IBN SINA NATIONAL COLLEGE FOR MEDICAL STUDIES

JEDDAH, KINGDOM OF SAUDI ARABIA

RESEARCH CENTER

APPLICATION FOR HUMAN ETHICS COMMITTEE APPROVAL

(Please attach research proposal along with this form)

  1. Applicant Details

A.1 / Principal Researcher/investigator
Name
ID number
Program
Department
Contact email
Contact number / Choose oneMedicine ProgramClinical Pharmacy ProgramDentistry ProgramNursing Program
A.2 / Co-investigator/s
No. / Name / Participation type / Program/ Department / Designation / Contact details
1 / Co-investigator Research assistant
2 / Co-investigator Research assistant
3 / Co-investigator Research assistant
4 / Co-investigator Research assistant
5 / Co-investigator Research assistant
  1. Project overview

B.1 / Title of the Research Project
B.2 / Project summary
B.3 / Expected location of study / Choose an item. /
B.4 / Funding source / Choose an item. /
B.5 / If your answer was others to the previous, please specify(name, address etc.)
B.6 / List any other individuals or organizations supporting/enabling the project
B.7 / Expected start date
Expected finish date
  1. Methodology

5 / Address and other details of Sponsorship, If any (Government/Private)
6 / Contact Address of Sponsor
7 / Total Budget
8 / Who will bear the cost of investigation/implants/ drugs
9 / Type of Study : Cross sectional/ case control/ cohort/ Clinical Trial Review
10 / Participating Centre : Single center/ Multi-centric/ Others
11 / Does the study involve use of :
Drugs/ Devices/ Vaccines/ drugs from traditional and Alternate Systems of Medicine/ Any other
12 / Is it approved and marketed
In Saudi Arabia, Europe USA
Other countries, specify
13 / Does it involve a change in use, dosage, route of administration?
14 / In vitro studies data
15 / Preclinical Studies done? Provide data
16 / Are you aware if this study/similar
study is being done elsewhere
17 / Brief description of the proposal – Introduction, review of literature, aim& objectives, justification for study, methodology describing the potential risks and benefits, outcome measures, statistical analysis (500 words, attach a separate sheet)
18 / Number of subjects
19 / Duration of study
20 / Will subjects from both sexes be recruited?
21 / Inclusion and exclusion criteria
22 / Type of subjects Volunteers/ Patients
23 / Privacy and confidentiality
24 / Use of biological/genetic/ hazardous materials
25 / Use of organs or body fluids
26 / Use of ionizing radiation/radioisotopes
27 / Will any sample collected from the patients be sent abroad?
If Yes, justify with details of collaborators
28 / Details of Participant Information Sheet and Consent form? Please attach the form in both Arabic and English
29 / Is the risk reasonable compared to the anticipated benefits?
30 / Is there any physical / social / psychological risk / discomfort?
31 / Is there compensation for participation in the study/in case of adverse effects/toxic effects
32 / Is there compensation for injury? If Yes, by Sponsor or by Investigator or by insurance or by any other
Company? Provide details.

Declaration by Investigator/Investigators

  1. I/We agree to the rules and regulations of the college/department/ethics committee.
  2. I/We agree and understand the guidelines of “National committee of bio and medical ethics”(1434H- 2013) published by King Abdulaziz City for Science & Technology, Kingdom of Saudi Arabia.

S. No / Applicant / Name / Signature and date
1 / Principal investigator
2 / Co-Investigator
3 / Co-Investigator

CHECKLIST FOR ATTACHED DOCUMENTS

Attachments / Yes/No
Project proposal
CV of Investigators
Patient information sheet and Informed Consent form
Investigator’s brochure for recruiting subjects
Definite undertaking as to who will bear the expenditure of injury related to the project. In case an insurance cover is intended, Insurance certificate must be provided

For office use only

Date of application received:

Signature of recipient:

Risk Assessment Tool

The Risk assessment Tool should be used by all students and staff members at ISNC to determine whether or not their project is high risk or low risk.

If the answer is ‘YES’ to any question on the Risk Checklist below, your study is deemed to be of high risk level.

If you answer ‘NO’ to all questions on the Risk Checklist, your study is deemed to be of low risk level.

Note:

1. This document should be used as a tool to determine the risk level of your proposed study, a SIGNED COPY TO BE SUBMITTED as part of your application.

2. The Risk Checklist Tool guidelines DOES NOTneed to be submitted as part of your application.

Please refer to guidance notes for each question to assist you in answering the questions in the most appropriate manner.

Yes / No
A / Does the study involve participants who are particularly vulnerable or unable to give informed consent or in a dependent position (e.g. vulnerable children, your own students, over-researched groups, people with learning difficulties, people with mental health problems, young offenders, and people in care facilities, including prisons)?
B / Will participants be asked to take part in the study without their consent or knowledge at the time or will deception of any sort be involved (e.g. covert observation of people in non-public places)?
C / Is there a risk that the highly sensitive nature of the research topic might lead to disclosures from the participant concerning their own involvement in illegal activities or other activities that represent a threat to themselves or others (e.g. drug use, or professional misconduct)?
D / Could the study induce psychological stress or anxiety, or produce humiliation or cause harm or negative consequences beyond the risks encountered in normal life?
E / Does the study involve imaging techniques such as MRI scans or ultrasound?
F / Does the study involve sources of non-ionising radiation (e.g. lasers)?
G / Does the study involve physically intrusive procedures, use of bodily materials, or DNA/RNA analysis? (see guidelines for more details)
If ‘Yes’ to question G, continue below.
Yes / No
G1: / Does the study involve the use or collection of bodily materials or tissue from a human being?
G2: / Does the study involve DNA or RNA analysis of any kind?
G3: / Are substances or products to be administered (such as non-food substances or drugs)?
G4: / Does the study involve only moderately intrusive procedures (taking less than 40ml blood, collecting bodily waste, cheek swabs)?
G5: / Are invasive, intrusive or potentially harmful procedures not already covered by items G1 – G4 to be used in this study?

Name of the Applicant:

Signature of applicant:

Date: