The Effectiveness of Intravenous Dexamethasone Prophylaxis in Preventing Post-operative Urinary Retention in Spinal Anesthesia at Al-Makassed Hospital
Phase: NA
Conditions: Post Operative Urinary Retention, Spinal Aneshtesia
Sponsor: Al-Quds University

 
                          
Official Title of the Study: 
A Randomized Controlled Study Investigating the 
Effectiveness of Intravenous Dexamethasone 
Prophylaxis in Preventing Post-operative Urinary 
Retention in Spinal Anesthesia at Al-Makassed 
Hospital 
 
NCT Number: 
NCT07077850 
 
Date of Document: 
01/07/2025 
 
 
 

REC OFFICE USE 
HUMAN RESEARCH 
ETHICS COMMITTEE No 
 
 
Date Received  
 
Institute/Centre/Faculty  
 
Campus 
 
 
Master’s project 
 
Grants Awarded 
 
Small Grants Awarded 
 
General 
 
Clinical Trials 
 
               
Al-Quds University 
Research Ethics committee (REC) 
Application Form 
Ethics Research Committee, Al-Quds University 
 Application Form December 2012 Page 2 
 
 
 
 
1. Project Title (in full) 
 
Effectiveness of Intravenous Dexamethasone Prophylaxis in Preventing 
Post-operative Urinary Retention in Spinal Anaesthesia at Al-Makassed 
Hospital 
 
 
RESEARCH PERSONNEL  
 
General Supervisor 
 
Name 
Dr.  Mohammed Maree 
Title 
General surgeon 
Qualifications 
MD 
University Position Held: 
employee, affiliate (indicate 
type; eg. honorary associate, 
clinical academic), visiting 
 
clinical academic 
Faculty of Medicine 
Al-Quds University 
 
Full mailing address 
Ramallah, Palestine 
 
 
Telephone 
00972592309896 
Fax 
- 
E-mail 
mohammedmaree1983@gmail.com 
Principal Investigator 
 
Name 
Dr. Abeer Dar Hasan 
Title 
Resident doctor – surgery 
Qualifications 
MD 

REC OFFICE USE 
HUMAN RESEARCH 
ETHICS COMMITTEE No 
 
 
Date Received  
 
Institute/Centre/Faculty  
 
Campus 
 
 
Master’s project 
 
Grants Awarded 
 
Small Grants Awarded 
 
General 
 
Clinical Trials 
 
               
Al-Quds University 
Research Ethics committee (REC) 
Application Form 
Ethics Research Committee, Al-Quds University 
 Application Form December 2012 Page 3 
University Position Held: 
employee, affiliate (indicate 
type; eg. honorary associate, 
clinical academic), visiting 
 
- 
Full mailing address 
Jerusalem, Palestine 
 
 
Telephone 
00972534541877 
Fax 
- 
E-mail 
abee.9.1994@gmail.com 
 
 
Associate Investigator(s) 
 
 
Associate Investigator 1 
Name 
Dr. Ahlam Hammoudeh 
Title 
Resident doctor – anesthesia 
Qualifications 
MD 
University Position Held: 
employee, affiliate (indicate 
type eg honorary associate, 
clinical academic), visiting 
 
- 
Full mailing address 
Jerusalem , Palestine 
 
 
Telephone 
00972595744577 
Fax 
- 
E-mail 
ahlamhammoudeh123@yahoo.com 
 
Associate Investigator 2 
Name 
Dr. Islam Khairaldin 
Title 
Resident doctor – anesthesia 
Qualifications 
MD 

REC OFFICE USE 
HUMAN RESEARCH 
ETHICS COMMITTEE No 
 
 
Date Received  
 
Institute/Centre/Faculty  
 
Campus 
 
 
Master’s project 
 
Grants Awarded 
 
Small Grants Awarded 
 
General 
 
Clinical Trials 
 
               
Al-Quds University 
Research Ethics committee (REC) 
Application Form 
Ethics Research Committee, Al-Quds University 
 Application Form December 2012 Page 4 
University Position Held: 
employee, affiliate (indicate 
type eg honorary associate, 
clinical academic), visiting 
 
