About the ethics research

http://www.who.int/ethics/research/en/

REAF-G- Version 1.0

Unicaf University Research Ethics application Forms Guidelines

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UNICAF UNIVERSITY

RESEARCH ETHICS APPLICATION FORMS GUIDELINES

Contents General Information ........................................................................................................................................................... 2

A. REAF Form Completion Guidelines ......................................................................................................................... 3

Personal information ...................................................................................................................................................... 3

1. External Research Funding (if applicable): .......................................................................................................... 3

2. The research project .............................................................................................................................................. 3

3. Project Execution .................................................................................................................................................. 3

4. Participants ........................................................................................................................................................... 4

5. Potential Risks of the Proposed Research Study. ................................................................................................. 5

6. Further Approvals ................................................................................................................................................. 8

7. Data collection and management (storage, access and disposal of research data) ................................................ 8

8. Reporting of results ............................................................................................................................................... 8

9. Application Checklist ........................................................................................................................................... 8

10. Further documents ............................................................................................................................................ 8

11. Final Declaration by Applicants ....................................................................................................................... 8

B. Informed Consent Form ............................................................................................................................................ 9

C. Guardian Informed Consent Form .......................................................................................................................... 10

D. Gatekeeper Letter Guidelines .................................................................................................................................. 11

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General Information

The Research Ethics Application Form (REAF) should be completed by:

• Bachelor’s students undertaking undergraduate final year projects requiring relevant ethics review and consideration.

• Master’s students in academic programmes with research based dissertation / project modules.

Important Notes:

• For students at all levels, an electronic version of the completed form should be uploaded to the relevant submission link in the VLE. Your supervisor will then review this and provide

feedback commentary. Once initial approval is given, then the supervisor will forward this on,

for final approval by the Unicaf University Research Ethics Committee (UREC).

• Please type your application and do not submit paper copy scans. Only PDF or Word format documents should be submitted to the Committee.

• If you need to supply any supplementary material, not specifically requested by the application form, please do so in a separate file. Any additional document(s) should be clearly labelled and

uploaded in the relevant VLE link.

• If you have any queries completing the form, please address them to your project supervisor.

This document provides information and guidelines to be followed during the completion of the

form. A short description of the information to be included in each section will be provided

below.

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A. REAF Form Completion Guidelines

Personal information

This section requires student’s and supervisor’s personal information. The student/researcher should

use the drop-down lists to choose the university and pathway s/he is enrolled in.

1. External Research Funding (if applicable):

a. If you have external funding for your research, answer YES and answer the questions 1b and 1c.

b. Please list any external (third party) sources of funding you plan to utilise for your project. You need to include full details on the source of funds (e.g. state, private or individual

sponsor), any prior / existing or future relationships between the funding body / sponsor and

any of the principal investigator(s) or co-investigator(s) or student researcher(s), status and

timeline of the application and any conditions attached.

c. If there are any perceived ethical issues or potential conflicts of interest arising from applying for and receiving external funding for the proposed research then these need to be fully

disclosed below and also further elaborated on, in the relevant sections on ethical

considerations later on in this form.

2. The research project

This section has two subsections, namely a. Project Summary and b. Significance of the Proposed

Research Study and Potential Benefits.

a. Project Summary

In this section please fully describe the purpose and underlying rationale for the proposed research

project. Ensure that you pose the research questions to be examined, state the hypotheses, and

discuss the expected results of your research and their potential.

It is important in your description to use plain language so it can be understood by all members of

the UREC, especially those who are not necessarily experts in the particular discipline. To that

effect please ensure that you fully explain / define any technical terms or discipline-specific

terminology. Please note that there is a word limit of 300 words (+/- 10%).

b. Provide details of the research setting (i.e. school, company) and location at which you will apply your research project (maximum 200 words).

Describe where the research is going to take place. If it is a company/school and in which

geographical area you will conduct your research project.

3. Project Execution

This section focuses on the description of the specifics of the research project. This involves the

description of whether the study is experimental, desktop study etc. and defines which method(s) is

to be employed for data collection.

a. Type of project

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Under point 4.a. students should choose only one option out of the four provided options. To be

precise students should indicate whether the research project is:

- An experimental study hence, involves primary research. Primary research assumes the participation of human individuals in the study. Participants may, among others, complete a

questionnaire, participate in an interview or both. As a result, primary research aims at

generating data which are later on analysed.

