Ethics Application

Introduction

Joint Penang Independent Ethics Committee (JPEC) is a 13-member committee formed under the joint authority of the Penang Medical College and Info Kinetics/Clinical Research Centre, Penang. JPEC conducts initial and continuing ethical review of clinical trials conducted at private medical institutions in Penang. JPEC is unique in that while most ethics committees are institutional i.e formed by and comprising of members from one particular institution, JPEC unites members from private and public medical institutions from Penang, Malaysia. This enables greater diversity in review expertise as well as prevents duplication of resources. Running an ethics committee that stands up to the internationally accepted Good Clinical Practice standards consumes much resources and a joint committee makes sense for medical centers that infrequently conducts clinical trials. In a joint committee like JPEC, pooling of resources also means members gain more experience in regularly reviewing a wider range of trials of differing complexities.

JPEC’s reference standards

JPEC complies with the requirements of the Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects and ICH Good Clinical Practice as well as the Malaysian GCP.

JPEC has written Standard Operating Procedures (SOPs) as well as performance markers that guide JPEC’s continuous improvement process.  JPEC’s SOPs are reviewed recently to incorporate further characteristics, in line with the WHO Operating Guidelines for Ethics Committees that Review Biomedical Research 2000.

In December 2005, JPEC is officially registered with the Office of Human Research Protection (OHRP) in USA. Registration with OHRP enables JPEC to conduct ethical review of studies that are funded by the USA National Institute of Health (NIH), one of the largest and most widely known research funders in America.

JPEC is one of the 13 ethics committees in Malaysia that is registered with the Drug Control Authority (DCA), an authority established for the purpose of regulating the Control of Drugs and Cosmetics Regulations, 1984 and undergoes regular GCP audit inspection from the National Pharmaceutical Control Bureau (NPCB).

Main objective of JPEC

The primary objective of JPEC is to protect trial subject welfare, rights and safety. At the same time, JPEC also takes into consideration the risks and benefits of trials. JPEC is aware of the need for well-designed scientific trials for medical progress.

How to submit an application to JPEC

Application forms are available from the Secretary of JPEC at:

Application forms are available from the Secretariat of JPEC at:

The JPEC Secretariat c/o Clinical Research Centre
5th Floor, Gleneagles Penang
1, Jalan Pangkor,
10050, Penang.
Phone number: 04-2285760 or 04-2229111 (Ext 9503, 9502)
Fax number: 04-2285715

All applications must be typewritten. Electronic copies of all forms are available below. Subjects should not be enrolled in a trial before written approval of the trial from JPEC. During the trial, the investigator should provide to JPEC all documents subject to review. These include amendments made to the study protocol, subject information sheet, informed consent, advertisements, investigator’s brochure, etc. No deviations from, or changes of, the protocol should be initiated without prior written JPEC approval/favourable opinion on an appropriate amendment, except where necessary to eliminate immediate hazards to the subjects or when the change(s) involve only logistical or administrative aspects of the trial. E.g.: change of monitor(s), telephone number(s), etc.

Submitting a new application to conduct a Clinical Trial

Application Procedure:

Submit 13 copies (1 original and 12 photocopies =2 full dossiers+ 10 simplified dossiers) of the following supporting documents (e.g study protocol, consent form, subject information sheet, advertisements, questionnaire, investigator’s brochure(only for original and full dossiers), product summary, investigator(s)’ curriculum vitae and GCP certificates, recruitment material, insurance coverage for subjects in event of trial-related injury, statement from sponsor indemnifying the relevant staff, investigator, institution and JPEC). Principal Investigators that will conduct an interventional clinical trial should be trained and certified in an approved training of Good Clinical Practice (GCP) by the National Committee for Clinical Research (NCCR). All new application are to be submitted with a one-off application fee of RM2,000 per research project made payable to ‘Info Kinetics Sdn Bhd’. Application will only be processed upon receipt of full payment. It is the prerogative of JPEC to waive this fee for investigator-driven research, which does not receive funding.  Any incomplete applications will lead to a delay in review.