- 
Full mailing address 
Jerusalem , Palestine 
 
 
 
Telephone 
00972533491136 
Fax 
- 
E-mail 
islamkhairaldeen@gmail.com 
 
Associate Investigator 3 
Name 
Dr. Majdi Abu Daoud 
Title 
Resident doctor – surgery  
Qualifications 
MD 
University Position Held: 
employee, affiliate (indicate 
type eg honorary associate, 
clinical academic), visiting 
 
- 
Full mailing address 
Bethlehem, Palestine 
 
 
Telephone 
00972595414606 
Fax 
- 
E-mail 
majdi.aziz1998@gmail.com 
 
Associate Investigator 4 
Name 
Dr. Mohammad Qino 
Title 
Resident doctor – surgery 
Qualifications 
MD 
University Position Held: 
employee, affiliate (indicate 
type eg honorary associate, 
clinical academic), visiting 
 
- 
Full mailing address 
Jerusalem, Palestine 
 

REC OFFICE USE 
HUMAN RESEARCH 
ETHICS COMMITTEE No 
 
 
Date Received  
 
Institute/Centre/Faculty  
 
Campus 
 
 
Master’s project 
 
Grants Awarded 
 
Small Grants Awarded 
 
General 
 
Clinical Trials 
 
               
Al-Quds University 
Research Ethics committee (REC) 
Application Form 
Ethics Research Committee, Al-Quds University 
 Application Form December 2012 Page 5 
 
Telephone 
00972597484208 
Fax 
- 
E-mail 
M.qinoo@gmail.com 
 
 
Associate Investigator 5 
Name 
Anas Barabrah 
Title 
Medical Student 
Qualifications 
undergraduate 
University Position Held: 
employee, affiliate (indicate 
type eg honorary associate, 
clinical academic), visiting 
 
Medical Student 
Faculty of Medicine 
Al-Quds University 
Full mailing address 
Ramallah, Palestine  
 
Telephone 
0597159258 
Fax 
- 
E-mail 
anasmufeed3@gmail.com 
 
 
Associate Investigator 6 
Name 
Tareq Jarrar 
Title 
Medical Student 
Qualifications 
undergraduate 
University Position Held: 
employee, affiliate (indicate 
type eg honorary associate, 
clinical academic), visiting 
 
Medical Student 
Faculty of Medicine 
Al-Quds University 
Full mailing address 
Ramallah, Palestine  
 
Telephone 
00972595076137 
Fax 
- 
E-mail 
tareq.jarrar2@students.alquds.edu 

REC OFFICE USE 
HUMAN RESEARCH 
ETHICS COMMITTEE No 
 
 
Date Received  
 
Institute/Centre/Faculty  
 
Campus 
 
 
Master’s project 
 
Grants Awarded 
 
Small Grants Awarded 
 
General 
 
Clinical Trials 
 
               
Al-Quds University 
Research Ethics committee (REC) 
Application Form 
Ethics Research Committee, Al-Quds University 
 Application Form December 2012 Page 6 
 
 
Associate Investigator 7 
Name 
Amani Ahmed 
Title 
Resident doctor-Surgery 
Qualifications 
MD 
University Position Held: 
employee, affiliate (indicate 
type eg honorary associate, 
clinical academic), visiting 
 
- 
Full mailing address 
Jerico, Palestine 
 
 
Telephone 
00972569045086 
Fax 
- 
E-mail 
amanibashar243@gmail.com 
 
 
Associate Investigator 8 
Name 
Osama Mohammed Sawalha 
Title 
MD 
Qualifications 
Anaesthesiologist 
University Position Held: 
employee, affiliate (indicate 
type eg honorary associate, 
clinical academic), visiting 
- 
Full mailing address 
Tulkarem , Palestine  
 
