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WHAT IS THE PURPOSE OF THE MEDICAL RESEARCH & ETHICS COMMITTEE (MREC)?
The Medical Research & Ethics Committee (MREC), Ministry of Health Malaysia was established in 2002 with the primary purpose to ensure the protection of the welfare and rights of human participants. The objective of MREC is to provide independent guidance, advice and decision on health research/specific protocol involving human subjects conducted by staff members of Ministry of Health (MOH) or involving MOH facilities and is responsible for approval of involvement of human subjects in research. MREC may also act as an Independent Ethics Committee for non –MOH institutions. MREC abides by international and local regulatory requirements in the protection of the dignity, rights, safety and well-being of human subjects which includes ICH-GCP, Malaysian GCP and other international guidelines on research involving human subjects. In 2013, MREC became first Ethics Committee/Independent Review Board in Malaysia to be recognised by the Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP) Recognition Program. -
WHEN DO I NEED MREC ETHICAL APPROVAL?
MREC ethical approval is needed when you are using staff members of Ministry of Health (MOH)/ MOH facilities and involving humans as subjects in your research. Human subject(s) refers to living individuals whom an investigator conducting research obtains: (a) data through intervention or interaction with the individual or (b) identifiable private information -
WHO ARE THE MEMBERS OF MREC?
MREC is composed of medical, scientific and non-scientific members including lay persons. It is independent in its reflection, advice and decision. The MREC is constituted and operates under the authority of the Director-General (DG) of Health, Malaysia. -
WHOSE RESPONSIBILITY IS IT TO APPLY FOR MREC APPROVAL?
It is the responsibility of the principle investigator and where the medical research is to be conducted to apply to the MREC to seek its approval for the conduct of the proposed research. The investigator may delegate the responsibility for the MREC submission to the sponsor or sponsor’s Clinical Research Organisation (CRO), but the ultimate responsibility for the integrity of the submission always resides with the investigator and /or institution. -
WHAT IF MY STUDY HAS STARTED RECRUITING, SHOULD I GET MREC APPROVAL?
This would be considered as research misconduct. The decision concerning whether MREC is willing to review the research protocol is at the discretion of the Chairperson. -
IS ETHICAL APPROVAL REQUIRED FOR A QUESTIONNAIRE SURVEY?
Yes, if your research is involving human subjects. -
IS MY PROJECT A RESEARCH?
“Research” is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities, which meet this definition, constitute research for purposes of this policy, whether or not they are conducted or supported under a program, which is considered research for other purposes. There is a Systematic Investigation and the current design produces generalizable knowledge. -
WHAT IS THE MEANING OF CONTRIBUTION TO GENERALIZABLE KNOWLEDGE?
Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions (i.e., knowledge gained from a study which may be applied to populations outside of the specific study population), inform policy, or generalize findings. To develop or contribute to generalizable knowledge requires that the results (or conclusions) of the activity are intended to be extended beyond a single individual or an internal program. Activities involving human subjects or human subjects data where there is an intention to publish the results in a peer-reviewed journal or to present at a regional or national meeting are generally assumed to be generalizable. In addition, theses or dissertation projects conducted to meet the requirements of a graduate degree are usually considered generalizable -
WHAT ARE THE TYPES OF PROTOCOLS THAT ARE REVIEWED?
Industry Sponsored Research (ISR) -Any interventional study (including Bio-equivalence) and Observational study (including registry) that is sponsored by industry. This includes pharmaceutical, medical device, biotechnology research and complementary medicine research
Investigator Initiated Research (IIR) -Any study that is not sponsored by industry. The research protocol and data collected from the study is owned by Investigator. This includes relevant student academic projects -
WHAT ARE THE REVIEW PROCEDURES FOR ETHICAL APPROVAL?
Studies that are received by MREC are first screened and the type of review path is determined based on the risk and benefit assessment and the involvement of vulnerable population. The 3 review paths are:Full Board Review
Expedited review
Exempt (Review by Chairperson only) -
WHAT ARE THE CRITERIA FOR EXEMPT REVIEW (REVIEW BY CHAIRPERSON ONLY)?
The research is a part of a course requirement for paramedics which is not fulfilling research criteria i.e. non generalizable
Protocol involving questionnaire / interviews of a non-sensitive nature of which data is non-generalizable.
Research involving data, documents or specimens that have already been collected or will be collected with no identifiers / de identified
Audit
Continuing review of research previously approved with no modifications to the original (applicable for non-clinical trials only)
Protocol and studies that have taken place , and no identifiable additional risks to subjects
Amendment of approved protocol (non-substantial, less than minimal risk)
Administrative revisions such as correction of typographical errors, revision the version/date/title/header/ footer of the documents reviewed or definition/ elaboration of terms used (reference to possible loss of mobility/ mortality is excluded)
Addition or deletion of non-procedural items such as addition of study personnel names, laboratories, etc.
