IRB_IMDC

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.

1. Effects of late night eating on BMI, blood glucose and oxidative stress in medical students of Islamabad medical and dental college
2: Effect of Energy drinks on brain waves and reaction time
3. Practices of drug dose adjustment in admitted patients of a tertiary care hospital in accordance to creatinine clearance.
4 Relationship between learning styles and achievement of third year MBBS and BDS students.
5 Student Support Services in a Blended Learning Environment.
6 Prescription practices of physicians: A Mixed Methods Study from Rawalpindi, Pakistan
7 Development and validation of self-assessment instrument to measure digital professionalism of healthcare professionals using social media
8 Prevalence of poor sleep quality in diabetic patient and its associated factors
9 Literature based drug – drug interaction evaluation in hospitalized patients of a teaching hospital and their clinical assessment on the basis of risk to benefit ratio.
10 A resilience-focused education inquiry during the forming years of undergraduate nursing students
11 Assessment of diabetic autonomic neuropathy using heart rate variability
12 assessment of peripheral and cardiac autonomic neuropathy & their association with HbA1c, vitamin-B12 and vitamin-D
13 Correlation of broiler chicken, polycystic ovary syndrome PCOS) and deficient vitamin D levels in female medical students
14 Effect of different music genre on EEG.
15 Chronic kidney disease and its relation with high BMI and uncontrolled hypertension evidence from cross sectional study in tertiary care hospital
16 Effect of maternal anemia (iron deficiency anemia): impact on fetal APGAR score, weight & gestational age.
17 Link of Depression and Anxiety with Isotretinoin treatment of Acne; A cross-sectional study at Akbar Niazi Teaching Hospital (ANTH)
18 Frequency of musculoskeletal problems in working women of Islamabad
19 Frequency of adhesive capsulitis in diabetic geriatric population of twin cities
20 Frequency of lower limb osteoarthritis in postmenopausal women of twin cities
21 Prevalence of plantar fasciitis in surgeons and OT technicians during surgery due to long-standing
22 The effects of Q-angle measurement with respect to various body parameters among young population of Islamabad, Pakistan: An analytical cross section survey
23 What happens when they go home? A qualitative exploration of stroke survivors
24 Efficacy of Bovine Colostrum in The Treatment of Acute Diarrhea in Infants and Children
25 A comparative study of covid – 19 vaccination & its effect on the menstrual cycle amongst women of different age groups.
26 Stress from in-laws and its association with the control of reproductive Decision among rural women of Pakistan
27 An international, cluster randomised-sequence study of a ‘Safe- anastomosis’ Quality Improvement Intervention to reduce anastomotic leak following right colectomy and ileocaecal resection.
28 Chronic Effects on Pulmonary Function Tests of Young Adult Vape or E-Cigarette Smokers Before & After Exposure to Exercise
29 Is there any role of prevention of early and late complications by suture and technique of closure of midline surgery wound? ; A comparative prospective analysis of outcome after complications after conventional vs continuous horizontal mattress technique.
30 Frequency of different types of mutation in β-Thalassemia major patients presenting at ANTH.
31 Frequency of Viral Hep C among dialysis patients at ANTH
32 Audit of Bone marrow Biopsies in patients presenting with Cytopenias
33 Hemovigilance at Tertiary care Hospital
34 Microalbuminuria in diabetes mellitus: Association with Hba1C, age, sex, weight, and creatinine clearance.
35 Improving treatment adherence among young hypertensive patients visiting two secondary healthcare facilities of district Sukkur, Sindh: a randomized controlled trial
36 Bacterial profile and antibiotic susceptibility pattern of isolates from urine culture of children with urinary tract infection
37 Extended spectrum beta lactamase producing Enterobacteriaceae in a tertiary care hospital
38 Detection of surface contamination by microorganisms in a tertiary care Hospital
39 Pak Surg 1: Determining the epidemiology and risk factors of surgical site infections in Pakistan - A multicenter, prospective cohort study
40 Differences in Athletic Performance and Pulmonary Function between Untrained Persons Living at High and Low Altitudes
41 Awareness amongst house officers and nurses regarding specimen collection for various laboratory tests
42 Expert prediction of item difficulty versus difficulty index measured by psychometric analysis
43 Supplementation of Vitamin D in females with uterine leiomyoma
44 Awareness of Telemedicine and its benefits among medical and dental students and clinicians of a private medical institute Comparison of amitriptyline, pregabalin and duloxetine on the basis of efficacy for pain relief in diabetic neuropathy.

DEFINES MINIMAL MEMBERSHIP

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

CRITERIA FOR APPROVAL

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

INFORMED CONSENT

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

For more information about review process, please click here.

RESEARCH COMMITTEE

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

HOW DOES IRB 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 IRB 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 IRB 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 IRB about 20 days before the scheduled Friday of the meeting.
Proposal submitted after the deadline will not be entertained in the upcoming IRB meeting.
Three hard copies and a soft copy of Research proposal, IRB form, consent form and supervisor letter should be submitted in the office of secretary IRB. Proposal will not be reviewed if incomplete documents are provided.
Relevant documents should be emailed at saima.latif@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 IRB
IRB will require at least 15 days to review the projects.

MEMBERS IRB(IRB MEDICAL & ALLIED)

1	Mr. Yasir Niazi(Managing Director)	10	Prof. Dr. Bushra Kanth(HOD Gynae)
2	Dr. Areej Niazi(Deputy Director)	11	Prof. Dr. Muhammad Sajid(Science Of Dental Materials)
3	Prof. Dr. Syed Irfan Ahmad(Principal IMDC)	12	Dr. Nadia Tariq(Associate CM)
4	Prof. Dr. Asma Irfan(Chairperson IRB,HOD)	13	Muhammad Kamra(lecturer MLT)
5	Prof .Dr. Rizwan Aziz Qazi(HOD Medicine)	14	Mr. Younus Mashi(lecturer INC)
6	Prof.Dr. Saffia Shaukat(HOD Anatomy)	15	Dr. Hina Mehmood(Associate Prof.Periodontology)
7	Prof.Dr. Sadaf Jafar(HOD Biochemistry)	16	Dr. Hadiqa Adnan(lecturer DPT)
8	Dr. Memoona Mansoor(Assistant Professor Department of DME)	17	Dr. Saima Latif Qureshi(Secretary IRB)

MEMBERS IRB (IRB DENTAL SECTION)

1	Dr. Khurshid Ahmed	5	Prof. Saima Azam
2	Mr. Yasir Niazi (Managing Director)	6	Prof. Tayyaba Saleem
3	Prof. Haroon Shahid Qazi. Principal IDH	7	Prof. Khalid Mahmood Siddique
4	Dr. Hina Mahmood