Telephone 
00972598603554 
Fax 
- 
E-mail 
modosawalhajr@gmail.com 
 
Associate Investigator 9 
Name 
Khaled Nassed Alshawa 
Title 
MD ,MRCS 

REC OFFICE USE 
HUMAN RESEARCH 
ETHICS COMMITTEE No 
 
 
Date Received  
 
Institute/Centre/Faculty  
 
Campus 
 
 
Master’s project 
 
Grants Awarded 
 
Small Grants Awarded 
 
General 
 
Clinical Trials 
 
               
Al-Quds University 
Research Ethics committee (REC) 
Application Form 
Ethics Research Committee, Al-Quds University 
 Application Form December 2012 Page 7 
Qualifications 
General Surgeon 
University Position Held: 
employee, affiliate (indicate 
type eg honorary associate, 
clinical academic), visiting 
 
Clinical Lecturer 
Faculty of medicine 
Azhar University 
Full mailing address 
Gaza, Palestine  
 
Telephone 
00972599335031 
Fax 
- 
E-mail 
khaledshawa@gmail.com 
 
 
PROJECT AND SITE DETAILS 
 
2. Please provide details of the research setting (Research laboratory, Hospital, etc) 
This research project will be done at Al-Makassed Hospital by surgery, anaesthesia doctors, and 
undergraduate medical students. Data will be collected verbally in the surgery department by resident 
doctors. 
 
3. Provide information to demonstrate that the researchers involved in the project have the necessary 
training, expertise and experience to carry out their role in the research. 
This research will be supervised by Dr. Mohammad Maree and sponsored by AMRA. All authors had 
enrolled in previous similar research projects. Most of the research team completed the following 
modules from TRREE: 
Module 1: Introduction to Research Ethics 
Module 3: Informed Consent 
Module 3.2: Good Clinical Practice 
 
4. Please outline (or attach) the proposed procedure for dealing with any health emergencies that may 
arise during the conduct of the research. If the Principal Investigator at the proposed University site is 

REC OFFICE USE 
HUMAN RESEARCH 
ETHICS COMMITTEE No 
 
 
Date Received  
 
Institute/Centre/Faculty  
 
Campus 
 
 
Master’s project 
 
Grants Awarded 
 
Small Grants Awarded 
 
General 
 
Clinical Trials 
 
               
Al-Quds University 
Research Ethics committee (REC) 
Application Form 
Ethics Research Committee, Al-Quds University 
 Application Form December 2012 Page 8 
not a health practitioner, please provide details of the medical practitioner who will be responsible for 
dealing with medical emergencies. 
The team consists of general surgery specialists and well-trained doctors. Therefore, if any emergency 
occurs during the research process, they will deal with it. 
 
5. Risk assessment (please indicate that the following are accurate): 
☑ 
The site has adequate data protection and security systems to ensure protection of participant’s 
privacy 
☑ 
The site has adequate, secure systems for storage of investigational products  
☑ 
Participants are able to report adverse events and study outcomes reliably 
 
6. Is this research at the University site commercially sponsored?  
 
☑ 
NO  
☐ 
YES – please provide a copy of the certificates  

REC OFFICE USE 
HUMAN RESEARCH 
ETHICS COMMITTEE No 
 
 
Date Received  
 
Institute/Centre/Faculty  
 
Campus 
 
 
Master’s project 
 
Grants Awarded 
 
Small Grants Awarded 
 
General 
 
Clinical Trials 
 
               
Al-Quds University 
Research Ethics committee (REC) 
Application Form 
Ethics Research Committee, Al-Quds University 
 Application Form December 2012 Page 9 
DECLARATION BY INVESTIGATORS 
 
I confirm that I have read and understand the attached Code of Good Practise and Helsinki declaration in 
Research Conduct in Human Research. 
 
I confirm that I have read and understand the Code of Good Practise and Helsinki declaration in Research 
Conduct in Human (Provided and declared by the Ethics Research Committee, Al-Quds University) 
 
I confirm that the above information is accurate, and that the project will continue in accordance with the Human 
Research Ethics Committee approved protocol. 
 
