Frequently Asked Questions (1)

All researchers with no exception, must apply for permission to conduct research or data collection in HASA (site approval).

PJI goes by the Rule of 30. The applicant is encouraged to send in their application by a minimum of 30 days prior to starting their research, and from our end, we will issue an approval letter (or appropriate feedback if the application is unsuccessful) within 30 days of receiving a complete submission.

REC/FRC is an Independent Ethics Committee (IEC) that primarily govern research to safeguard safety, rights and well-being of the subjects while HASA being the locality where the research is taking place, reserve the rights to know all research that is currently ongoing under its roof.

In simple word: risk management. HASA needs to manage its risk appropriately in addition to aiding the IEC in safeguard ‌the safety, rights and well-being of our patients while at the same time complying with MSQH standards.

A vast majority of data in HASA is private and confidential especially those pertaining to human data. Therefore, HASA has taken steps to ensure there is safety & security of the data, highest accountability and quality control measures are in place and last but certainly not least to deter breaches and data leakages (see infographics: risk management). 

All research apart from clinical audit or case report/series must be applied for and received approval prior to commencement.

No, but you will need to apply for an ethical clearance or exemption from FRC Faculty of Medicine, UiTM. (see FAQ: ethics)

No, but some journals might require evidence of ethical clearance  or exemption. In that case, please apply from FRC FOM.

While PJI does not hold any legal authority and neither are we a law enforcer, please be mindful that this behaviour is not tolerated and reflects negatively on the PI. If found to be liable, we hold the right to write a formal complaint to the institution and PI action could be deemed as trespassing and will be dealt with accordingly by the hospital.

No, you are applying for site approval and subsequently having the research registered. REC/FRC being the highest authority and consisting of team of experts has evaluated the scientific and ethical elements of your research such as those pertaining to informed consent, favourable risk-reward ratio, fair subject selection, and the rest of the matrices. Do note that ethics approval from UiTM REC/FRC is a prerequisite to conduct research in HASA.

Yes, you do (see also: external researcher).

Please apply via UiTM Research Ethics Depository (RED) website at https://red.uitm.edu.my/

Please fill in REC 11 form and email it to frcmedic@uitm.edu.my 

You may register for a new account using your NRIC. Please pick Pejabat Naib Canselor (Penyelidikan & Inovasi) as the body that will evaluate your research proposal.

HASA does not have its own IEC for 2 main reasons. The first is the redundancy factor, whereby the majority of FRC members consist of medical lecturers who are clinicians at HASA. Therefore, it is not practical to create another overlapping IEC at HASA which then is likely to appoint the same personnel for the same function. The second reason is the legality aspect of it. Currently, only UiTM branches and faculties are allowed to set up their own IEC (refer to Circular of the Deputy Vice-Chancellor, Research and Innovation, bil. 3/2016, Establishment of Research Committees at Faculty and UiTM Branches). However, this could potentially be amended in the future.

Sub-Investigator (use interchangeably with co-investigator or co-i) is a team member assisting the Principal Investigator (PI) in conducting the research project. In this context, a sub-i is HASA staff appointed by PI to be part of his/her team in conducting research in HASA.

Similar to subject recruitment, there is no coercion to participate in the research as a sub-i. The appointment is 100% voluntary and staff may accept or politely decline the invitation

There is no restriction on the position of the sub-i, however, the person must be relevant to the disipline or area of the research

This indicate to us that first, PI have a point-of-contact in HASA and second is that the HOD has given permission for his/her staff to participate in the research and for the PI to conduct research in that department.

Among the benefits of sub-i are gaining research experience, pointer for LNPT, honorarium/ letter of appreciation / opportunity for co-authorship. (see also: sub-i)

Sub-i roles in this context is to be the point-of-contact and providing assistance to PI in facilitating his/her research given that many (non-HASA) PI may be unfamiliar with HASA system, area and typical day-to-day operation. 

Sub-I appointment is a mandatory requirement to conduct research in HASA. Exceptions apply in 3 cases:

1) HASA staff is the PI*

2) Faculty of Medicine’s student with medical lecturer as supervisor

3)  Faculty of Medicine’s lecturer as PI.

*N.B. HASA staff that pursue further education under external institution is considered to be an external applicant and thereby warrant the appointment of sub-i as per non-HASA staff.  

HIS is an acronym for Hospital Information System which is an umbrella term that encompasses all data based systems in the hospitals  such as Electronic Medical Record or EMR (Unimeds). PACS, LIS, RIS, PIS and other non medical data such as Financial Information System, Facility Management System and others.

UniMEDS is an EMR that is use in HASA. It is proudly developed and designed by HASA's in-house IT team.

All applicants that would like to access or extract data from HIS are required to sign the confidentiality undertakings.

Normally this is not necessary as PI would already sign a Clinical Trial Agreement (CTA) or a Research/Memorandum of Agreement (MoA) that usually contain a standard confidentiality clause with the sponsor.

We are in the process of creating a limited-access research account for research purposes. PJI is actively pursuing this agenda and we hope to be able to announce this in the near future.

For the time being, PI must request data extraction through Patient Information Department (PID). PI need to submit the HIS data request form and confidentiality undertaking together with the rest of the application checklist to PJI. Following approval, PI will have to set up an appointment with PID for data extraction.

PID will vet each and every application data request meticulously. Be mindful that the data requested are subject to the absolute discretion of the department and therefore some of the data specifics may be prohibited and restricted. 

PI may liaise directly with the Patient Information Department (PID) to request access to patient BHT. Please adhere to PID SOP for requesting patients BHT. For more info, please visit HASA website (under directory: Patient Information Department) or call 03 3396 3000 (ext: 14802).