Masters Research Ethics

Application Form

Version February 2024

Please open this form in Adobe Acrobat Reader

ethics.arpb@its.edu.mt

Information for applicants

External to ITS entities submitting a survey/research request to ITS for approval to hold their survey/research within the Institute are required to submit this application to ethics.arpb@its.edu.mt for ethical clearance. The ARPB Ethics committee (REC) will seek to process the application within 10 days of its receipt excluding the recesses and national/ public holidays as per ITS Academic Calendar.

Please make sure to tick ALL the items. Incomplete forms will not be accepted.

YES	NOT NEEDED
1a.	Recruitment letter/ information sheet for subjects, in English	x
1b.	Recruitment letter/ information sheet for subjects, in Maltese	x
2a.	Consent form, in English, signed by interviewee and including interviewer contact details	x
2b.	Consent form, in Maltese, signed by interviewee and including interviewer contact details	x
3a.	In the case of children or other vulnerable groups, consent forms for parents/ guardians, in English
3b.	In the case of children or other vulnerable groups, consent forms for parents/ guardians, in Maltese
4a.	Tests, questionnaires, interview or focus group questions, etc, in English	x
4b.	Tests, questionnaires, interview or focus group questions, etc in Maltese
5a.	Other institutional approval for access to subjects: Health Division, Directorate for Quality and Standards in Education, Department of Public Health, Curia…
5b.	Other institutional approval for access of data: Registrar, Data Protection Officer Health Division/ Hospital, Directorate for Quality and Standards in Education, Department of Public Health…
5c.	Approval from Person Directly responsible for subjects: Medical Consultants, Nursing Officers, Head of School

For ARPB Use Only:

Received by ARPB
Discussed by ARPB Research Ethics Committee on
Approved by ARPB Research Ethics Committee on

Request for Approval of Human Subjects Research

Please type. Handwritten forms will not be accepted.

FROM: (name, address for correspondence)	Research title:
MOBILE NO.
EMAIL:.
COURSE AND YEAR: .
DURATION OF RESEARCH: From: To:

Please give a brief summary of the research methodology and why it includes human subjects. Survey – includes human Interviews – sub objective 2 Observation – Central research question and subjective 1
2. Give details of procedures that relate to subjects’ participation: (a) How are subjects recruited? What inducement is offered? (Append copy of letter or advertisement or poster, if any.)
(b) Salient characteristics of subjects – number of participants, age range, sex, institutional affiliation, other special criteria: Survey – Interviews – Observation – Focus group –

2.(c) Describe how permission has been obtained from cooperating institution(s) – company, school, hospital, non-profit organisation, and other relevant organization (append letters).
2.(d) What are the participants expected to do? What information is gathered? (Append copies of instructions or tests or questionnaires) How many times will observations, test, etc., be conducted? How long will their participation take? Survey to answer
(e) Which of the following data categories are collected? Please tick where appropriate. None of the data below will be revealed. Race and ethnic origin Political opinions Religious and philosophical beliefs Trade union memberships Health Sex life Biological information Data that reveals:

3. How do you explain the research to participants and obtain their informed consent to participate? (If in writing, append a copy of consent form.) If subjects are minors, mentally infirm, or otherwise not legally competent to consent to participation, how is their assent obtained and from whom is proxy consent obtained? How is it made clear to subjects that they can quit the study at any time?
4. Do subjects risk any harm – physical/ psychological/ legal/ social – by participating in the research? Are the risks necessary? What safeguards do you take to minimize the risks?
5. Are subjects deliberately deceived in any way? If so, what is the nature of the deception? Is it likely to be significant to subjects? Is there any other way to conduct the research that would not involve deception, and, if so, why have you not chosen that alternative? What explanation for the deception do you give to subjects following their participation? My participants are not going to be deceived in any wayfgfhvnjkkldf
6. How will participation in this research benefit subjects? If subjects will be ‘debriefed’ or receive information about the research project following its conclusion, how do you ensure the educational value of the process? (Include copies of any debriefing or educational materials)

TERMS AND CONDITIONS FOR APPROVAL IN TERMS OF THE DATA PROTECTION ACT Personal data shall only be collected and processed for the specific research purpose. The data shall be adequate, relevant and not excessive in relation to the processing purpose. All reasonable measures shall be taken to ensure the correctness of personal data Personal data shall not be disclosed to third parties and may only be required by the University or the Supervisor for verification purposes. All necessary measures shall be implemented to ensure confidentiality and where possible, data shall be anonymized. Unless otherwise authorized by the ITS Research Ethics Committee, the researcher shall obtain the consent from the data subject (respondent) and provide him with the following information: The researcher’s identity and habitual residence, the purpose of processing and the recipients to whom personal data may be disclosed. The data subject shall also be informed about his rights to access, rectify, and where applicable erase the data concerning him. I, the undersigned hereby undertake to abide by the terms and conditions for approval as attached to this application. I, the undersigned, also give my consent to the ITS ARPB Research Ethics Committee to process my personal data for the purpose of evaluating my request and other matters related to this application. I also understand that I can request in writing a copy of my personal information. I shall also request rectification, blocking or erasure of such personal data that has not been processed in accordance with the Act.

APPLICANT’S SIGNATURE: I hereby declare that I will not start my research on human subjects before approval	TUTOR’S SIGNATURE I have reviewed this completed application and I am satisfied with the adequacy of the proposal
DATE	DATE

To be completed by the ARPB Research Ethics Committee We have examined the above proposal and advise Acceptance Refusal Conditional Acceptance For the following reason/s: Name/s and Surname/s of ARPB Research Ethics Committee Representative/s: Signature/s : Date: