FREQUENT ASKED QUESTIONS

This information may assist you to understand better our services and the work process.

01

What is the purpose of MREC?

The UMMC-MREC is responsible for reviewing and providing ethical approval for research involving human subjects conducted in UMMC. The MREC is constituted in compliance with the Malaysian Guideline for Good Clinical Practice and policies of UM and UMMC.

02

When does a researcher need to obtain UMMC-MREC approval?

  • UMMC-MREC approval needs to be sought when it is a medical research protocol involving human participants that are conducted in and using the name of the Faculty of Medicine, UM or UMMC.

  • A researcher needs to obtain UMMC-MREC approval if the study involves human participants UMMC does not review studies that involve human subjects but are not medical/health-related; these studies will be referred to University of Malaya Research Ethics Committee (UMREC). Studies involving non-human living vertebrates are referred to the Animal Care Committee of the Faculty of Medicine, UM.

03

Who can apply for MREC approval?

  1. FOM-UM staff and students

  2. UMMC staff and students

  3. UM staff and students who are not from FOM-UM

  4. Non-UM/UMMC Principal Investigators (PIs)

04

What are the documents needed?

You would need to apply in the online application form HERE and answer the questions appropriately. You would need to upload the study protocol, written participant information sheet and consent form in English or Bahasa Malaysia, and brief curriculum vitae of PI and co-investigators.

 

If applicable: subject recruitment procedures/advertisements, questionnaires, data collection form, interview guide, investigator’s brochure, safety information, information about payment and compensation, Good Clinical Practice (GCP) certificates of PI and co-investigators (for clinical trials).

05

How much is the application fee?

The application fees are:

  • RM100 for non-interventional investigator-initiated research.

  • RM300 for interventional clinical research.

  • RM1000 for industrial sponsored research.

06

What is the turnaround time of MREC approval? (new application and amendment)

The review time of a new study from the receipt of an application by the secretariat to the MREC Chair’s first decision is 60 working days.

The turnaround time would be 60 days from the submission date.

07

What happens after the MREC approval?

08

What is the timeline in reporting SAE/SUSAR?

  • Serious Adverse Event (SAE) or Suspected Unexpected Serious Adverse Reaction (SUSAR) that is fatal/life threatening: As soon as possible but not later than 7 calendar days from awareness of event by investigator, followed by a complete report within 8 additional calendar days.

  • All other SUSARs: As soon as possible but no later than 15 calendar days from awareness of event by investigator. Follow up information should be actively sought and submitted as it becomes available.

09

TIPS to expedite your ethics application:

  • Ensure all questions are answered carefully and thoroughly, get someone to guide you through if necessary (supervisors, principal investigators, senior researchers etc.)

  • Scientific rigour & societal essentiality - Your study design should be scientifically sound and should anticipate significance to society.

  • Participant Information Sheet - the use of layman language to explain your study to the research subjects

  • Insurance coverage - required if the subjects are exposed to more than minimal risk such as invasive interventions, randomised into different arms of procedures that may potentially cause harm etc. Please find out more details from Clinical Investigation Centre (CIC), UMMC.

  • Compensation for the inconvenience - The researcher should consider compensating for the participants' effort and time to participate in research activities if the procedures involved are not part of their routine care. The amount of compensation should not influence their decision to participate in research.

  • Data confidentiality - Please make sure you describe in detail how and where to keep the research data securely.

  • Other documents - Always attach all study-related documents such as data collection forms, interview guide, questionnaire for ethical review.

10

What do I do if I encountered issue to proceed after STEP 2 in i-Research Application System? 

Please ensure the following steps have been done: 
1. Click ‘Search’ on item 12.

2. Proceed with ‘Add New PI’ and fill in the form accordingly, make sure you have saved it. 
3. Please select the PI from the saved list, then you will be able to proceed with the next step. 

 

*If the problem persist, please kindly email to IT officer, Puan Nor Alia (noraliaramlan@ummc.edu.my) to rectify the issue and do carbon-copied (cc) to the Secretariat at ummc-mrec@ummc.edu.my.

11

[i-Research] Why can’t I proceed with the next step after I have filled in the details accordingly?

Please ensure that the answers do not exceed the stipulated word limit. 

12

[i-Research] After I submitted the payment, error page appears (payment failure) and my payment status is ‘Pending’ / ‘Fasa 4’, what do they mean?

It means there are technical issues with the system and please contact IT officer, Puan Nor Alia (noraliaramlan@ummc.edu.my) to rectify the issues and do carbon-copied (cc) to the Secretariat at ummc-mrec@ummc.edu.my.

13

[i-Research] What will happen to my application if I missed out to reply the revision requested by the Secretariat/Committee/Chair/Deputy Chair of UMMC?

For modification/revision to the new study, the cut-off date is within 2 months from request for modification. Otherwise, the study will be archived, and new application required.

14

May I know how long an ethics approval is valid?

Please kindly check the approval letter for the approved period for your study. For instance, your research project duration is 1.1.2021 - 31.12.2023 and this period has been approved by the ethics committee.

You are required to submit annual progress reports preferably 30 days before 1.1.2022 and 1.1.2023 and a study closure report by the end of the study. You may also request for extension if necessary but it must be applied 30 days before the expired date. You are advised to submit these essential documents to avoid lapse of the study.

15

What do I need to prepare for annual and closure report?

You may refer to this template HERE, and answer the questions appropriately. You would need to upload the report in i-Research.

16

What is the checklist for research on stem cell and cell-based therapies and the application procedure? 

Please refer to this documents:

MREC will check the application based on the checklist before forwarded it to NCERT for their recommendations.

*NCERT= Jawatankuasa Kebangsaan Etika Penyelidikan dan Terapi Sel

17

What is amendment and notifications?

  • Amendments for studies that are approaching the original study completion date or nearing the expiry date of MREC approval and requesting for extension of the completion date or ethics approval, should be submitted to MREC via the online system at least 30 days prior to the expiry date.

  • A study protocol amendment is a change to contents of approved study documents. Approval should be obtained from the MREC prior to the implementation of an amendment.

  • The online system logs the date of submission of any amendment submitted online.

  • The MREC Chair/Deputy Chair shall determine within 14 working days whether an amendment will undergo expedited or full board review. Amendments shall be reviewed not later than 30 working days after classification by the Chair.

List of Amendments

List of Notifications

18

What is the payment fee for initial application?

Please refer to this to view the guidelines : Payment guidelines

19

Do I need to get ethical clearance for a single case report/study?

For a case report, it usually appears that there are no interventional or experimental aspects and furthermore, the study is on only one patient, hence there is no comparative aspect (e.g. case series) to it as well.  Provided that confidentiality and identity of the patient are safeguarded (which is usually enforced through publication policies) and no stigmatisation or commercial controversies can be traced to the patient, this study can be exempted from review by the Medical Research Ethics Committee (MREC).

 

Generally, it is advisable to seek MREC opinion prior to submissions for publication to avoid difficulties with the editorial office of journals.