JEPeM USM Frequently Asked Questions

• JEPeM-USM consists of medical, scientific, non-scientific members, non-medical and non-institutional members including experts in specific areas and lay persons.

• This would be considered as research misconduct.JEPeM-USM does not provide retrospective ethical approval.

Ethical approval is required if:

• A USM staff member or student is the Principal Investigator and/or
• Data are collected from participants within or from USM and/or
• USM is the main funding body for the research

This applies to research involving:

• Human subjects
• Human samples
• Data derived from humans
• Products (biological or non-biological) to be tested on humans

• Applications must be submitted via the JEPeM online system: ( eJEPeM Online System )
• USM staff and students can login using SSO (Single Sign-on) USM email.
• Non-USM applicants must register and sign up.

• Any member of the research team (Principal Investigator, Co-Investigators, lecturers, postgraduates, researchers, or CRA) from inside or outside USM may apply. Undergraduate students from USM should contact the JEPeM Secretariat.

• Yes, if your research involves human subjects.

1. This form is required if your research involves Hospital Pakar USM (HPUSM) including patient records, facilities, patients and human resources.
2. Information on how to obtain the OBB:
3. OBB form can now be applied online. To fill in the OBB form, please register and apply at HPUSM eAdmin System (using USM WiFi/LAN only).
   For inquiries, please contact 09-7673015.

1. Industry Sponsored Research (ISR): Any interventional or observational study sponsored by industry (pharmaceutical, device, biotechnology, or complementary medicine).
2. Investigator Initiated Research (IIR): Any study not sponsored by industry (includes student projects).
3. This includes research in medical/health sciences and social-behavioural research.

• Once you have submitted your research proposal, the research proposal will be screened whether to undergo full board review or expedited review based on the level of risk of the research.
• For more information, please click the following, JEPeM SOP II .

Please refer to Section 7.1 – Determination of the Type of Review (Page 17).

• For either full board or expedited review, two primary reviewers will be assigned to review the research proposal, and their reports will be discussed in the meeting for first decision-making
• Decision will be made for the proposal to either approval, modifications, re-submission, or disapproved

Criteria for exemption from review include:

1. Protocols that do not involve human participants or identifiable human tissue or biological samples.
2. Systematic reviews and meta-analysis.
3. Audits/evaluations organised by management for the purpose of quality improvement within the institution only.
4. Protocols that involve the use of publicly available data or information.

Note: Some journals require proof of exemption. Please check with the journal you intend to publish in. If you require a certificate of exemption, please submit a proposal before starting your data collection. If you are uncertain whether your proposal qualifies for an exemption, please contact the JEPeM Secretariat.

These include:

1. Study Justification, Literature review, Objectives, Research design, Sample size estimation, Sampling method, Inclusion and exclusion criteria,Vulnerability of the subject/participant, Recruitment of subject/participant & informed consent seeking, Assent form requirement, Randomization, matching, blinding * , Suitability of study area/study location, Validity of research instruments, Method of intervention* , Control group * , Data collection / Specimen handling, Potential risk to subject/participant (e.g. psychological distress), Direct & indirect benefit to subject/participant,Duration of participant involvement, Withdrawal criteria, Proposed data analysis, storage and management, Incentive, compensation &/or reimbursement, Declaration of conflict of interest, Handling privacy & confidentiality issues, Community sensitivities & benefits, PI & Co-Investigator qualification (including GCP Certificate), Collaborative study terms of reference (e.g. Intellectual property, etc.)

Note: Items marked with * are more relevant for interventional protocols.

• Yes, if the research proposal involves either

A) Whenever a USM staff or student is the principal investigator of the research and/or

B) Data are collected from participants within or from USM and/or

C) USM is the main funding body for the research

must obtain JEPeM-USM ethical approval regardless of where the research is conducted.