- A desktop study hence, involves secondary research (secondary refers to published work). Secondary research assumes that the research conducted is a summary, collation and/or

synthesis of existing research. It does not involve the generation of data but it uses primary

research as a source for data analysis.

- A desktop study using existing databases involving information of human/animal subjects. This type of desktop study is characterised as a secondary research despite the (meta)analysis

of primary data by accessing existing databases as the data analysed have been collected by

other researchers.

In the case that none of the three options above are suitable the student is advised to choose the final

option ‘Other’ and indicate briefly what will the study involve.

b. Methods

In point 4b. students have to choose which method (qualitative and/or quantitative) will be used.

After defining which method will be followed the tools/materials to be used should also be defined.

Students may choose more than one option here as multiple methods and/or tools/materials may be

used in order to achieve triangulation of data.

In the case that none of the options provided are suitable the student is advised to choose the final

option ‘Other’ and indicate briefly what will the study involve.

c. Describe how you will analyse your data

Please indicate the way you plan to analyse your data. To be precise specify whether a statistical

software will be used and refer to the methods followed (maximum 200 words).

d. Describe the expected results of your research project

In this section please describe what the expected outcome of the research project. Specify what

answers you expect to find to your research questions (maximum 150 words).

4. Participants

Information on potential participants should be provided in this section. The definition of

“participation” includes active participation, such as when participants knowingly take part in an

interview or complete a questionnaire.

a. Participants recruitment

If participants are taking part in the research project Question 4a. should be ticked as ‘Yes’ and all

other relevant information should be listed under Question 4b. If you have answered NO please

proceed directly to Question 8.

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b. Participant details

Information provided in this section should refer to the number of participants involved, their age

range and gender. Also, information related to inclusion and exclusion criteria should be provided.

In the case of a case study it should be specified under the inclusion criteria which restrictions will

apply. If a research project studies topic X in private education in Cyprus then under inclusion criteria

the following information should be provided:

i. Participants are from Cyprus ii. Participants are owners of institutions within private education sector etc.

Exclusion criteria may refer to participants being below 80 years old.

Further information on participants’ disabilities if any should also be provided under the relevant

section. Any learning, mobility, language and/or any other disability should be mentioned here as

this may render the research a ‘high risk’ study due to the vulnerability of the participants.

c. Recruitment process

In this section students should describe how the potential participants will be identified, approached

and recruited. That is, it should be indicated whether the researcher will contact the participants face

to face to ask them to participate in the study or whether an email will be sent. If an email will be

sent it should be defined where the researcher will find participant’s information (email account).

Please note that there is a word limit of 200 words.

d. Research Participants Informed Consent

Select below which categories of participants will participate in the study. Complete the relevant

Informed Consent form and submit it along with the REAF form.

Informed Consent Form is completed by Typically Developing population(s) above the maturity

age*

Guardian Informed Consent Form is completed by the legal guardian (i.e. parent) of any participant

who:

1. is under maturity age*. 2. is mentally impaired therefore is not able to provide his/her own consent irrespective of

the age (please refer to Question 5).

*Maturity age is defined by national regulations in laws of the country in which the research is being

conducted.

e. Relationship between the principal investigator and participants

A description of the relationship between the principal investigator and participants should be clearly

defined. For example, if you are conducting research in a school environment on students in your

classroom (e.g. instructor-student) or asking employees of your own company to complete

questionnaires on leadership styles (e.g. employer - employee).

If there is a relationship between the principal investigator and participants, answer YES and specify in the box (maximum 100 words).

5. Potential Risks of the Proposed Research Study.

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The purpose of this section is to identify the hazards and associated risks related to the research

activities which are carried out for the purpose of research project/dissertations.

It is important that researchers consider what hazards -the potential of harm- may arise in the course

of their research activities both of their own safety and for the safety of their participants. Then

researchers should consider the measures required to reduce the level of risk -the probability of that

harms occurring within a defined time interval and the severity of its consequences- posed by these

hazards to safeguard health and safety.

Potential risks, psychological harm and/or ethical issues associated with the proposed research study,

other than risks pertaining to everyday life events, such as the risk of a road accident when travelling

to a remote location for data collection, should be provided in this section.

