INSTITUTIONAL REVIEW BOARD

The Institutional Review Board (IRB) (also known as an independent ethics committee (IEC) or ethical review board (ERB)) was formed on the instructions of the Academic Council of Islamabad Medical & Dental College (IM&DC), affiliated with Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad (Ref: Academic Council Meeting held on April 30, 2014).

It is an independent body consisting of medical, scientific, non-scientific members, whose responsibility is to ensure protection of the rights, safety and well-being of the research subjects involved in a trial by, among other things, reviewing, approving and providing continuing review of trial protocol and amendments of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

MISSION STATEMENT

To promote the growth of scientific research in a safe and ethical research environment according to the international ethical principles and guidelines.

OBJECTIVES OF IRB

  • To provide standards of conducting ethical research, and to protect human and animal subjects in accordance with the National Research Act (law in 1974).
  • To ensure that any research project that receives research grant must demonstrate that its methods are ethical.
  • At least 5 members
  • Neither all men nor all women
  • Subjects will be selected and treated fairly
  • Qualified via experience and expertise
  • Diversity of race, gender, cultural background
  • Sensitive to community interests
  • Knowledgeable about subject matter of research
  • Knowledgeable about specific populations
  • At least one member whose primary concern is scientific
  • At least one member whose primary concern is not scientific
  • At least one member not affiliated with the institution

1. Risks to subjects are minimized

  • a. Using procedures consistent with sound scientific design
  • b. Using procedures already planned for diagnosis or treatment
  • 2. Risks are reasonable in relation to anticipated benefit and importance of the knowledge reasonably expected

  • a. Can only consider the risks and benefit from the research itself, not from those subjects would be exposed to anyway
  • b. IRB should not consider long-range effects
  • 3. Selection of subjects is equitable

  • a. Requires gender/minority sub analyses for phase 3 clinical trials
  • b. Exceptions may be approved based on scientific or safety concerns
  • 4. Informed consent is obtained from subject or guardian.

  • a. Informed consent may be waived if certain conditions are met
  • 5. Informed consent is properly documented

  • a. Written informed consent may be waived if certain conditions are met
  • 6. Research plan has provisions for monitoring

    7. Research plan has provisions for protecting privacy and confidentiality

    8. Additional provisions for

  • a. Pregnant women and fetuses
  • b. Prisoners
  • c. Children
Voluntary, informed, written consent is essential for research involving human subjects and include:
  • Description of the nature of the research.
  • Statement that research is voluntary and participants can withdraw at any time
  • Identification of risks and benefits.
  • Description of how confidentiality will be protected
  • Description of compensation
  • Description of what information researchers will share with participants
  • Identification of who is responsible for research with contact information.
  • Cover the act performed appropriately
  • Person is legally competent to give consent
  • Not for illegal procedures
  • Not obtained by misinterpretation
  • Implied or expressed instructions

IRB REVIEW PROCESS:

The researcher/ principal investigator must submit an application to obtain IRB approval. Two types of application may be submitted based on the categories of research as follows: Type 1: If a researcher/IRB (RC) secretary believes that the project meets the requirements for exemption, an application for exemption should be submitted. The Chair or designated member of the IRB will review the proposal to make sure that it meets the criteria for exemption. Type 2: If a project does not meet the criteria for exemption, an application for Expedited or Full Board Review may be submitted.

For more information about review process, please click here.

RESEARCH COMMITTEE

To monitor research activities in the college at all levels, two Research Committees (RC) were formed by the Institutional Review Board of Islamabad Medical & Dental College (IM&DC) on January 7, 2016 (Ref: IMDC/HR/IRB-2016). The RC (IRB Medical & Allied) caters to all the research projects undertaken by the faculty and students at the Medical college, Nursing, DPT, MLT etc., while RC (Dental Section) scrutinizes the research projects of the faculty, house-officers, post-graduate and under-graduate students of Islamabad Dental College and Hospital.

Research projects involving human subjects (as individuals or communities), including the use of tissues from the recently dead, embryos and fetal material, undertaken or supported by IM&DC/Islamabad Dental Hospital/Akbar Niazi Teaching Hospital/Islamabad Nursing College/DPT faculty, staff or students, wherever conducted, will be first reviewed by the Research Committee. The committee will not only evaluate the scientific/technical content but also related ethical issues when needed through consultation with subject experts.

Approval from RC/IRB of Islamabad Medical & Dental College is mandatory before starting a research project with effect from April 20, 2016.

HOW DOES RESEARCH COMMITTEE WORK?