 
General Supervisor  
 
Dr.  Mohammed Maree  
Name 
 
Signature 
 
Date 
 
 
Principal Investigator  
 
Dr. Abeer Dar Hasan 
Name 
 
Signature 
 
Date 
 
Associate Investigator(s) 
 
Dr. Ahlam Hammoudeh 
Name 
 
Signature 
 
Date 
 
 
 
Dr. Islam Khairaldin 
Name 
 
Signature 
 
Date 
 
 
Dr. Majdi Abu Daoud 
Name 
 
Signature 
 
Date 
 
 
10/02/202
10/02/202
10/02/202
10/02/202
10/02/202
10/02/202

REC OFFICE USE 
HUMAN RESEARCH 
ETHICS COMMITTEE No 
 
 
Date Received  
 
Institute/Centre/Faculty  
 
Campus 
 
 
Master’s project 
 
Grants Awarded 
 
Small Grants Awarded 
 
General 
 
Clinical Trials 
 
               
Al-Quds University 
Research Ethics committee (REC) 
Application Form 
Ethics Research Committee, Al-Quds University 
 Application Form December 2012 Page 10 
Dr. Mohammad Qino 
Name 
 
Signature 
 
Date 
 
 
Anas Barabrah 
Name 
 
Signature 
 
Date 
 
 
Tareq Jarrar 
Name 
 
Signature 
 
Date 
 
 
Amani Ahmed                                                
 
Name 
 
 
Signature 
 
Date 
 
 
 
Osama Sawalha                                             
 
Name 
 
Signature      
 
Date 
                                                                            
 
 
 
 
Khaled Alshawa                                                             
 
Name 
 
 
Signature          
 
Date 
 
 
 
10/02/202
10/02/202
10/06/202
5
10/02/202
10/02/202

REC OFFICE USE 
HUMAN RESEARCH 
ETHICS COMMITTEE No 
 
 
Date Received  
 
Institute/Centre/Faculty  
 
Campus 
 
 
Master’s project 
 
Grants Awarded 
 
Small Grants Awarded 
 
General 
 
Clinical Trials 
 
               
Al-Quds University 
Research Ethics committee (REC) 
Application Form 
Ethics Research Committee, Al-Quds University 
 Application Form December 2012 Page 11 
 
 
SECTION 1: ADMINISTRATION 
 
 
 
1.1 
 
(a) 
Provide a brief summary of the project in non technical language (approximately 100 words) 
 
 
 
This research is going to investigate the efficacy of administering intravenous dexamethasone in 
preventing post-operative urinary retention in patients going under regional and general anesthesia for 
any type of general surgery operation. The study population will be adult males. Any patient who has a 
contraindication to dexamethasone or is known to have a pre-existing urologic condition will be excluded. 
The participants will be divided into two groups (active drug and placebo). At the end, the study will 
compare the outcomes between both groups. 
 
 
(b) Outline the academic/scientific merits of this study (including potential contributions to 
the body of knowledge and methodological rigor) (approximately 100 words) 
 
 
Postoperative urinary retention is a significant and frequent postoperative complication. This study could have a 
huge impact on dealing with these cases in clinical practice, especially since it will include a large sample size and 
deliberate randomization. 
 
 
1.2 
(a) 
Has this project already been submitted to any other HREC(s)? 
 
  ☑ 
 
N
 
Y 
 
 
 
(b) 
Will this project be submitted to any other HREC(s)? 
☑ 
  
 

REC OFFICE USE 
HUMAN RESEARCH 
ETHICS COMMITTEE No 
 
 
Date Received  
 
Institute/Centre/Faculty  
 
Campus 
 
 
Master’s project 
 
Grants Awarded 
 
Small Grants Awarded 
 
General 
 
Clinical Trials 
 
               
Al-Quds University 
Research Ethics committee (REC) 
Application Form 
Ethics Research Committee, Al-Quds University 
 Application Form December 2012 Page 12 
 
N 
 
Y 
 
 
 
If you answered YES to (a) or (b), give the name of the HREC(s) 
 
The ethics committee of Al-Makassed Hospital  
 
1.3 
(a) 
Indicate the proposed date of commencement of the project.  
 
 
Projects should not commence without the prior written approval of the REC. 
 
 
 
Date   July 2025 
 
 
(b) Indicate the proposed completion date of the project. 
 
Date   Jan 2026 
 
 
 
 
 
1.4 
(a) 
Has this protocol received research funding/contracting or is this submission 
☑ 
  
 
being made as part of an application for research funding/contracting? 
N 
 
Y 
 
 
If you answered YES, list the funding/contracting bodies to which you have submitted, or intend to submit, 
this project. Attach a copy of the grant application(s), contract(s) or similar agreement(s). 
 

REC OFFICE USE 
HUMAN RESEARCH 
ETHICS COMMITTEE No 
 
 
Date Received  
 
Institute/Centre/Faculty  
 
Campus 
 
 
Master’s project 
 
Grants Awarded 
 
Small Grants Awarded 
 
General 
 
Clinical Trials 
 
               
Al-Quds University 
Research Ethics committee (REC) 
Application Form 
Ethics Research Committee, Al-Quds University 
 Application Form December 2012 Page 13 
Funding/Contracting body 1: 
Funding/Contracting body 2: 
Funding/Contracting body 3: 
 
 
 
 
SECTION 2: NATURE OF RESEARCH  
 
 
 
2.1 The nature of this project is most appropriately described as research involving:- 
 
(more than one may apply): 
 
– 
behavioural observation 
   
 
 Y 
– 
self-report questionnaire(s) 
  ☑ 
 
 
     Y 
– 
interview(s) 
 
 
 
 
     Y 
– 
qualitative methodologies (e.g. focus groups) 
 
 ☑ 
 
  
   Y 
– 
psychological experiments 
 
 
 
 
    Y 
– 
epidemiological studies 
 
 
 
 
     Y 
– 
data linkage studies 
 
 
 
      Y 
– 
psychiatric or clinical psychology studies 
 
 
 
      Y 
– 
human physiological investigation(s) 
 
 
 
      Y 

REC OFFICE USE 
HUMAN RESEARCH 
ETHICS COMMITTEE No 
 
 
Date Received  
 
Institute/Centre/Faculty  
 
Campus 
 
 
Master’s project 
 
Grants Awarded 
 
Small Grants Awarded 
 
General 
 
Clinical Trials 
 
               
Al-Quds University 
Research Ethics committee (REC) 
Application Form 
Ethics Research Committee, Al-Quds University 
 Application Form December 2012 Page 14 
– 
biomechanical device(s) 
 
 
 
      Y 
– 
human tissue  
 
 
 
      Y 
– 
human genetic analysis 
 
 
 
      Y 
– 
a clinical trial of drug(s) or device(s) 
 
 ☑ 
 
      Y 
– 
Other (please specify in the box below) 
 
 
 
      Y 
 
Proceed to Section 3. 
 
 

REC OFFICE USE 
HUMAN RESEARCH 
ETHICS COMMITTEE No 
 
 
Date Received  
 
Institute/Centre/Faculty  
 
Campus 
 
 
Master’s project 
 
Grants Awarded 
 
Small Grants Awarded 
 
General 
 
Clinical Trials 
 
               
Al-Quds University 
Research Ethics committee (REC) 
Application Form 
Ethics Research Committee, Al-Quds University 
 Application Form December 2012 Page 15 
SECTION 3: PARTICIPANTS AND RECRUITMENT 
 
 
 
3.1 
(a) 
What is the age range of all participants involved in this study? 
 
 
 
≥ 18 (Adults) 
 
 
(b) 
Are the participants include children (defined by statute for this purpose as  
 
 
☑ 
anyone under 18)  
Y 
 
N 
 
 
 
If you answered NO, give reasons why not. 
 
Post-operative urinary retention might be a relatively rare occurrence in children compared to adults. Also, age-
related differences in etiology, risk factors, and management of postoperative urinary retention might differ 
between adults and children due to anatomical, physiological, and developmental variations. 
 
3.2 
Are the participants:- (more than one may apply) 
 
 
– 
in a teacher–student relationship with the researchers or their associates? 
 
 
 
 
Y 
 
– 
in an employer–employee relationship with the researchers or their associates?  
 