• A Good Clinical Practice (GCP) certificate is mandatory for interventional studies and/or randomised controlled trials (RCTs)

• Interventional studies: These are usually prospective studies in which the researcher actively assigns participants to one or more interventions (such as a drug, treatment, device, or preventive measure) to evaluate its direct effects on health outcomes. Examples include randomised controlled trials and bio-equivalence studies
• Non-interventional / Observational studies: These studies do not involve any intervention by the researcher. Instead, they observe participants in real-world conditions to assess relationships between exposures (e.g., risk factors) and outcomes. The decision for any treatment is not derived from the study. Common designs include cohort studies, case-control studies, cross-sectional studies, and registries

Source: National Center for Biotechnology Information (NCBI)

• 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 JEPeM USM reviewers.
• It is required to obtain permission from the data guardian e.g., Director of HPUSM via the OBB form

• Yes, please refer JEPeM USM website ( JEPeM-USM Website )

• Industry Sponsored Research (ISR): Any interventional or observational study sponsored by industry (pharmaceutical, device, biotechnology, or complementary medicine).
• Investigator Initiated Research (IIR): Any study not sponsored by industry (includes student projects).
• Including medical sciences and social behavioural research

Criteria for exemption from review include:

1. Protocols that do not involve human participants or identifiable human tissue or biological samples.
2. Systematic reviews and meta-analysis.
3. Audits/evaluations organised by management for the purpose of quality improvement within the institution only.
4. Protocols that involve the use of publicly available data or information.

Note: Some journals require proof of exemption. Please check with the journal you intend to publish in. If you require a certificate of exemption, please submit a proposal before starting your data collection. If you are uncertain whether your proposal qualifies for an exemption, please contact the JEPeM Secretariat.

These include:

1. Study Justification, Literature review, Objectives, Research design, Sample size estimation, Sampling method, Inclusion and exclusion criteria,Vulnerability of the subject/participant, Recruitment of subject/participant & informed consent seeking, Assent form requirement, Randomization, matching, blinding * , Suitability of study area/study location, Validity of research instruments, Method of intervention* , Control group * , Data collection / Specimen handling, Potential risk to subject/participant (e.g. psychological distress), Direct & indirect benefit to subject/participant,Duration of participant involvement, Withdrawal criteria, Proposed data analysis, storage and management, Incentive, compensation &/or reimbursement, Declaration of conflict of interest, Handling privacy & confidentiality issues, Community sensitivities & benefits, PI & Co-Investigator qualification (including GCP Certificate), Collaborative study terms of reference (e.g. Intellectual property, etc.)

Note: Items marked with * are more relevant for interventional protocols.

• 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. Parental consent is still required. The assent form must use age-appropriate language.

• The JEPeM USM 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 JEPeM USM. Late submissions may not be processed in time, and you are not allowed to continue the study without approval.

• Yes, upon completion of your study, you are required to submit a Study Final Report to JEPeM. Subsequently, an acknowledgement letter will be issued to confirm the completion of the study. Please download the required form from the ( JEPeM Forms ).

• Yes, upon termination of your study, you are required to submit a Study Termination Form to JEPeM USM. Subsequently we will send you an acknowledgement letter for notification on the termination of that study. Please download the required form from the ( JEPeM Forms ).

• Please submit Study Protocol Amendment Form and relevant documents to JEPeM USM secretariat. Please download the required form from the ( JEPeM Forms )

• Reporting needs to be submitted within seven (7) days. Please refer to the Guideline of Reporting SAE on the JEPeM website ( JEPeM References )

• No standard template for SUSAR reports (outside USM). However, for local SAE (USM site), please refer to the JEPeM USM template for SAE reports. ( JEPeM Forms ).

• All SOPs are available on the JEPeM-USM website JEPeM USM’s SOP are published in JEPeM USM website ( JEPeM-USM Website ).

Human Research Ethics Committee USM

Research Creativity and Management Office (RCMO)

USM Health Campus,

16150, Kubang Kerian,

Kelantan.

Telephone: 09-767 2354/2352/2350

OR

Human Research Ethics Committee USM

Research Creativity and Management Office (RCMO)

USM Main Campus,

11800 Minden, Pulau Pinang

USM Pulau Pinang.

Telephone: 04-6546559

• Yes. Please refer to the Summary of Advertisement Guidance for JEPeM-USM ( JEPeM-USM Website ).