Applicants are required to register all research projects with the National Medical Research Register (NMRR) at https://www.nmrr.gov.my/fwbLoginPage.jsp.  The full NMRR ID should be provided to JPEC for trials seeking approval from JPEC. No approval will be given without the NMRR ID.

Forms required for submission with supporting documents:

Application form to conduct a new research project involving human subjects

Applicant’s Document Checklist for Submitting an Application to conduct a new research project.

Check that the informed consent form and subject information sheet/statement collectively contain 24 elements (unless it is not applicable) in the Applicant’s checklist of minimum elements in the informed consent form and written subject information. (Source Malaysian Guidelines for Good Clinical Practice, Oct 2011). This checklist is available online below.

Review of a new application:

Applicants will be notified of the date and time of the JPEC meeting (at least 7 days in advance) where the application is to be reviewed. The investigator will be required to attend this meeting to answer queries from JPEC members.

Submitting an application to amend a previously JPEC approved Clinical Trial

Application Procedure:

Complete the ‘Application for Amendment to Research Project involving Human Subjects’ form and submit one original copy with relevant supporting documents. For applications, that may affect subject safety, rights or welfare, the proposed amendments and study documents(s) with proposed amendments clearly indicated (tracked changes) and the rationale for the amendment needs to be submitted along the “Application for Amendment to Research Project Involving Human Subjects”.

If the amendments are purely administrative or logistical; or clearly do not affect subject safety, rights or welfare; it will undergo an expedited review. For amendments affecting the subject’s safety, rights or welfare, it will be tabled in a meeting review.

Sometimes minor administrative amendments are submitted to JPEC for its information only. These include amendments involving logistical or administrative aspects of the trial. (e.g.: change of monitor(s), telephone number(s), change of address of central laboratory etc.) The JPEC officer will review and acknowledge receipt of the information on such amendments.

What does JPEC look for in its review of applications?

In its review, JPEC takes the following aspects of a trial into consideration:

  • Scientific design and conduct of study
  • Recruitment of subjects
  • Care and protection of subjects
  • Protection of subject confidentiality
  • Informed consent process
  • Community considerations
  • Notification of JPEC decisions

 

JPEC informs applicants of its decision in writing within 14 days from its review. In cases of a positive decision, a statement of responsibilities of the investigator is provided. In cases of negative decisions, reasons are provided.

JPEC approvals for new research projects are valid for 18 months from the date of issue of the JPEC Decision Notification Form. A new application to JPEC will have to be submitted for research projects that are not commenced within 18 months from the date of issue of the JPEC Decision Notification Form.

In some instances, JPEC grants conditional approvals. In these cases applicants must show evidence that they have complied with these conditions within 8 weeks from this notification to receive a full approval. After that date, the file on this application will be closed if no response is received by JPEC. A new application will need to be submitted if the applicant is keen on pursuing ethical approval.

Reporting of serious adverse events to JPEC

All adverse drug reactions (ADRs), which are both serious and/or unexpected, are to be reported to JPEC. In the case of serious adverse events ( SAEs ) occurring in the investigator’s institution, the investigator is to notify the JPEC Chairperson within 24 calendar hours of its notification to the investigator, using the JPEC Serious Adverse Event Report.

For SAEs outside of the investigator’s institution (applicable in multicentre trials):

a) Only Suspected, Unexpected and Serious Adverse Reaction (SUSAR) are to be submitted to JPEC

b) Those that are fatal/life-threatening : Investigator is to report (cc. local investigator) the SUSAR to JPEC within 7 calendar daysfrom first knowledge by the INVESTIGATOR. If there is additional information, this should be submitted within 8 calendar days.

c) Those that are non-fatal/life-threatening SUSARs, to submit to JPEC within 15 calendar days from first knowledge by the INVESTIGATOR.

d) Only protocol specific investigational product(s) SUSARs are to be submitted to JPEC.