 
 
Y 
 
– 
in any other dependent relationship with the researchers or their associates? 
 
 
 
 
Y 
 
– 
prisoners? 
 
 
 
 
Y 
 
– 
refugees? 
 
 
 
 
Y 
 
– 
members of the security services? 
 
 

REC OFFICE USE 
HUMAN RESEARCH 
ETHICS COMMITTEE No 
 
 
Date Received  
 
Institute/Centre/Faculty  
 
Campus 
 
 
Master’s project 
 
Grants Awarded 
 
Small Grants Awarded 
 
General 
 
Clinical Trials 
 
               
Al-Quds University 
Research Ethics committee (REC) 
Application Form 
Ethics Research Committee, Al-Quds University 
 Application Form December 2012 Page 16 
 
 
Y 
 
– 
mentally ill? 
 
 
 
 
Y 
 
– 
intellectually impaired?  
 
 
 
 
Y 
 
– 
unconscious or critically ill patients? 
 
 
 
 
Y 
 
– 
in a doctor–patient relationship or a health giver–receiver relationship 
 
 ☑ 
with the researchers or their associates? 
 
Y 
 
 
 
 
If you answered YES to any of the above, provide details. 
 
3.3 
(a) 
What is the sample size for the study? Comment on how this sample size will allow the aims 
of the study to be achieved. 
 
 
 
 
The target sample will be about 1084 patients. The sample size was calculated by a power analysis based on the 
expected effect size and significance level. This allows for a reduction of bias and provides a precise relationship 
between an intervention and the outcome. 
3.4 
Will participants receive any reimbursement  
☑ 
 
 
 
N 
 
Y 
 
 
 
If you answered YES, what is the amount or nature of the reward and the justification for this? 
 
 
 

REC OFFICE USE 
HUMAN RESEARCH 
ETHICS COMMITTEE No 
 
 
Date Received  
 
Institute/Centre/Faculty  
 
Campus 
 
 
Master’s project 
 
Grants Awarded 
 
Small Grants Awarded 
 
General 
 
Clinical Trials 
 
               
Al-Quds University 
Research Ethics committee (REC) 
Application Form 
Ethics Research Committee, Al-Quds University 
 Application Form December 2012 Page 17 
Proceed to section 4 
 
SECTION 4: PRIVACY 
 
 
 
4.1 
Is there a requirement for the researchers to identify, collect, use, or disclose information of a 
personal nature (either identifiable or potentially identifiable) about individuals without their 
consent? 
 
 
 
☑ 
 
 
 
N 
 
Y 
If you answered YES, state what information will be sought and how many records will be accessed. 
 
 
 
 
 
IF YOU ANSWERED NO, YOU DO NOT NEED TO COMPLETE ANY MORE OF SECTION 4. GO TO SECTION 
5 
Please provide details 
 
 
 
 
 
Proceed to Section 5. 
 
SECTION 5: COLLECTION OF DATA  
 

REC OFFICE USE 
HUMAN RESEARCH 
ETHICS COMMITTEE No 
 
 
Date Received  
 
Institute/Centre/Faculty  
 
Campus 
 
 
Master’s project 
 
Grants Awarded 
 
Small Grants Awarded 
 
General 
 
Clinical Trials 
 
               
Al-Quds University 
Research Ethics committee (REC) 
Application Form 
Ethics Research Committee, Al-Quds University 
 Application Form December 2012 Page 18 
 
 
5.1 
Will any part of the study involve recordings using audio tape, film/video, 
☑ 
 
 
 
or other electronic medium ? 
N 
 
Y 
 
 
If you answered YES, what is the medium and how it will be used? 
 
 
 
 
5.2 
Does your research involve the secretive use of photographs, tape-recordings, 
☑ 
 
 
 
or any other form of record-taking? 
N 
 
Y 
 
 
 
If you answered YES, provide details and a justification for the secrecy. 
 
 
 
5.3 
(a) 
How will the results of the study be disseminated (e.g. via publication in journals and  
presentations in scientific meetings)? 
 
The results will be published in a journal, and shared in conferences. 
 