Research activity with minimal risk.
Minor changes to approved research activities that do not increase risk to subjects.
However, these criteria are meant as guidance purpose only and the final decision on the type of review procedure is made by the Chairperson of MREC. -
MY RESEARCH IS INVOLVING PATIENTS IN THE UNIVERSITY HOSPITAL. DO I NEED ETHICS APPROVAL FROM MREC?
No, unless the research is involving MOH facilities (MOH patient and staffs) or if the Institution does not have a qualified Ethics Committee and wishes to obtain approval from MREC as an Independent Review Board. -
WHAT IS A CLINICAL PROTOCOL?
Clinical Trial Protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial. The protocol usually also gives the background and reason the trial is being conducted, but these could be provided in other documents referenced in the protocol (such as an Investigator’s Brochure). -
WE HAVE RECEIVED A PHASE 4 DIABETES PROTOCOL, WITH THE INVESTIGATIVE PRODUCT IS NOT AN APPROVED DRUG IN MALAYSIA. WILL THE PHASES OF THE PROTOCOL BE AFFECTED?
Yes. It will become a phase 3 trial in case the IP is not an approved drug in Malaysia. -
WHEN DO I NOT NEED A PATIENT INFORMATION SHEET & INFORM CONSENT FORM (PIS/ICF)?
All research needs Patient Information Sheet & Inform Consent Form. MREC requires PIS/ ICF to be in both English and Malay Language unless specified otherwise. PIS/ICF can be waived when the Medical records and biological specimens are taken in the course of clinical care but were eventually used for research without the consent of the patients/subjects. Example of criteria used to request for waiving consent from MREC includes:The research involves no more than minimal risk;
The waiver or alteration will not adversely affect the rights and welfare of the subjects;
The research is designed to answer an important question and the research could not practicably be carried out without the waiver or alteration
Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
That their privacy and confidentiality or anonymity are assured
Study involving the collection or use of existing data, documents, records, pathological specimens, or diagnostics if these sources are publicly available, or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Study designed to investigate, evaluate or examine public service programmes.
However, these criteria are meant as guidance purpose only and the final decision on the waiver is made by the MREC reviewers. -
HOW TO REQUEST FOR WAIVER OF PATIENT INFORMATION SHEET & INFORM CONSENT FORM (PIS/ICF)?
The Principal Investigator prepares a cover letter stating clearly his/ her request for the waiver of informed consent (when fulfils the above criteria) and justifying the request. -
IS THERE ANY TEMPLATE FOR THE PATIENT INFORMATION SHEET AND INFORMED CONSENT FORM?
Yes. Please refer to the MREC website for the template. -
WHAT IS THE DIFFERENCE BETWEEN A CONSENT FORM AND AN ASSENT FORM?
Consent forms are legal documents that can only be signed by adults, and assent forms give minors (i.e., children) the opportunity to convey their own independent decision to participate in research. The permission of a parent or guardian, using a parental consent form, must be obtained as well. The assent form must be written at a language-level appropriate for the potential participants. (Please refer MREC ‘Guideline for minors’ for further information) -
WHO IS AN IMPARTIAL WITNESS?
Impartial witness is a person who is independent of the trial who cannot be unfairly influenced by people involve in the trial, who attend the inform consent process, if the subject or the subject’s legally acceptable representative cannot read, and who read the inform consent form and any other written information supplied to the subject. Please refer to item 1.3.1 , 4.8.6 , 4.8.9 in the GCP guideline. -
CAN FAMILY MEMBERS BE IMPARTIAL WITNESS?
Yes. Family members can be an impartial witness -
HOW LONG WILL THE APPROVAL PROCESS TAKE FOR MINIMAL RISK STUDY?
We aim for 2 months or more for MREC approval after obtaining your NMRR ID. Please see MREC web site for further details on timeline. -
IS THERE ANY MREC TEMPLATE FOR SAE REPORTS?
No. MREC accepts any type of SAE reporting format. However, we do require a complete and comprehensive report from the investigator pertaining to the SAE. -
DO ALL ADVERSE EVENTS; EXAMPLE NAUSEA, HEADACHE ETC. HAVE TO BE REPORTED TO MREC?
No. Only serious adverse event (SAE) and suspect unexpected serious adverse reaction (SUSAR) have to be reported to MREC. -
FAQS FOR SERIOUS ADVERSE EVENT (SAE)?