In order to be able to provide the correct information researchers should be familiarised with the

following definitions:

- Risk Assessment: The process of deciding on actions to be taken to reduce risk to an acceptable level, preferably, “low” or “high” through the implementation of control measures /

procedures. Risk Assessment involves consideration of physical and psychological risks

along with the protection of privacy. The student / researcher must develop procedures that

reduce and minimize any risks to human participants.

- Risk Rating: the simplest form of risk assessment is to rate risk as “low” or “high”, depending on how likely the activity is to cause harm and how serious that harm might be.

- Low Risk: Harm arises under controlled conditions. Low risk activities show that you have correctly identified a hazard, but that in the particular circumstances, the risk is insignificant.

No more than minimal risk is greater than what is typically encountered in everyday life.

Low Risk research activities do not involve:

o Those who are considered vulnerable (persons who are incapable of protecting their own interests):

▪ Children under 18. ▪ Persons who have relative or absolute impairments in decisional capacity,

education, resources, strength, or other attributes needed to protect their own

interests.

▪ People who are marginalized, stigmatized, or face social exclusion or prejudice that increases the likelihood that others place their interests at risk,

whether intentionally or unintentionally.

▪ Individuals in hierarchical relationships. ▪ Institutionalized persons. ▪ Women under specific circumstances: e.g. studies with female or transsexual

sex workers; research on sexual and intimate partner violence; studies with

trafficked women, refugees and asylum seekers.

▪ People living with special needs. ▪ Homeless persons, nomads, refugees or displaced persons. ▪ People with incurable or stigmatized conditions or diseases. ▪ People faced with physical frailty, for example, because of age and co-

morbidities.

▪ Individuals who are politically powerless. ▪ Members of communities unfamiliar with modern medical concepts. ▪ All research with children and young people under 18 covered by this Risk

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Assessment is carried out in the presence of a parent, legal guardian or a

professional with a duty of care in a professional setting with children and/or

young people. Parental/legal guardian or carer consent should be taken prior

to undertaking the research; these forms will be completed at a later stage.

o Significant psychological stress or anxiety, or humiliation (make someone feel ashamed and foolish by injuring their dignity and pride) or cause of more than fleeting

harm / negative consequences beyond the risks encountered in the normal life of

participants.

o Discussion of a sensitive or controversial topic in an interview that has potential to cause distress to participants because it delves into personal histories or traumatic

experiences and provokes strong feelings in respondents.

o administration of drugs, placebos or other substances as part of this study. o Intervention procedures that are used for diagnosis or treatment. o Offer any financial inducement to participate in this study. o Serving prisoners or serving young offenders. o Deception, coercion or manipulation of behaviour.

- High Risk: More than minimal risk exists when the possibility of physical or psychological harm or harm related to breach of confidentiality or invasion of privacy is greater than what

it typically encountered in everyday life.

Unicaf University follows the international guidelines for research with human participants, as

prepared by CIOMS (Council for International Organizations of Medical Sciences) in collaboration

with the World Health Organization (WHO). The document, International Ethical Guidelines for

Health-related Research Involving Humans, Geneva (2016), indicates how the ethical principles set

forth in the Declaration of Helsinki of the World Medical Association could be effectively applied,

particularly in low-resource settings: https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-

EthicalGuidelines.pdf

Note: Participants’ identity/data will be considered confidential if an assigned ID code or number is

used, but it will not be anonymous. Anonymous data are defined as those which cannot be in any

way traced back to an individual participant.

a. Please indicate if there are any potential risks, psychological harm and/or ethical issues associated with the proposed research study, other than risks pertaining to everyday life

events (such as the risk of an accident when travelling to a remote location for data

collection)?

If there are any potential risks, psychological harm and/or ethical issues associated with the proposed

research study point 5a should be ticked as ‘Yes’ and all other relevant information should be

specified (maximum 150 words).

b. Please choose the appropriate option

Please answer YES or NO to the questions i-x and provide additional information.

c. Are there any other ethical issues associated with the proposed research study that are not already adequately covered in the preceding sections?

If there are any other ethical issues please describe in the box (maximum 150 words).

d. Please indicate the Risk Rating.

