Ethics Application (JPEC)
Introduction
JPEC or Joint Penang Independent Ethics Committee is a 11-member committee formed under the joint authority of the Penang Medical College and Gleneagles Clinical Research Centre, Penang . JPEC conducts initial and continuing ethical review of clinical trials conducted in Penang Medical College and study sites under the coordination of Info Kinetics. It may also, upon request, review ethical aspects of clinical trials conducted at other private medical institutions or medical clinics. JPEC is unique in that while most ethics committees are institutional i.e. formed by and comprising members from one particular institution, JPEC unites members from the private and public medical centers and institutions in 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 conduct 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. In its latest review of its SOPs in 2004, JPEC incorporated further characteristics, in line with the WHO Operating Guidelines for Ethics Committees that Review Biomedical Research 2000.
JPEC received ISO 9001: 2000 Total Quality Management certification in the year 2004 and is likely to be the first ethics committee in Malaysia with such accreditation.
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.
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:
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 12 copies (1 original and 11 photocopies) of the following forms with supporting documents (e.g.: study protocol, consent form, subject information sheet, advertisements, questionnaire, investigator’s brochure, product summary, investigator(s)’ curriculum vitae and GCP certificates, recruitment material, insurance coverage for subjects in event of trial-related injury, statement from trial sponsor indemnifying the relevant staff, investigator, institution and JPEC ). At least one of the study team members should be trained/certified in Good Clinical Practice (GCP). All new applications are to be submitted with a one-off application fee of RM 1,000 per research project made payable to ‘Info Kinetics Sdn Bhd.’ It is the prerogative of JPEC to waive this fee for investigator-driven research, which do not receive funding. Incomplete applications lead to a delay in its review.
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 21 elements (unless it is not applicable) in the ‘Applicant’s checklist of 21 elements in the informed consent form and written subject information’ (Source: Malaysian Guidelines for Good Clinical Practice, Oct 1999) 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 with relevant supporting documents. If the amendment is administrative or logistical; or clearly do not affect subject safety, rights or welfare, only 1 original copy of the application is to be submitted. For all other amendments, the applicant must submit 12 copies (1 original and 11 photocopies). This difference arises as the former types of amendments are reviewed by the JPEC officer in an expedited review while the latter is reviewed by all JPEC members in a meeting. When in doubt as to how many copies to submit, please contact the JPEC secretariat.
Review of an application to amend a clinical trial:
Applications to amend a previously JPEC-approved clinical trial may be given an expedited review where an opinion is given by the JPEC officer, provided these amendments are deemed not to affect the safety, rights and welfare of trial subjects. Amendments that may affect the safety of subjects cannot be given an expedited review and are reviewed at a JPEC meeting.
For applications to make amendments, which do not qualify for expedited review, applicants will be notified of the time and date of the scheduled JPEC meeting where the application is scheduled for 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 ONE year 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 ONE year 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 2 working days 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), ( ie SAEs notified via CIOMS reports, the investigator is required to notify JPEC annually within 7 working days of its receipt by the investigator or Sponsor. An annual compilation of ADRs (both serious or otherwise) is to be submitted as part of the research project progress report.
How does JPEC monitor ongoing trials?
After JPEC has 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 o JPEC.
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.
JPEC forms and resources
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
Resources:
Reaching out to you