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WHAT IS THE TIMELINE TO SUBMIT LOCAL SAEs/SUSARS?
Reporting needs to be submitted immediately /as soon as possible -
WHAT ABOUT PROTOCOL DEVIATION?
Protocol deviation involving MREC approved sites needs to be reported immediately to MREC. -
HOW TO REQUEST AMENDMENT?
You may refer to the Step by Step Request for Amendment guide which is present in the NMRR User Manual. For further details pertaining amendment request, please refer to the amendment submission in MREC website -
HOW LONG WILL IT TAKE TO APPROVE AN AMENDMENT?
It will take up to 20 working days for an amendment involving non-substantial/ less than minimal risk changes. -
DOES HAEMATOPOITIC STEM CELLS USAGE OTHER THAN LEUKAEMIA & LYMPHOMA NEED TO REGISTER?
The use of hematopoietic stem cells outside of approved indications ie. leukemia, lymphoma is considered research and basically should be submitted as a research proposal to the local IRB and MREC for ethics review and to be registered in NMRR. The MREC will also submit a copy to the National Committee on Ethics of Stem Cell Research and Therapy. -
IS PROFESSIONAL INDEMNITY A REQUIREMENT FOR MREC APPROVAL?
Professional Indemnity is not a requirement for ethics approval as it is not mentioned in the GCP guideline. However MREC encourage investigators to obtain professional indemnity to indemnify (legal and financial coverage) the sponsor and institution against claims arising from the trial due to professional malpractice and/or negligence of the investigator. -
MAY I PLEASE ENQUIRE WHETHER THE PROFESSIONAL CLINICAL INDEMNITY CERTIFICATE FOR THE PRINCIPAL INVESTIGATOR NEEDS TO RENEWED AND TO SUBMIT TO MREC IF THERE IS NO ACTIVE SUBJECTS AT SITE?
If no active subjects at PI’s site (no more recruitment; site completed the trial; PI is no longer conducting a clinical trial & his/her site has completed) then not necessary to renew. To be renewed when and if the PI will participate in a new trial. -
HOW LONG IS THE ETHICAL APPROVAL VALID FOR A PARTICULAR STUDY?
The MREC approval is only valid for one year (12 months from the date of the approval letter issued) however it should be renewed yearly for the continuation of the approval. Two (2) months before expiry of the validity period, the Continuing Review Form should be submitted to MREC. Late submissions may not be processed in time, and you are not allowed to continue the study without approval. In some cases it would be stated on the approval letter that you need to submit the Continuing Review Form more frequently (e.g., 6 monthly) and therefore please comply as we believe this study is more risky and may need more frequent monitoring. The Continuing Review Form could be downloaded for the MREC website and is required to be uploaded as an amendment submission in the NMRR system when requesting for ethical renewal. One Continuing Review Form is required to be completed per protocol during each annual renewal. -
WHAT HAPPENS WHEN I HAVE COMPLETED MY STUDY? DO I NEED TO INFORM MREC?
Yes upon completion of your study, you are required to send in a Study Final Report to MREC. Subsequently we will send you an acknowledgement letter which will be also sent to your hospital director and the local CRC for notification on the completion of that study.
NOTE: Closure of a study means no further research, follow-up or data analysis will be performed in all MREC approved sites. If any subjects are still participating in your study or research results are still being reviewed, the study is not completed/ closed. -
WHAT HAPPENS WHEN MY STUDY IS TERMINATED AND THEREFORE NOT COMPLETED? DO I NEED TO INFORM MREC?
Yes upon termination of your study, you are required to send in a Study Termination Memorandum to MREC. Subsequently we will send you an acknowledgement letter which will be also sent to your hospital director and the local CRC for notification on the termination of that study. -
WHERE CAN I OBTAIN MREC’S SOP?
Parts of MREC’s SOP are published within the MREC website. However, to view the MREC procedural SOP needed, a written request needs to be directed to the Secretary of MREC. -
WHERE CAN I OBTAIN MREC’S SOP?
Parts of MREC’s SOP are published within the MREC website. However, to view the MREC procedural SOP needed, a written request needs to be directed to the Secretary of MREC. -
WHO DO I CONTACT SHOULD I HAVE ANY QUESTIONS REGARDING MY RIGHTS AS A STUDY SUBJECT/PARTICIPANT?
You may contact:
The MREC Secretary
Secretariat of the National Institutes of Health (NIHSEC)
c/o Institute for Health Management
Jalan Rumah Sakit, Bangsar
59000 Kuala Lumpur
Email: mrecsec@nih.gov.my
Tel: +(603) – 2282 9082; 2282 9085 (MREC / General Enquiries)