 
 
5.4 
How will the confidentiality of the data, including the identity of participants, be ensured during 
collection and dissemination? 

REC OFFICE USE 
HUMAN RESEARCH 
ETHICS COMMITTEE No 
 
 
Date Received  
 
Institute/Centre/Faculty  
 
Campus 
 
 
Master’s project 
 
Grants Awarded 
 
Small Grants Awarded 
 
General 
 
Clinical Trials 
 
               
Al-Quds University 
Research Ethics committee (REC) 
Application Form 
Ethics Research Committee, Al-Quds University 
 Application Form December 2012 Page 19 
 
 
- Participants will be asked some questions after the surgery, no collection of their name or address will be done.  
- Participants' file number will not be shared with the data or the research results. 
 
 
5.5 
(a) 
What is the proposed storage location of, and access to, materials collected during the 
study (including files, audiotapes, questionnaires, videotapes, photographs)? 
 
 
 
Please cross (X) the appropriate box: 
 
 
Principal investigator’s Office 
Room No. 
 
Building   
 
Faculty / Departmental Office 
Room No. 
 
Building   
X 
Other (Please provide details below) 
 
 
 
 
 
A shared Google drive by authors 
 
(b) 
On completion of the study, where will the materials that were collected during the study 
(including files, audiotapes, questionnaires, videotapes, photographs) be stored? 
 
Please cross (X) the appropriate box: 
 
 
Principal Investigator’s Office 
Room No. 
 
Building   
 
Faculty / Departmental Office 
Room No. 
 
Building  
X 
Other (Please provide details below) 
 
 
 
 
 
A shared Google drive by authors 
 
 
 
 
 

REC OFFICE USE 
HUMAN RESEARCH 
ETHICS COMMITTEE No 
 
 
Date Received  
 
Institute/Centre/Faculty  
 
Campus 
 
 
Master’s project 
 
Grants Awarded 
 
Small Grants Awarded 
 
General 
 
Clinical Trials 
 
               
Al-Quds University 
Research Ethics committee (REC) 
Application Form 
Ethics Research Committee, Al-Quds University 
 Application Form December 2012 Page 20 
 
SECTION 6: ASSESSMENT OF RISKS 
 
6.1 Indicate if the participants might experience any of the following: 
 
Risk of physical harm (e.g., falling, muscle pain)  
 
 
      Y  
   
Physical discomfort (e.g., tiredness, weakness, nausea) 
 
      Y  
   
 
Risk of psychological or emotional harm (e.g., trauma) 
 
      Y  
   
 
Psychological or emotional discomfort (e.g., anxiety, stress, loss of confidence, regret for disclosing personal  
information)  
 
      Y  
   
 
Legal repercussions for participating in the study (e.g., possibility of being sued, charged with criminal activity) 
 
      Y  
   
 
6.2  POTENTIAL RISK TO PARTICIPANTS AND RISK MANAGEMENT PROCEDURES  
 
Identify, as far as possible, all potential risks to participants (e.g. physical, psychological, social, legal or 
economic), associated with the proposed research. Please explain what risk management procedures will 
be put in place. 
 
 
- No potential risks. 
- Any patient who is expected to develop drug-related complications will be excluded from the 
study. 
 
 
6.3 ARE THERE ANY SPECIFIC RISKS TO RESEARCHERS THAT ARE GREATER THAN THOSE 
ENCOUNTERED IN NORMAL DAY TO DAY LIFE?  

REC OFFICE USE 
HUMAN RESEARCH 
ETHICS COMMITTEE No 
 
 
Date Received  
 
Institute/Centre/Faculty  
 
Campus 
 
 
Master’s project 
 
Grants Awarded 
 
Small Grants Awarded 
 
General 
 
Clinical Trials 
 
               
Al-Quds University 
Research Ethics committee (REC) 
Application Form 
Ethics Research Committee, Al-Quds University 
 Application Form December 2012 Page 21 
 
 
 
 
 
 
End of the application 
 
 
 
 
☐ 
YES 
☑ 
NO 
(If YES, please describe.)