All periodic SUSAR reporting (line listing) are to be accompanied by a brief report by sponsor highlighting main points of concern, if any.

Annual Safety Report is expected on an annual basis throughout the whole clinical trial course. This report will describe concisely all new safety information relevant for the trial and to assess the safety conditions of subjects in the trial.

For more detailed information, please contact the JPEC Secretariat.

How does JPEC monitor ongoing trials?

After JPEC issued ethical approval for a trial to begin, it continues to monitor the trial to ensure that the subjects’ welfare, safety and rights are protected through the dynamics of time. This is done by receiving notification from investigators of the following:

  • Amendments to the trial
  • Reports – serious adverse event, trial progress and closure reports
  • Or by conducting an audit of the trial

To enable JPEC to monitor ongoing trials for subject safety, rights and protection, JPEC requires investigators to submit a research project progress report, serious adverse event reports and finally the research project closure report. Forms for filing all these reports are available below.

It is the responsibility of investigators conducting the trial to inform JPEC of serious adverse events, any new information that alters the risk to subjects as well as all amendments to the study protocol, informed consent or investigator’s brochure. A research project progress report is to be submitted to JPEC at specified intervals (usually annually) once a trial is ongoing. Upon study closure, a research project closure report is to be submitted to JPEC. Normally, the first research project progress report is due one year from the date of issue of the JPEC Decision Notification Form. However, studies with higher risk to subjects may require more frequent progress reporting. The Research Progress report is not applicable to short studies, which are closed within a year from date of issue of the Decision Notification Form. In this instance, only the study closure report needs to be submitted to JPEC.

Investigator(s) involved in ongoing trial(s) are required to submit to JPEC their most recent, updated curriculum vitae and Annual Practicing Certificate annually (beginning of each year) until JPEC is notified of study or site closure.

Non-compliance with JPEC requirements

JPEC requirements are made clear to investigators upon ethical approval of a trial. In cases where there is serious non-compliance by investigators, JPEC may choose to withdraw its ethical approval and inform the National Pharmaceutical Control Bureau of Malaysia of this withdrawal.

Procedures for Appeal

If the applicant perceives a request for amendment, substantial change, resubmission or non approval unfair or unwarranted, the applicant will initially confer with the Secretary for clarification of the reasoning of JPEC.

If, after consultation with the Secretary, the applicant is not satisfied, the applicant has the right to request, and JPEC is obligated to provide reconsideration of negative decision through an appeal process.

Only appeals that are made in writing will be considered. Letters of appeal must be received within 30 days in advance of the next scheduled JPEC meeting.

The appeal process would involve four steps

  • A discussion of the issue appealed
  • A review of the evidence
  • A considered decision arrived at
  • Communication of the decision outcome made during a convened meeting

JPEC may invite the appellant to attend the meeting

The decision of the appeal is based on

  • A full and clear understanding of the facts of the original review
  • The nature of the appeal
  • Legal opinion
  • Adherence to the ICH and Malaysian Guideline for GCP
  • Adherence to JPEC SOPs
  • Attention to the internal and external reputation of Penang Medical College and Info Kinetics Sdn Bhd Clinical Research Centre

The outcomes to appeal would include

  • Whether the appeal is successful or not
  • Reasons for the decision
  • Communication of the decision is within 7 days of the meeting
  • JPEC’s decision is final.

 

JPEC forms

Application Form to Conduct a New Research Project Involving Human Subjects download
Applicant’s Document Checklist for Submitting an Application to Conduct A New Research Project download
Application for Amendment to Research Project involving Human Subjects download
JPEC Serious Adverse Event Report download
Research Project Progress Report Form download
Research Project Closure Report Form download
Applicant’s checklist of minimum requirements in the informed consent form and written subject information download
Additional checklist for research projects involving genetic tests download