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Risk rating of the Proposed Research Study is indicated as High or Low.

6. Further Approvals

At this point information of any other approval needed, other than the ethics clearance from UREC,

should be provided. If any kind of institutional permission (e.g. school principal or company director)

or approval from a local ethics or professional regulatory body is required should be included here.

All researchers are advised to check the regulations pertaining to research and General Data

Protection Regulation (GDPR) of the country in which the research will take place as each country

may have different restrictions on conducting research. If your answer is YES, please provide more information (maximum 100 words).

7. Data collection and management (storage, access and disposal of research data)

Please mark all the points that apply from the list. The list indicates how the collected research data

will be stored, accessed and disposed.

8. Reporting of results

a. Will the project outcomes be made public at the end of the project?

At this point if you answered YES, describe the intended report and how and who will have access

to the report. If you answered NO, explain why the project outcome will not be made public

(maximum 250 words).

b. Will report(s) of the project outcomes be made available to participants at the end of the project?

If participants will have access to the project outcomes, answer YES and describe the intended report

and how it will be made available. If you answered NO, explain the reason why it will not be available

to participants (maximum 250 words).

9. Application Checklist

All research students should read carefully the points listed under Question 9 and tick which ones

apply to his/her research.

10. Further documents

Check from the list below which documents are applicable to your Research Project and make sure

you complete and submit them with your application.

11. Final Declaration by Applicants

It is strongly advised that all research students read carefully all points under the final declaration

and sign that they agree with all points mentioned.

After printing student’s name and as this is a student application it should be submitted via the

relevant link in the VLE. Please submit only electronically filled in copies; do not hand fill and submit

scanned paper copies of this application.

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B. Informed Consent Form

Part 1: Debriefing of Participants This section requires student’s and supervisor’s personal information. The student should use the

drop-down lists to choose the university and type the program of study s/he is enrolled in. Write your

Research Project Title and the date below.

Provide a short description (purpose, aim and significance) of the research project, and explain why

and how you have chosen this person to participate in this research. Please note that there is a word

limit of 150 words.

The student should sign the form at the bottom of page 1.

Please note that the copy of Part 1: Debriefing of Participants should be given to the Participant.

Part 2: Certificate of Consent

The section with personal information will be filled up for you if you completed Part 1 of the Form.

Fill up the box with Participant’s Print name and Date. The participant should sign the form.

If a Participant is illiterate, the Witness’s name and signature is required.

Please note that the copy of Part 2: Certificate of Consent should be collected and retained for

archiving purposes.

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C. Guardian Informed Consent Form Part 1: Debriefing of Participants

This section requires student’s and supervisor’s personal information. The student/researcher should

use the drop-down lists to choose the university and type the program of study s/he is enrolled in.

Write your Research Project Title and the date below.

Provide a short description (purpose, aim and significance) of the research project, and explain why

and how you have chosen this person to participate in this research. Please note that there is a word

limit of 150 words.

The student should sign the form at the bottom of page 1.

Please note that the copy of Part 1: Debriefing of Participants should be given to the legal guardian

of the participant.

Part 2: Certificate of Consent

This section is mandatory and should to be signed by the participant’s legal guardian.

The section with personal information will be filled up for you if you completed Part 1 of the Form.

Type the names of legal guardian and name of participant in the fields as follow: I, (name of legal guardian) the legal guardian of (name of participant) allow and provide consent

that (name of participant) can willingly participate in the study.

I, (name of legal guardian), the legal guardian of (name of participant) have been ensured that

verbal consent given by (name of participant) will also be taken before the study.

Legal guardian – the parent of the participant or a professional with a duty of care in a professional

setting with children and/or young people.

Please note that the copy of Part 2: Certificate of Consent should be collected and retained for

archiving purposes.

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D. Gatekeeper Letter Guidelines

Follow the structure of the form and provide relevant information for each section.

• Student’s and Supervisor’s personal information. • Project / research topic and area • Research Project description • Describe what would be required of the person, for example, sending an e-mail on your behalf,

allowing you to recruit on their premises, giving you access to personal data after participants

have consented, allow children to complete experiments during school hours etc. Include the

estimated time for the engagement of this person.

UU_GIC_Guardian Inform Consent Form.pdf