Translating Research into Highest Quality Patient Care

DSRB FAQ


   

General FAQs (Questions 1-6)
DSRB Application Form FAQs (Questions 7-16)

 

(1) I'm doing a simple survey! Do I need ethics approval? Go

(2) Do I need to pay for the ethics review of my application? Go

(3) What if I am part of a multi-center study in Singapore and the PI of this study is from SingHealth? Go

(4) What if the study PI or collaborators are from NUS? Go

(5) What sort of communications can I expect from the DSRB after the submission of my application? Go

(6) When can I start my study? Go

(7) Should I submit an Exempt or Non Exempt DSRB Application Form? Go

(8) Section E1: Who should be responsible for the payment and compensation of injury or illness arising from participation of subjects in the study? Go

(9) Section F8: What details should I provide about the experimental design and procedures of my research study?  Go

(10) Section F9: I am doing a pilot study and there is no sample size calculation. Does DSRB need any further information? Go

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

(12) Section P1: When should the consent process take place with the potential subject? Go

(13) Section P2: Where should the consent process take place with the potential subject? Go

(14) Section P4: How should the consent process be conducted to minimise the possibility of coercion or undue influence? Go

(15) Section Q: Does my research study qualify for a waiver of consent? Go

(16) Section R: How should I store the research data to protect its confidentiality? Go
 

 

 

General FAQs (Questions 1-6)

 

Q1. 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 involving anonymous participants (no direct or indirect patient identifiers are maintained), the research proposal will be reviewed by the Chairperson via the exempt procedure.

Research proposals that include 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 the expedited procedure if the Chairperson determines that only minimal risk is involved.

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Q2. Do I need to pay for the 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 applications and any subsequent amendments.

For studies which are sponsored by industry / commercial entities, the following review fees will apply:
    

•  Initial Application review involving Single Cluster institution(s) – $1,500 ($1,605 incl. GST)

•  Initial Application review involving Cross Cluster institution(s) – $2,500 ($2,675 incl. GST)

•  Subsequent Study Amendments review – $200 ($214 incl. GST)

•  Subsequent Study Amendment review for the addition of 1st Cross Cluster site – $1,000 ($1,070 incl. GST)

 

The review fee for study amendments is charged per submission and is not dependent on the number of documents submitted and/or changes made to the DSRB application form. Payment will be waived if the study amendment only involves administrative changes (e.g. change in study administrators and/or study team members, submission of translated documents etc.). When in doubt, please contact the DSRB for clarification.

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 B3 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

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Q3. 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 studies 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.

Example:

•  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 should be selected and the application 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.

For more information, please refer to the latest DSRB-CIRB FAQ.

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Q4. 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 (for indirect biomedical research) or NHG DSRB (for direct biomedical research).

Do contact us or NUS IRB if you are unsure whether your study is 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.

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Q5. 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 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. 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 on 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 an email notification once the outcome has been determined and the letter will be available for download in the ROAM portal.

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Q6. When can I start my study?

You may start your research only after receiving the Approval letter from DSRB and fulfilling any prior requirements required by your institution. No research activities (e.g. subject recruitment) should be conducted before DSRB approval.

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DSRB Application Form FAQs (Questions 7-16)

 

 

Q7. 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. 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 for Exempt review. Submissions using Application Form 1 will be reviewed via the Full Board or Expedited route.

NOTE: If the application is submitted via Application Form 2 but does not fall under any of the Exempt Categories, it has to be re-submitted using Application Form 1 for Non Exempt review.

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Q8. 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 National Clinical Trial (CT) Group Insurance Policy or for 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.

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Q9. Section F8: What details should I provide about the experimental design and procedures of my research study?

The DSRB application should include 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, please specify the period of data collection. All data should already be in existence and not be prospectively collected.

If your study involves the administration of an anonymous survey, please describe how the questionnaire / demographic data collection form will be distributed and re-collected 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 via a collection box or by using the return envelope provided).

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Q10. Section F9: I am doing a pilot study and there is no sample size calculation. Does DSRB need any further information?

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

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Q11. Section F19: Is it mandatory to take informed consent from all subjects? Can I apply for a waiver? What if my research study involves both prospective recruitment of subjects and a retrospective medical records review?

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. Consent cannot be waived for US FDA-regulated studies.

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 stated under Question 19.

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 in Section Q.

If you would like to request for a waiver of documentation of consent, please select ‘Informed Consent will be taken for all study subjects’ and provide your justification in Section P9.

If your research study involves both prospective recruitment of subjects and a retrospective medical records review, please select ‘A combination of both Informed Consent and Waiver of Consent is required for different study populations’, You 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.

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Q12. 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 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 need to describe an appropriate time when you will conduct the informed consent process with your subjects.

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Q13. 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 if the study is not related to the procedure.

You should also consider the location’s appropriateness to protect the subject’s privacy (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 need to describe an appropriate place where you would conduct the informed consent process with your subjects.

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Q14. Section P4: How should the consent process be conducted to minimise the possibility of coercion or undue influence?

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 compelled to participate. The subject must also have sufficient time to decide whether or not to participate, and have the option of further discussing with their family members before making the decision.

It is also advisable for consent not to be obtained by the subject’s attending physician as the subject may feel obliged to join the research, or may be more willing to participate because of a heightened sense of faith and trust in their own physician.

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Q15. Section Q: Does my research study qualify for a waiver of consent?

The DSRB may waive the requirement to obtain informed consent if 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.

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Q16. Section R: How should I store the research data to protect its confidentiality?

You may store 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 be limited to authorised study team members in order to maintain the confidentiality of the research data and subjects’ identities.

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