Principal investigators (PI) after discussing the research proposal with their respective supervisor will have to submit the following documents in the office of the Secretary RC:

  • Filled RC form
  • Research proposal (with proforma/questionnaire)
  • Consent form (both English & Urdu)

The secretary RC will check the general layout and similarity index (plagiarism) of the proposal and has the authority to return the manuscript if found lacking. The documents will be initially reviewed by two reviewers (who are members of the Research Committee) for scientific content and ethical issues. They will submit their report within 7 days. The reviewers’ comments will then be sent to the PI and supervisor for incorporating the suggestions. On receiving the corrected copy of the proposal, the secretary of the committee will call a meeting, depending upon the proposals received and reviewed respectively. The PI along with the supervisor and co-investigators will present their proposal as a power point presentation before the members of RC in this meeting. After due deliberation, the committee decision will be conveyed through email to the investigator, preferably within 07 days of submission. If the RC is convinced that there is no reason for any ethical consideration, a final decision of approval or disapproval of the proposal will be given by the committee itself. However, if the study is interventional and involves administration of medicine(s), operative procedure(s), or reflects any ethical consideration, the research proposal will be referred to IRB Advisory Board for review. The Board Members will scrutinize the ethical issue(s) and send its report to the RC for final disposal, preferably within one month.

On approval of the research proposal, a letter of approval is issued by the RC/IRB as a hard copy to the principal investigator.

A research proposal must state the purpose of the research, the reasons for using humans as subjects, budget details, the nature and degree of all known risks to the subjects and the means for ensuring that the subjects’ consent will be adequately informed and voluntary.

PROCESS OF SUBMISSION

  • Research projects should be submitted to RC for scientific/technical as well as ethical evaluation.
  • The research proposal should be duly signed by the researcher/candidate/principal investigator/author and supervisor.
  • Research proposal should have supervisor letter stating that it has been reviewed by the supervisor and fulfill the requirement of research methodology, meet the statistical requirement and is in line with the regulations regarding ethical consideration of research of human subjects/animals.
  • Principal investigator should have biostatistics review before submission.
  • All research protocols need to be submitted to secretary RC about 20 days before the scheduled Friday of the meeting.
  • Proposal submitted after the deadline will not be entertained in the upcoming RC meeting.
  • Three hard copies and a soft copy of Research proposal, RC form, consent form and supervisor letter should be submitted in the office of secretary RC. Proposal will not be reviewed if incomplete documents are provided.
  • Relevant documents should be emailed at asma.irfan@imdcollege.edu.pk (RC IRB Medical & Allied) and abdul.rahman@iideas.edu.pk (RC IRB Dental Section)
  • Research proposal / synopsis will be reviewed by two members of the RC
  • RC will require at least 15 days to review the projects.

 

MEMBERS RC (IRB MEDICAL & ALLIED)

1
Prof. Dr. Naila Irum Hadi
8
Dr. Nadia Tariq
2
Prof. Dr. Asma Irfan
9
Dr. Wajeeha Mahjabeen
3
Prof. Dr. Syed Irfan Ahmad
10
Dr. Ahmed Abdullah
4
Prof. Dr. Naghmi Asif
11
Dr. Sadaf Jaffar
5
Prof. Dr. Saeed Alam
12
Dr. Memoona Mansoor
6
Col. Prof. Dr. Ehtesham-ul-Haq
13
Dr. Sadaf Khalid
7
Prof. Dr. Farah Rashid
 

 

MEMBERS RC (IRB DENTAL SECTION)

In a notification (IDH/Notification/Meeting/054) dated 28th November, 2018, the following members will be part of the institutional review board of IDH:

1
Prof. Dr. Naila Irum Hadi
7
Maj. Gen. (R). Shahid Shuja Qazi
2
Dr. Khurshid Ahmed
8
Prof. Dr. Kamran Alin
3
Prof. Dr. Haroon Shahid Qazi
9
Dr. Hina Mahmood
4
Prof. Dr. Saima Azam
10
Mr. Yasir Niazi
5
Prof. Dr. Tayyaba Saleem
11
Mr. Raja Nasir
6
Dr. Khalid Mahmood Siddiqui
12
Ms. Ayesha Usmani

Any additional member can be incorporated from the faculty as and when required.

IRB ADVISORY MEMBERS

Sr. #

Internal Members:

Sr. #

External Members:

1
Prof. Dr. Naila Irum Hadi
1
Prof. Dr. Irfan Zia Qureshi
(Prof. of Animal Sciences, Quaid-e-Azam University)
2
Prof. Dr. Syed Shoaib Shah
2
Prof. Dr. Jawad Hassan
(Biochemistry Department, NUST/ Atta-ur-Rehman School of Applied Biosciences)
3
Prof. Dr. Asma Irfan
3
Prof. Dr. Ayesha Mohiyuddin (NUMS)
4
Prof. Dr. Syed Irfan Ahmad
4
Prof. Dr. Ansar
(Biological Sciences, NUMS)
5
Prof. Dr. Haroon Shahid Qazi
5
Dr. Faiza Mujeeb
(Director Research, RMU)
6
Prof. Dr. Tayyaba Saleem
 
7
Prof. Dr. Saima Azam
 
8
Prof. Dr. Rehmah Sarfraz
 
9
Prof. Dr. Naghmi Asif
 
10
Prof. Dr. Kinza Alam
 
11
Dr. Wajeeha Mahjabeen
 
12
Dr. Hina Mahmood
 

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