB Application Form FAQs (Questions 11-20)

11. Should I submit an Exempt or Non Exempt DSRB Application Form?

You should use Application Form 2 – Exempt category if your research activity qualifies for Exempt review under the Exempt Categories. The Exempt Categories can be found in the DSRB Application Form Guidebook.

You should use Application Form 1 – Non Exempt category if your research activity does not qualify under the Exempt Categories. Submissions using Application Form 1 will be reviewed via the Full Board or Expedited route.

NOTE: If the application does not fall under any of the Exempt Categories and is submitted using the DSRB Application Form 2 for Exempt Review, the application has to be re-submitted using the DSRB Application Form 1 for Non Exempt Review when it reaches DSRB.

12. Section E1: Who should be responsible for the payment and compensation of injury or illness arising from participation of subjects in the study?

The PI should ensure that insurance coverage is available to provide payment and compensation to research subjects for any injury or illness arising from their participation in the study.

You may contact your institutional research office / clinical research unit on whether your institution is declared for insurance under the NHG Clinical Trial (CT) Group Insurance Policy or information on other available insurance coverage options.

For Sponsored Studies, Sponsors should be primarily responsible for ensuring that subjects receive payment and compensation in the event of injury or illness as a result of their participation in a research study, according to the Association of British Pharmaceutical Industry (ABPI) guidelines, or offer a no-fault compensation to research subjects. The PI should check to ensure that pharma-sponsors have in place the necessary CT Policies including coverage to the PIs and the Sites.

In the event of any injury or illness to research subjects arising from their participation in the trials, the pharma-sponsors’ CT Policies shall be the primary policies to provide compensation to the research subjects.


13. Section F8: What details should I provide about the experimental design and procedures of my research study?

The description in your DSRB application should include, but is not limited to, information on blinding, randomization, number of study arms, phase of trial, approximate time to complete study recruitment, expected duration of subject participation, sequence and duration of all trial periods (including follow up), changes in scheduling, single or multi centre, healthy or sick population, in or outpatient etc.
If your study involves a retrospective medical records review, you would need to specify the period of data collection. All the data that you intend to collect should already be in existence and not prospectively collected.

If your study involves the administration of an anonymous survey, you would need to describe in details, how the questionnaire/demographic data collection form will be distributed and collected back to ensure anonymity (e.g. the questionnaire/ demographic data collection forms will be given to participants at the clinic and they can return the completed forms by dropping them into a collection box or by using the return envelope provided).

14. Section F9: I am doing a pilot study and there is no sample size calculation. Is there anything that I should inform the DSRB?

If you are conducting a pilot study and no sample size calculation is performed, you would need to provide a rationale on how the recruitment target is determined (e.g. based on literature or expected number of cases that will be seen in the study period, etc).

15. Section F19: Is it mandatory to take informed consent from all subjects? Could I apply for a waiver? What if my research study involves both prospective recruitment of subjects and a retrospective medical records review?

DSRB requires that written informed consent should be obtained from all subjects and documented prior to their participation in any research, unless the DSRB approves the waiver of consent or waiver of documentation of consent.

The DSRB may waive consent if you are able to justify that all the criteria for waiver of consent are met. You may refer to the criteria in Question 9 below. Consent cannot be waived for US FDA-regulated studies. If you would like to request for a waiver of consent, please select ‘Waiver of Informed Consent is requested for all study subjects’ and provide your justification/rationale in Section Q. If you would like to request for a wavier of documentation of consent, please select ‘Informed Consent will be taken for all study subjects’ and provide your justification/rationale in Section P9.

If your research study involves both prospective recruitment of subjects and a retrospective medical records review, you could select ‘A combination of both Informed Consent and Waiver of Consent is required for different study populations’, You would need to elaborate why a combination of both informed consent and waiver of consent is required, and which population(s) will require waiver of consent and which population(s) will be able to give informed consent.

16. Section P1: When should the consent process take place with the potential subject?

Informed Consent should be obtained before initiation of the study, i.e. before any procedures that are being performed solely for the research.

Subjects should not be approached when they are under duress, for example, it would not be appropriate to approach a subject immediately before a procedure or surgery, while in labour, while under sedation and any other situation where a subject might feel compromised.

You would need to describe to the DSRB an appropriate time when you would conduct the informed consent process with your subjects.


17. Section P2: Where should the consent process take place with the potential subject?

Subjects should be approached in a quiet and conducive environment. It would not be appropriate to approach a subject in an Operating Theatre for a study when he/she is getting ready for a procedure, even though the study is not related to the procedure.

You should also consider the appropriateness of the location to protect the privacy of the subject (e.g. when approaching subjects for survey involving sexually transmitted diseases, approaching the subject in the Waiting Area of a General Clinic may violate the subject’s privacy).

You would need to describe to the DSRB an appropriate place where you would conduct the informed consent process with your subjects.


18. Section P4: How should the consent process be conducted to minimise the possibility of coercion or undue influence?

You must take precaution that in the process of obtaining consent from subjects, the time and place must be suitable and comfortable for the subject to discuss the research with you, and he/she must not be made to feel compelled to participate. The subject must also be given sufficient time to decide whether or not to participate in the research, and have the option of further discussing with their family members before making the decision.

It is also advisable that the attending physician of the subject should not obtain the consent of their own patient for research, as the subject may feel obliged to join the research, or have a heightened sense of faith and trust in their own physician, and may be more likely to participate.


19. Section Q: Does my research study qualify for a waiver of consent?

The DSRB may waive the requirement to obtain informed consent if the DSRB finds that the study meets the following criteria:

  • The study poses no more than minimal risk to research subjects (e.g. The information collected are not sensitive in nature, and the data are derived from clinically indicated procedures.)
  • Waiver of informed consent will not adversely affect the rights and welfare of research subjects (e.g. None of the information collected would affect the clinical decisions about the individual’s care, and patients are not being deprived of clinical care to which they would normally be entitled to.)
  • The study cannot be practically conducted without the waiver of informed consent. (e.g. the subjects are no longer on follow-up, lost to follow-up or deceased)
  • Whenever appropriate, the research subjects will be provided with additional pertinent information after participation


20. Section R: How should I store the research data to protect the confidentiality of the research data?

You could protect the confidentiality of research data by storing the records in a locked file cabinet, in a locked office, on a computer protected by a password (which should be changed periodically), or on a computer that is not linked onto a network. You could also code the data with an identifier, and keep the key to the code located in another physical location or on a separate computer.

Access to the study data should also be limited to authorised study team members in order to maintain the confidentiality of the research data and subject identities.